Drug delivery device sensing modules

CROSS REFERENCE TO RELATED APPLICATIONS

0001The present application claims priority to U.S. Prov. Pat. App. No. 62/934,607 entitled “Drug Delivery Device Sensing Modules” filed Nov. 13, 2019, which is hereby incorporated by reference in its entirety.

FIELD

0002The present disclosure relates generally to drug delivery device sensing modules.

BACKGROUND

0003Pharmaceutical products (including large and small molecule pharmaceuticals, hereinafter “drugs”) are administered to patients in a variety of different ways for the treatment of specific medical indications. Regardless of the manner of the administration, care must be taken when administering drugs to avoid adverse effects on the patient. For example, care must be taken not to administer more than a safe amount of the drug to the patient. This requires consideration of the amount of dose given and the time frame over which the dose is delivered, sometimes in relation to previous doses, or doses of other drugs. Moreover, care must be taken not to inadvertently administer an incorrect drug to the patient, or drugs that have degraded due to their age or storage conditions. All of these considerations can be conveyed in guidance associated with the specific drugs or drug combinations. However, this guidance is not always followed correctly, for example due to mistakes, such as human error. This can lead to adverse effects on the patient or result in inappropriate drug administration, for example insufficient or excessive volume of drug being administered for the specific medical indication.

0004In relation to how a drug is administered to the patient, there are various dosage forms that can be used. For example, these dosage forms may include parenteral, pulmonary, oral, ophthalmic, topical and suppository forms of one or more drugs.

0005The dosage forms can be administered directly to the patient via a drug administration device. There are a number of different types of drug administration devices commonly available for delivery of the various dosage forms including: syringes, topical dispensers, nasal delivery devices, injection devices (e.g., autoinjectors, jet injectors, and infusion pumps), and inhalers.

0006It can be desirable to monitor compliance with the guidance that is associated with the drugs that are administered to a patient in various dosage forms. This can provide assurance that correct procedures are being followed and avoid the adoption of incorrect and potentially dangerous approaches. Further, this can also enable optimization of the administration of the drug to the patient.

0007However, it can be difficult to determine if a drug is properly administered to a patient via a drug administration device and to monitor compliance. The burden for detecting and for reporting proper drug administration is typically on the patient, which may burden the patient with administrative tasks and/or may not be properly or timely reported to a medical professional able to address improper drug administration in a timely manner. Similarly, the burden is typically on the patient for tracking and reporting compliance with the guidance provided to the patient by a physician or healthcare provider. Patients may feel uncomfortable reporting actions that do not comply with the guidance, thus resulting in inaccurate data being reported to and considered by a medical professional, which may adversely affect the patient's overall treatment.

0008Accordingly, there remains a need for monitoring drug administration.

SUMMARY

0009In general, drug delivery device sensing modules and methods of using drug delivery device sensing modules are provided.

0010In one aspect, a sensing module for a drug delivery device is provided herein. In one embodiment, the sensing module includes a base configured to be attached to an outer surface of a drug delivery device, and a sensor located on the base and configured to gather data regarding at least one of date, time, vibration, temperature, sound, motion, humidity, pressure, fluid level, force, location, proximity, and spatial orientation. The sensing module also includes a communication interface located on the base and configured to wirelessly transmit data to an external source, and a processor located on the base and configured to receive data from the sensor indicative of the gathered data and to cause the communication interface to wirelessly transmit data indicative of the received data to the external source.

0011The sensing module can vary in any number of ways. For example, the sensing module can also include a flexible circuit board with the sensor, the processor, and the communication interface thereon. For another example, the sensing module can also include a rigid circuit board with the sensor, the processor, and the communication interface thereon.

0012For yet another example, the base can include a housing with the sensor, the processor, and the communication interface disposed therein. In at least some embodiments, the sensing module can also include a circuit board with the sensor, the processor, and the communication interface thereon, and the circuit board can be disposed within the housing.

0013For another example, the base can include a thin-film device, and the sensing module can include an adhesive configured to attach the thin-film device to the outer surface of the drug delivery device. For yet another example, the base can be configured to be non-removably attached to the outer surface of the drug delivery device.

0014For still another example, the sensing module can also include a power source configured to provide power to at least one of the sensor, the processor, and the communication interface. In at least some embodiments, the sensing module can also include an insulator or a conductive trace. The insulator can be attached to the base in a first position, in which the insulator prevents the power source from providing the power to at least one of the sensor, the processor, and the communication interface. The insulator can be configured to be manually moved by a user from the first position to a second position, in which the insulator allows the power source to provide the power to at least one of the sensor, the processor, and the communication interface. The insulator can include a tab configured to be manually torn to move from the first position to the second position, and/or the sensing module can include a switch operatively connected to the power source and with the insulator in the first position the switch can be in an open position and with the insulator in the second position the switch can be in a closed position. The insulator can include a first tab, the sensing module can also include a second tab attached to the base in a third position, in which the sensor is not gathering the data, the second tab can be configured to be manually moved by a user from the third position to a fourth position, and the movement of the second tab from the third position to the fourth position can allow the sensor to begin gathering the data. The conductive trace can be configured to be manually moved by a user from a first position, in which the conductive trace prevents the power source from providing the power to at least one of the sensor, the processor, and the communication interface to a second position, in which the conductive trace allows the power source to provide the power to at least one of the sensor, the processor, and the communication interface. The conductive trace can be on a tab configured to be manually torn to move the conductive trace from the first position to the second position, and/or the sensing module can include a switch operatively connected to the power source and with the conductive trace in the first position the switch can be in an open position and with the conductive trace in the second position the switch can be in a closed position.

0015For another example, the sensor can include an accelerometer configured to gather data regarding vibration and spatial orientation. For still another example, the sensor can include a temperature sensor configured to gather data regarding temperature. For yet another example, the sensor can be configured to gather data regarding date, time, and at least one of vibration, temperature, sound, motion, humidity, pressure, fluid level, force, location, proximity, and spatial orientation. For another example, the drug delivery device can either be a drug delivery device containing a drug therein configured to be delivered from the drug delivery device or a drug delivery training device configured to simulate drug delivery therefrom.

0016In another aspect, a drug delivery system is provided that in one embodiment includes a drug delivery device, and a sensing module configured to be attached to an outer surface of the drug delivery device. The sensing module includes a sensor configured to gather data regarding at least one of date, time, vibration, temperature, sound, motion, humidity, pressure, fluid level, force, location, proximity, and spatial orientation, a communication interface configured to wirelessly transmit data to an external source, and a processor configured to receive data from the sensor indicative of the gathered data and to cause the communication interface to wirelessly transmit data indicative of the received data to the external source.

0017The system can vary in any number of ways. For example, the system can include a flexible circuit board with the sensor, the processor, and the communication interface thereon. For another example, the system can include a rigid circuit board with the sensor, the processor, and the communication interface thereon.

0018For yet another example, the sensing module can include a housing with the sensor, the processor, and the communication interface disposed therein, and the housing can be attached to the outer surface of the drug delivery device. In at least some embodiments, the sensing module can include a circuit board with the sensor, the processor, and the communication interface thereon, and the circuit board can be disposed within the housing.

0019For still another example, the sensing module can include a thin-film device, and the system can include an adhesive configured to attach the thin-film device to the outer surface of the drug delivery device. For another example, the sensing module can be non-removably attached to the outer surface of the drug delivery device.

0020For yet another example, the sensing module can include a power source configured to provide power to at least one of the sensor, the processor, and the communication interface. In at least some embodiments, the system can also include an insulator or a conductive trace. The insulator can be in a first position, in which the insulator prevents the power source from providing the power to at least one of the sensor, the processor, and the communication interface, and the insulator can be configured to be manually moved by a user from the first position to a second position, in which the insulator allows the power source to provide the power to at least one of the sensor, the processor, and the communication interface. The drug delivery device can include a cap configured to be manually removed by a user from a housing of the drug delivery device, and the removal of the cap can be configured to cause the insulator to automatically move from the first position to the second position. The drug delivery device can include a trigger configured to be manually actuated by a user to trigger drug delivery from the drug delivery device, and the actuation of the trigger can be configured to cause the insulator to automatically move from the first position to the second position. The insulator can include a tab configured to be manually torn to move from the first position to the second position. The system can include a switch operatively connected to the power source, and with the insulator in the first position the switch can be in an open position and with the insulator in the second position the switch can be in a closed position. The insulator can include a first tab, the system can also include a second tab attached to the base in a third position, in which the sensor is not gathering the data, the second tab can be configured to be manually moved by a user from the third position to a fourth position, and the movement of the second tab from the third position to the fourth position can allow the sensor to begin gathering the data. The conductive trace can be configured to be manually moved by a user from a first position, in which the conductive trace prevents the power source from providing the power to at least one of the sensor, the processor, and the communication interface to a second position, in which the conductive trace allows the power source to provide the power to at least one of the sensor, the processor, and the communication interface. In at least some embodiments, the drug delivery device can include a cap configured to be manually removed by a user from a housing of the drug delivery device, and the removal of the cap can be configured to cause the power source to begin providing power to the at least one of the sensor, the processor, and the communication interface. The drug delivery device can include a cap configured to be manually removed by a user from a housing of the drug delivery device, and the removal of the cap can be configured to cause the conductive trace to automatically move from the first position to the second position. The drug delivery device can include a trigger configured to be manually actuated by a user to trigger drug delivery from the drug delivery device, and the actuation of the trigger can be configured to cause the conductive trace to automatically move from the first position to the second position. The conductive trace can be on a tab configured to be manually torn to move from the first position to the second position. The system can include a switch operatively connected to the power source, and with the conductive trace in the first position the switch can be in an open position and with the insulator in the second position the switch can be in a closed position.

0021For still another example, the sensor can include an accelerometer configured to gather data regarding vibration and spatial orientation. For another example, the sensor can include a temperature sensor configured to gather data regarding temperature. For yet another example, the sensor can be configured to gather data regarding date, time, and at least one of vibration, temperature, sound, motion, humidity, pressure, fluid level, force, location, proximity, and spatial orientation. For still another example, the drug delivery device can either be a drug delivery device containing a drug therein configured to be delivered from the drug delivery device or a drug delivery training device configured to simulate drug delivery therefrom. For another example, the drug can include one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, and paliperidone palmitate.

0022In another aspect, a method of using a drug delivery device is provided that in one embodiment includes gathering, using a sensor of a sensing module attached to an outer surface of a drug delivery device configured to deliver a drug, data regarding at least one of date, time, vibration, temperature, sound, motion, humidity, pressure, fluid level, force, location, proximity, and spatial orientation. The method also includes causing, using a processor of the sensing module, a communication interface of the sensing module to wirelessly transmit data indicative of the gathered data to a source external to the drug delivery device and external to the sensing module.

0023The method can vary in any number of ways. For example, a power source of the sensing module can begin providing power to at least one of the sensor and the processor in response to a cap of the drug delivery device being manually removed by a user from a housing of the drug delivery device. In at least some embodiments, the removal of the cap can cause an insulator to be removed from an electrical path between the power source and the at least one of the sensor and the processor, or the removal of the cap can cause a conductive trace between the cap and the sensing module to become disconnected. In at least some embodiments, the sensor can begin the gathering of the data in response to the power source beginning to provide power to the at least one of the sensor and the processor. In at least some embodiments, the sensor can begin the gathering of the data in response to a tab being manually removed by a user from the drug delivery device.

0024For another example, a power source of the sensing module can begin providing power to at least one of the sensor and the processor in response to a trigger of the drug delivery device being manually actuated by a user. In at least some embodiments, the actuation of the trigger can cause an insulator to be removed from an electrical path between the power source and the at least one of the sensor and the processor, or the actuation of the trigger can cause a conductive trace to become disconnected. In at least some embodiments, the sensor can begin the gathering of the data in response to the power source beginning to provide power to the at least one of the sensor and the processor. In at least some embodiments, the sensor can begin the gathering of the data in response to a tab being manually removed by a user from the drug delivery device.

0025For another example, the sensor can include an accelerometer that gathers data regarding vibration and spatial orientation. For yet another example, the sensor can include a temperature sensor that gathers data regarding temperature. For still another example, the sensor can gather data regarding date, time, and at least one of vibration, temperature, sound, motion, humidity, pressure, fluid level, force, location, proximity, and spatial orientation. For another example, the data can be gathered during delivery of the drug from the drug delivery device. For yet another example, the data can be gathered prior to starting delivery of the drug from the drug delivery device.

0026For another example, the method can include causing a computer system that is external to the drug delivery device to provide instructions for using the drug delivery device during delivery of the drug from the drug delivery device, and the instructions can be based on data gathered using the sensor. The instructions can be provided via an app.

0027For still another example, the drug can include one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, and paliperidone palmitate.

0028In another aspect, a method of using a drug delivery training device is provided that includes gathering, using a sensor of a sensing module attached to an outer surface of a drug delivery training device that simulates delivery of a drug, data regarding at least one of date, time, vibration, temperature, sound, motion, humidity, pressure, fluid level, force, location, proximity, and spatial orientation. The method also includes causing, using a processor of the sensing module, a communication interface of the sensing module to wirelessly transmit data indicative of the gathered data to a source external to the drug delivery training device and external to the sensing module.

0029The method can have any number of variations. For example, a power source of the sensing module can begin providing power to at least one of the sensor and the processor in response to a cap of the drug delivery training device being manually removed by a user from a housing of the drug delivery training device. In at least some embodiments, the removal of the cap can cause an insulator coupled to the sensing module to be removed from an electrical path between the power source and the at least one of the sensor and the processor, or the removal of the cap can cause a conductive trace between the cap and the sensing module to become disconnected. In at least some embodiments, the sensor can begin the gathering of the data in response to the power source beginning to provide power to the at least one of the sensor and the processor. In at least some embodiments, the sensor can begin the gathering of the data in response to a tab being manually removed by a user from the drug delivery training device.

0030For another example, a power source of the sensing module can begin providing power to at least one of the sensor and the processor in response to a trigger of the drug delivery training device being manually actuated by a user. In at least some embodiments, the actuation of the trigger can cause an insulator to be removed from an electrical path between the power source and the at least one of the sensor and the processor, or the actuation of the trigger can cause a conductive trace to become disconnected. In at least some embodiments, the sensor can begin the gathering of the data in response to the power source beginning to provide power to the at least one of the sensor and the processor. In at least some embodiments, the sensor can begin the gathering of the data in response to a tab being manually removed by a user from the drug delivery training device.

0031For another example, the sensor can include an accelerometer that gathers data regarding vibration and spatial orientation. For yet another example, the sensor can include a temperature sensor that gathers data regarding temperature. For still another example, the sensor can gather data regarding date, time, and at least one of vibration, temperature, sound, motion, humidity, pressure, fluid level, force, location, proximity, and spatial orientation. For another example, the drug delivery training device simulates an autoinjector.

0032For still another example, the method can include causing a computer system that is external to the drug delivery training device to provide instructions for using the drug delivery training device during use of the drug delivery training device, and the instructions can be based on data gathered using the sensor. The instructions can be provided via an app.

BRIEF DESCRIPTION OF DRAWINGS

The present invention is described by way of reference to the accompanying figures which are as follows:

<figref idref="DRAWINGS">FIG. <b>1</b></figref> is a perspective view of one embodiment of a drug delivery device with one embodiment of a sensing module attached thereto;

<figref idref="DRAWINGS">FIG. <b>2</b></figref> is a perspective view of the sensing module of <figref idref="DRAWINGS">FIG. <b>1</b></figref>;

<figref idref="DRAWINGS">FIG. <b>3</b></figref> is a schematic view of the sensing module of <figref idref="DRAWINGS">FIG. <b>1</b></figref>;

<figref idref="DRAWINGS">FIG. <b>4</b></figref> is a schematic view of one embodiment of a communication network system;

<figref idref="DRAWINGS">FIG. <b>5</b></figref> is a perspective view of another embodiment of a drug delivery device with another embodiment of a sensing module attached thereto;

<figref idref="DRAWINGS">FIG. <b>6</b></figref> is a bottom view of the sensing module of <figref idref="DRAWINGS">FIG. <b>5</b></figref>;

<figref idref="DRAWINGS">FIG. <b>7</b></figref> is a bottom view of a printed circuit board of the sensing module of <figref idref="DRAWINGS">FIG. <b>6</b></figref>;

<figref idref="DRAWINGS">FIG. <b>8</b></figref> is a perspective view of the printed circuit board of the sensing module of <figref idref="DRAWINGS">FIG. <b>6</b></figref>;

<figref idref="DRAWINGS">FIG. <b>9</b></figref> is a side view of another embodiment of a drug delivery device with the sensing module of <figref idref="DRAWINGS">FIG. <b>6</b></figref> attached thereto;

<figref idref="DRAWINGS">FIG. <b>10</b></figref> is a perspective view of another embodiment of a drug delivery device with one embodiment of a tab and another embodiment of a sensing module attached thereto and with internal components thereof removed for clarity of illustration;

<figref idref="DRAWINGS">FIG. <b>11</b></figref> is another perspective view of the drug delivery device of <figref idref="DRAWINGS">FIG. <b>10</b></figref>;

<figref idref="DRAWINGS">FIG. <b>12</b></figref> is a cross-sectional view of the drug delivery device of <figref idref="DRAWINGS">FIG. <b>10</b></figref>;

<figref idref="DRAWINGS">FIG. <b>13</b></figref> is an exploded view of the tab and the sensing module of <figref idref="DRAWINGS">FIG. <b>10</b></figref>;

<figref idref="DRAWINGS">FIG. <b>14</b></figref> is a perspective view of a printed circuit board of the sensing module of <figref idref="DRAWINGS">FIG. <b>13</b></figref>;

<figref idref="DRAWINGS">FIG. <b>15</b></figref> is a perspective view of another embodiment of a tab and another embodiment of a sensing module coupled to the tab;

<figref idref="DRAWINGS">FIG. <b>16</b></figref> is a bottom view of the sensing module and tab of <figref idref="DRAWINGS">FIG. <b>15</b></figref>;

<figref idref="DRAWINGS">FIG. <b>17</b></figref> is a perspective view of another embodiment of a drug delivery device with the tab and the sensing module of <figref idref="DRAWINGS">FIG. <b>15</b></figref>;

<figref idref="DRAWINGS">FIG. <b>18</b></figref> is another perspective view of the drug delivery device of <figref idref="DRAWINGS">FIG. <b>17</b></figref>;

<figref idref="DRAWINGS">FIG. <b>18</b>A</figref> is a cross-sectional view of one end portion of the drug delivery device of <figref idref="DRAWINGS">FIG. <b>17</b></figref>;

<figref idref="DRAWINGS">FIG. <b>19</b></figref> is a side, partial view of the sensing module of <figref idref="DRAWINGS">FIG. <b>15</b></figref>;

<figref idref="DRAWINGS">FIG. <b>20</b></figref> is a perspective view of the tab of <figref idref="DRAWINGS">FIG. <b>15</b></figref>, a connector, and a partial portion of the sensing module of <figref idref="DRAWINGS">FIG. <b>15</b></figref>;

<figref idref="DRAWINGS">FIG. <b>21</b></figref> is a perspective view of the tab of <figref idref="DRAWINGS">FIG. <b>15</b></figref>;

<figref idref="DRAWINGS">FIG. <b>22</b></figref> is a perspective view of the connector of <figref idref="DRAWINGS">FIG. <b>20</b></figref>;

<figref idref="DRAWINGS">FIG. <b>23</b></figref> is a side, partial view of another embodiment of a sensing module;

<figref idref="DRAWINGS">FIG. <b>24</b></figref> is a perspective view of yet another embodiment of a drug delivery device and yet another embodiment of a sensing module;

