Electronic module configured to detect phase differences of specific sensor output values and to derive actions thereof

Abstract

The present disclosure relates to an electronic module (100) comprising at least an electric power source (109) configured to power electronic components of the electronic module (100), a circuit board assembly (110) electrically connected to the electric power source (109), at least a first sensor arrangement (112) configured to provide a first sensor output signal (A), at least a second sensor arrangement (113) configured to provide a second sensor output signal (B), and a processor unit (114) configured to perform a first dose count by processing specific first sensor output values (Aindex) of the first sensor output signal (A) and a second dose count by processing specific second sensor output values (Bjndex) of the second sensor output signal (B). In order to provide an improved electronic module (100), the processor unit (114) is further configured to detect phase differences (Pindex) between a specific first sensor output value (Ainedx) and corresponding specific second sensor output value (Bjndex). In addition, the processor unit (114) is configured to detect an error in the phase differences (Pindex). Furthermore, the processor unit (114) is configured to decide based on the error how the first dose count and / or the second dose count are to be considered when reporting a dose count to a user, and / or to manipulate the phase differences (Pindex) to increase processability of the first sensor output signal (A) and / or the second sensor output signal (B).

Description

[0001] Description

[0002] ELECTRONIC MODULE CONFIGURED TO DETECT PHASE DIFFERENCES OF SPECIFIC SENSOR OUTPUT VALUES AND TO DERIVE ACTIONS THEREOF

[0003] The present disclosure is generally directed to an electronic module, for example to an electronic module which is releasably attached to a drug delivery device or integrated into a drug delivery device.

[0004] Electronic modules are generally known and often used to provide further functionalities to drug delivery devices. As such for example electronic modules are known which may be releasably attached to a drug delivery device. In this regard, electronic modules are regularly used to count and / or record doses, e.g. a number of drug units which are dialed and / or dispensed. To this end, it is further known to integrate a sensor in the electronic module which senses corresponding relative movements to detect the dialed and / or dispensed dose units. In order to process and log the sensor data, it is also known to transmit corresponding sensor data to a processor unit, a storage unit and / or to use means for transmitting sensor data to a mobile device, such as a smartphone.

[0005] An exemplary data collection device for attachment to an injection device is shown in WO 2016 / 198516 A1. Further injection monitoring modules are for example known from WO 2020 / 217094 A1 , WO 2021 / 140352 A1 and WO 2021 / 214 275 A1.

[0006] When detecting movements, it is further known to count dose units by detecting signal peaks above predetermined thresholds. However, there are often inaccuracies that can be caused by inconsistent movement patterns of relevant components, e.g. due to manufacturing tolerances, wear and tear of components during use, changing environmental conditions or simply due to different handling of the drug delivery device by the user. In addition, when using two sensors each providing a sensor signal used to provide a respective dose count, the two sensor signals may be out of phase with each other. In other words, for example peak values of one sensor signal used for the dose count may not occur at the same point in time as corresponding peak values from the other sensor detecting same dose incidents of a dose event. This misalignment or phase difference makes processing of the sensor signals more difficult and less accurate.

[0007] September 22, 2025 S 100 P 549 WO Exemplary devices which have two sensors whose signals are misaligned are known from US 2021 / 236738 A1 and JP 2023 530005 A.

[0008] Based on the aforementioned problem, it is an object of the present disclosure to provide an improved electronic module.

[0009] The present invention is defined by the appended claims. This object is essentially solved by an electronic module according to claim 1.

[0010] The electronic module comprises at least an electric power source, such as a battery, configured to power electronic components of the electronic module. Electronic components may be processor units, display units, sensor arrangements, storage units, communication modules, for example wireless modules, chips, conductors or the like. The electronic module may comprise a housing in which the electric power source and / or any of the further electronic components are arranged. In this regard, the housing may comprise several parts or a single part, e.g. an injection-molded plastic part.

[0011] Further, the electronic module comprises a circuit board assembly electrically connected to the electric power source. The aforementioned electronic components may be electrically connected to the circuit board assembly. The electric power source may thus power the electronic components by means of the circuit board assembly. The circuit board assembly may comprise a substrate equipped with the electronic components. The circuit board assembly may comprise a printed circuit board assembly (PCB). The circuit board assembly may be arranged inside the housing.

[0012] In addition, the electronic module comprises at least a first sensor arrangement and at least a second sensor arrangement. However, according to one aspect, the electronic module may also comprise more than two sensor arrangements. The sensor arrangements may each comprise a different type of sensor or the same sensor. Sensors which may be used as a first sensor arrangement and / or a second sensor arrangement may be an accelerometer, a gyroscope, a light sensor, a sound or acoustic sensor, a pressure sensor, a temperature sensor, a proximity sensor, an infrared sensor, an ultrasonic sensor, a color sensor, a humidity sensor, a tilt sensor, a flow sensors, a Hall effect sensor, a radiation sensor, a lidar, an electrical current sensor, an optical sensors, a force or torque sensor, a strain gauge or mechanical switch, for example, sensing relative movement of components by switch activation. Preferably the sensor arrangements comprise different sensors.

[0013] September 22, 2025 S 100 P 549 WO The first sensor arrangement is therefore configured to provide a first sensor output signal and the second sensor arrangement is configured to provide a second sensor output signal. The sensor output signals refer to the same dose event. In other words, a single dose event, for example, a dose dialing and / or dose dispensing, may lead simultaneously to a first sensor output signal and to a second sensor output signal, wherein both sensor output signals refer to the same event for example a dose delivery event, and may provide dose incidents referring to the same respective dose event.

[0014] Further, the first sensor arrangement and the second sensor arrangement may be configured to detect dose incidents which are in temporal connection. The sensor output signals may for example be a voltage pulse related to a condition detected by a specific sensor. For example, greater reflections detected by an optical sensor may cause a larger voltage pulse than fewer or no reflections. Similarly, sounds, for example click sounds from a drug delivery device, may trigger a larger voltage pulse than the ambient sounds or no sounds perceived by the acoustic sensor. Similarly, pressure applied to the dose button during dose delivery may trigger a voltage pulse and so on.