<figref idref="DRAWINGS">FIG. <b>25</b></figref> is another perspective view of the drug delivery device of <figref idref="DRAWINGS">FIG. <b>24</b></figref>;

<figref idref="DRAWINGS">FIG. <b>26</b></figref> is a perspective view of still another embodiment of a drug delivery device and yet another embodiment of a sensing module;

<figref idref="DRAWINGS">FIG. <b>27</b></figref> is another perspective view of the drug delivery device of <figref idref="DRAWINGS">FIG. <b>26</b></figref>;

<figref idref="DRAWINGS">FIG. <b>28</b></figref> is a perspective view of another embodiment of a drug delivery device with another embodiment of a tab and another embodiment of a sensing module attached thereto;

<figref idref="DRAWINGS">FIG. <b>29</b></figref> is another perspective view of the drug delivery device of <figref idref="DRAWINGS">FIG. <b>28</b></figref>;

<figref idref="DRAWINGS">FIG. <b>30</b></figref> is a perspective view of the tab and the sensing module of <figref idref="DRAWINGS">FIG. <b>28</b></figref>;

<figref idref="DRAWINGS">FIG. <b>31</b></figref> is a perspective view of the tab of <figref idref="DRAWINGS">FIG. <b>30</b></figref>;

<figref idref="DRAWINGS">FIG. <b>32</b></figref> is a cross-sectional, partial view of the sensing module of <figref idref="DRAWINGS">FIG. <b>30</b></figref>;

<figref idref="DRAWINGS">FIG. <b>33</b></figref> is a perspective view of one end portion of the drug delivery device of <figref idref="DRAWINGS">FIG. <b>28</b></figref>;

<figref idref="DRAWINGS">FIG. <b>34</b></figref> is a perspective view of the drug delivery device of <figref idref="DRAWINGS">FIG. <b>28</b></figref> with an outer boot and end cap removed;

<figref idref="DRAWINGS">FIG. <b>35</b></figref> is a perspective view of the drug delivery device of <figref idref="DRAWINGS">FIG. <b>28</b></figref> with the outer boot removed;

<figref idref="DRAWINGS">FIG. <b>36</b></figref> is a perspective, partial view of yet another embodiment of a drug delivery device with yet another embodiment of a tab attached thereto, the tab being in a first position;

<figref idref="DRAWINGS">FIG. <b>37</b></figref> is another perspective, partial view of the drug delivery device of <figref idref="DRAWINGS">FIG. <b>36</b></figref> with the tab in a second position;

<figref idref="DRAWINGS">FIG. <b>38</b></figref> is a perspective view of another embodiment of a drug delivery device with another embodiment of a tab and another embodiment of a sensing module attached thereto;

<figref idref="DRAWINGS">FIG. <b>39</b></figref> is a top view of a printed circuit board of the sensing module of <figref idref="DRAWINGS">FIG. <b>38</b></figref>;

<figref idref="DRAWINGS">FIG. <b>40</b></figref> is a top view of a power source of the sensing module of <figref idref="DRAWINGS">FIG. <b>38</b></figref>;

<figref idref="DRAWINGS">FIG. <b>41</b></figref> is a bottom view of the tab of <figref idref="DRAWINGS">FIG. <b>38</b></figref>;

<figref idref="DRAWINGS">FIG. <b>42</b></figref> is a dual side and front view of one embodiment of a pill bottle with another embodiment of a tab and another embodiment of a sensing module attached thereto;

<figref idref="DRAWINGS">FIG. <b>43</b></figref> is a front view of the pill bottle of <figref idref="DRAWINGS">FIG. <b>42</b></figref> with another embodiment of a tab and another embodiment of a sensing module attached thereto;

<figref idref="DRAWINGS">FIG. <b>44</b></figref> is a view of one embodiment of a drug delivery training app page on a mobile phone;

<figref idref="DRAWINGS">FIG. <b>45</b></figref> is a view of another embodiment of a drug delivery training app page on the mobile phone of <figref idref="DRAWINGS">FIG. <b>44</b></figref>;

<figref idref="DRAWINGS">FIG. <b>46</b></figref> is a view of yet another embodiment of a drug delivery training app page on the mobile phone of <figref idref="DRAWINGS">FIG. <b>44</b></figref>; and

<figref idref="DRAWINGS">FIG. <b>47</b></figref> is a flowchart of one embodiment of a method of a sensing module establishing communication with an external source.

DETAILED DESCRIPTION

0082Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices, systems, and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. A person skilled in the art will understand that the devices, systems, and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

0083Further, in the present disclosure, like-named components of the embodiments generally have similar features, and thus within a particular embodiment each feature of each like-named component is not necessarily fully elaborated upon. Additionally, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape. A person skilled in the art will appreciate that a dimension may not be a precise value but nevertheless be considered to be at about that value due to any number of factors such as manufacturing tolerances and sensitivity of measurement equipment. Sizes and shapes of the systems and devices, and the components thereof, can depend at least on the size and shape of components with which the systems and devices will be used.

0084Various exemplary drug delivery device sensing modules and methods of using drug delivery device sensing modules are provided. In general, a sensing module can be configured to be attached to a drug delivery device configured to deliver a drug. The drug delivery device can be any of a variety of types of drug delivery devices, such as a syringe, an injection device (e.g., an autoinjector, a jet injector, and an infusion pump), a nasal delivery device, and an inhaler. The sensing module can be configured to gather data for one or more parameters related to drug delivery and to transmit data indicative of the gathered data to an external source configured to analyze the data received from the sensing module. The sensing module may help improve compliance by allowing errors in drug delivery to be identified based on the gathered data and thus provide opportunity for the errors to be addressed and/or by allowing any missed and off-schedule doses for a user to be identified based on the gathered data and thus provide a user's health care provider with information to discuss with the user and/or better analyze the user's treatment. The sensing module may similarly help increase clarity into clinical trial data by allowing errors in drug delivery during the clinical trial to be identified based on the gathered data and thus provide opportunity for the errors to be addressed before completion of the clinical trial and/or by allowing any missed and off-schedule doses for a clinical trial participant to be identified based on the gathered data and thus provide a clinical trial administrator with information to discuss with the clinical trial participant and/or better analyze clinical trial results.

0085Examples of the parameters related to drug delivery that can be sensed by the sensing module include date, time, vibration, temperature, sound, motion, humidity, pressure, fluid level, force, location, proximity, and spatial orientation. Gathering date data and/or time data may allow for other sensed parameter(s) to be accurately date and/or time stamped, e.g., correlated with a particular date and/or time. Gathering vibration data may allow for detecting when drug delivery has begun, e.g., by detected vibration being indicative of spring or other mechanical action such as advancement of a needle or retraction (manually or automatically caused) of a needle cover sleeve to expose a needle, etc., for detecting when drug delivery has been completed, e.g., by detected vibration being indicative of spring or other mechanical action such as retraction of a needle or advancement (manually or automatically caused) of a needle cover sleeve that locks in place over a needle, etc., for detecting when reconstitution or mixing of the drug to be delivered has begun in the drug delivery device, e.g., by detected vibration being indicative of the drug delivery device being shaken manually by a user to cause the reconstitution or mixing, etc., for detecting when reconstitution or mixing of the drug to be delivered has stopped in the drug delivery device, e.g., by the ceasing of detected vibration being indicative of a stop of the drug delivery device's manual shaking, etc., and/or for evaluating quality of reconstitution or mixing of the drug to be delivered, e.g., by detected vibration being indicative of a shaking force that either meets or fails predetermined shaking force criteria for proper reconstitution or mixing, etc. Gathering temperature data may provide ambient temperature information to indicate whether the drug is at a safe temperature for storage and/or for delivery to a user. Gathering sound data may allow for detecting when drug delivery has begun, e.g., by detected acoustic data within a particular frequency range being indicative of when drug delivery has begun, by detected sound being indicative of an inhaler's drug canister being pressed down, by detected sound being indicative of a needle being advanced through spring or other mechanical action, by a detected click sound being indicative of a trigger of the drug delivery device being pressed, etc., for detecting when drug delivery has been completed, e.g., by detected sound being indicative of spring or other mechanical action retracting a needle, by detected sound being indicative of when aerosol delivery of the drug has stopped, by a detected click sound being indicative of a trigger of the drug delivery device being released, etc., for detecting when reconstitution or mixing of the drug to be delivered has begun in the drug delivery device, e.g., by detected sound being indicative of activation of the device's reconstitution or mixing mechanism, etc., and/or for detecting when reconstitution or mixing of the drug to be delivered has stopped in the drug delivery device, e.g., by the ceasing of detected sound being indicative of deactivation of the device's reconstitution or mixing mechanism, etc. Gathering motion data may allow for detecting when drug delivery has begun, e.g., by detected motion being indicative of an inhaler's drug canister being pressed down, of a plunger being pushed down, etc., and/or for detecting when drug delivery has been completed, e.g., by detected motion being indicative of an inhaler's drug canister being released to allow the canister to move up to a resting position, the drug delivery device being lifted manually from an injection site, etc. Gathering humidity data may provide information as to whether the drug is at a safe humidity level for storage and/or for delivery to a user. Gathering pressure data may allow for detecting when drug delivery has begun, e.g., by detected pressure being indicative of spring or other mechanical action advancing a needle, of an inhaler's drug canister being pressed down, of a plunger being pushed down, etc., and/or for detecting when drug delivery has been completed, e.g., by detected pressure being indicative of spring or other mechanical action retracting a needle, of an inhaler's drug canister being released to allow the canister to move up to a resting position, etc. Gathering fluid level data may allow for detecting the presence of liquid drug in the drug delivery device's reservoir, which may be indicative of no drug delivery having yet occurred from the device, and/or for detecting the absence of liquid drug in the drug delivery device's reservoir, which may be indicative of drug delivery having occurred. Gathering force data may allow for detecting a force with which the drug delivery device as an injection device is being held against a patient (e.g., against the patient's skin), which may help inform whether drug injection fails since too low a force can cause injection failure. Gathering location data may allow for detecting a geographic location of a patient, which may allow for other sensed parameter(s) to be accurately location stamped, e.g., correlated with a particular location. Gathering proximity data may allow for detecting a distance of the drug delivery device from skin before, during, and/or after delivery of the drug from the drug delivery device, which may help indicate whether the drug delivery device is being held against skin while the drug is being delivered, e.g., as with an injection device intended to be held against a skin surface during drug delivery, and/or whether the drug delivery device is removed from skin before delivery of the drug has completed, e.g., as with an injection device intended to be removed from a skin surface after delivery of the drug has completed. Gathering spatial orientation data may allow for detecting the drug delivery device's orientation relative to ground when the drug is delivered, which may be indicative of whether the drug was properly administered, and/or for evaluating quality of reconstitution or mixing of the drug to be delivered, e.g., by detected spatial orientations over a period of time being indicative of a number of inversions of the drug delivery device that either meets or fails predetermined inversion number criteria for proper reconstitution or mixing, etc.

0086Further discussion of gathering data and using gathered data in determining proper reconstitution or mixing for drug delivery devices and drug delivery training devices are provided in U.S. Pat. Pub. No. 2018/0182263 entitled “Devices And Methods For Drug Administration And Mixing, And Training Of Proper Techniques Therefor” published Jun. 28, 2018, U.S. Pat. Pub. No. 2018/0190153 entitled “Devices And Methods For Drug Administration And Mixing, And Training Of Proper Techniques Therefor” published Jul. 5, 2018, U.S. Pat. Pub. No. 2018/0190154 entitled “Devices And Methods For Drug Administration And Mixing, And Training Of Proper Techniques Therefor” published Jul. 5, 2018, and U.S. Pat. Pub. No. 2019/00433386 entitled “Devices And Methods For Drug Administration And Mixing, And Training Of Proper Techniques Therefor” published Feb. 7, 2019, which are hereby incorporated by reference in their entireties.

0087In an exemplary embodiment, the sensing module is configured to be attached to an outer surface of the drug delivery device. The sensing module being attachable to a drug delivery device's outer surface may safely isolate the sensing module's electronic components from the drug contained in the drug delivery device and from the drug delivery device's drug delivery components (e.g., needle, syringe, plunger, pump, pressurized drug canister, etc.). The sensing module being attachable to a drug delivery device's outer surface may facilitate use of the sensing module with existing drug delivery devices because the drug delivery device need not be modified in order to accommodate the sensing module. The sensing module may simply be attached to an outer surface of the drug delivery device and thus may allow for drug delivery devices to be designed without needing to reserve valuable, limited internal real estate within the drug delivery device for the sensing module since the sensing module may simply be attached to an outer surface of the drug delivery device. The sensing module being attachable to a drug delivery device's outer surface may ease incorporation of the sensing module into a drug delivery device's manufacturing process since the sensing module can be attached to the drug delivery device's outer surface after the drug delivery device has otherwise been assembled.

0088The drug to be delivered using the drug delivery device having the sensing module thereto can be any of a variety of drugs. Examples of drugs that can be delivered using a drug delivery device as described herein (or trained for delivery using a drug delivery training device as described herein) include Remicade® (infliximab), Stelara® (ustekinumab), Simponi® (golimumab), Simponi Aria® (golimumab), Darzalex® (daratumumab), Tremfya® (guselkumab), Eprex® (epoetin alfa), Risperdal Constra® (risperidone), Invega Sustenna® (paliperidone palmitate), and Invega Trinza® (paliperidone palmitate).

0089The sensing module can be configured to be attached to a drug delivery training device configured to simulate delivery of a drug for training purposes. The sensing module may facilitate the training of users to properly use a drug delivery device since the sensing module's use with a drug delivery training device may provide insight into various factors affecting proper drug delivery, including whether a user is using the drug delivery device correctly and whether the user is adhering to the intended drug delivery schedule. The drug delivery training device to which the sensing module can be attached can be any of a variety of types of drug delivery training devices, such as a syringe, an injection device (e.g., an autoinjector, a jet injector, and an infusion pump), a nasal delivery device, and an inhaler. The sensing module used with a drug delivery training device is configured and used similar to that discussed herein for a drug delivery device configured to deliver a drug.

0090<figref idref="DRAWINGS">FIGS. <b>1</b> and <b>2</b></figref> illustrate one embodiment of a sensing module <b>10</b> configured to gather data for one or more parameters related to drug delivery and to transmit data indicative of the gathered data to an external source configured to analyze the data received from the sensing module <b>10</b>. <figref idref="DRAWINGS">FIG. <b>2</b></figref> illustrates the sensing module <b>10</b> as a standalone element. <figref idref="DRAWINGS">FIG. <b>1</b></figref> illustrates the sensing module <b>10</b> attached to one embodiment of a drug delivery device <b>12</b> configured to deliver a drug <b>14</b>, which is a clear liquid in this illustrated embodiment. The drug delivery device <b>12</b> in this illustrated embodiment is an autoinjector configured to inject the drug <b>14</b> from a container <b>16</b> in a housing <b>18</b> of the device <b>12</b> and out of a needle (obscured in <figref idref="DRAWINGS">FIG. <b>1</b></figref> by a needle shield <b>20</b> of the device <b>12</b>).

0091The sensing module <b>10</b> is attached to an outer surface of the device <b>12</b>. The outer surface is an outer surface of the housing <b>18</b>, but the sensing module <b>10</b> can be attachable to another outer surface of a drug delivery device, such as on a depressible head of the device, on a rotatable dose setter of the device, a trigger of the device, etc. The sensing module <b>10</b> is attached to the device <b>12</b> with an adhesive <b>22</b>, e.g., a layer of an adhesive on the sensing module <b>10</b>, in this illustrated embodiment. For example, the sensing module <b>10</b> can be a thin label-type device similar to a sticker in which the adhesive <b>22</b> is on one side of the thin label that is attached to the device <b>12</b> or is on both sides of the thin label (similar to double-sided tape) with one side adhered to the sensing module <b>10</b> and one side adhered to the device <b>12</b>. For another example, the sensing module <b>10</b> can include a small box or other small housing with the adhesive <b>22</b> on one side thereof. The sensing module <b>10</b> being attachable to a drug delivery device using adhesive (with a thin label-type device or a small housing) facilitates retrofitting existing drug delivery devices with the sensing module <b>10</b> since the existing drug delivery device need not be modified in any way to accommodate the attachment of the sensing module <b>10</b> thereto. However, the sensing module <b>10</b> can be attached to a drug delivery device in other ways, such as by being press fit into a cavity formed in an outer surface of a drug delivery device (e.g., by the sensing module <b>10</b> including a small box or other small housing having a size and shape configured to be securely press fit into the cavity), by including one or more protrusions configured to snap or otherwise fit into one or more corresponding holes formed in an outer surface of a drug delivery device (e.g., by the sensing module <b>10</b> including a small box or other small housing that includes the one or more protrusions), or by including one or more holes configured to receive therein one or more corresponding protrusions extending from an outer surface of a drug delivery device (e.g., by the sensing module <b>10</b> including a small box or other small housing that includes the one or more protrusions). In some embodiments, more than one type of attachment mechanism can be used to attach a sensing module to a drug delivery device to provide redundancy to help ensure that the sensing module remains attached to the drug delivery device through final use of the drug delivery device. For example, a sensing module can include an adhesive layer and an additional attachment mechanism (e.g., one or more protrusions, one or more holes, a body configured to be press fit into a cavity of the drug delivery device, etc.). For another example, a sensing module can include one or more protrusions and one or more holes.

0092In an exemplary embodiment, as in the illustrated embodiment of <figref idref="DRAWINGS">FIG. <b>1</b></figref>, the sensing module <b>10</b> is non-removably attached to the drug delivery device <b>12</b>, which may help ensure that the sensing module <b>10</b> is always available to gather data, that the sensing module <b>10</b> is not reused, and/or that the sensing module <b>10</b> is attached properly to the device <b>12</b> by being attached thereto as part of a manufacturing process before the device <b>12</b> is shipped for provision to a user. In embodiments (discussed below) in which a sensing module includes a tamper-resistant feature, the sensing module being non-removably attached to a drug delivery device may help ensure that the sensing module accurately provides evidence of tampering or no tampering. In other embodiments a sensing module can be removably attached to a drug delivery device, which may facilitate use of the sensing module with multiple drug delivery devices, such as with each of a plurality of single-dose drug delivery devices for the same user or with each successive multi-dose drug delivery device used by the same user. A sensing module configured to be removably attached to a drug delivery device can be provided to a user already adhered to the drug delivery device, or the sensing module can be configured to be adhered to the drug delivery device by a user, in which case the sensing module can include a removable protective layer of paper, plastic, etc. configured to be removed by a user to expose adhesive for attachment of the sensing module to the drug delivery device.

0093The sensing module <b>10</b> includes a variety of electronic components to facilitate the gathering of data and the transmission of gathered data to an external source. <figref idref="DRAWINGS">FIG. <b>3</b></figref> illustrates one embodiment of the sensing module's electronic components. The sensing module <b>10</b> includes a processor <b>24</b>, a sensor <b>26</b> configured to gather data regarding one or more parameters and transmit the gathered data to the processor <b>24</b>, a memory <b>28</b> configured to receive data from the processor <b>24</b> for storage in the memory <b>28</b> and configured to store instructions therein that are executable by the processor <b>24</b>, a communication interface <b>30</b> configured to transmit data to an external source at the instruction of the processor <b>24</b>, and a power source <b>32</b> configured to provide power to one or more of the sensing module's other electronic components.

0094In an exemplary embodiment, the sensing module's electronic components are mechanically supported on a printed circuit board (PCB) and electrically connected to one another as needed on the PCB. To facilitate the electrical connections, the PCB can include a bus system, e.g., one or more separate physical buses, communication lines/interfaces, and/or multi-drop or point-to-point connections, connected by appropriate bridges, adapters, and/or controllers. The PCB can be flexible, which may facilitate attachment of the sensing module <b>10</b> to a curved surface of a drug delivery device. Alternatively, the PCB can be rigid, which may provide durability to the sensing module <b>10</b>. Whether rigid or flexible, the PCB can be disposed in a housing <b>34</b>. The housing <b>34</b> can define a base of the sensing module <b>10</b> configured to be attached to the outer surface of the drug delivery device <b>12</b> using one or more attachment mechanisms as described herein. The housing <b>34</b> containing the sensing module's electronic components therein can help protect the electronic components from damage.

0095The processor <b>24</b> can include any type of microprocessor or central processing unit (CPU), including programmable general-purpose or special-purpose microprocessors and/or any one of a variety of proprietary or commercially available single or multi-processor systems. In an exemplary embodiment the processor <b>24</b> is a single processor, which may help control cost and/or size of the sensing module <b>10</b>.

0096The memory <b>28</b> is configured to provide storage for data, e.g., instructions (e.g., code) to be executed by the processor <b>24</b> and data gathered by the sensor <b>26</b>. The memory <b>28</b> can include storage using, e.g., read-only memory (ROM), flash memory, one or more varieties of random access memory (RAM) (e.g., static RAM (SRAM), dynamic RAM (DRAM), or synchronous DRAM (SDRAM)), and/or a combination of memory technologies.

0097The communication interface <b>30</b> (also referred to herein as a “network interface”) is configured to enable communication over a network with sources external to the sensing module <b>10</b> and the drug delivery device <b>12</b> to which the sensing module <b>10</b> is attached. In an exemplary embodiment the communication interface <b>30</b> is configured to communicate wirelessly using any of a number of wireless techniques, e.g., Wi-Fi, Near Field communication (NFC), Bluetooth, Bluetooth Low Energy (BLE), cellular communication, etc. In one exemplary embodiment, the communication interface <b>30</b> is configured to communicate wirelessly using BLE. In another exemplary embodiment, the communication interface <b>30</b> is configured to communicate wirelessly using Bluetooth. In yet another exemplary embodiment, the communication interface <b>30</b> is configured to communicate wirelessly using NFC. In still another exemplary embodiment, the communication interface <b>30</b> is configured to communicate wirelessly using each of NFC and BLE. In still another exemplary embodiment, the communication interface <b>30</b> is configured to communicate wirelessly using each of NFC and Bluetooth.

0098The communication interface <b>30</b> being configured to communicate wirelessly using NFC, as the communication interface's only wireless capability or as one of a plurality of wireless capabilities of the communication interface <b>30</b> (e.g., NFC and BLE, NFC and Bluetooth, etc.), may allow for data stored at the sensing module <b>10</b>, e.g., in the memory <b>28</b>, to be retrieved from the sensing module <b>10</b> even if the power source <b>32</b> has been deleted of power or lacks sufficient power to allow for communication from the communication interface <b>30</b>, for example if the power source <b>32</b> as a battery has run out of battery power or lacks sufficient battery power to allow for communication from the communication interface <b>30</b>. NFC technology allows a data source to wirelessly receive energy from a data destination. Accordingly, the communication interface <b>30</b> being configured to communicate using NFC allows the communication interface <b>30</b> to receive power from the external source, e.g., from an NFC reader, such that data stored at the sensing module <b>10</b> can be communicated from the communication interface <b>30</b> using NFC even if the power source <b>32</b> has been deleted of power or lacks sufficient power to allow for communication from the communication interface <b>30</b>.

0099The power source <b>32</b> may run out of power or have an insufficient power supply for communication from the communication interface <b>30</b> before all desired data has been retrieved from the sensing module <b>10</b> for any of a variety of reasons. For example, the communication interface <b>30</b> may be out of range of the external source until after the power source <b>32</b> has been depleted of power. For another example, the sensing module <b>10</b> including the power source <b>32</b> may have been manufactured long enough ago that the power source <b>32</b> was depleted of power before all desired data could be retrieved from the sensing module <b>10</b>. For yet another example, the power source <b>32</b> may have become damaged and/or otherwise experienced an error preventing the power source <b>32</b> from providing power as needed for data to be communicated from the sensing module <b>10</b> to the external source.

0100The communication interface <b>30</b> being configured to communicate wirelessly using NFC, as the communication interface's only wireless capability or as one of a plurality of wireless capabilities of the communication interface <b>30</b> (e.g., NFC and BLE, NFC and Bluetooth, etc.), may allow for data to be stored on the sensing module <b>10</b>, e.g., in the memory <b>28</b>, as part of the sensing module's manufacturing process and/or at other time(s) before a user begins using a drug delivery device to which the sensing module <b>10</b> is attached. NFC technology allows data to be communicated from the external source, e.g., an NFC reader, to the communication interface <b>30</b> for storage on the sensing module <b>10</b>. For example, drug study or clinical trial data can be stored on the sensing module <b>10</b> related to a drug study or clinical trial in which a drug delivery device having the sensing module <b>10</b> attached thereto will be used. Drug study or clinical trial data can thus be retrieved from the sensing module <b>10</b> to, e.g., help ensure that the sensing module's data is correctly associated with the drug study or clinical trial and/or to help verify that the drug and/or drug delivery device complies with requirements of the drug study or clinical trial. Examples of drug study or clinical trial data include drug type or name, drug expiration date, drug manufacture date, drug study or clinical trial number, etc. For another example, drug delivery device data can be stored on the sensing module <b>10</b>. Drug delivery device data can thus be retrieved from the sensing module <b>10</b> to identify the drug delivery device to which the sensing module <b>10</b> is attached, which may facilitate compliance analysis and/or analysis of correct device usage. Examples of drug delivery device data include drug delivery device type or name, drug delivery data manufacture date, manufacturing site, device identification number or code, etc.

0101The sensing module <b>10</b> can include any of a variety of other software and/or hardware components not shown in <figref idref="DRAWINGS">FIG. <b>3</b></figref>. For example, the sensing module <b>10</b> can include an LED or other light to show sensing status of the sensing module <b>10</b> (e.g., light on when the sensor <b>26</b> is gathering data and light off when the sensor <b>26</b> is not gathering data, etc.), to show power status of the sensing module <b>10</b> (e.g., light on when the power source <b>32</b> is providing power to one or more components of the sensing module <b>10</b> and light off when the power source <b>32</b> is not providing power to one or more components of the sensing module <b>10</b>, etc.), and/or to show other information (e.g., a light in one color before drug delivery begins and in a different color after drug delivery, etc.). For another example, the sensing module <b>10</b> can include a speaker configured to provide audio to a user (e.g., a beep when the sensing module <b>10</b> is powered on, a beep when drug delivery begins, a beep when drug delivery ends, a beep indicating low power, etc.). For yet another example, the sensing module <b>10</b> can include a graphic and/or text display configured to provide graphic and/or text information to a user (e.g., graphic and/or text indicating that the sensing module <b>10</b> has been powered on, graphic and/or text indicating that drug delivery has started, graphic and/or text indicating that drug delivery is in progress, graphic and/or text indicating that drug delivery has ended, graphic and/or text indicating low power, etc.). The sensing module <b>10</b> including a user interface that includes a light, a speaker, and/or a graphic and/or text display may allow a user to receive information that may otherwise be provided to the user via an app on a mobile phone (or other computer system), such as when the user does not have access to the app at all or temporarily lacks access to the app.

0102In other embodiments, the sensing module may differ in architecture and operation from that shown and described in <figref idref="DRAWINGS">FIG. <b>3</b></figref>. For example, the sensor <b>26</b> and communication interface <b>30</b> can be integrated together. For another example, the processor <b>24</b> and communication interface <b>30</b> can be integrated together. For yet another example, the sensor <b>26</b> can include its own local memory in addition to the sensing module <b>10</b> including the memory <b>28</b>. For still another example, the power source can be off-board the sensing module <b>10</b>. For another example, the sensor <b>26</b>, communication interface <b>30</b>, and processor <b>24</b> can be integrated together. For still another example, the housing <b>34</b> can include multiple housings that each house therein at least one component of the sensing module <b>10</b>, e.g., a first housing that houses the communication interface <b>30</b> and a second housing that houses the remaining sensing module components, a first housing that houses the sensor <b>26</b> and a second housing that houses the remaining sensing module components, a first housing that houses the sensor <b>26</b> and the communication interface <b>30</b> and a second housing that houses the remaining sensing module components, a first housing that houses the power source <b>32</b> and a second housing that houses the remaining sensing module components, etc. Using multiple housings allows the housings to be attached to the drug delivery device at different locations and may allow for each of the housings to be smaller than if a single housing was used and thereby facilitate attachment of the housings to smaller parts of the drug delivery device and/or make the sensing module <b>10</b> less likely to interfere with a user's handling of the drug delivery device.

0103The communication interface <b>30</b> is configured to communicate with an external source such as a computer system located remotely from the sensing module <b>10</b>, such as a central computer system <b>100</b> shown in <figref idref="DRAWINGS">FIG. <b>4</b></figref>. As shown in <figref idref="DRAWINGS">FIG. <b>4</b></figref>, the communication interface <b>30</b> is configured to communicate with the central computer system <b>100</b> through a communication network <b>102</b> from any number of locations where the sensing module <b>10</b> attached to the drug delivery device <b>12</b> may be located, such as a medical facility <b>106</b>, e.g., a hospital or other medical care center, a home base <b>108</b> (e.g., a patient's home or office or a care taker's home or office), or a mobile location <b>110</b>. In some embodiments, the central computer system <b>100</b> can be located at a same location as the communication interface <b>30</b> but be remotely located from the central computer system at that location, e.g., the communication interface <b>30</b> being in one room of the home base <b>108</b> or medical facility <b>106</b> and the central computer system <b>100</b> being in another room of the home base <b>108</b> or medical facility <b>106</b>.

0104The communication interface <b>30</b> can be configured to access the system <b>100</b> through a wired and/or wireless connection to the network <b>102</b>. In an exemplary embodiment the communication interface <b>30</b> is configured to access the system <b>100</b> wirelessly using any of a number of wireless techniques, which can facilitate accessibility of the system <b>100</b> from almost any location in the world where the sensing module <b>10</b> attached to the drug delivery device <b>12</b> may be located. A person skilled in the art will appreciate that communications over the network <b>102</b> can include security features to help protect unauthorized access to transmitted data and/or to nodes within the network <b>102</b>.

0105The central computer system <b>100</b> can have any of a variety of configurations, as will be appreciated by a person skilled in the art, including components such as a processor, a communication interface, a memory, an input/output interface, and a bus system. The computer system <b>100</b> can also include any of a variety of other software and/or hardware components, including by way of non-limiting example, operating systems and database management systems. The central computer system <b>100</b> can be any of a variety of types of computer systems, such as a desktop computer, a workstation, a minicomputer, a laptop computer, a tablet computer, a personal digital assistant (PDA), a mobile phone, a smart watch, etc.

0106The computer system <b>100</b> can include a web browser for retrieving web pages or other markup language streams, presenting those pages and/or streams (visually, aurally, or otherwise), executing scripts, controls and other code on those pages/streams, accepting user input with respect to those pages/streams (e.g., for purposes of completing input fields), issuing HyperText Transfer Protocol (HTTP) requests with respect to those pages/streams or otherwise (e.g., for submitting to a server information from the completed input fields), and so forth. The web pages or other markup language can be in HyperText Markup Language (HTML) or other conventional forms, including embedded Extensible Markup Language (XML), scripts, controls, and so forth. The computer system <b>100</b> can also include a web server for generating and/or delivering the web pages to client computer systems. The presented pages and/or streams may allow a user of the computer system <b>100</b> to view data received from the sensing module <b>10</b> and/or analysis of the data as performed by the computer system <b>100</b>.

0107In general, the sensor <b>26</b> is configured to gather data regarding at least one parameter and to transmit the data to the processor <b>24</b>. The processor <b>24</b> is configured to cause the data received from the sensor <b>26</b> to be transmitted to the communication interface <b>30</b>, either from the processor <b>24</b> before (or without) storage of the data in the memory <b>28</b> or from the memory <b>28</b> after causing the data to be stored in the memory <b>28</b>. The data may not be stored in the memory <b>28</b> if, e.g., the memory <b>28</b> has limited storage space. The communication interface <b>30</b> is configured to transmit the data to the external source, e.g., the central computer system <b>100</b>, for review by a user and/or for analysis by a processor of the central computer system <b>100</b> for review by a user. In some embodiments, the processor <b>24</b> can be configured to analyze the data instead of or in addition to a processor of the central computer system <b>100</b> analyzing the data. The central computer system <b>100</b> may be more robust than the computer system of the drug delivery device <b>12</b>, and thus the processor of the central computer system <b>100</b> may have more processing power than the processor <b>24</b> of the drug delivery device <b>12</b> and/or be more capable of analyzing large amounts of data.

0108In an exemplary embodiment, data is transmitted from the communication interface <b>30</b> to the external source with an identifier uniquely identifying the device <b>12</b> and/or the sensing module <b>10</b>. The identifier may help ensure patient privacy because the data is associated with a particular device <b>12</b> and/or a particular sensing module <b>10</b> rather than with a particular patient, and/or can allow the device <b>12</b> to be identified as an authentic device authorized to gather and transmit data to the receiver of the data. The external source that receives the data from the communication interface <b>30</b> can be configured to identify the patient with which the identifier is associated, such as by accessing a stored lookup table correlating particular patients with particular identifiers for each of a plurality of drug delivery devices and/or sensing modules. The identifier can have a variety of configurations, e.g., numeric, alphanumeric, etc. In an exemplary embodiment, the identifier is an identification code of the device <b>12</b> as reflected on a bar code attached to the device <b>12</b>, which drug delivery devices often have for tracking purposes. The bar code can be scanned with an appropriate scanner and stored in the memory <b>28</b> for transmission by the communication interface <b>30</b> in connection with sensed data. In some embodiments, a photograph can be taken of the bar code, such as with a camera of a mobile phone (or other computer system), and the image can be analyzed by the mobile phone (or other computer system) that took the picture to identify the bar code from the image.

0109In another exemplary embodiment, data transmission can be encrypted (e.g., an encrypted BLE transmission, etc.), and the unique identifier can be part of the encrypted transmission. The identifier being part of the data transmission allows for unique identification without a user needing to scan a bar code, take a photograph, or take another action. The data would be decrypted by the computer system that receives the data to allow for identification of the identifier. Various encryption techniques can be used, as will be appreciated by a person skilled in the art, such as by using a key-based security system, e.g., a public key/private key cryptographic system, to allow for data encryption and decryption. Public and private keys can be stored in a memory and can be generated using cryptographic algorithms. Keys can be used to encrypt data for transmission and to decrypt encrypted data received from a different computing device. In such systems, a public key associated with the intended receiver of the data can be utilized to encrypt data, however, only the recipient's private key can be used to decrypt the encrypted data. In at least some embodiments, a cryptographic system such as a public key infrastructure (PM), in which one or more third parties, known as “certificate authorities,” can be used to certify ownership of the public and private key pairs. Examples of key-based security systems include the Diffie-Hellman key exchange protocol, the Digital Signature Standard (DSS) protocol, password-authenticated key agreement protocols, the Rivest-Shamir-Adelman (RSA) encryption algorithm, the Cramer-Shoup cryptosystem, and the YAK authenticated key agreement protocol. Any type of encryption (including Wired Equivalent Privacy (WEP), Wi-Fi Protected Access (WPA), Wi-Fi Protected Access II (WPA2), and Wi-Fi Protected Access III (WPA3) encryption methods) can be used to encrypt transmitted data. Various digital certificate validation schemes and cryptographic protocols, including the Secure Sockets Layer protocol (SSL), the Transport Layer Security protocol (TLS), RSA, or any other public/private key protocols can be utilized in establishing the communication.

0110In addition to or instead of transmitting encrypted data for identifier purposes, any other transmitted data described herein can be encrypted to improve security.

0111As mentioned above, the sensor <b>26</b> can be configured to sense any one or more of a variety of parameters, such as date, time, vibration, temperature, sound, motion, humidity, pressure, fluid level, force, location, proximity, and spatial orientation. As will be appreciated by a person skilled in the art, the sensor <b>26</b> can include one sensor configured to sense all of the parameter(s) being sensed by the sensing module <b>10</b>, or the sensor <b>26</b> can include two or more sensors each configured to sense one or more of the parameters being sensed by the sensing module <b>10</b>. In embodiments in which the sensor <b>26</b> includes multiple sensors, each of the sensors can be configured to sense different parameter(s) from one another, which may maximize a number of parameters that the sensing module <b>10</b> can sense. In embodiments in which multiple parameters are sensed, a combination of sensed parameters can be used to confirm proper drug delivery device <b>12</b> operation, e.g., by using each of sound and motion to determine when the drug delivery process has begun and/or for detecting when drug delivery has been completed.

0112Examples of a sensor <b>26</b> configured to gather date data and/or time data include a clock generator and a timer. The sensor <b>26</b> being configured to gather date data and/or time data may allow for other sensed parameter(s) to be accurately date and/or time stamped. The date/time stamping can thus facilitate identification of when the drug <b>14</b> was delivered from the device <b>12</b> as indicated by one or more other parameter(s) sensed by the sensor <b>26</b>, as discussed further below. Similarly, date/time stamping can facilitate a determination that the drug <b>14</b> was not delivered on schedule, e.g., if the one or more other parameter(s) sensed by the sensor <b>26</b> at an expected date/time or in an expected date/time range are not indicative of the drug <b>14</b> being delivered from the device <b>12</b>. In this way, sensing date and/or time may facilitate evaluation of patient compliance with a predetermined drug delivery schedule and/or evaluation of a patient's condition based on how often and/or when the drug is being administered to the patient on demand.

0113Examples of a sensor <b>26</b> configured to gather vibration data include an accelerometer and a motion sensor. The sensor <b>26</b> being configured to gather vibration data may allow for detecting when the drug delivery process has begun and/or for detecting when drug delivery has been completed. Vibration of an autoinjector such as the device <b>12</b> is indicative of a spring (obscured in <figref idref="DRAWINGS">FIG. <b>1</b></figref>) disposed within the housing <b>18</b> and operatively coupled to the needle shield <b>20</b> being actuated to cause the needle to be advanced after the needle shield <b>20</b> has moved in response to being pressed against a skin surface. Similarly, vibration of an autoinjector such as the device <b>12</b> is indicative of another spring (obscured in <figref idref="DRAWINGS">FIG. <b>1</b></figref>) disposed within the housing <b>18</b> causing the needle shield <b>20</b> to move to a locked position after the drug <b>14</b> has been delivered. Knowing that drug delivery has occurred (with or without being time/date stamped) may facilitate compliance analysis because it can be known whether a dose was delivered from the device <b>12</b>. Vibration data indicative of a desired action (e.g., start of drug delivery, end of drug delivery, shaking of the device <b>12</b> for drug mixing purposes, etc.) can be distinguished from other vibration data that may be gathered by the sensor <b>26</b> due to, e.g., transport of the device <b>12</b>, removing the device <b>12</b> from packaging, bumping of the device <b>12</b> against something, etc. As will be appreciated by a person skilled in the art, an algorithm can allow for differentiation between different signals, such as by using a fast Fourier transform (FFT) to analyze a frequency spectrum of gathered vibration data. Correlating vibration data with a date/time may allow for more precise compliance analysis and/or may facilitate a determination that the drug <b>14</b> was delivered properly. For example, a certain, known amount of time (or range of time) may be expected to pass between the start of the drug delivery process and the end of the drug delivery process. If the vibration data indicates that too little time or too much time passes between the start of the drug delivery process and the end of the drug delivery process, improper drug delivery may have occurred and may be flagged for follow-up by a medical professional with the user. For another example, if only one vibration event is detected as happening, then the drug delivery process may have begun (as indicated by first vibration data) but not ended properly (as indicated by a lack of second vibration data following the first vibration data) due to device malfunction, such as by the needle not being retracted and/or the needle shield not extending over the needle.