[0015] A processor unit is configured to perform a first dose count by processing specific first sensor output values of the first sensor output signal. Further, the processor unit is configured to perform a second dose count by processing specific second sensor output values of the second sensor output signal. In this regard, it is generally assumed that there should be specific first sensor output values referring to the first sensor arrangement and specific second sensor output values referring to the second sensor arrangement having similar time points. In other words, a specific first sensor output value should be temporally related to a specific second sensor output value since both sensor arrangements detect the same incidents during a dose event. However, the specific first and corresponding second sensor output values may have phase differences. In other words, the specific first and corresponding second sensor output value may be misaligned.

[0016] The processor unit may be integrated within a housing of the electronic module, for example within the same housing as the sensor arrangements, or may be connected, for example wirelessly connected, to the sensor arrangements and may thus only be used to further process the sensor data and may thus be in a functional connection to the electronic module.

[0017] The specific sensor output values of the sensor output signals may also be referred to as definite sensor output values. The sensor output values may be called specific or definite as they allow to identify dose incidents. In other words, the specific or definite sensor output

[0018] September 22, 2025 S 100 P 549 WO values may be used to perform a dose count. In general, the specific or definite sensor output values are those sensor output values which by their characteristic, for example due to preprocessing, may be considered as dose units, i.e. set and / or delivered dose units, and are therefore in principle detected as such by the processor unit.

[0019] For example, the specific sensor output values may be peak values above a predetermined threshold value, for example a voltage limit. Furthermore, the specific sensor output values may be generated by pre-processing the sensor output signal by the processor unit before performing a dose count. For example, the sensor output signal may first be modulated, e.g. smoothed, rectified, amplified, etc. before the sensor output values may be considered as specific or definite sensor output values.

[0020] As in general, the specific or definite sensor output values are those sensor output values which may be considered as dose units, those specific sensor output values may not necessarily refer to actual dose units. In other words, the specific sensor output values may indicate a dose unit, for example, because the specific sensor output values are above a predetermined threshold value, such as a voltage limit, and for example sufficiently distanced in time to a preceding sensor output value, however, an actual event that has led to the specific sensor output value may not be related to a dose delivery or a dose setting. For example, regarding an acoustic sensor, a background noise may have caused a specific sensor output value.

[0021] Therefore, since the processor unit would consider the specific sensor output values as dose units, such specific first sensor output values result in a first dose count and such specific second sensor output values result in a second dose count. In other words, an increase in specific first sensor output values may increase the first dose count and an increase in specific second sensor output values may increase the second dose count. Still, however, the specific sensor output values relevant to provide the first dose count and the second dose count may be misaligned, i.e., there may be a phase difference between corresponding specific first and second sensor output values. A phase difference may be understood as a time offset between a specific first sensor output value and the corresponding specific second sensor output value. Consequently, and due to the phase differences, processing of the sensor output signals may be less accurate and more difficult. In addition, simply considering the first or second dose count as the general dose count may not be correct.

[0022] Therefore, the processor unit is further configured to detect phase differences between a specific first sensor output value and specific second sensor output value. In addition, the

[0023] September 22, 2025 S 100 P 549 WO processor unit is configured to detect an error in the phase differences. In other words, the processor unit may detect misalignments between the specific first sensor output values and corresponding specific second sensor output values. Still not any misalignment may be an error. An error in the phase differences may thus only be considered an error if the phase differences change significantly between several different specific sensor output values, for example. Alternatively, an error in the phase differences may only be considered an error if the phase differences exceed a certain threshold value.

[0024] Further, the processor unit is configured to decide based on the error how the first dose count and / or the second dose count are to be considered when reporting a dose count to a user. The reported dose count may be the first dose count, the second dose count and / or a general dose count. The general dose count may be derived from the first dose count and the second dose count.

[0025] As such and depending on the error in the phase differences, the processor unit may for example decide not to report a dose count but may just report that a dose event happened, for example that a dose has been delivered. In this regard, the user may then for example manually log the amount of dose delivered. Further, a dose count, for example a first dose count, a second dose count, the first and second dose count or a general dose count, may be reported together with a warning that the user should check the dose count. The user may then change the reported dose count manually, if it is wrong. Alternatively, if the processor unit detects an error in the phase difference but the first dose count and the second dose count are equal, the processor unit may also consider the error to be acceptable and may report the first and / or second dose count or the general dose count as normal or as correct.

[0026] Further, the processor unit is alternatively or additionally configured to decide based on the error to manipulate the phase differences to increase processability of the first sensor output signal and / or the second sensor output signal. A manipulation may result in reducing and / or eliminating the phase differences for example prior to processing for dose counting. An increased processability may be determined on the basis of an accuracy of the dose counts that may eventually be determined using the sensor output signals. Furthermore, the processability may be determined in a time it takes to process a signal. Thus, an increased processability may be understood as a shorter time period needed to process the sensor output signals. Other parameters, such as fewer complex algorithms, may also be understood as an increased processability.

[0027] September 22, 2025 S 100 P 549 WO In summary, the electronic module may thus be configured to provide an improved electronic module which is configured to perform different actions based on the sensor output signals and which is configured to improve processability of sensor output signals and therefore, for example improve an accuracy of a dose count.

[0028] The drug delivery device, with which the electronic module may be used, may for example be the drug delivery device known from EP 3 164 173 A1. Other suitable working principles of drug delivery devices to be used may for example be described in EP 1 570 876 B1 , EP 2 814 547B1 , EP 2 890 434 B1 , WO 2005 / 018721 A1 , WO 2009 / 132777 A1 , WO 2014 / 033195 A1 , US 5,693,027 A, US 6,663,602 B2, US 7,241 ,278 B2 or US 9,937,294 B2. The drug delivery device may comprise a clicker arm in order to provide a click sound during dose delivery and / or dose setting.