0114Examples of a sensor <b>26</b> configured to gather temperature data include a temperature sensor (e.g., a thermistor, a thermocoupler, etc.). The sensor <b>26</b> being configured to gather temperature data (e.g., ambient temperature data) may provide information as to whether the drug <b>14</b> is at a safe temperature for storage and/or for delivery to a user, as a safe temperature (or safe temperature range) for the drug <b>14</b> is a known value. The sensor <b>26</b> being configured to gather temperature data (e.g., ambient temperature data) may provide information helpful for instances in which the sensing module <b>10</b> is being used in a clinical trial since monitoring temperature may help make sure the drug didn't undergo a temperature excursion that would throw off the clinical data. Correlating temperature data with a date/time may facilitate analysis of the patient's treatment using the drug <b>14</b> since the drug <b>14</b> being delivered when at or previously at an improper temperature may adversely affect the drug's efficacy.

0115Examples of a sensor <b>26</b> configured to gather sound (acoustic) data include an acoustic sensor, a microphone, and an accelerometer. The sensor <b>26</b> being configured to gather sound data may allow for detecting when the drug delivery process has begun and/or for detecting when drug delivery has been completed. Acoustic data can be indicative of when drug delivery has begun, e.g., by detected sound being indicative of the needle of the device <b>12</b> being advanced through spring or other mechanical action by being data within a predetermined frequency range and/or of a particular duration, by detected sound being indicative of a cap (not shown) being removed from the needle shield <b>20</b> by being data within a predetermined frequency range and/or of a particular duration, by detected sound (e.g., a “click” noise or other noise created by mechanical part(s)) being indicative of a trigger of a drug delivery device being manually depressed, by detected sound being indicative of a malfunction, etc. Similarly, acoustic data can be indicative of when drug delivery has stopped, e.g., by detected sound being indicative of the needle of the device <b>12</b> being retracted through spring or other mechanical action by being data within a predetermined frequency range and/or of a particular duration, by detected sound being indicative of the needle shield <b>20</b> advancing over the needle by being data within a predetermined frequency range and/or of a particular duration, by detected sound being indicative of a piston of the device <b>12</b> stopping movement through the container <b>16</b> to displace the drug <b>14</b> through the needle by being data within a predetermined frequency range and/or of a particular duration, by detected sound being indicative of a trigger of a drug delivery device being manually released, etc. Correlating sound data with a date/time may allow for more precise compliance analysis and/or may facilitate a determination that the drug <b>14</b> was delivered properly similar to that discussed above regarding vibration data.

0116Examples of a sensor <b>26</b> configured to gather motion data include a motion sensor, an accelerometer, a micro switch, a capacitive switch, an optical position switch, and a magnetic sensor. The sensor <b>26</b> being configured to gather motion data may allow for detecting when the drug delivery process has begun, for detecting when drug delivery has been completed, and/or for detecting premature removal of the device <b>12</b> from a patient before completion of drug delivery. The device <b>12</b> moving from a still state to a state of movement, as detected by the motion sensor, may be indicative of a possible start of a drug delivery process, e.g., by the device <b>12</b> being picked up by a user. If after the start of injection has been sensed, the sensor <b>26</b> detects motion prior to the sensor <b>26</b> sensing end of drug delivery and within a predetermined expected duration of drug delivery, it can be determined that the device <b>12</b> was lifted too early and that drug delivery therefore likely did not properly complete. The sensor <b>26</b> being configured to gather motion data may allow for detecting an orientation of the drug delivery device <b>12</b> during drug delivery to allow for determining whether the device <b>12</b> was in a proper orientation for injection, such as a proper position of an injector being in a vertical, substantially perpendicular orientation relative to the patient's skin versus an improper position of being at a non-perpendicular angle relative to the patient's skin. A date/time stamp of detected motion can be correlated with one or more other date/time stamped sensed parameters to determine whether the detected motion is actually indicative of the start of the drug delivery process as opposed to other motion, such as the device <b>12</b> being transported by a user. Correlating motion data with a date/time may thus allow for more precise compliance analysis and/or may facilitate a determination that the drug <b>14</b> was delivered properly similar to that discussed above regarding vibration data.

0117Examples of a sensor <b>26</b> configured to gather humidity data include a thermistor, a humistor, and a hygrometer. The sensor <b>26</b> being configured to gather humidity data may provide information as to whether the drug <b>14</b> is at a safe humidity level for storage and/or for delivery to a user, as a safe humidity level (or safe humidity level range) for the drug <b>14</b> is a known value. The sensor <b>26</b> being configured to gather humidity data may provide information helpful for instances in which the sensing module <b>10</b> is being used in a clinical trial since monitoring humidity may help make sure the drug didn't undergo a humidity excursion that would throw off the clinical data. Correlating humidity data with a date/time may facilitate analysis of the patient's treatment using the drug <b>14</b> similar to that discussed above regarding temperature.

0118Examples of a sensor <b>26</b> configured to gather pressure data include a pressure sensor and a Hall effect sensor. The sensor <b>26</b> being configured to gather pressure data may allow for detecting when drug delivery has begun by the sensing module <b>10</b> being positioned on the device <b>12</b> at a location where a user is likely to hold the device <b>12</b> for drug delivery. Thus, pressure on the sensing module <b>10</b> as detected by the pressure sensor can be indicative of the device <b>12</b> being held at a start of the drug delivery process. Similarly, pressure decreasing as detected by the pressure sensor can be indicative of the device <b>12</b> being released at an end of the drug delivery process. The sensor <b>26</b> being configured to gather pressure data may allow for detecting an altitude at which the drug delivery device <b>12</b> is located, as pressure (absolute or relative) can indicate an elevation above sea level. Different drugs may flow or perform differently at different altitudes, which gathered pressure data may allow to be identified. A date/time stamp of detected pressure can be correlated with one or more other date/time stamped sensed parameters to determine whether the detected pressure is actually indicative of the start of the drug delivery process as opposed to other pressure, such as the device <b>12</b> being transported by a user. Correlating pressure data with a date/time may allow for more precise compliance analysis and/or may facilitate a determination that the drug <b>14</b> was delivered properly similar to that discussed above regarding vibration data.

0119Examples of a sensor <b>26</b> configured to gather fluid level data include a non-contact water level switch (e.g., Doppler). The sensing device <b>10</b> in this illustrated embodiment is not attached to the device <b>12</b> at a position where fluid level of the drug <b>14</b> in the container <b>16</b> can be accurately gathered, but in other embodiments, a sensing device could be positioned relative to a container so as to be configured to accurately gather data regarding a level of fluid in the container.

0120Examples of a sensor <b>26</b> configured to gather force data include a forge gauge and a flexible force sensor. The sensor <b>26</b> being configured to gather force data may allow for detecting whether the device <b>12</b> is being held with sufficient force against the patient's skin during injection (which may be detected using one or more types of parameter data as discussed herein), which may help detect or explain injection failure if inadequate force was detected as compared to a predetermined force threshold that is known for proper injection.

0121Examples of a sensor <b>26</b> configured to gather location data include a location sensor such as a global positioning satellite (GPS) sensor. The location sensor can be part of a device already associated with the patient, such as a smart phone with location sensing capability. The sensor <b>26</b> being configured to gather location data may allow for other sensed parameter(s) to be accurately location stamped. The location stamping can thus facilitate identification of a geographic location where the drug <b>14</b> was delivered from the device <b>12</b> as indicated by one or more other parameter(s) sensed by the sensor <b>12</b>, as discussed further below. In this way, sensing location may facilitate evaluation of patient compliance with a predetermined drug delivery schedule, e.g., by allowing identification of locations where the patient is missing scheduled dose(s) and receiving scheduled dose(s).

0122Examples of a sensor <b>26</b> configured to gather proximity data include a proximity sensor (e.g., an optical sensor, a Hall effect sensor, etc.). The sensor <b>26</b> being configured to gather proximity data may allow for detecting that the device <b>12</b> is being held against skin when drug delivery begins, such as with an autoinjector or other injection device that is held against skin during drug delivery. If at a time/date of when a start of injection has been sensed, the sensor <b>26</b> detects a distance of the device <b>12</b> from skin that is above a predetermined threshold distance (or that is outside of a predetermined threshold distance range), it can be determined that the device <b>12</b> was not being held against skin when drug delivery started and that drug delivery therefore was not properly performed and/or that the full dose of drug was likely not delivered to the patient. The sensor <b>26</b> is at a known location on the drug delivery device <b>12</b> such that the sensor <b>26</b> will have a known distance from skin when the device <b>12</b> is being held properly against a skin surface for drug delivery, e.g., when the device <b>12</b> is being held normal to a skin surface. The predetermined threshold distance (or predetermined threshold distance range, which may account for one or more factors such as manufacturing tolerances) can thus be based on the known distance of the sensor <b>26</b> from skin. The sensor <b>26</b> being configured to gather proximity data may allow for detecting premature removal of the device <b>12</b> from a patient, e.g., from a skin surface of the patient such as with an autoinjector or other injection device, before completion of drug delivery. If after a start of injection has been sensed and before the end of injection has been sensed, the sensor <b>26</b> detects a distance of the device <b>12</b> from skin that is above a predetermined threshold distance (or that is outside of a predetermined threshold distance range), it can be determined that the device <b>12</b> was lifted too early, e.g., as indicated by the distance of the device <b>12</b> from skin being too high, and that drug delivery therefore likely did not properly complete. The sensor <b>26</b> being configured to gather proximity data may allow for confirming an end of drug delivery. In some instances it may be difficult to differentiate between an end of drug delivery and occurrence of another event that occurs very near the end of drug delivery. For example, a needle shield of an autoinjector can be deployed very near the end of drug delivery, such as the needle shield being automatically deployed in response to the drug delivery device being lifted up and removed from the patient's skin. A first spring of the autoinjector can cause the sensor <b>26</b> that includes a first sound sensor to detect a sound when injection of the drug is complete due to the first spring's involvement in needle deployment, and a second spring of the autoinjector cause the sensor <b>26</b> that includes a sound sensor to detect a second sound when injection has ended due to the second spring's involvement in deploying the needle shield when the autoinjector is lifted from skin. The first and second sounds can be close enough in time that it may be difficult to determine which of the first and second sounds began first. The proximity data can be used in combination with the sound data to determine whether the autoinjector was lifted from skin before drug delivery was complete, e.g., by allowing date/time stamped proximity data to be correlated with date/time stamped sound data.

0123Examples of a sensor <b>26</b> configured to gather spatial orientation data include an accelerometer, a tilt/angle switch (mercury free), and a position sensor. The sensor <b>26</b> being configured to gather spatial orientation data may allow for detecting the drug delivery device's orientation relative to ground. A particular spatial orientation of the device <b>12</b> may be known to correspond to a drug delivery position of the device <b>12</b>, e.g., when the device <b>12</b> is being held normal to a skin surface. Correlating spatial orientation data with a date/time may allow for more precise compliance analysis and/or may facilitate a determination that the drug <b>14</b> was delivered properly similar to that discussed above regarding vibration data. Correlating spatial orientation data with sound data and/or proximity data may allow for more precise compliance analysis and/or may facilitate a determination that the drug <b>14</b> was delivered properly, e.g., determining whether the full dose of the drug was injected (or otherwise delivered) and/or whether the drug delivery device was in the correct orientation when the drug was delivered (such as by being in a vertical, substantially perpendicular orientation relative to the patient's skin versus being at a non-perpendicular angle relative to the patient's skin).

0124<figref idref="DRAWINGS">FIGS. <b>5</b> and <b>6</b></figref> illustrate another embodiment of a sensing module <b>210</b> configured to gather data for one or more parameters related to drug delivery and to transmit data indicative of the gathered data to an external source configured to analyze the data received from the sensing module <b>210</b>. <figref idref="DRAWINGS">FIG. <b>6</b></figref> illustrates the sensing module <b>210</b> as a standalone element. The sensing module <b>210</b> is generally configured and used similar to the sensing module <b>10</b> of <figref idref="DRAWINGS">FIGS. <b>1</b> and <b>2</b></figref>. <figref idref="DRAWINGS">FIG. <b>5</b></figref> illustrates the sensing module <b>210</b> attached to another embodiment of a drug delivery device <b>212</b> configured to deliver a drug <b>214</b>, which is a clear liquid in this illustrated embodiment. The drug delivery device <b>212</b> in this illustrated embodiment is an autoinjector configured to inject the drug <b>214</b> from a container <b>216</b> in a housing <b>218</b> of the device <b>212</b> and out of a needle (obscured in <figref idref="DRAWINGS">FIG. <b>5</b></figref>) in response to manual depressing of a head <b>220</b> of the device <b>212</b> relative to the housing <b>218</b>. The drug delivery device <b>212</b> also includes a removable cap <b>208</b> configured to be removed from a remainder of the device <b>212</b> by a user to expose a needle shield of the device <b>212</b>.

0125The sensing module <b>210</b> is attached non-removably to an outer surface of the device <b>212</b>, although as mentioned above the sensing module <b>210</b> can instead be removably attached to the device <b>212</b>. The outer surface is an outer surface of the depressible head <b>220</b>, but the sensing module <b>210</b> can be attachable to another outer surface of the drug delivery device <b>210</b>, such as on the housing <b>218</b>, etc. The sensing module <b>210</b> can be attached anywhere on the head <b>220</b> but in this illustrated embodiment is attached to a top surface of the head <b>220</b>. The top surface of the head <b>220</b> is where a user typically applies pressure to the head <b>220</b> to depress the head <b>220</b> and cause drug delivery. The sensing module <b>210</b> is attached to the device <b>212</b> with an adhesive, e.g., a layer of an adhesive on the sensing module <b>210</b>, in this illustrated embodiment, but the sensing module <b>210</b> can be attached to a drug delivery device in other ways, as discussed above.

0126The sensing module <b>210</b> includes a variety of electronic components to facilitate the gathering of data and the transmission of gathered data to an external source similar to that discussed above regarding the sensing module <b>10</b> of <figref idref="DRAWINGS">FIGS. <b>1</b> and <b>2</b></figref>. <figref idref="DRAWINGS">FIGS. <b>7</b> and <b>8</b></figref> illustrate one embodiment of a PCB <b>224</b> supporting the sensing module's electronic components. The PCB <b>224</b> is a MetaWear sensor available from MbientLab of San Francisco, Calif. <figref idref="DRAWINGS">FIG. <b>6</b></figref> illustrates the PCB <b>224</b> attached to an underside of a base <b>222</b> configured to have the layer of adhesive thereon surrounding the PCB <b>224</b>.

0127As shown in <figref idref="DRAWINGS">FIGS. <b>7</b> and <b>8</b></figref>, the PCB <b>224</b> is rigid and includes a processor <b>226</b>, a memory <b>228</b>, a power source <b>230</b> in the form of a coin cell battery, a communication interface <b>232</b> configured to communicate using BLE, a motion sensor <b>234</b>, a pressure sensor <b>236</b> in the form of a push button, and an LED <b>238</b>. The PCB <b>224</b> also includes free real estate <b>240</b> for one or more additional sensors. The sensing module <b>210</b> being attached to the top surface of the head <b>220</b> allows the pressure sensor <b>236</b> to be pressed on when the head <b>220</b> is depressed manually by a user and for the pressure on the pressure sensor <b>236</b> to be released when the user removes pressure from the head <b>220</b>. The motion sensor <b>234</b> being on the head <b>220</b> facilitates motion being used as an indicator of the start of drug delivery since the head <b>220</b> is moved from its resting position (shown in <figref idref="DRAWINGS">FIG. <b>5</b></figref>) by being pressed down in a direction toward and relative to the housing <b>218</b> to start the drug delivery process. The motion sensor <b>234</b> being on the head <b>220</b> also facilitates motion being used as an indicator of the end of drug delivery since the head <b>220</b> stops moving relative to the housing <b>218</b> when the drug delivery process has ended.

0128<figref idref="DRAWINGS">FIG. <b>9</b></figref> illustrates another embodiment of a drug delivery device <b>242</b> with the sensing module <b>210</b> of <figref idref="DRAWINGS">FIG. <b>6</b></figref> attached thereto. The drug delivery device <b>242</b> in this illustrated embodiment is a safety syringe contained in a removable grip accessory <b>248</b> and is configured to inject a drug (obscured in <figref idref="DRAWINGS">FIG. <b>9</b></figref>) from a barrel <b>246</b> of the device <b>242</b> and out of a needle (obscured by a needle shield <b>250</b> of the grip accessory <b>248</b> in <figref idref="DRAWINGS">FIG. <b>9</b></figref>) in response to manual depressing of a plunger <b>244</b> of the device <b>242</b>.

0129<figref idref="DRAWINGS">FIGS. <b>10</b>-<b>13</b></figref> illustrate another embodiment of a sensing module <b>310</b> configured to gather data for one or more parameters related to drug delivery and to transmit data indicative of the gathered data to an external source configured to analyze the data received from the sensing module <b>310</b>. <figref idref="DRAWINGS">FIG. <b>13</b></figref> illustrates the sensing module <b>310</b> as a standalone element. The sensing module <b>310</b> is generally configured and used similar to the sensing module <b>10</b> of <figref idref="DRAWINGS">FIGS. <b>1</b> and <b>2</b></figref>. <figref idref="DRAWINGS">FIGS. <b>10</b>-<b>12</b></figref> illustrate the sensing module <b>310</b> attached to another embodiment of a drug delivery device <b>312</b> configured to deliver a drug (not shown). The drug delivery device <b>312</b> in this illustrated embodiment is an autoinjector configured to inject the drug from a container (not shown) in a housing <b>318</b> of the device <b>312</b> and out of a needle (not shown) in response to a needle shield <b>320</b> of the device <b>312</b> moving upward toward and into the housing <b>318</b>, e.g., by the needle shield <b>320</b> being pressed against a patient's skin. The drug delivery device <b>312</b> also includes a removable cap <b>308</b> configured to be removed from a remainder of the device <b>312</b> by a user to expose the needle shield <b>320</b>.

0130The sensing module <b>310</b> is attached non-removably to an outer surface of the device <b>312</b>, although as mentioned above the sensing module <b>310</b> can instead be removably attached to the device <b>312</b>. The outer surface is an outer surface of the housing <b>318</b>, but the sensing module <b>310</b> can be attachable to another outer surface of the drug delivery device <b>310</b> as discussed herein. The sensing module <b>310</b> can be attached anywhere on the housing <b>318</b> but in this illustrated embodiment is attached adjacent to the cap <b>308</b> to facilitate use of a tab <b>306</b> as a tamper resistant feature, as discussed further below. The sensing module <b>310</b> is attached to the device <b>312</b> with an adhesive, e.g., a layer of an adhesive on a bottom portion <b>322</b> of a housing of the sensing module <b>310</b>. However, as discussed herein, the sensing module <b>310</b> can be attached to a drug delivery device in other ways.

0131The sensing module <b>310</b> includes a variety of electronic components to facilitate the gathering of data and the transmission of gathered data to an external source similar to that discussed above regarding the sensing module <b>10</b> of <figref idref="DRAWINGS">FIGS. <b>1</b> and <b>2</b></figref>. The sensing module <b>310</b> includes a housing defined by the bottom housing portion <b>322</b> and a top housing portion <b>327</b> that are fixed together. A PCB <b>324</b>, shown in <figref idref="DRAWINGS">FIGS. <b>13</b> and <b>14</b></figref>, is disposed in the housing and supports the sensing module's electronic components. The PCB <b>324</b> in this illustrated embodiment is rigid, although as mentioned above may instead be flexible. The PCB <b>324</b> includes a processor <b>326</b>, a memory <b>328</b>, a communication interface <b>332</b> in the form of a chip antenna, switch contact pads <b>334</b>, a switch <b>336</b>, and free real estate <b>340</b> for one or more sensors.

0132A power source <b>330</b> is disposed within the housing and is configured to selectively provide power to one or more of the sensing module's electronic components, e.g., the processor <b>326</b>, sensor(s), etc. The power source <b>330</b> being configured to selectively provide power may help ensure that the power source <b>330</b> is not depleted of power before the drug is injected from the device <b>312</b> (e.g., because of a length of time the device <b>312</b> was stored before use) and/or may allow the power source <b>330</b> to be relatively small and/or inexpensive since power only need be provided for a relatively short duration of time during one-time use of the device <b>312</b> for drug delivery. The power source <b>330</b> is configured to not provide power when the tab <b>306</b> is coupled to the sensing module <b>310</b> and is configured to provide power when the tab <b>306</b> is not coupled to the sensing module <b>310</b>. The tab <b>306</b> is configured to move from a first position, in which the tab <b>306</b> is coupled to the sensing module <b>310</b> (corresponding to the power source <b>330</b> not providing power), to a second position, in which the tab <b>306</b> is not coupled to the sensing module <b>310</b> (corresponding to the power source <b>330</b> providing power). With the tab <b>306</b> in the first position, as shown in <figref idref="DRAWINGS">FIGS. <b>10</b>-<b>12</b></figref>, the tab <b>306</b> acts as an insulator to prevent the switch <b>336</b> from engaging the switch contact pads <b>334</b> (<figref idref="DRAWINGS">FIG. <b>14</b></figref>), thereby creating an open circuit that prevents the power source <b>330</b> from providing power to electronic components of the sensing module <b>310</b>. The electronic components are thus “off” as a result of not receiving power. The tab <b>306</b> is made from an insulating material, such as Mylar® or non-conductive, insulating material, to allow the tab <b>306</b> to act as an insulator. With the tab <b>306</b> in the second position, the switch <b>336</b> is allowed to engage the switch contact pads <b>334</b>, thereby creating a closed circuit that allows the power source <b>330</b> to provide power to electronic components of the sensing module <b>310</b>. The tab <b>306</b> is thus configured to “wake up” the sensing module <b>310</b> by moving from the first position to the second position. The sensing module's power source <b>330</b> may therefore not run out of power before the end of drug delivery since power will not begin being used until the tab <b>306</b> is removed, e.g., the power source <b>330</b> has zero shelf life power consumption.

0133The tab <b>306</b> can have a variety of sizes, shapes, and configurations. In this illustrated embodiment, the tab <b>306</b> has a first, lower portion located outside of the sensing module <b>310</b> and attached to the cap <b>308</b>, such as by being adhered thereto with adhesive or other attachment mechanism. The tab <b>306</b> has a second, upper portion extending from the first portion and extending into the sensing module <b>310</b>, e.g., into the housing of the sensing module <b>310</b>. The second portion of the tab <b>306</b> is positioned so as to prevent the switch <b>336</b> from engaging the switch contact pads <b>334</b>. In this way, when the tab <b>306</b> is removed from the sensing module <b>310</b> and is no longer located within the housing <b>318</b>, the tab <b>306</b> no longer prevents the switch <b>336</b> from engaging the switch contact pads <b>334</b>, e.g., closing the open circuit that exists when the tab <b>306</b> is in the first position.

0134The tab <b>306</b> being attached to the cap <b>308</b> facilitates movement of the tab <b>306</b> from the first position to the second position. When the cap <b>308</b> is manually removed by a user from a remainder of the drug delivery device <b>312</b>, the tab <b>306</b> attached thereto is also removed from the remainder of the drug delivery device <b>312</b>, thereby also de-coupling the tab <b>306</b> from the sensing module <b>310</b> that is attached to the drug delivery device <b>312</b>. The tab <b>306</b> is thus configured to move from the first position to the second position in response to removal of the cap <b>308</b>. A user therefore need not take any special action to activate the power source <b>330</b>, e.g., cause the power source <b>330</b> to start providing power, since cap <b>308</b> removal is a normal part of using the device <b>312</b>. In other words, when the cap <b>308</b> is pulled off the housing <b>318</b>, the tab <b>306</b> is pulled out of the sensing module <b>310</b> to move from the first position to the second position.

0135As in this illustrated embodiment, the tab <b>306</b> can be configured as a tamper resistant feature. The tab <b>306</b> being absent but the cap <b>308</b> being on the drug delivery device <b>308</b> may be evidence of tampering, e.g., evidence that the cap <b>308</b> was removed at some prior time and then replaced back on the device <b>312</b>. Similarly, the tab <b>306</b> being attached to the cap <b>308</b> without the tab's second portion located in the housing of the sensing module <b>310</b> may be indicative of tampering, evidence that the cap <b>308</b> was removed at some prior time and then replaced back on the device <b>312</b>.

0136<figref idref="DRAWINGS">FIGS. <b>15</b> and <b>16</b></figref> illustrate another embodiment of a sensing module <b>410</b> configured to gather data for one or more parameters related to drug delivery and to transmit data indicative of the gathered data to an external source configured to analyze the data received from the sensing module <b>410</b>. <figref idref="DRAWINGS">FIGS. <b>15</b> and <b>16</b></figref> illustrate the sensing module <b>410</b> as a standalone element. The sensing module <b>410</b> is generally configured and used similar to the sensing module <b>10</b> of <figref idref="DRAWINGS">FIGS. <b>1</b> and <b>2</b></figref>. <figref idref="DRAWINGS">FIGS. <b>17</b> and <b>18</b></figref> show another embodiment of a drug delivery device <b>412</b> configured to deliver a drug (obscured in <figref idref="DRAWINGS">FIGS. <b>17</b> and <b>18</b></figref>) and having the sensing module <b>410</b> attached thereto. The drug delivery device <b>412</b> in this illustrated embodiment is an autoinjector configured to inject the drug from a container (obscured in <figref idref="DRAWINGS">FIGS. <b>17</b> and <b>18</b></figref>) in a housing <b>418</b> of the device <b>412</b> and out of a needle (not shown) in response to manual actuation by a user of a trigger <b>420</b> of the device <b>412</b>. The drug delivery device <b>412</b> also includes a removable cap <b>408</b> configured to be removed from a remainder of the device <b>412</b> by a user to expose the needle.

0137The sensing module <b>410</b> is obscured in <figref idref="DRAWINGS">FIGS. <b>17</b> and <b>18</b></figref> because the sensing module <b>410</b> is on an outer surface of the housing <b>418</b> but is disposed under an outer boot <b>402</b> of the drug delivery device <b>412</b>. The sensing module <b>410</b> being disposed under the outer boot <b>402</b> of the drug delivery device <b>412</b> may help protect the sensing module <b>410</b> from damage by, e.g., helping to prevent the sensing module <b>410</b> from coming into contact with liquid, providing a protective layer over the sensing module <b>410</b> that may provide protection in the event that the device <b>412</b> is dropped, etc. The outer boot <b>402</b> is rubber in this illustrated embodiment, which may facilitate user gripping of the device <b>412</b>, ease attachment of the outer boot <b>402</b> to the housing <b>418</b> easier by stretching over the housing <b>418</b>, ensure a secure connection to the housing <b>418</b> by stretching to accommodate the size and shape of the housing <b>418</b>, and/or enhance crash protection of the sensing module <b>410</b>, but the outer boot <b>402</b> can be made of other materials. The sensing module <b>410</b> being disposed within the outer boot <b>402</b> may facilitate attachment of the sensing module <b>410</b> to an outer surface of the housing <b>418</b>. After the drug delivery device <b>412</b> is otherwise manufactured, the sensing module <b>410</b> can be positioned outside the housing <b>418</b> and coupled to the housing <b>418</b> by the outer boot <b>402</b> being placed over the sensing module <b>410</b>. In other embodiments, the sensing module <b>410</b> can be located on an exterior surface of the outer boot <b>402</b>, which may facilitate retrofitting of the sensing module <b>410</b> onto an existing drug delivery device, and/or can be located in the outer boot <b>402</b>, e.g., embedded therein.

0138The sensing module <b>410</b> includes a variety of electronic components to facilitate the gathering of data and the transmission of gathered data to an external source similar to that discussed above regarding the sensing module <b>10</b> of <figref idref="DRAWINGS">FIGS. <b>1</b> and <b>2</b></figref>. The electronic components are located at an end <b>414</b> of the drug delivery device <b>412</b> that is opposite to the end with the cap <b>408</b>. The sensing module <b>410</b> includes a PCB <b>424</b> that includes a processor <b>426</b>, a memory (not shown), a communication interface <b>432</b> in the form of a Bluetooth module, and a sensor <b>434</b>. As shown in <figref idref="DRAWINGS">FIGS. <b>15</b>, <b>16</b>, and <b>19</b></figref>, the sensing module <b>410</b> also includes a receiver coil <b>440</b> configured to facilitate communication using the communication interface <b>432</b>, a power source <b>430</b> in the form of a coin cell battery, and a flexible circuit <b>436</b>. The receiver coil <b>440</b> can also facilitate wireless charging of the power source <b>430</b>. The circuit <b>436</b> being flexible may facilitate smooth, close positioning of the circuit <b>436</b> along a longitudinal length of an outer surface of the housing <b>418</b> (as shown in <figref idref="DRAWINGS">FIG. <b>17</b></figref>), which may be curved or have surface features thereon that the flexibility may accommodate. In other embodiments, however, the circuit <b>436</b> can be rigid.

0139As shown in <figref idref="DRAWINGS">FIG. <b>18</b>A</figref>, an end cap <b>442</b> is positioned over the portion of the sensing module <b>410</b> at the end <b>414</b> of the device <b>412</b>. The end cap <b>442</b> is configured to provide protection for the sensing module <b>410</b>.

0140The power source <b>430</b> is configured to selectively provide power to one or more of the sensing module's electronic components, e.g., the processor <b>426</b>, the communication interface <b>432</b>, the sensor <b>434</b>, etc., similar to that discussed above regarding the power source <b>330</b> of <figref idref="DRAWINGS">FIG. <b>13</b></figref>. The power source <b>430</b> is configured to not provide power when a tab <b>406</b> is coupled to the sensing module <b>410</b> and is configured to provide power when the tab <b>406</b> is torn or is not coupled to the sensing module <b>410</b>. The tab <b>406</b> is shown coupled to the sensing module <b>410</b> in <figref idref="DRAWINGS">FIGS. <b>15</b>-<b>17</b> and <b>20</b></figref> (and <figref idref="DRAWINGS">FIG. <b>18</b></figref>, although the tab <b>406</b> is obscured in <figref idref="DRAWINGS">FIG. <b>18</b></figref>) and is shown as a standalone element in <figref idref="DRAWINGS">FIG. <b>21</b></figref>. The tab <b>406</b> is configured to move from a first position, in which the tab <b>406</b> is coupled to the sensing module <b>410</b> (corresponding to the power source <b>430</b> not providing power), to a second position, in which the tab <b>406</b> is torn or is not coupled to the sensing module <b>410</b> (corresponding to the power source <b>430</b> providing power). With the tab <b>406</b> in the first position, the tab <b>406</b> prevents the flexible circuit <b>436</b> from electrically connecting the power source <b>430</b> with the electronic components of the PCB <b>424</b> by interrupting current flow, which prevents the power source <b>430</b> from providing power to the electronic components of the PCB <b>424</b>. With the tab <b>406</b> in the second position, the flexible circuit <b>436</b> electrically connects the power source <b>430</b> with the electronic components of the PCB <b>424</b> by allowing current flow, which allows the power source <b>430</b> to provide power to the electronic components of the PCB <b>424</b>. The tab <b>406</b> is thus configured to “wake up” the sensing module <b>410</b> by moving from the first position to the second position. The sensing module's power source <b>430</b> may therefore not run out of power before the end of drug delivery since power will not begin being used until the tab <b>406</b> is removed, e.g., the power source <b>430</b> has zero shelf life power consumption.

0141Similar to that discussed above regarding the tab <b>306</b> of <figref idref="DRAWINGS">FIG. <b>13</b></figref>, the tab <b>406</b> is configured to be removed from the sensing module <b>410</b>, e.g., to move from the first position to the second position, in response to removal of the cap <b>408</b> by a user. The tab <b>406</b> has a first, lower portion located outside of the sensing module <b>410</b> and attached to the cap <b>408</b>, such as by being adhered thereto with adhesive and/or other attachment mechanism. The tab <b>406</b> has a second, upper portion extending from the first portion and extending into contact with the flexible circuit <b>436</b> of the sensing module <b>410</b>. The second portion of the tab <b>406</b> extends along an outer surface of the housing <b>418</b>. The second portion of the tab <b>406</b> is attached to the outer surface of the housing <b>418</b> with an adhesive and/or other attachment mechanism. In this illustrated embodiment, when the cap <b>408</b> is pulled off the housing <b>418</b>, the tab <b>406</b> is configured to tear, e.g., at a junction between the first and second portions of the tab <b>406</b>, to move from the first position to the second position.

0142As shown in <figref idref="DRAWINGS">FIGS. <b>15</b>-<b>17</b>, <b>20</b>, and <b>21</b></figref>, the tab <b>406</b> includes a conductive trace <b>404</b> thereon. The conductive trace <b>404</b> can be provided in a variety of ways, such as with conductive ink or conductive tape. In this illustrated embodiment the conductive trace <b>404</b> is formed with conductive ink printed on the tab <b>406</b>, which can be paper or other material. With the tab <b>406</b> in the first position, the conductive trace <b>404</b> is coupled to the flexible circuit <b>436</b> of the sensing module <b>710</b> to form a circuit that prevents the flexible circuit <b>436</b> from electrically connecting the power source <b>430</b> to the PCB <b>424</b>, e.g., by a pin of the sensing module's processor reading zero volts due to the tab <b>406</b> interrupting current flow such that the processor is not receiving electrical power and thus cannot register any voltage. With the tab <b>406</b> in the second position, the conductive trace <b>404</b> is not coupled to flexible circuit <b>436</b>, so the conductive trace <b>404</b> no longer forms a circuit with the flexible circuit <b>436</b>. The flexible circuit <b>436</b> is thereby allowed to complete a circuit between the power source <b>430</b> and the PCB <b>424</b>, e.g., by the pin of the sensing module's processor reading non-zero volts (e.g., one volt), to allow the power source <b>430</b> to start providing power to the electronic components of the PCB <b>424</b>. As shown in <figref idref="DRAWINGS">FIG. <b>20</b></figref>, a connector <b>438</b> is provided to facilitate electrical connection between the flexible circuit <b>436</b> and the conductive trace <b>404</b> when the tab <b>406</b> is in the first position. The connector <b>438</b> is shown as a standalone element in <figref idref="DRAWINGS">FIG. <b>22</b></figref>. As shown in <figref idref="DRAWINGS">FIG. <b>22</b></figref>, the connector <b>438</b> includes two conductive terminals, which connect to the flexible circuit <b>436</b> and that are connected together by the conductive trace <b>404</b> until the tab <b>406</b> is torn or de-coupled from the sensing module <b>410</b>, e.g., until the tab <b>406</b> moves from the first position to the second position.

0143<figref idref="DRAWINGS">FIG. <b>19</b></figref> illustrates one embodiment of positioning the flexible circuit <b>436</b> relative to the power source <b>430</b> and PCB <b>424</b>. The flexible circuit <b>436</b> in this “two-layer” embodiment has a portion positioned between the PCB <b>424</b> and electronic components thereon and wraps around the PCB <b>424</b> to have another portion positioned between the PCB <b>424</b> and the power source <b>430</b>. <figref idref="DRAWINGS">FIG. <b>23</b></figref> illustrates another embodiment of positioning the flexible circuit <b>436</b> relative to the power source <b>430</b> and PCB <b>424</b>. The flexible circuit <b>436</b> in this “one-layer” embodiment has a portion positioned below the electronic components on the PCB <b>424</b> and wraps around both the electronic components and the PCB <b>424</b> to have another portion positioned between the PCB <b>424</b> and the power source <b>430</b>. The “one-layer” configuration or “two-layer” configuration may be easier to manufacture depending on the particular configuration of the PCB <b>424</b> and electronic components thereon.

0144<figref idref="DRAWINGS">FIGS. <b>24</b> and <b>25</b></figref> illustrate another embodiment of a drug delivery device <b>512</b> with the sensing module <b>410</b> of <figref idref="DRAWINGS">FIG. <b>15</b></figref> and another embodiment of a tab <b>506</b> coupled thereto. The tab <b>506</b> is the same as the tab <b>406</b> of <figref idref="DRAWINGS">FIG. <b>15</b></figref> except that the tab <b>506</b> has a shorter longitudinal length. The sensing module <b>410</b> is non-removably attached to the device <b>512</b> similar to its non-removable attachment to the drug delivery device <b>412</b> of <figref idref="DRAWINGS">FIGS. <b>17</b> and <b>18</b></figref>. The sensing module <b>410</b> is disposed on an outer surface of the housing <b>518</b> and under an outer boot <b>502</b> similar to its disposal under the outer boot <b>402</b> of <figref idref="DRAWINGS">FIGS. <b>17</b> and <b>18</b></figref>, although as mentioned above the sensing module <b>410</b> can instead be on an outer surface of the outer boot <b>502</b> or be within the outer boot <b>502</b>. The device <b>512</b> of <figref idref="DRAWINGS">FIGS. <b>24</b> and <b>25</b></figref> is the same as the device <b>412</b> of <figref idref="DRAWINGS">FIGS. <b>17</b></figref> and <b>18</b> except that in the illustrated embodiment of <figref idref="DRAWINGS">FIGS. <b>24</b> and <b>25</b></figref> the outer boot <b>502</b> has a longer longitudinal length than the outer boot <b>402</b> of <figref idref="DRAWINGS">FIGS. <b>17</b> and <b>18</b></figref>. The outer boot <b>502</b> of <figref idref="DRAWINGS">FIGS. <b>24</b> and <b>25</b></figref> extends along an entire longitudinal length of the drug delivery device's housing <b>518</b> and terminates just proximal to the cap <b>508</b>. The outer boot <b>502</b> extending along the housing's entire longitudinal length may allow for a shorter tab <b>506</b> (e.g., less longitudinal length) than may be used with an outer boot, such as the outer boot <b>402</b> of <figref idref="DRAWINGS">FIGS. <b>17</b> and <b>18</b></figref>, that extends along only a partial longitudinal length of the device's housing. A shorter tab <b>506</b> may facilitate de-coupling of the tab's conductive trace, e.g., from the flexible circuit <b>436</b>.