[0029] In one aspect, before the error in the phase differences is detected, the processor unit may be configured to level the phase differences by dividing each specific phase difference by a time interval related to the phase difference. Leveling the phase differences may be understood as bringing all phase differences between specific first sensor output values and corresponding specific second sensor output values to a same level. For example, if the phase difference between an initial specific first sensor output value and an initial specific second sensor output value as well as the phase difference between a second specific first sensor output value and a second specific second sensor output value are different, after leveling the phase differences, the phase differences may be the same. Differences in phase between two specific sensor output values may indicate problems with the sensor output signals. For example, one of the sensor arrangements may have erroneous specific sensor output values, i.e., too many or missing specific sensor output values compared to the dose units which have actually been set and / or dispensed. Further, the user may have caused the sensor arrangement to provide specific sensor output values during dose setting so that the processor unit may count more dose units as have been actually delivered. Furthermore, the time interval may be determined from a first or second time point of a corresponding specific first or second sensor output value used to determine the phase difference and a following or preceding first or second time point of a further corresponding specific first or second sensor output value. Alternatively, the time interval may be determined from a following first or second time point and a preceding first or second time point of further first or second sensor output values following and preceding a corresponding specific first or second sensor output value used to determine the phase difference. In this regard, first time points indicate points in time of the specific first sensor output values and second time points indicate points in time of the specific second sensor output values. Leveling phase differences before an error in the phase differences is detected

[0030] September 22, 2025 S 100 P 549 WO may especially be helpful if the dispense speed for example increases or changes during dose delivery, and wherein phase differences may thus be shorter or may simply differ.

[0031] According to one aspect, the processor unit may be configured to compare a single phase difference and / or a difference between any two phase differences with a first predetermined threshold value to detect an error in the phase differences. The single phase difference may for example be a leveled phase difference. Thus, if the phase differences have been leveled, only a single comparison with a first predetermined threshold value may be sufficient. On the other hand, a difference between any two phase differences may be considered if the phase differences have not been leveled. Hence, the number of comparisons may be reduced if the phase differences are leveled beforehand. The comparison may include determining if a magnitude of the phase difference exceeds the first predetermined threshold value, and / or if a magnitude of a change in phase difference between two phase differences exceeds a first predetermined threshold value. An error in phase differences may thus for example only be considered if the first predetermined threshold value is exceeded. Nevertheless, in some cases this error may be insignificantly small. Consequently, only a statement may be possible as to whether there is an error, but not as to its significance.

[0032] In one aspect of the disclosure, the processor unit may be configured to compare a difference between two adjacent phase differences or a difference between an initial phase difference and a final phase difference with the first predetermined threshold value. Adjacent phase differences may be interpreted as a first phase difference between a specific first sensor output value and a specific second sensor output value and a second phase difference between a following specific first sensor output value and a following specific second sensor output value. The initial phase difference may be the phase difference between initial specific sensor output values and a final phase difference may be the phase difference between final specific sensor output values. In this regard, initial specific sensor output values may be specific sensor output values which are the first specific sensor output values in time with respect to a dose event. Further, final specific sensor output values may be specific sensor output values which are the last specific sensor output values in time with respect to a dose event. A switch may be actuated before the initial specific sensor output values are detected, wherein the switch may activate the sensor arrangements and / or the electronic components of the electronic module. After the final specific sensor output values, a switch may be actuated to deactivate the sensor arrangements and / or the electronic components of the electronic module. Using adjacent phase differences for the comparison may allow to define a more precise first predetermined threshold value and an action based on this evaluation may be more accurate. However, using

[0033] September 22, 2025 S 100 P 549 WO an initial phase difference and a final phase difference for the comparison may allow to provide a more general evaluation of the sensor output signals.

[0034] In one aspect, and as already mentioned before in less detail, when an error in the phase differences is detected, the processor unit may be configured to decide at least one of the following:

[0035] • not to report a dose count to the user;

[0036] • to report the first dose count and / or second dose count to the user together with a warning;

[0037] • to determine a first number of specific first sensor output values and a second number of specific second sensor output values, and to report the first dose count or the second dose count to the user, if the first number and the second number are equal;

[0038] • to process the first and / or second sensor output signal if the error exceeds a second threshold value.

[0039] Hence, the processor unit is configured to derive different actions based on an error in the phase differences. In this regard, processing the first and / or second sensor output signal may comprise manipulating the phase differences to increase processability of the first sensor output signal and / or the second sensor output signal. The second threshold value may be predetermined or may be variable and dependent on the sensor output signal, for example on a factor of a phase difference or the like. Using a second threshold value may thus not only allow to determine whether there is an error in the phase differences but also if the error in the phase differences is significant or in other words if the error in the phase differences is of relevance.

[0040] Further, in one aspect, the processor unit may be configured to determine a first number of specific first sensor output values and a second number of specific second sensor output values. In other words, the processor unit may be configured to count the specific first and second sensor output values in order to determine a first number and a second number. Furthermore, the processor unit may be configured to determine at least two phase differences between at least two different pairs of specific first sensor output values and specific second sensor output values. In addition, the processor unit may be configured to determine, depending on a ratio of the first number of specific first sensor output values and the second number of specific second sensor output values and a difference between the at least two phase differences, whether the first number of specific first sensor output values or the second number of specific second sensor output values is to be considered as a general dose count or whether the first sensor output signal or the second sensor output signal is to be corrected.

[0041] September 22, 2025 S 100 P 549 WO In this context, "ratio" may mean that it is determined whether the first number is greater than the second number or vice versa, or whether the numbers are equal. There may also be a threshold value to which the difference between at least two phase differences is compared. As aforementioned, the general dose count may be regarded as the actual real dose count, i.e. the number of dose units which have actually been set or delivered. Since there are two sensor arrangements, the first and second dose counts are ideally identical. However, the first and second dose counts may also be different from one another. In this case, either one of the dose counts may be corrected, wherein for example the number of one of the dose counts is increased, if missing dose counts are detected, or wherein the number of one of the dose counts is decreased, if excessive dose counts are detected. In this regard, time intervals between specific sensor output values, threshold values and the like may be used in order to determine if the dose counts are correct or if there may be incorrect specific second sensor output values which erroneously led to a false dose count.

[0042] In one aspect, the processor unit may be configured to consider the first number of specific first sensor output values as the general dose count, when the first number of specific first sensor output values is less than the second number of specific second sensor output values and the difference between the at least two phase differences exceeds a threshold value. Further, the processor unit may be configured to consider the first number of specific first sensor output values as the general dose count, when the first number of specific first sensor output values is greater than the second number of specific second sensor output values and the difference between the at least two phase differences deceeds a threshold value. Furthermore, the processor unit may be configured to correct the first sensor output signal, when the first number of specific first sensor output values is less than the second number of specific second sensor output values and the difference between the at least two phase differences deceeds a threshold value. In addition, the processor unit may be configured to correct the first sensor output signal, when the first number of specific first sensor output values is greater than the second number of specific second sensor output values and the difference between the at least two phase differences exceeds a threshold value. The aforementioned alternatives may thus be examples of how to evaluate a ratio of the first number and the second number and a difference between the at least two phase differences.