0145<figref idref="DRAWINGS">FIGS. <b>26</b> and <b>27</b></figref> illustrate another embodiment of a drug delivery device <b>612</b> with the sensing module <b>410</b> of <figref idref="DRAWINGS">FIG. <b>15</b></figref> and another embodiment of a tab <b>606</b> coupled thereto. The tab <b>606</b> is the same as the tab <b>406</b> of <figref idref="DRAWINGS">FIG. <b>15</b></figref> except that the tab <b>606</b> has a longer longitudinal length. The tab <b>606</b> also has a longer length than the tab <b>506</b> of <figref idref="DRAWINGS">FIG. <b>24</b></figref>. The sensing module <b>410</b> is non-removably attached to the device <b>612</b> similar to its non-removable attachment to the drug delivery device <b>412</b> of <figref idref="DRAWINGS">FIGS. <b>17</b> and <b>18</b></figref>. The sensing module <b>410</b> is disposed on an outer surface of a housing <b>618</b> of the drug delivery device <b>612</b> and under an outer boot <b>602</b> similar to its disposal under the outer boot <b>402</b> of <figref idref="DRAWINGS">FIGS. <b>17</b> and <b>18</b></figref>, although as mentioned above the sensing module <b>410</b> can instead be on an outer surface of the outer boot <b>602</b> or be within the outer boot <b>602</b>. The device <b>612</b> of <figref idref="DRAWINGS">FIGS. <b>26</b> and <b>27</b></figref> is the same as the device <b>412</b> of <figref idref="DRAWINGS">FIGS. <b>17</b> and <b>18</b></figref> except that in the illustrated embodiment of <figref idref="DRAWINGS">FIGS. <b>26</b> and <b>27</b></figref> the outer boot <b>602</b> has a shorter longitudinal length than the outer boot <b>402</b> of <figref idref="DRAWINGS">FIGS. <b>17</b> and <b>18</b></figref>. The outer boot <b>602</b> also has a shorter longitudinal length than the outer boot <b>502</b> of <figref idref="DRAWINGS">FIGS. <b>24</b> and <b>25</b></figref>. The outer boot <b>602</b> of <figref idref="DRAWINGS">FIGS. <b>26</b> and <b>27</b></figref> extends along only a partial longitudinal length of the drug delivery device's housing <b>618</b> and terminates proximal to the device's cap <b>608</b> and to the device's trigger <b>620</b>. The outer boot <b>602</b> extending along a relatively short length of the housing's longitudinal length may allow for a shorter flexible circuit of the sensing module than may be used with an outer boot, such as the outer boots <b>402</b>, <b>502</b> of <figref idref="DRAWINGS">FIGS. <b>17</b>, <b>18</b>, <b>24</b>, and <b>25</b></figref> that extend along a longer longitudinal length of the device's housing. A shorter flexible circuit and shorter outer boot may lower manufacturing cost.

0146<figref idref="DRAWINGS">FIGS. <b>28</b> and <b>29</b></figref> illustrate another embodiment of a drug delivery device <b>712</b> with another embodiment of a sensing module <b>710</b> (<figref idref="DRAWINGS">FIG. <b>30</b></figref>) attached thereto. The sensing module <b>710</b> is generally configured and used similar to the sensing module <b>10</b> of <figref idref="DRAWINGS">FIGS. <b>1</b> and <b>2</b></figref>. The drug delivery device <b>712</b> in this illustrated embodiment is a jet autoinjector configured and used similar to the jet injector discussed above with respect to <figref idref="DRAWINGS">FIGS. <b>17</b> and <b>18</b></figref>. The device <b>712</b> is configured to inject the drug from a container (obscured in <figref idref="DRAWINGS">FIGS. <b>28</b> and <b>29</b></figref>) in a housing <b>718</b> of the device <b>712</b> and out of a needle (not shown) in response to manual actuation by a user of a trigger <b>720</b> of the device <b>712</b>. The drug delivery device <b>712</b> also includes a removable cap <b>708</b> configured to be removed from a remainder of the device <b>712</b> by a user to expose the needle. The device <b>712</b> also includes an outer boot <b>702</b> disposed over the sensing module <b>710</b> similar to the sensor module's disposal under the outer boot <b>402</b> of <figref idref="DRAWINGS">FIGS. <b>17</b> and <b>18</b></figref>, although as mentioned above the sensing module <b>710</b> can instead be on an outer surface of the outer boot <b>702</b> or be within the outer boot <b>702</b>. The sensing module <b>710</b> is shown as a standalone element in <figref idref="DRAWINGS">FIG. <b>30</b></figref> with another embodiment of a tab <b>706</b> coupled thereto. The tab <b>706</b> is shown as a standalone element in <figref idref="DRAWINGS">FIG. <b>31</b></figref>. The tab <b>706</b> is the same as the tab <b>406</b> of <figref idref="DRAWINGS">FIG. <b>15</b></figref> except that the tab <b>706</b> has a different size and shape at least at its proximal end to interface properly with the sensing module <b>710</b>, e.g., with a flexible circuit <b>736</b> thereof. Also, a conductive trace <b>704</b> is provided on the tab <b>706</b> using conductive tape in this illustrated embodiment.

0147The sensing module <b>710</b> is similar to the sensing module <b>410</b> of <figref idref="DRAWINGS">FIG. <b>15</b></figref>. The sensing module's electronic components are located at an end <b>714</b> of the drug delivery device <b>712</b> that is opposite to the end with the cap <b>708</b>. However, unlike the device <b>412</b> of <figref idref="DRAWINGS">FIGS. <b>17</b> and <b>18</b></figref>, the device <b>512</b> of <figref idref="DRAWINGS">FIGS. <b>27</b> and <b>28</b></figref>, and the device <b>612</b> of <figref idref="DRAWINGS">FIGS. <b>26</b> and <b>27</b></figref>, the device end <b>714</b> is not protruding, e.g., does not have an enlarged diameter compared to the drug delivery device's housing. A protruding end may help indicate that a drug delivery device has a sensing module attached thereto. Not having a protruding end may allow a drug delivery device to have a more aesthetically appealing profile.

0148As shown in <figref idref="DRAWINGS">FIG. <b>32</b></figref>, the sensing module <b>710</b> in this illustrated embodiment has a “one-layer” configuration similar to that discussed above with respect to <figref idref="DRAWINGS">FIG. <b>23</b></figref>. The flexible circuit <b>736</b> extends from the tab <b>706</b> to have a portion positioned below the electronic components on the sensing module's PCB <b>724</b> and wraps around both the PCB <b>724</b> and the electronic components on the PCB <b>724</b> to have another portion positioned between the PCB <b>724</b> and the sensing module's power source <b>730</b>. The power source <b>730</b> in this illustrated embodiment is a coin cell battery. The sensing module <b>710</b> also includes a receiver coil <b>740</b> similar to the receiver coil <b>440</b> of <figref idref="DRAWINGS">FIG. <b>19</b></figref>.

0149The sensing module <b>710</b> in this illustrated embodiment includes an LED on the PCB <b>724</b>. As shown in <figref idref="DRAWINGS">FIG. <b>33</b></figref>, light emitted from the LED is configured to be visible through the outer boot <b>702</b>. As mentioned above, the light can be used to indicate various conditions as programmed for the sensing module's processor, such as sensing status of the sensing module <b>710</b> (e.g., light on when the sensing module's sensor(s) are gathering data and light off when the sensor(s) are not gathering data), to show power status of the sensing module <b>710</b> (e.g., light on when the power source <b>730</b> is providing power, corresponding to the tab <b>706</b> being in its second position as having been removed, and light off when the power source <b>730</b> is not providing power, corresponding to the tab <b>706</b> being in its first position as being coupled to the sensing module <b>710</b>).

0150As shown in <figref idref="DRAWINGS">FIG. <b>30</b></figref>, the flexible circuit <b>736</b> in this illustrated embodiment includes a guide marker <b>738</b> thereon. The guide marker <b>738</b> is configured to help guide placement of the tab <b>706</b> relative to the flexible circuit <b>736</b> during manufacturing to help ensure that the tab's conductive trace <b>704</b> is properly electronically coupled to the flexible circuit <b>736</b>.

0151<figref idref="DRAWINGS">FIG. <b>34</b></figref> shows the sensing module <b>710</b> and the tab <b>706</b> attached to the device <b>712</b> before an end cap <b>742</b> (<figref idref="DRAWINGS">FIG. <b>35</b></figref>) is attached to the device <b>712</b> to provide protection for the sensing module <b>710</b>. A bottom of the sensing module <b>710</b> is attached to a top of the device <b>712</b>, e.g., a top outer surface of the housing <b>718</b>. To facilitate this attachment, the sensing module <b>710</b> includes an adhesive layer <b>744</b> on a bottom thereof, as shown in <figref idref="DRAWINGS">FIGS. <b>30</b> and <b>32</b></figref>. The adhesive layer <b>744</b> includes adhesive tape in this illustrated embodiment but can have other forms. The outer boot <b>702</b> is put into position over the device <b>712</b> as illustrated in <figref idref="DRAWINGS">FIG. <b>35</b></figref> to result in the device <b>712</b> of <figref idref="DRAWINGS">FIGS. <b>28</b> and <b>29</b></figref>. The outer boot <b>702</b> can be configured to hold the end cap <b>742</b> in place, but in some embodiments, an adhesive and/or other attachment mechanism can be used to help hold the end cap <b>742</b> to the sensing module <b>710</b> before application of the outer boot <b>702</b> and/or an adhesive and/or other attachment mechanism can be used to help hold the end cap <b>742</b> to the outer boot <b>702</b> after the end cap's placement over the sensing module <b>710</b>. In this illustrated embodiment the outer boot <b>702</b> has a window <b>750</b> (<figref idref="DRAWINGS">FIG. <b>28</b></figref>) formed therein as a hole to allow for visualization of the tab <b>706</b> therethrough to help ensure proper alignment of the tab <b>706</b> with respect to the flexible circuit <b>736</b>.

0152<figref idref="DRAWINGS">FIGS. <b>36</b> and <b>37</b></figref> illustrate another embodiment of a drug delivery device <b>812</b> with another embodiment of a tab <b>806</b> attached thereto. The tab <b>806</b> includes a conductive trace <b>804</b> and is configured and used similar to other embodiments of tabs discussed above. The tab <b>806</b> is configured to couple to a sensing module, e.g., a flexible circuit thereof, similar to that discussed above with respect to other embodiments of tabs. The tab <b>806</b> is configured to move from a first position, in which the tab <b>806</b> is coupled to the sensing module (corresponding to a power source of the sensing module not providing power), to a second position, in which the tab <b>806</b> is torn or is not coupled to the sensing module (corresponding to the sensing module's power source providing power). With the tab <b>806</b> in the first position, which is shown in <figref idref="DRAWINGS">FIG. <b>36</b></figref>, the tab <b>806</b> prevents the flexible circuit from electrically connecting the power source with the sensing module's electronic components, which prevents the power source from providing power thereto. With the tab <b>806</b> in the second position, which is shown in <figref idref="DRAWINGS">FIG. <b>37</b></figref>, the flexible circuit electrically connects the power source with the electronic components of the sensing module, which allows the power source to provide power thereto. The tab <b>806</b> is thus configured to “wake up” the sensing module by moving from the first position to the second position. The sensing module's power source may therefore not run out of power before the end of drug delivery since power will not begin being used until the tab <b>806</b> is removed, e.g., the power source has zero shelf life power consumption.

0153In the illustrated embodiment of <figref idref="DRAWINGS">FIGS. <b>36</b> and <b>37</b></figref>, a first, lower portion of the tab <b>806</b> is attached to a trigger <b>820</b> of the drug delivery device <b>812</b>, and a second, upper portion of the tab <b>806</b> is attached to a housing <b>818</b> of the drug delivery device <b>812</b>. The conductive trace <b>804</b> is present on both of the first and second portions of the tab <b>806</b>. When the trigger <b>820</b> is manually pressed by a user to cause drug delivery, the depression of the trigger causes the tab <b>806</b> to tear to separate the first and second portions of the tab <b>806</b> from one another and thereby cause a break in the conductive trace <b>804</b> and the tab <b>806</b> to move from the first position to the second position.

0154In some embodiments, the tab can include a sensor configured to gather motion data. The sensor configured to gather motion can include a communication interface configured to transmit data to an external source as discussed above and/or the sensor can be configured to transmit gathered data to a processor of the sensing module for communication to an external source via the sensing module's communication interface. For example, the tab <b>806</b> of <figref idref="DRAWINGS">FIGS. <b>36</b> and <b>37</b></figref> can include a sensor configured to detect motion of the trigger <b>820</b>, which may allow for detecting when drug delivery has begun, e.g., by detected motion of the trigger <b>820</b> being pressed, and/or for detecting when drug delivery has been completed, e.g., by detected motion of the trigger <b>820</b> being released after being pressed.

0155Whether or not the tab <b>806</b> includes a sensor configured to gather motion data, the tab <b>806</b> in some embodiments can include a magnet on the first portion thereof and a Hall effect sensor can be attached to the drug delivery device housing <b>818</b>. The Hall effect sensor can thus be configured to detect movement of the trigger <b>820</b> since the magnet will move with the trigger <b>820</b> during depression of the trigger <b>820</b> and during release of the trigger <b>820</b>. In some embodiments, instead of being attached to the tab <b>806</b>, the magnet can be attached elsewhere with or without the tab <b>806</b> being used with the device <b>812</b>. For example, a sensing module such as the sensing module <b>210</b> of <figref idref="DRAWINGS">FIG. <b>6</b></figref> can include the Hall effect sensor and be attached to the housing <b>818</b>.

0156<figref idref="DRAWINGS">FIG. <b>38</b></figref> illustrates another embodiment of the drug delivery device <b>312</b> of <figref idref="DRAWINGS">FIGS. <b>10</b>-<b>12</b></figref> with another embodiment of a sensing module <b>910</b> attached thereto. The sensing module <b>910</b> is attached non-removably to an outer surface of the device <b>312</b>, although as mentioned above the sensing module <b>910</b> can instead be removably attached to the device <b>312</b>. The outer surface is an outer surface of the drug delivery device's housing <b>318</b>, but the sensing module <b>910</b> can be attachable to another outer surface of the drug delivery device <b>312</b> as discussed herein. The sensing module <b>910</b> is attached to the device <b>312</b> with an adhesive, e.g., a layer of an adhesive on a bottom portion of a housing <b>925</b> of the sensing module <b>910</b>. However, as discussed herein, the sensing module <b>910</b> can be attached to a drug delivery device in other ways. The sensing module <b>910</b> can be attached anywhere on the housing <b>318</b> but in this illustrated embodiment is attached adjacent to the drug delivery device's cap <b>308</b> to facilitate use of a tab <b>906</b>. The tab <b>906</b> is shown as a standalone element in <figref idref="DRAWINGS">FIG. <b>41</b></figref>. The tab <b>906</b> is the same as the tab <b>306</b> of <figref idref="DRAWINGS">FIG. <b>13</b></figref> except that the tab <b>906</b> has a different size and shape at least at its proximal end to interface properly with the sensing module <b>910</b>, as discussed further below. Also, a conductive trace <b>904</b> is provided on the tab <b>906</b> in this illustrated embodiment.

0157The sensing module <b>910</b> is generally configured and used similar to the sensing module <b>310</b> of <figref idref="DRAWINGS">FIGS. <b>10</b>-<b>13</b></figref>. In this illustrated embodiment, the housing <b>925</b> of the sensing module <b>910</b> is longer than the housing of the sensing module <b>310</b> and thus extends along more of the drug delivery device's longitudinal length than the housing of the sensing module <b>310</b>. The longer housing <b>925</b> provides more space within the housing <b>925</b> for components of the sensing module <b>910</b>. The sensing module <b>910</b> may thus have one or more enhanced features than a smaller sensing module, such as the sensing module <b>310</b> of <figref idref="DRAWINGS">FIGS. <b>10</b>-<b>13</b></figref>, such as greater processing capability (e.g., by having a larger processor and/or a greater number of processors for more processing capability than a smaller processor), more available memory storage (e.g., by having a larger memory and/or a greater number of memories for greater maximum storage than a smaller memory), more available power (e.g., by having a larger power source and/or a greater number of power sources for more available on-board power), greater communication capability (e.g., by a having a more robust communication interface and/or a greater number of communication interfaces for more range and/or for a greater number of available wireless techniques), etc.

0158The sensing module <b>910</b> includes a variety of electronic components to facilitate the gathering of data and the transmission of gathered data to an external source similar to that discussed above regarding the sensing module <b>310</b> of <figref idref="DRAWINGS">FIGS. <b>10</b>-<b>13</b></figref>. As shown in <figref idref="DRAWINGS">FIGS. <b>39</b> and <b>40</b></figref>, the sensing module <b>910</b> includes a PCB <b>924</b> that includes a processor <b>926</b>, a memory <b>928</b>, a communication interface <b>930</b>, a sensor <b>934</b>, a receiver coil <b>940</b>, and first and second contact pads <b>934</b><i>a</i>, <b>934</b><i>b</i>. The PCB <b>924</b> is disposed in the sensing module's housing <b>925</b> similar to that discussed above regarding the sensing module <b>310</b> of <figref idref="DRAWINGS">FIG. <b>13</b></figref>. The sensing module <b>910</b> also includes a power source in the form of first and second coin cell batteries <b>930</b><i>a</i>, <b>930</b><i>b</i>. The first and second power sources <b>930</b><i>a</i>, <b>930</b><i>b </i>are configured to operatively engage the first and second contact pads <b>934</b><i>a</i>, <b>934</b><i>b</i>, respectively, as discussed further below. The sensing module <b>910</b> including two power sources <b>930</b><i>a</i>, <b>903</b><i>b </i>may allow for the sensing module <b>910</b> to have more available on-board power than other sensing modules that include only one power source.

0159The power source <b>930</b><i>a</i>, <b>930</b><i>b </i>is configured to selectively provide power to one or more of the sensing module's electronic components, e.g., the processor <b>926</b>, the communication interface <b>932</b>, the sensor <b>934</b>, etc., similar to that discussed above regarding the power source <b>330</b> of <figref idref="DRAWINGS">FIG. <b>13</b></figref>. The power source <b>930</b><i>a</i>, <b>930</b><i>b </i>is configured to not provide power when the tab <b>906</b> is coupled to the sensing module <b>910</b> and is configured to provide power when the tab <b>906</b> is torn or is not coupled to the sensing module <b>910</b>. The tab <b>906</b> is shown coupled to the sensing module <b>910</b> in <figref idref="DRAWINGS">FIG. <b>38</b></figref>. The tab <b>906</b> is configured to move from a first position, in which the tab <b>906</b> is coupled to the sensing module <b>910</b> (corresponding to the power source <b>930</b><i>a</i>, <b>930</b><i>b </i>not providing power), to a second position, in which the tab <b>906</b> is torn or is not coupled to the sensing module <b>910</b> (corresponding to the power source <b>930</b><i>a</i>, <b>930</b><i>b </i>providing power). With the tab <b>906</b> in the first position, the tab <b>906</b> is located between the PCB <b>924</b> and the power source <b>930</b><i>a</i>, <b>930</b><i>b </i>and thereby prevents the first and second power sources <b>930</b><i>a</i>, <b>930</b><i>b </i>from contacting the first and second contact pads <b>934</b><i>a</i>, <b>934</b><i>b</i>, respectively. The power sources <b>930</b><i>a</i>, <b>930</b><i>b </i>are thus not electrically connected with the electronic components of the PCB <b>924</b> with the tab <b>906</b> in the first position since the tab <b>906</b> interrupts current flow. Instead of engaging the first and second contact pads <b>934</b><i>a</i>, <b>934</b><i>b </i>of the PCB <b>924</b>, the first and second power sources <b>930</b><i>a</i>, <b>930</b><i>b </i>engage first and second contact pads <b>935</b><i>a</i>, <b>935</b><i>b</i>, respectively, of the tab <b>906</b> with the tab <b>906</b> in the first position. With the tab <b>906</b> in the second position, the first and second power sources <b>930</b><i>a</i>, <b>930</b><i>b </i>contact the first and second contact pads <b>934</b><i>a</i>, <b>934</b><i>b</i>, respectively, which allows the power source <b>930</b><i>a</i>, <b>930</b><i>b </i>to provide power to the electronic components of the PCB <b>424</b>.