[0043] According to one aspect, the processor unit may be configured to shift all specific first sensor output values or all specific second sensor output values by a fixed time offset prior to detecting any phase differences. In other words, a fixed time offset, i.e. a time offset which is fixed and equal for all specific sensor output values, may be added to either all specific first sensor output values or to all specific second sensor output values. Adding a fixed time offset may allow to

[0044] September 22, 2025 S 100 P 549 WO reduce the phase differences of at least some of the phase differences between the specific sensor output values and may thus allow to improve processing of the sensor output signals.

[0045] According to a further aspect, the processor unit may be configured to shift all specific first sensor output values or all specific second sensor output values by a phase difference determined between a specific first sensor output value and specific second sensor output value. In other words, there may for example be a phase difference determined between two specific sensor output values, for example a phase difference between the initial specific first sensor output value and the initial specific second sensor output value or a phase difference between the final specific first sensor output value and the final specific second sensor output value or a phase difference between any other two specific first and second sensor output values, which may then be added to all specific first sensor output values or to all specific second sensor output values. Adding a time offset which is a phase difference, may allow to reduce the phase difference at least between the specific sensor output values from which the phase difference was calculated and may thus allow to improve processing of the sensor output signals. At the same time, using a phase difference as a time offset may ensure that the actual specific sensor output values are taken into account in the correction or shift of specific sensor output values.

[0046] In one aspect, the processor unit may be configured to normalize second time intervals of specific second sensor output values by setting all second time intervals between two consecutive specific second sensor output values to a second equal value. In other words, the second time intervals may thus be equalized. In this regard, the term "time interval" may be used as a time span between two consecutive specific sensor output values of the same sensor output signal, for example between two specific second senor output signals. Further, the processor unit may be configured to normalize each first time interval between two specific first sensor output values to a first equal value by using a normalized second time point of a corresponding specific second sensor output value and by adding a phase difference divided by a second time interval to the normalized second time point in order to receive a first equal value. In this regard, in general the term "time point" may indicate a point in time of a specific sensor output value, a first time point may thus indicate a point in time of a specific first sensor output value and a second time point may indicate a point in time of a specific second sensor output value. Further, a normalized second time point may thus be a second time point referring to a specific second sensor output value which may be determined once the second time intervals have been normalized. In one aspect, the first equal value and the second equal value may be the same. The sensor output signals which may be received after normalization may already be suitable for further processing as the phase difference between corresponding

[0047] September 22, 2025 S 100 P 549 WO specific first and second sensor output values are equal. Still, it may be beneficial if prior to the aforementioned processing and normalizing, a fixed offset or a phase difference is first added to all specific first sensor output values or to all specific second sensor output values as aforementioned. Adding the fixed offset or the phase difference may allow to further align the specific first sensor output values with the corresponding specific second sensor output values.

[0048] In one aspect, the electronic module may comprise a switch which may be actuated, for example deactivated, at the end of a dose delivery. In this regard, the switch may be actuated at the beginning of a dose delivery and may thus be actuated once again at the end of the dose delivery, which may be considered a deactivation of the switch. The processor unit may further be configured to manipulate the phase differences after the switch is actuated at the end of a dose delivery. For example, after the switch has been deactivated. Using a switch may thus allow to define when the sensor output signals for a specific dose event are considered to be complete, so that the processing of these sensor output signals may be performed taking into account all specific sensor output values.

[0049] According to one aspect, the processor unit may be configured to perform a dose correction algorithm after the phase differences have been manipulated. A dose correction algorithm may determine whether specific sensor output values are missing in one of the sensor output signals or may determine whether there are too many specific sensor output values in one of the sensor output signals. The correction algorithm may thus allow to use time points, time periods and / or time intervals in order to perform the correction algorithm. If there are missing specific sensor output values, the correction algorithm may increase the respective dose count of the sensor output signal comprising the missing specific sensor output values. If there are too many specific sensor output values in one of the sensor output signals, the correction algorithm may decrease the respective dose count of the sensor output signal comprising the missing specific sensor output values. Since the processability of the sensor output signals may have been improved, the correction algorithm may be performed more accurately than without improving the processability.

[0050] Further, according to one aspect, the electronic module may comprise a communication unit configured to transmit the dose count to a signal generator to report the dose count to the user. The signal generator may be any device or means configured to report the dose count to the user. In one aspect, the signal generator may be a signal generator configured to generate a visual signal. As such, the signal generator may for example be a display, for example a display on the drug delivery device or the electronic module, or a LED or the like. However, the signal

[0051] September 22, 2025 S 100 P 549 WO generator may also be configured to generate a tactile, oral or any combined signal. The signal generator may form part of the electronic module, the drug delivery device or may be part of an external device, such as a mobile device, for example a smartphone. The signal generator may thus provide the user with respective information about the dose units which have been set and / or delivered and may thus allow to improve a dose regimen.

[0052] In one aspect, the electronic module may further be configured to be releasably attached to a drug delivery device. For example, the electronic module may be releasably attached to the drug delivery device by fastening means for releasable attachment, for example, interacting mechanical coupling elements or by frictional or elastic engagement. In this regard, the housing of the electronic module may comprise the aforementioned fastening means for releasable attachment to a drug delivery device. The electronic module may be configured to be releasably attached to a dose button of a drug delivery device. The electronic module may be configured to be releasably attached to a dial grip of a drug delivery device. An assembly of the drug delivery device and the electronic module may thus comprise a drug delivery device and an electronic module configured for releasable attachment to the drug delivery device. The electronic module may for example be detached when the electric power source needs to be recharged or when sensor data needs to be transferred to a further device. Further, the electronic module may be attached to the drug delivery device when dose counts are to be detected. In this regard, the electronic module may be configured to be releasably attached to a dial grip of a drug delivery device.

[0053] Further, in one aspect, the at least one first sensor arrangement may comprise an acoustic sensor. Further, the at least one second sensor arrangement may comprise at least one optical sensor. Using two types of different sensors, one of which is not affected by a relative rotational movement between the electronic module and the drug delivery device, has the advantage of a more reliable detection of dose counts. For example, using an acoustic sensor has the advantage that this type of sensor is typically only affected by sounds, wherein the optical sensor is only affected by visual impacts. Consequently, the sensors react to different effects, which are typically overlapping or occur together during dose delivery or dose dialing. The acoustic sensor may for example be configured to detect clicks, i.e. click sounds, or any other sounds which are generated when a dose is dialed and / or dispensed. The sounds, for example the click sounds or beep sounds, may be generated mechanically, electromechanically or electronically, e.g. by a physical impact, the conversion of a mechanical contact into an electronic signal or by a purely electronic signal. The acoustic sensor may for example comprise a microphone. The optical sensor may be configured to generate a signal, e.g. voltage signal, based on detection of light, e.g. light reflected or interrupted by an encoder surface.

[0054] September 22, 2025 S 100 P 549 WO The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0055] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0056] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dualchamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0057] September 22, 2025 S 100 P 549 WO The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (anti-diabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0058] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0059] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0060] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human

[0061] September 22, 2025 S 100 P 549 WO insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N- (w-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0062] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, GRMD-0901 , NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1 , ZYD-1 , GSK-2374697, DA-3091 , MAR-701 , MAR709, ZP- 2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA- 15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide- XTEN and Glucagon-Xten.

[0063] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

[0064] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0065] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0066] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0067] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human,

[0068] September 22, 2025 S 100 P 549 WO non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0069] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0070] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen. Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0071] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0072] September 22, 2025 S 100 P 549 WO Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope of the present invention, which encompass such modifications and any and all equivalents thereof.

[0073] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0074] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

[0075] As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608- 1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0076] In the following, non-limiting, examples of the electronic module and more precisely of the corresponding sensor output signals and their processing are described in more detail by making reference to the drawings, in which:

[0077] Figure 1 shows an exemplary drug delivery device configured to be equipped with an electronic module;

[0078] Figure 2 shows an exemplary electronic module configured to be releasably attached to the drug delivery device shown in Fig. 1 ;

[0079] Figure 3 shows an exemplary voltage pulse of a sensor output signal;

[0080] September 22, 2025 S 100 P 549 WO Figure 4 shows an exemplary first and second sensor output signal together with corresponding switch incidents;

[0081] Figure 5A shows exemplary first and second sensor output signals and a phase difference between specific sensor output values;

[0082] Figure 5B shows a diagram showing all phase differences according to the sensor output signals shown in Fig. 5A;

[0083] Figure 5C shows a diagram, wherein the phase differences shown in Fig. 5B are leveled;

[0084] Figures 6A to 6B show further exemplary first and second sensor output signals and two different phase differences;

[0085] Figure 7 shows exemplary first and second sensor output signals with shifted specific first sensor output values;

[0086] Figure 8A shows an exemplary first and second sensor output signal;

[0087] Figure 8B shows the exemplary first and second sensor output signal of Fig. 8A with normalized first and second time intervals; and

[0088] Figure 8C shows the exemplary first and second sensor output signal of Fig. 8A, wherein specific first sensor output values are shifted as in Fig. 7 and normalized as in Fig. 8B.

[0089] In the Figures, identical elements, especially time components referring to similar conditions in different examples or embodiments are provided with the same reference signs. In this regard, however, a phase difference PM for example shown in Figure 6A is not the same as a phase difference P in Figure 6B. Still, it may be noted that a phase difference Pindex indicates a time span between two corresponding specific sensor output values Aindex and Bindex of different sensor output signals A and B.

[0090] Figure 1 shows an exploded view of an exemplary medicament or drug delivery device 1. The drug delivery device 1 is a pen-type injector comprising a housing 10, i.e. a housing 10 of a

[0091] September 22, 2025 S 100 P 549 WO drug delivery device 1 or a drug delivery device housing 10, in which a drive mechanism for dose setting and dose dispensing is arranged. The drug delivery device 1 extends from a distal point to a proximal direction P or from a proximal point to a distal direction D along a drug delivery device axis Y of the drug delivery device 1 , i.e. a longitudinal axis of the drug delivery device 1. In order to set or dial a dose for delivery a user may rotate or dial a dose dial grip 12 with respect to the housing 10, wherein the dose dial grip 12 is arranged at a proximal end of the housing 10. During dose setting the dose dial grip 12 may perform a helical movement, i.e. a combined axial and rotational movement, or may perform pure rotational movement.

[0092] The drive mechanism of the drug delivery device 1 may comprise a plunger, a drive sleeve 13, a clutch, a clutch spring, a number sleeve, a last dose nut and so on, which may move during dose setting and / or dose dispensing. Although not all of these components are shown in detail, for example, the drive mechanisms disclosed in EP 1 570 876 [= FlexPen], EP 2 814 547 [= UnoPen], US 9,937,294 B2 [= BD Vystra] or WO 2004 / 078239 A1 [= SoloStar] represent suitable drive mechanisms for the present disclosure.

[0093] Although the aforementioned drive mechanisms disclose suitable drive mechansims for the present disclosure, this does not exclude that although some of these mechanisms may for example be adapted to provide, for example a click sound during dose setting and / or delivery.

[0094] Once the dose is set by means of the dose dial grip 12, the user may press a dose button 11 arranged at the proximal end of the drug delivery device 1 in the distal direction D in order to dispense the dose. When pressing the dose button 11 , the user applies a force directed towards the proximal end of the drug delivery device 1 , wherein the force moves the dose button 11 in the distal direction of the pen and parallel to the second longitudinal axis Y. This axial movement of the dose button 11 releases the drive mechanism for example by decoupling a number sleeve from the drive sleeve, wherein irrespective of which component of the drug delivery device 1 performs a rotational movement during dose delivery, the dose dial grip 12 is coupled to a respective component in order to perform a rotational movement during dose delivery.

[0095] This rotational movement of the dose dial grip 12 during dose delivery may be used to determine, for example, the actual dose delivered by means of an electronic module 100 and more precisely by processing corresponding sensor output signals. In this regard, the drug delivery device 1 may comprise a clicker arm in order to provide a click sound during dose delivery and / or dose setting. Hence, the drug delivery device 1 may emit, produce or generate a sound, e.g. a click sound, when the dose dial grip 12 is rotated to set a dose, when the button

[0096] September 22, 2025 S 100 P 549 WO 11 is pressed to dispense a dose, when components, for example the drive sleeve 13, inside the drug delivery device move relative to other components, e.g. rotate, when an end position is reached, e.g. an end position during a dose delivery, etc. The sound may be triggered, for example, by a deflected arm, e.g. a deflected clicker arm, inside the drug delivery device 1 , which may be deflected due to relative movements of components of the drug delivery device 1. However, providing a click sound is not necessarily required.