0160Similar to that discussed above regarding the tab <b>306</b> of <figref idref="DRAWINGS">FIG. <b>13</b></figref>, the tab <b>906</b> is configured to be removed from the sensing module <b>910</b>, e.g., to move from the first position to the second position by sliding out of the sensing module's housing <b>925</b>, in response to removal of the drug delivery device's cap <b>908</b> by a user. The tab <b>906</b> has a first, lower portion <b>907</b> located outside of the sensing module <b>910</b> and attached to the cap <b>408</b>, as shown in <figref idref="DRAWINGS">FIG. <b>38</b></figref>, such as by being adhered thereto with adhesive and/or other attachment mechanism. The tab <b>906</b> has a second, upper portion <b>909</b> extending from the first portion <b>907</b> and extending into the sensing module's housing <b>925</b> and into contact with the first and second power sources <b>930</b><i>a</i>, <b>930</b><i>b. </i>

0161<figref idref="DRAWINGS">FIG. <b>42</b></figref> illustrates another embodiment of a sensing module <b>1010</b> configured to gather data for one or more parameters related to a drug and to transmit data indicative of the gathered data to an external source configured to analyze the data received from the sensing module <b>1010</b>. The sensing module <b>1010</b> is generally configured and used similar to the sensing module <b>10</b> of <figref idref="DRAWINGS">FIGS. <b>1</b> and <b>2</b></figref>. <figref idref="DRAWINGS">FIG. <b>42</b></figref> shows the sensing module <b>1010</b> attached to a pill bottle <b>1012</b> configured to contain a drug therein in the form of pills. <figref idref="DRAWINGS">FIG. <b>42</b></figref> shows a single sensing module <b>1010</b> in two views on the pill bottle <b>1012</b>, a front view (sensing module <b>1010</b> on the right in <figref idref="DRAWINGS">FIG. <b>42</b></figref>) and a side view (sensing module <b>1010</b> on the left in <figref idref="DRAWINGS">FIG. <b>42</b></figref>).

0162The pill bottle <b>1012</b> in this illustrated embodiment is a standard pill bottle including a housing <b>1018</b> configured to contain the pills therein. The pill bottle <b>1012</b> also includes a removable cap <b>1008</b> configured to be removed from the housing <b>1018</b> by a user to access the pills in the housing <b>1018</b>. The sensing module <b>1010</b> is attached to an outer surface of the housing <b>1018</b>, which may facilitate retrofitting of the sensing module <b>1010</b> onto an existing pill bottle and/or may ease incorporation of the sensing module <b>1010</b> into a pill bottle's manufacturing process since the sensing module <b>1010</b> can be attached to the pill bottle's outer surface after the pill bottle has otherwise been filled with pills and closed with a removable cap.

0163The sensing module <b>1010</b> includes a variety of electronic components to facilitate the gathering of data and the transmission of gathered data to an external source similar to that discussed above regarding the sensing module <b>10</b> of <figref idref="DRAWINGS">FIGS. <b>1</b> and <b>2</b></figref>. The electronic components of the sensing module <b>1010</b> includes a PCB <b>1024</b>, a power source in the form of first and second batteries <b>1030</b><i>a</i>, <b>1030</b><i>b</i>, a sensor <b>1034</b>, and a reed switch <b>1036</b>. The PCB <b>1024</b> includes various electronic components as discussed above, e.g., a processor, a memory, a communication interface, etc. The PCB <b>1024</b> and the sensor <b>1034</b> are flexible in this illustrated embodiment, which may facilitate smooth, close positioning of the sensing module <b>1010</b> on the pill bottle's curved outer surface. In other embodiments, however, the PCB <b>1024</b> and/or the sensor <b>1034</b> can be rigid.

0164The sensor <b>1034</b> can include any of a variety of sensors, as discussed herein. In an exemplary embodiment, the sensor <b>1034</b> includes a level sensor, e.g., a capacitive-based liquid level sensor such as the TIDA-00317 capacitive-based liquid level sensor available from Texas Instruments Incorporated of Dallas, Tex.

0165The power source <b>1030</b><i>a</i>, <b>1030</b><i>b </i>is configured to selectively provide power to one or more of the sensing module's electronic components, similar to that discussed above regarding the power source <b>330</b> of <figref idref="DRAWINGS">FIG. <b>13</b></figref>. The power source <b>1030</b><i>a</i>, <b>1030</b><i>b </i>is configured to not provide power when a tab <b>1006</b> is coupled to the sensing module <b>1010</b> and is configured to provide power when the tab <b>1006</b> is torn or is not coupled to the sensing module <b>1010</b>. The tab <b>1006</b> is shown coupled to the sensing module <b>1010</b> in <figref idref="DRAWINGS">FIG. <b>42</b></figref>.

0166The tab <b>1006</b> includes a first portion <b>1006</b><i>a </i>and a second portion <b>1006</b><i>b </i>that is configured to be separated from the first portion <b>1006</b><i>a </i>at a tear line <b>1006</b><i>c</i>. The first portion <b>1006</b><i>a </i>of the tab <b>1006</b> is attached to the cap <b>1008</b> and is aligned with a magnet <b>1035</b>. The magnet <b>1035</b> can have a variety of configurations. For example, the magnet <b>1035</b> can be printed, e.g., ink jet printed with magnetic ink, on the tab <b>1006</b>, e.g., on the first portion <b>1006</b><i>a </i>thereof. For another example, the magnet <b>1035</b> can be put on a heat shrink wrap around the tab <b>1006</b>, e.g., the first portion <b>1006</b><i>a </i>thereof. For yet another example, the magnet <b>1035</b> can be attached to the tab <b>1006</b> by being adhered thereto with an adhesive. For still another example, the magnet <b>1035</b> can be attached to or printed on the cap <b>1008</b> with the first portion <b>1006</b><i>a </i>of the tab <b>1006</b> then being positioned to overlie the magnet <b>1035</b>.

0167The tab <b>1006</b> is configured to move from a first position, in which the tab <b>1006</b> is coupled to the sensing module <b>1010</b> (corresponding to the power source <b>1030</b><i>a</i>, <b>1030</b><i>b </i>not providing power), to a second position, in which the tab <b>1006</b> is torn or is not coupled to the sensing module <b>1010</b> (corresponding to the power source <b>1030</b><i>a</i>, <b>1030</b><i>b </i>providing power). The first portion <b>1006</b><i>a </i>of the tab <b>1006</b> is operatively engaged with the power source, e.g., the first power source <b>1030</b><i>a</i>, with the tab <b>1006</b> in the first position. The magnet <b>1035</b> is aligned with the reed switch <b>1036</b> with the tab <b>1006</b> in the first position.

0168Similar to that discussed above regarding the tab <b>306</b> of <figref idref="DRAWINGS">FIG. <b>13</b></figref>, the tab <b>1006</b> is configured to be removed from the sensing module <b>1010</b>, e.g., to move from the first position to the second position, in response to movement of the cap <b>1008</b> by a user. The cap <b>1008</b> is configured to be rotated counter-clockwise relative to the housing <b>1018</b>, as shown by arrow <b>1008</b><i>a</i>. When the cap <b>1008</b> is rotated counter-clockwise relative to the housing <b>1018</b> (and to the sensing module <b>1010</b> attached to the housing <b>1018</b>), the tab <b>1006</b> will be pulled out of engagement from the power source, e.g., the second portion <b>1006</b><i>b </i>of the tab <b>1006</b> will move out of engagement form the first power source <b>1030</b><i>a</i>, and the magnet <b>1035</b> will rotate with the cap <b>1008</b> and become misaligned from the reed switch <b>1036</b>. The reed switch <b>1036</b> will therefore detect a change in magnetic field. The change in magnetic field is indicative of the cap <b>1008</b> being removed from the housing <b>1018</b>. The reed switch <b>1036</b> is configured to communicate the detected change to the PCB <b>1024</b>, e.g., to a processor thereof, so as to inform the PCB <b>1024</b> of cap <b>1008</b> removal. Cap <b>1008</b> removal is indicative of pill(s) being removed from the pill bottle <b>1002</b> and taken by a patient in accordance with drug administration instructions.

0169The tab <b>1006</b> is only removed from the sensing module <b>1010</b> the first time the cap <b>1008</b> is removed from the housing <b>1018</b>. Thus, when the cap <b>1008</b> is removed from the housing <b>1018</b> for the first time, the second portion <b>1006</b><i>b </i>of the tab <b>1006</b> will be dangling from the cap <b>1008</b> and can be removed by tearing the tab <b>1006</b> at the tear line <b>1006</b><i>c</i>. The second portion <b>1006</b><i>b </i>of the tab <b>1006</b> will therefore not be in a user's way during subsequent use of the pill bottle <b>1012</b>.

0170When the cap <b>1008</b> is reattached to the housing <b>1018</b>, the magnet <b>1035</b> and the reed switch <b>1036</b> will again be aligned. The reed switch <b>1036</b> will therefore detect a change in magnetic field. The change in magnetic field is indicative of the cap <b>1008</b> being reattached to the housing <b>1018</b>. The reed switch <b>1036</b> is configured to communicate the detected change to the PCB <b>1024</b>, e.g., to a processor thereof, so as to inform the PCB <b>1024</b> of cap <b>1008</b> reattachment. Cap <b>1008</b> removal and cap <b>1008</b> reattachment can occur any number of subsequent times, with the reed switch <b>1036</b> detecting magnetic field changes and communicating the detected changes to the PCB <b>1024</b> so as to repeatedly indicate pill(s) being removed from the pill bottle <b>1002</b> and taken by a patient.

0171In other embodiments, the cap <b>1008</b> can be configured to be removed from the housing <b>1018</b> by being rotated clockwise relative to the housing <b>1018</b> (and the sensing module <b>1010</b> attached to the housing <b>1018</b>), with the tab <b>1006</b> and power source arranged accordingly to operate as discussed above.

0172<figref idref="DRAWINGS">FIG. <b>43</b></figref> illustrates another embodiment of a sensing module <b>1110</b> configured to gather data for one or more parameters related to a drug and to transmit data indicative of the gathered data to an external source configured to analyze the data received from the sensing module <b>1110</b>. <figref idref="DRAWINGS">FIG. <b>43</b></figref> shows the sensing module <b>1110</b> attached to the pill bottle <b>1012</b> of <figref idref="DRAWINGS">FIG. <b>42</b></figref> but can be similarly used with other pill bottles. The sensing module <b>1110</b> is generally configured and used similar to the sensing module <b>1010</b> of <figref idref="DRAWINGS">FIG. <b>42</b></figref>, e.g., includes a PCB <b>1124</b>, a power source in the form of first and second batteries <b>1130</b><i>a</i>, <b>1130</b><i>b</i>, a sensor <b>1134</b>, and a reed switch <b>1136</b>.

0173A tab <b>1106</b> is configured to move from a first position, in which the tab <b>1106</b> is coupled to the sensing module <b>1110</b> (corresponding to the power source <b>1130</b><i>a</i>, <b>1130</b><i>b </i>not providing power), to a second position, in which the tab <b>1106</b> is torn or is not coupled to the sensing module <b>1110</b> (corresponding to the power source <b>1130</b><i>a</i>, <b>1130</b><i>b </i>providing power). In the illustrated embodiment of <figref idref="DRAWINGS">FIG. <b>42</b></figref>, removing the cap <b>1008</b> from the housing <b>1018</b> is configured to automatically release the tab <b>1006</b> from the sensing module <b>1010</b>, e.g., from the power source, and to misalign the magnet <b>1035</b> and the reed switch <b>1036</b>. In the illustrated embodiment of <figref idref="DRAWINGS">FIG. <b>43</b></figref>, removing the cap <b>1008</b> is configured to similarly misalign a magnet <b>1135</b> and the reed switch <b>1136</b>, but the tab <b>1106</b> is not automatically released from the sensing module <b>1110</b>. Instead, in the illustrated embodiment of <figref idref="DRAWINGS">FIG. <b>43</b></figref>, the tab <b>1106</b> is configured to be manually removed from the sensing module <b>1110</b> by being pulled by a user. As in this illustrated embodiment, the tab <b>1106</b> can be shaped like an arrow to indicate a direction in which the tab <b>1106</b> should be pulled to be removed from the sensing module <b>1110</b>. An arrow can additionally or alternatively be printed on the tab <b>1006</b>. The tab <b>1106</b> can have other shapes other than arrow-shaped, such as rectangular, triangular, hourglass-shaped, pear-shaped, I-shaped, etc.

0174A user of the pill bottle <b>1012</b> can be provided with instructions to remove the tab <b>1106</b> before the cap <b>1008</b> is first removed from the housing <b>1018</b>. In this way, the electronic components of the sensing module <b>1100</b> can be “woken up” before the cap <b>1008</b> is first removed from the housing <b>1018</b>. The tab <b>1106</b> can be pulled by a patient who will take the pills in the pill bottle <b>1012</b>. Alternatively, the tab <b>1106</b> can be pulled by an authorized user such as a health care provider, a pharmacist, or other authorized user who provides the pill bottle <b>1012</b> to a patient who will take the pills in the pill bottle <b>1012</b>. The tab <b>1106</b> being pulled by an authorized user instead of the patient may help ensure that the tab <b>1106</b> is pulled and the sensing module <b>1100</b> “wakes up” before the cap <b>1108</b> is removed for the first time from the housing <b>1018</b>.

0175The embodiments of <figref idref="DRAWINGS">FIGS. <b>42</b> and <b>43</b></figref> use a magnet and a reed switch in detecting cap removal, but other implementations are possible. For example, a magnet can be attached to a pill bottle cap similar to the magnets <b>1035</b>, <b>1135</b> discussed above, and a sensing module similar to the sensing modules <b>1010</b>, <b>1110</b> discussed above can include a Hall effect sensor configured to detect a change in magnetic field similar to the reed switches <b>1036</b>, <b>1136</b> discussed above. For another example, a sensing module similar to the sensing modules <b>1010</b>, <b>1110</b> discussed above can include an infrared (IR) transmitter and receiver configured to emit an IR light toward a removable cap of a pill bottle to which the sensing module is attached. The cap can either be reflective or include a reflective area toward which the IR light is emitted. The reflective cap or the reflective area of the cap is configured to reflect the IR light to the IR receiver. The cap being removed from the pill bottle's housing will thus interrupt the IR light reflection and receipt, thereby indicating that the cap has been removed.

0176The manually pullable tab <b>1106</b> of <figref idref="DRAWINGS">FIG. <b>43</b></figref> is the only tab used with the sensing module <b>1110</b> and the pill bottle <b>1012</b>. The automatically pullable tab <b>1006</b> of <figref idref="DRAWINGS">FIG. <b>42</b></figref> is the only tab used with the sensing module <b>1110</b> and the pill bottle <b>1012</b>. The embodiments of sensing modules used with tabs discussed above with respect to <figref idref="DRAWINGS">FIGS. <b>10</b>-<b>13</b></figref> (sensing module <b>310</b> and tab <b>306</b>), <figref idref="DRAWINGS">FIGS. <b>15</b> and <b>16</b></figref> (sensing module <b>410</b> and tab <b>406</b>), <figref idref="DRAWINGS">FIGS. <b>24</b> and <b>25</b></figref> (sensing module <b>410</b> and tab <b>506</b>), <figref idref="DRAWINGS">FIGS. <b>26</b> and <b>27</b></figref> (sensing module <b>410</b> and tab <b>606</b>), and <figref idref="DRAWINGS">FIGS. <b>28</b> and <b>29</b></figref> (sensing module <b>710</b> and tab <b>706</b>) involve use of a single tab with a drug delivery device. The tab <b>806</b> of <figref idref="DRAWINGS">FIGS. <b>36</b> and <b>37</b></figref> is the only tab used with the drug delivery device <b>812</b>.

0177In other embodiments, a drug delivery device or pill bottle can be used with two tabs. A first one of the tabs can be operatively coupled to a sensing module and configured to be manually moved to “wake up” the sensing module, similar to the manually pullable tab <b>1106</b> of <figref idref="DRAWINGS">FIG. <b>43</b></figref>. The sensing module can thus begin collecting data using one or more sensors of the sensing module, such as date, time, temperature, humidity, etc., before drug delivery begins. The sensing module can thus gather data for a period of time before drug delivery begins that may indicate that the drug was exposed to adverse conditions, e.g., too high a temperature, too low a temperature, too high humidity, too high pressure, etc., before delivery and may thus not perform as expected. The sensing module can be configured to gather data continuously after the sensing module “wakes up.” Alternatively, the sensing module can be configured to gather data on a predetermined periodic basis after the sensing module “wakes up,” such as once every minute, once every thirty minutes, once every hour, once every two hours, once every twenty-four hours, etc. In embodiments in which the sensing module is configured to monitor more than one parameter, each parameter can be monitored on the same time schedule, e.g., each being sensed once every minute, once every thirty minutes, once every hour, once every two hours, once every twenty-four hours, etc., or each can be monitored on its own schedule that is different from at least one other of the monitored parameters.

0178A user of the drug delivery device can be provided with instructions to remove the first tab a certain amount of time before expected drug delivery, e.g., forty-eight hours before expected drug delivery, twenty-four hours before drug delivery, at least forty-eight hours before drug delivery, at least twenty-four hours before drug delivery, one hour before drug delivery, at least one hour before drug delivery, etc. Removing the first tab a certain amount of time before expected drug delivery may help ensure that the sensing module's power source does not run out of power before the end of drug delivery (or before a pill supply is exhausted) since power will not begin being used until the user removes the first tab. Removing the first tab a certain amount of time before expected drug delivery may facilitate data analysis by providing more data for comparison purposes, e.g., more spatial orientation data to determine a drug delivery device's movements, more temperature data to determine if the drug experienced temperature swings before delivery etc.

0179A second one of the tabs can be configured to be automatically moved in response to a user action, e.g., cap removal, trigger actuation, etc., that occurs at a time the drug delivery process begins or shortly before the drug delivery process begins from a drug delivery device or shortly before pill(s) are removed from a pill bottle. Removing the second tab fully “wakes up” the drug delivery device or pill bottle so the power source is providing power to electronic components to gather data and allow for drug delivery or pill access as appropriate for the particular drug delivery device or pill bottle. With the drug delivery device or pill bottle fully “awake,” all electronic functionality of the drug delivery device or pill bottle is available. Examples of such second tabs include tabs similar to the tabs discussed above that are each configured to move in response to a user action in the form of cap removal. Examples of electronic components of a drug delivery device that can begin receiving power in response to the second tab being removed include components configured to gather data regarding the drug delivery process, e.g., an accelerometer, a microphone, a proximity sensor, etc.

0180The positions of the first and second tabs can define power modes of the drug delivery device or pill bottle. Before the first and second tabs are removed, the drug delivery device or pill bottle can be in a no power mode because the power source is not yet providing power to electronic components. After the first tab is removed and before the second tab is removed, the drug delivery device or pill bottle can be in a low power mode in which the power source is providing power to electronic components to gather data before drug delivery begins or before pills are removed from the pill bottle. After the first and second tabs are moved, the drug delivery device or pill bottle can be in a high power mode in which the power source is providing power to electronic components to gather data and allow for drug delivery or pill access as appropriate for the particular drug delivery device or pill bottle. Less power is required from the power source for data gathering than for the data gathering in addition to allowing for drug delivery or pill access, so the low power mode may help conserve power and thereby help ensure that the power source has sufficient power throughout drug delivery or pill access in the high power mode. Less power may also be required for data gathering in the low power mode since less data may be gathered before drug delivery or pill access begins than after drug delivery or pill access begins, so the low power mode may help conserve power and thereby help ensure that the power source has sufficient power throughout drug delivery or pill access in the high power mode.

0181In some embodiments, instead of the first tab being configured to be manually moved by a user to “wake up” the sensing module, the first tab can be configured to be automatically moved in response to a user action to “wake up” the sensing module. The user action to “wake up” the sensing module is different from the user action that moves the second tab. The user action configured to “wake up” the sensing module can include opening a package containing the drug administration device (or pill bottle) therein. The first tab can be operatively connected to each of the package and the drug administration device (or pill bottle) such that opening of the package causes the first tab to be removed from the drug administration device (or pill bottle). For example, the first tab can be connected to a blister pack lid that is pulled off by a user to gain access to the drug administration device (or pill bottle) in the blister pack. The pulling off of the lid can automatically cause the first tab to be removed from the sensing module. For another example, the first tab can be connected to a portion of a cardboard box package, e.g., a side thereof marked as the side of the package to open, such that moving that portion of the box to gain access to the drug administration device (or pill bottle) in the box automatically cause the first tab to be removed from the sensing module.

0182A drug delivery device with a sensing module and first and second tabs attached thereto can have a variety of configurations. In one exemplary embodiment, the first tab and the second tab can each be a tab that acts as an insulator such that an open circuit exists to prevent the drug delivery device's power source from providing power to electronic components of the sensing module as discussed above. Examples of such tabs include the tab <b>306</b> of <figref idref="DRAWINGS">FIGS. <b>10</b>-<b>13</b></figref>, the tab <b>906</b> of <figref idref="DRAWINGS">FIG. <b>38</b></figref>, and the tab <b>1106</b> of <figref idref="DRAWINGS">FIG. <b>43</b></figref>. The power source can include a first power source operatively coupled with the first tab (with the first tab in its first position) and a second power source operatively coupled with the second tab (with the second tab in its first position). Instead of the first tab being configured to be automatically removed from the sensing module in response to removal of the drug delivery device's cap, such as with the tab <b>306</b> of <figref idref="DRAWINGS">FIGS. <b>10</b>-<b>13</b></figref> and the tab <b>906</b> of <figref idref="DRAWINGS">FIG. <b>38</b></figref>, the first tab is configured to be manually removed from the sensing module similar to that discussed above regarding the manually pullable tab <b>1106</b> of <figref idref="DRAWINGS">FIG. <b>43</b></figref>. The removal of the first tab “wakes up” the sensing module as discussed above, e.g., moves the drug delivery device from a no power mode to a low power mode. Additionally, unlike automatically movable insulator tabs such as the tab <b>306</b> of <figref idref="DRAWINGS">FIGS. <b>10</b>-<b>13</b></figref> that have a first, lower portion fixed to the drug delivery device, a first, lower portion of the first tab that is located outside of the sensing module is not fixed to the cap or to another portion of the drug delivery device in order to facilitate manual grasping and removal of the first tab. The first tab's removal from the sensing module can be configured to allow the first power source to begin providing power to a first one or more electronic components of the sensing module to which the first power source is operatively coupled. Examples of the first one or more of the electronic components include sensors configured to gather data. The second tab can be configured to be automatically removed from the sensing module in response to removal of the drug delivery device's cap, such as with the tab <b>306</b> of <figref idref="DRAWINGS">FIGS. <b>10</b>-<b>13</b></figref> and the tab <b>906</b> of <figref idref="DRAWINGS">FIG. <b>38</b></figref>. The movement of the second tab from its first position to its second position, e.g., by removing a cap of the drug delivery device, etc., fully “wakes up” the drug delivery device as discussed above, e.g., moves the drug delivery device from the low power mode to a high power mode. The second tab's removal from the sensing module can be configured to allow the second power source to begin providing power to a second, different one or more of electronic components of the sensing module to which the second power source is operatively coupled. Examples of the second one or more of the electronic components include components configured to gather data regarding the drug delivery process, e.g., an accelerometer, a microphone, a proximity sensor, etc.

0183In another exemplary embodiment, the first tab can be a tab that acts as an insulator such that an open circuit exists to prevent the drug delivery device's power source from providing power to electronic components of the sensing module as discussed above. Examples of such tabs include the tab <b>306</b> of <figref idref="DRAWINGS">FIGS. <b>10</b>-<b>13</b></figref>, the tab <b>906</b> of <figref idref="DRAWINGS">FIG. <b>38</b></figref>, and the tab <b>1106</b> of <figref idref="DRAWINGS">FIG. <b>43</b></figref>. Instead of the first tab being configured to be automatically removed from the sensing module in response to removal of the drug delivery device's cap, such as with the tab <b>306</b> of <figref idref="DRAWINGS">FIGS. <b>10</b>-<b>13</b></figref> and the tab <b>906</b> of <figref idref="DRAWINGS">FIG. <b>38</b></figref>, the first tab is configured to be manually removed from the sensing module similar to that discussed above regarding the manually pullable tab <b>1106</b> of <figref idref="DRAWINGS">FIG. <b>43</b></figref>. The removal of the first tab “wakes up” the sensing module as discussed above, e.g., moves the drug delivery device from a no power mode to a low power mode. Additionally, unlike automatically movable insulator tabs such as the tab <b>306</b> of <figref idref="DRAWINGS">FIGS. <b>10</b>-<b>13</b></figref> that have a first, lower portion fixed to the drug delivery device, a first, lower portion of the first tab that is located outside of the sensing module is not fixed to the cap or to another portion of the drug delivery device in order to facilitate manual grasping and removal of the first tab. The second tab can be a tab that includes a conductive trace thereon, where the second tab is configured to interrupt power from the power source to electronic components of the drug delivery device until the conductive trace is torn or de-coupled from the sensing module. Examples of such tabs include the tab <b>406</b> of <figref idref="DRAWINGS">FIGS. <b>15</b>-<b>17</b></figref> configured to move from the first position to the second position in response to cap <b>408</b> removal, the tab <b>506</b> of <figref idref="DRAWINGS">FIG. <b>24</b></figref> configured to move from the first position to the second position in response to cap <b>508</b> removal, the tab <b>606</b> of <figref idref="DRAWINGS">FIG. <b>26</b></figref> configured to move from the first position to the second position in response to cap <b>608</b> removal, the tab <b>706</b> of <figref idref="DRAWINGS">FIG. <b>28</b></figref> configured to move from the first position to the second position in response to cap <b>708</b> removal, and the tab <b>806</b> of <figref idref="DRAWINGS">FIGS. <b>36</b> and <b>37</b></figref> configured to move from the first position to the second position in response to pressing of the trigger <b>820</b>. The movement of the second tab from its first position to its second position, e.g., by removing a cap of the drug delivery device, by pressing a trigger of the drug delivery device, etc., fully “wakes up” the drug delivery device as discussed above, e.g., moves the drug delivery device from the low power mode to a high power mode.

0184The sensing modules discussed above are discussed with respect to non-training drug delivery devices but can each be similarly used with a drug delivery training device configured to simulate delivery of a drug for training purposes. The drug delivery training devices are configured and used similar to the drug delivery devices discussed above but have one or more features present to prevent actual drug delivery, such as by no drug or other liquid being contained therein, by the drug delivery training device not including a needle, or by saline or other safe non-drug being delivered instead of a drug. The drug delivery training devices are also configured, as will be appreciated by a person skilled in the art, to be reset after each use to allow the drug delivery training device to be re-used.

0185A sensing module used with a drug delivery training device can allow for data gathered during a drug delivery process to be used in real time with the simulated drug delivery process to assist in training the user during use of the training device and/or can be used after the simulated drug delivery process to help the user understand success/failure of the process and have a more helpful and/or faster training experience. Data gathered with respect to the drug delivery training device can also be used when the user uses an actual drug delivery device to help ensure that the user maintains good practices developed during training.

0186As will be appreciated by a person skilled in the art, a drug delivery training device can be used in cooperation with an application (also referred to herein as an “app”) installed on a computer system accessible by the trainee. Data gathered by the sensing module can be communicated to the computer system (as the external source that is located external to the drug delivery training device) using the sensing module's communication interface. The computer system can be configured to provide data as discussed herein to the user via the app after the simulated drug delivery process to help the user understand success/failure of the process. Alternatively or in addition, the computer system can be configured to provide data as discussed herein to the user via the app in real time with the simulated drug delivery process. An app for a drug delivery training device can, as will be appreciated by a person skilled in the art, walk the user through the process as part of the training. The data gathered by the sensing module and communicated to the computer system can allow the app to provide real time feedback to the user about potentially detected problems with the drug delivery process. Examples of such problems include an improper angle (spatial orientation) of the device during the process, a trigger or a plunger not being sufficiently depressed, the device's cap not being removed when the device is in position for simulated drug delivery, the device's cap not being put back on after drug delivery, and the device being removed from the patient's skin before completion of the simulated drug delivery. The app can be “smart” in that the app can be configured to learn mistake(s) the user is making when practicing with the drug delivery training device and can be configured to guide the user to correct the mistake(s) during subsequent practice with the drug delivery training device, e.g., by providing an instruction to help prevent the mistake(s) from occurring (e.g., to hold an injector perpendicular to the skin, to fully depress the device's trigger, etc.) or later during the user's use of an actual drug delivery device. As mentioned above, the app can similarly be used in connection with an actual drug delivery device to allow the app to provide real time feedback to the user about potentially detected problems with the drug delivery process and to learn mistake(s) that occur during drug delivery device use.

0187<figref idref="DRAWINGS">FIGS. <b>44</b>-<b>46</b></figref> illustrate embodiments of app pages on one embodiment of a computer system (a mobile phone). <figref idref="DRAWINGS">FIG. <b>44</b></figref> illustrates an embodiment of a welcome page showing a greeting and an image of the device that the user should be using for training. <figref idref="DRAWINGS">FIG. <b>45</b></figref> illustrates an embodiment of a process page with step-by-step instructions of the drug delivery simulation process. Each step, e.g., priming (removing bubbles), setting dose, injecting the drug, etc. is selectable by the user in order to provide further information on how to successfully perform that step. <figref idref="DRAWINGS">FIG. <b>46</b></figref> illustrates an embodiment of a priming step's page.

0188In an exemplary embodiment, data from the sensing module is incorporated into the pages for the steps. For example, if the sensed data indicates that the device is at an improper angle for priming or for injection (or for simulated injection in the case of a drug delivery training device) and/or that the device's removable cap has not been removed, a warning can appear on the priming page that a possible error has been detected. Information on how to correct the error can also be provided, e.g., an instruction of how to properly angle the device, an instruction to remove the cap, etc. For another example, if the sensed data indicates that the device's trigger has not been pushed, an instruction can appear on the injection page until the sensed data indicates that the device's trigger has been pushed. For still another example, if the sensed data indicates that the device's needle shield has not been moved to a position indicative of the device's needle having been fully exposed, an instruction can appear on the injection page until the sensed data indicates that the needle shield has moved a sufficient amount. For yet another example, if the sensed data indicates that the device is removed from the patient's skin before enough time has passed for injection to be completed (or for simulated injection to be completed in the case of a drug delivery training device), an error message can appear on the injection page indicating to the user that the device may have been removed prematurely from the patient. For another example, if the sensed data indicates that a step is performed out of sequence, an error message can appear on the current page indicating that a step was missed, such as if a plunger or trigger appears to be being pressed before a prior required step was completed. For yet another example, previously gathered sensed data (gathered during training or during actual device use) can be used to provide a message intended to correct previously detected mistake(s) whether the app is being used in training or in actual drug delivery, such as a message indicating the proper perpendicular angle relative to skin for proper drug injection, a message indicating that the device's trigger should be fully depressed to ensure drug delivery, a message indicating a duration of time the device should be held against skin during drug delivery, etc. For another example, the step-by-step instructions can begin with a list of one or more suggested remediations to address problem(s) identified by analyzing previously gathered sensed data, which may highlight the remediations to the user at the outset and thereby help the user remember to perform all steps correctly.

0189Similar to that discussed above regarding a drug delivery training device, the app can be used in connection with an actual drug delivery device to allow the app to walk the user through the drug delivery process and/or to provide real time feedback to the user about potentially detected problems with the drug delivery process. The app can also be configured to learn mistake(s) that occur during drug delivery device use similar to that discussed above. In embodiments in which the drug delivery device is used with an app, the external source to which the sensing module's communication interface communicates data can be the computer system providing the app. The computer system providing the app can be configured to communicate data received from the sensing module to a second external source such as a computer system located remotely from the sensing module, such as the central computer system <b>100</b> of <figref idref="DRAWINGS">FIG. <b>4</b></figref>. Alternatively or in addition, the sensing module can be configured to communicate data to the second external source.

0190<figref idref="DRAWINGS">FIG. <b>47</b></figref> illustrates one embodiment of a method <b>1200</b> of a sensing module establishing communication with an external source, e.g., a mobile phone or other computer system, configured to run an app for use in conjunction with a drug delivery device. The method <b>1200</b> is described with respect to an actual drug delivery device but can be similarly used with a drug delivery training device or a pill bottle.

0191As mentioned above, in some embodiments, opening a package in which a drug delivery device is contained can cause a sensing module attached to the drug delivery device to “wake up.” “Waking up” the sensing module is also referred to herein as “activating” the sensing module. In the method <b>1200</b>, if a user opening <b>1202</b> a package in which the drug delivery device is contained causes the sensing module to be activated, the sensing module's communication interface “wakes up” and starts <b>1204</b> advertising its presence, e.g., begins emitting a wireless signal. The external source includes a communication interface configured to receive the advertising signal, e.g., received by an antenna of the communication interface. The external source is a smartphone in this illustrated embodiment but can, as discussed herein, be another type of computer system. The antenna is activated <b>1206</b> in accordance with the external source's operation, such as by the external source being turned on, the external source's wireless capability being turned on, etc. The activation <b>1206</b> of the antenna can be before or after the sensing module starts <b>1204</b> advertising. In response to receiving the advertising signal from the sensing module, the external source asks <b>1208</b> a user for permission to connect the external source to the sensing module, which may be identified in the ask <b>1208</b> as the drug delivery device. The ask <b>1208</b> can be, for example, a prompt shown on a display of the external source. After receiving an affirmative response to the ask <b>1208</b> allowing the external source to connect to the sensing module, the external source displays <b>1210</b> information, e.g., via the app, about drug status as communicated to the external source from the sensing module. Drug status information can include, for example, when a next dose of drug is due for delivery, a type of the drug, drug expiration date, etc. The external source can additionally or alternatively display other information, such as information regarding the drug delivery device.

0192In the method <b>1200</b>, if the user opening <b>1202</b> the package in which the drug delivery device is contained does not cause the sensing module to be activated, the user sees <b>1212</b> printed Instructions For Use (IFU) for the drug delivery device in the package. If the user decides <b>1214</b> that further information is not desired from the IFU, the user removes <b>1216</b> the IFU from the package (and/or from the drug delivery device) and can proceed to use the drug delivery device. The user may decide <b>1214</b> that further information is not desired for any of a variety of reasons, such as the user already being familiar with how to use the drug delivery device, the user not having access to an external source with which the sensing module could communicate, etc. The IFU can be attached to the drug delivery device to help ensure that the user sees <b>1212</b> the IFU and decides <b>1214</b> whether or not more information is desired before using the drug delivery device.

0193If the user decides <b>1214</b> that further information is desired from the IFU, the user is notified <b>1218</b> to take various actions. The notification <b>1218</b> can be provided to the user in one or more ways. For example, the IFU can provide the notification <b>1218</b> via written instruction. For another example, the notification <b>1218</b> can be provided on the package via written instruction. For yet another example, the notification <b>1218</b> can be provided on the drug delivery device, such as a written instruction printed on the drug delivery device and/or on a label, sticker, etc. on the drug delivery device.

0194In this illustrated embodiment, the notification <b>1218</b> includes four instructions, but more than four instructions or fewer than four instructions can be provided in other embodiments. One of the instructions instructs the user to remove <b>1220</b> the IFU from the package (and/or from the drug delivery device). Another one of the instructions instructs the user to provide <b>1222</b> an input to the drug delivery device and/or the sensing module attached to the drug delivery device. The input in this illustrated embodiment is a push of a button but can be another input, such as toggling of a switch, rotation of a knob, etc. The button (or switch, knob, etc.) is operatively connected to the communication interface of the sensing module. The input causes the communication interface of the sensing module to start <b>1204</b> advertising its presence, with the method <b>1200</b> continuing from the start <b>1204</b> of the advertising as discussed above. Another one of the instructions instructs the user to wait <b>1224</b> a certain amount of time before beginning drug delivery from the drug administration device. The certain amount of time is thirty minutes in this illustrated embodiment but can be another amount of time. The amount of time can be different for any of a variety of reasons, such as the type of drug, whether the drug must be stored in a refrigerator and be warmed to room temperature before delivery, whether the drug must be delivered within a particular amount of time relative to another drug being administered, etc. In some embodiments the user need not wait <b>1224</b> any time at all before beginning drug delivery from the drug administration device, in which case this instruction need not be provided. Another one of the instructions instructs the user to download and install <b>1226</b> the app on the user's smartphone (or other computer system) if the app is not already so installed on the user's smartphone (or other computer system). Once installed <b>1226</b> on the smartphone (or other computer system), the app prompts <b>1228</b> the user for consent, e.g., to accept the app's terms of use, to acknowledge the app's privacy terms, etc., and for the user to select desired functions of the app. In some embodiments, the user does not have a choice to select desired functionality of the app with the app instead having preset functionality. For example, the user can choose whether or not to receive audio instructions in addition to or instead of written instructions provided on a display of the smartphone (or other computer system). For another example, the user can choose a default language (English, Spanish, French, etc.). After the prompts have been fulfilled, the antenna is activated <b>1206</b> and the method <b>1200</b> continues as discussed above. In some embodiments, the antenna can be activated <b>1206</b> before any of the prompts have been fulfilled or in response to a particular prompt being fulfilled, such as the antenna being activated <b>1206</b> in response to the user providing consent.

0195As discussed herein, one or more aspects or features of the subject matter described herein, for example components of the central computer system <b>100</b>, processor <b>24</b>, power source <b>32</b>, memory <b>28</b>, communication interface <b>30</b>, sensor <b>26</b>, can be realized in digital electronic circuitry, integrated circuitry, specially designed application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs) computer hardware, firmware, software, and/or combinations thereof. These various aspects or features can include implementation in one or more computer programs that are executable and/or interpretable on a programmable system including at least one programmable processor, which can be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device. The programmable system or computer system may include clients and servers. A client and server are generally remote from each other and typically interact through a communication network, e.g., the Internet, a wireless wide area network, a local area network, a wide area network, a wired network, a cellular network, etc. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other.

0196The computer programs, which can also be referred to as programs, software, software applications, applications, components, or code, include machine instructions for a programmable processor, and can be implemented in a high-level procedural language, an object-oriented programming language, a functional programming language, a logical programming language, and/or in assembly/machine language. As used herein, the term “machine-readable medium” refers to any computer program product, apparatus and/or device, such as for example magnetic discs, optical disks, memory, and Programmable Logic Devices (PLDs), used to provide machine instructions and/or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine-readable signal. The term “machine-readable signal” refers to any signal used to provide machine instructions and/or data to a programmable processor. The machine-readable medium can store such machine instructions non-transitorily, such as for example as would a non-transient solid-state memory or a magnetic hard drive or any equivalent storage medium. The machine-readable medium can alternatively or additionally store such machine instructions in a transient manner, such as for example as would a processor cache or other random access memory associated with one or more physical processor cores.

0197To provide for interaction with a user, one or more aspects or features of the subject matter described herein, for example a user interface of the central computer system <b>100</b>, can be implemented on a computer having a display screen, such as for example a cathode ray tube (CRT) or a liquid crystal display (LCD) or a light emitting diode (LED) monitor for displaying information to the user. The display screen can allow input thereto directly (e.g., as a touch screen) or indirectly (e.g., via an input device such as a keypad or voice recognition hardware and software).

0198The present disclosure has been described above by way of example only within the context of the overall disclosure provided herein. It will be appreciated that modifications within the spirit and scope of the claims may be made without departing from the overall scope of the present disclosure.