[0097] The exemplary drug delivery device 1 shown in Figure 1 comprises in addition to the dose dial grip 12 and the dose button 11 a display window 14, a needle 15 to which a container may be attached and a needle. The set dose may be displayed via the dosage window 14. The container may be filled directly with a drug, for example, insulin or may be configured to receive a cartridge and thus act as a cartridge holder.

[0098] The needle 16 may be affixed to the container or the receptacle. During dose dispensing the drug is dispensed through the needle 16. The needle 16 may be protected by an inner needle cap 17. In addition, the needle 16 or the inner needle cap 17 may be protected by an outer needle cap 18.

[0099] For example, in order for an electronic module 100 to be functionally attached to a drug delivery device 1 , i.e. attached and usable, either the drug delivery device 1 can be adapted to the electronic module 100 or, conversely, the electronic module 100 can be adapted to the drug delivery device 1. Regardless of this, the drug delivery device 1 as well as the electronic module 100 may have different examples, wherein the further description with respect to the drug delivery device 1 essentially deals with the dose button 11 , the dose dial grip 12 and the drive sleeve 13. However, according to one aspect, the electronic module could also be integrated within the drug delivery device 1.

[0100] Figure 2 shows an example of an electronic module 100 releasably attached to a distal end of a drug delivery device 1. In this regard, especially, a dose button 11 , a dose dial grip 12, a drive sleeve 13 and a number sleeve 19 of the drug delivery device 1 are shown. The electronic module 100 shown in Figure 2 comprises a first portion 101 configured to releasably attach the electronic module 100 to the dose dial grip 12 of the drug delivery device 1 . The first portion 101 may thus define an auxiliary dose dial grip 102, wherein the first portion 101 follows the movement of the dose dial grip 12 and vice versa.

[0101] Further, the electronic module 100 has a first longitudinal axis X and comprises a second portion 103 coupled to the first portion 101 allowing relative rotational movement about the first

[0102] September 22, 2025 S 100 P 549 WO longitudinal axis X and relative axial movement parallel to the first longitudinal axis X with respect to the first portion 101. In the example of Figure 2, the first longitudinal axis X and the second longitudinal axis Y are in line. Relative axial movement of the second portion 103 may thus apply pressure onto the dose button 11. The second portion 103 may thus be considered an auxiliary dose button configured to apply pressure onto the dose button 11 of the drug delivery device 1.

[0103] In this regard, a user may apply pressure onto a proximal end surface 104 of the second portion 103 in order to move the second portion 103 axially with respect to the first portion 101. Axial movement of the second portion 103 may thus apply pressure onto a push element 105 biased by a spring element 106 to return the second portion 103 to its initial position as shown in Figure 2 after being loaded. However, when the second portion 103 is axially moved towards the dose button 11 , the spring element 106 is compressed and push element 105 is configured to actuate a lever arm 107. Actuation of the lever arm 107 may thus actuate a switch 108, for example a microswitch, which may wake up electronic components of the electronic module 100.

[0104] In this respect, the electronic module 100 comprises an electric power source 109, here a battery, configured to power electronic components of the electronic module 100, a circuit board assembly 110 electrically connected to the electric power source 109. Thus, when the proximal end surface 104 is loaded and the second portion 103 is moved, thereby moving a distal surface 111 of the second portion 103 towards the dose button 11 , the switch 108 is activated and power is supplied to the electronic components, such as processor units, display units, sensor arrays, memory units, communication modules, such as wireless modules, chips, traces, or the like, connected to the circuit board assembly 110 or the electric power source 109.

[0105] Upon a correspondingly induced dose delivery by the drug delivery device 1 , the first portion 101 subsequently rotates relative to the second portion 103. A click sound may be generated for each delivered dose unit by a clicker arm within the drug delivery device 1 , for example. Accordingly, a first sensor arrangement 112, for example an acoustic sensor, may detect the click sound to provide a first sensor output signal A. Furthermore, a second sensor arrangement 113, for example an optical sensor, may detect the relative movement, for example a rotation between the first portion 101 and the second portion 103, and thereby provide a second sensor output signal B. More precisely, the first and second sensor arrangements 112 and 113 may detect a click sound as well as a relative movement and may provide a sensor signal which is transmitted to a processor unit 114.

[0106] September 22, 2025 S 100 P 549 WO The processor unit 114 may then further process the first and second sensor output signals A and B as described with reference to Figures 3 to 8C below, wherein the processor unit 114 is configured to detect phase differences Pindex between a specific first sensor output value Ajnedx and corresponding specific second sensor output value Bjndex, wherein the processor unit 114 is configured to detect an error in the phase differences Pindex, and wherein the processor unit 114 is configured to perform a decision based on the error.

[0107] Figure 3 shows an example of a voltage pulse of a sensor output signal of a single sensor plotted over time. The voltage pulse may for example belong to the sensor output signal of an acoustic sensor configured to detect click sounds which occur during dose dialing and / or dose delivery. The voltage pulse shown in Figure 3 exceeds a predetermined threshold value for the voltage VIM at two points. In other words, the voltage pulse comprises two voltage peaks, a first voltage peak Vp1 and a second voltage peak Vp2.

[0108] At the first voltage peak Vp1 , the voltage pulse only exceeds the predetermined threshold value for the voltage VIM slightly and for a very short period of time. At the second voltage peak Vp2, the voltage pulse exceeds the predetermined threshold value for the voltage VIM for a longer period of time. Still, in order to determine a number of doses that has been delivered or dialed, the voltage peaks Vp1 and Vp2 that exceed the predetermined threshold value for the voltage VIM are counted. Here, the count would be two. Consequently, and according to the voltage pulse, there may for example be two dose units that have been dispensed. However, this dose count only depends on a sensor output signal of a single sensor and may therefore be wrong. For example, the first voltage peak Vp1 may correspond to an unintended click sound at the beginning of the dose delivery and only the second voltage peak Vp2 may correspond to a delivered dose. Thus, although the presumed dose count would be two, the actual or general dose count should be one.

[0109] Further, although additionally a predetermined threshold value for the time tiM may be considered, wherein voltage peaks Vp1 and Vp2 above the predetermined threshold value for the voltage VIM are combined when these peak values are withing the predetermined threshold value for the time tiM, here the dose count is still two.

[0110] Figure 4 thus shows two exemplary sensor output signals, a first sensor output signal A referring to a signal, for example a modulated voltage pulse, of a first sensor and a second sensor output signal B referring to a signal, for example a modulated voltage pulse, of a second sensor. The sensor output signals A and B are plotted over time and each signal comprises

[0111] September 22, 2025 S 100 P 549 WO specific sensor output values Aindex and Bindex, wherein the respective index describes the relative position in time to another specific sensor output value of the same sensor output signal. For example, the specific first sensor output value AM is earlier in relation to the specific first sensor output value Aj. In addition, the specific first sensor output value Aj+i is later than the specific first sensor output value A and the specific first sensor output value Aj.

[0112] Further, the index relates to a respective dose incident during a dose event, for example delivered dose units during dose dispensing. For example, the first sensor output signal A comprises multiple specific first sensor output values Aindex which together provide for a first dose count, i.e. a presumed number of dose units delivered. Hence, each of the specific first sensor output values Aindex refer to a dose incident. As such, for example, the initial or first specific first sensor output value Ai refers to a first dose incident, the second specific first sensor output value A2 refers to a second dose incident and the last or final specific first sensor output value Anrefers to the last first dose incident.

[0113] Since the electronic module 100 comprises two sensor arrangements which are both active simultaneously in order to detect a dose incident and accordingly provide a sensor output signal, a first sensor arrangement 112 with an acoustic sensor, for example, detects a click sound which may indicate dispense of a dose unit, wherein in temporal connection to the click sound an optical sensor of a second sensor arrangement 113 may also detect for example a change in light. In other words, normally the number of specific first sensor output values Aindex and the number of specific second sensor output values Bindex should be the same. However, a dose correction algorithm may be used if the first dose count and the second dose count are not the same, i.e. the same in number. Still, normally a first dose incident, for example Ai, is normally also associated with a specific second sensor output value, for example Bj, in a temporal connection. Index i and j may thus comprise the same numerical value.

[0114] However, typically the specific sensor output values Aindex and Bindex are not aligned as for example shown in Figures 4 and 5A. In other words, there is typically a phase difference Pindex, for example Pi, between a specific first sensor output value Aindex, for example Ai, and a corresponding specific second sensor output value Bindex, for example Bi. The phase difference Pindex may thus indicate a time offset between two corresponding specific sensor output values. The respective phase difference Pindex may be calculated by subtracting two corresponding time points t(Aindex) and t(Bindex). For example, Pi may be calculated by subtracting t(Ai) from t(Bi). Further, also the absolute value may be considered for the phase difference Pindex.

[0115] September 22, 2025 S 100 P 549 WO In addition, a time span between two consecutive specific sensor output values of the same sensor output signal is regarded as a time interval. Correspondingly, a first time interval tintA is for example marked in Figure 5A between specific first sensor output values A2 and A3 of the first sensor output signal A. Further, a second time interval tints is for example marked in Figure 5A between specific first sensor output values Bi and B20f the second sensor output signal B.

[0116] A processor unit 114 may thus be configured to detect an error in the phase differences Pindex. Further, the processor unit 114 may be configured to decide based on the error how the first dose count and / or the second dose count are to be considered when reporting a dose count to a user and / or to manipulate the phase differences Pindex to increase processability of the first sensor output signal A and / or the second sensor output signal B. In this regard, before the error in the phase differences Pindex is detected, the phase differences Pindex may be leveled as described with respect to Figures 5B and 5C. Further processing of the sensor output signals A and B in order to, for example derive different actions based on an error in the phase differences Pindex is discussed with respect to Figures 6A to 8C.

[0117] As aforementioned, the index n or m stands for the last or final specific sensor output value Anor Bmand the index 1 stands for the first or initial specific sensor output value A1 or Bi. For example, Bi is the first or initial specific second sensor output value of the second sensor output signal B and Bmis the last or final specific second sensor output value of the second sensor output signal B. Likewise A1 is the first or initial specific first sensor output value of the first sensor output signal A and Anis the last or final specific first sensor output value of the first sensor output signal A. Further, A2 is the second specific sensor output value of the first sensor output signal A, wherein B2 is the second specific sensor output value of the second sensor output signal B.

[0118] Furthermore, the first sensor output signal A and the second sensor output signal B both show an initial switch incident Si and a final switch incident S2. Both switch incidents Si and S2 refer to a switch time point, wherein the initial switch incident Si refers to a first switch time point t(Si) and final switch incident S2 refers to a second switch time point t(S2).

[0119] It should be noted that the switch incidents Si and S2, i.e. operation of a switch 108, do not necessarily lead to a specific sensor output value, i.e. a click sound is not necessarily generated when the switch 108 is actuated. Consequently, the switch incidents Si and S2 plotted on the time axes are to be understood less as sensor output signals or a specific sensor output value and more as incidents which comprise a temporal connection to the specific sensor output values Aindex and Bindex. In other words, the depicted switch incidents Si and S2

[0120] September 22, 2025 S 100 P 549 WO may for example refer to the actuation of a switch 108, for example a microswitch, at the beginning and at the end of a dose event, for example at the beginning and at the end of a dose dispensing event, wherein the switch incidents Si and S2 occur before and after actual detection of dose incidents by the sensor arrangements 112 and 113. The switch incidents Si and S2 are therefore plotted at the same time points on the two corresponding time axes.

[0121] Nevertheless, one of the two sensor arrangements 112 or 113 could also be used as a switch. In this regard, if for example the first sensor arrangement 112 would be used as the switch, the switch incidents Si and S2 would still occur at the same points in time with respect to the sensor output signals A and B as only one switch incident Si occurs at the beginning and only one switch incident S2 occurs at the end of a dose event. Further, after the switch is actuated at the end of a dose delivery, i.e. after switch incident S2 is generated, the processor unit 114 may be configured to manipulate the phase differences.

[0122] As can be noted from Figure 5A, a phase difference Pindex is a misalignment between a specific first sensor output value Aindex and a corresponding specific second sensor output value Bindex of the other sensor output signal. In other words, a phase difference Pindex may be determined between two specific sensor output values Aindex and Bindex referring to the same dose count but to different sensor output signals A and B. In Figure 5A, a phase difference Pi between the initial specific first sensor output value A1 and the initial specific second sensor output value Bi is shown. In other words, the phase difference Pi is a time span between a first time point t(Ai) and a second time point t(Bi). The phase difference, for example a phase difference P4, between a further first time point, for example first time point t(A4), and a further second time point, for example second time point t(B4), may be different, for example shorter or longer, than phase difference Pi.

[0123] Phase difference Pi may be compared with a predetermined first threshold value in order to determine an error in the phase differences Pindex. The error may then be used to decide how a first dose count and / or a second dose count determined from the specific first and / or second sensor output values are to be considered when reporting a dose count to a user. In addition, or alternatively the error may be used to manipulate the phase differences Pindex to increase processability of the first sensor output signal A and / or the second sensor output signal B.

[0124] However, phase differences Pindex between specific sensor output values Aindex and Bindex of two sensor output signals A and B may not all have a same size. For example, a phase difference Pi may be greater than a phase difference P2. In Figure 5B, the phase differences Pi to P5 between the specific sensor output values A1 to As and Bi to Bs as shown in Figure 5A are

[0125] September 22, 2025 S 100 P 549 WO plotted with respect to their respective time span. It may thus be noted that phase differences Pi and P2 as well as phase differences P4 and P5 each have the same size respectively. However, phase differences P4 and P5 are smaller than phase differences Pi and P2. In addition, phase difference P3 is shorter or smaller than phase differences Pi and P2but longer or greater than phase differences P4 and P5.

[0126] Figure 5C shows the phase differences Pi to P5 as shown in Figure 5B, however, these phase differences Pi to P5 have been leveled. Consequently, all phase differences Pi to P5 between specific first sensor output values A1 to As and corresponding specific second sensor output values Bi to Bs have been brought to a same level. In this regard, the phase differences Pindex may have been leveled by dividing each specific phase difference Pi to P5 by a time interval related to the phase difference. For example, Pi may be divided by a time interval related to the phase difference Pi. The time interval may be determined from a first time point t(Ajndex) of a corresponding specific first sensor output value Aindex or from a second time point t(Bjndex) of a corresponding specific second sensor output value Bindex used to determine the phase difference Pindex and a following or preceding first or second time point t(Ajndex) or t(Bjndex) of a further corresponding specific first or second sensor output value Aindex or Bindex) .

[0127] For phase difference Pi, the time interval may have thus been determined from a second time point t(Bi) of a corresponding specific second sensor output value Bi used to determine the phase difference Pi and a following second time point t(B2) of a further corresponding specific second sensor output value B2.

[0128] Alternatively, the time interval may be determined from a following first or second time point t(Aindex) or t(Bindex) and a preceding first or second time point t(Ajndex) or t(Bjndex) of further first or second sensor output values Aindex or Bindex following and preceding a corresponding specific first or second sensor output value Aindex or Bindex used to determine the phase difference Pindex.

[0129] Thus, when the phase differences Pi to P5 have been leveled all phase differences Pi to P5 comprise the same time span. Leveling the phase differences may be conducted before the error in the phase differences Pindex is detected and may especially be helpful if the dispense speed for example increases or changes during dose delivery.

[0130] Two further different sensor output signals A and B are shown in Figures 6A and 6B. The first dose count of the first sensor output signal A, i.e. the number of specific first sensor output values Aindex, in Figure 6A is four. The second dose count of second sensor output signal B, i.e. the number of specific second sensor output values Bindex, in Figure 6A is six. Therefore,

[0131] September 22, 2025 S 100 P 549 WO the first dose count is smaller than the second dose count. Either one of the two dose counts may thus be wrong. In this regard, the processor unit 114 may be configured to determine a ratio of the first number of specific first sensor output values Aindex, i.e. the first dose count, and the second number of specific second sensor output values Bjndex, i.e. the second dose count, and a difference between the at least two phase differences in order to determine whether the first number of specific first sensor output values Aindex or the second number of specific second sensor output values Bjndex is to be considered as a general dose count or whether the first sensor output signal A or the second sensor output signal B is to be corrected.

[0132] With respect to Figure 6A, the difference may for example be determined between the phase differences PM and Pj+2. In addition, the ratio as well as the difference may be compared with a threshold value. To perform a suitable comparison typically absolute values of the phase differences Pindex are used.

[0133] In Figure 6A, the first dose count is smaller than the second dose count. Further, the difference between the phase differences PM and Pj+2 is greater than a threshold value. Thus, in the case shown in Figure 6A, the processor unit 114 may determine that the second dose count is wrong and may only report the first dose count to the user. Therefore, a dose count of four is reported to the user, for example using a signal generator.

[0134] In Figure 6B, however, the first dose count is greater than the second dose count. In addition, the difference between the phase differences PM and Pj+2 is smaller than a threshold value. Thus, in the case shown in Figure 6B, the processor unit 114 may again determine that the second dose count is wrong and may only report the first dose count to the user. Therefore, a dose count of five is here reported to the user. Consequently, if the phase differences increase by more than a threshold value as shown with respect to Figure 6A or if the phase differences decrease by more than a threshold value as shown in Figure 6B, the processor unit 114 may be configured to determine based on the first and second dose counts which one of the dose counts is reported or regarded as the general dose count.

[0135] However, if the difference increases by more than a threshold value and the first dose count is greater than the second dose count, the dose counts may be wrong and may for example comprise double counts or missing counts, i.e. too many specific sensor output values Aindex or Bjndex or missing specific sensor output values Aindex or Bjndex. In this regard, at least one of the dose counts may not be reported to the user. Also, if the difference decreases by more than a threshold value and the first dose count is smaller than the second dose count, the dose counts may be wrong and may for example comprise double counts or missing counts. Also

[0136] September 22, 2025 S 100 P 549 WO here, at least one of the dose counts may not be reported to the user. In addition, one of the dose counts may be corrected. For example, using a correction algorithm.

[0137] Furthermore, phase differences Pindex between the specific senor output values Aindex and Bindex makes it more difficult to compare the sensor output signals A and B. If the phase difference Pindex can be removed or reduced, the sensor output signals A and B can be processed more reliably.

[0138] Thus, for example a fixed time offset may be applied to all specific first and / or second sensor output values Aindex and Bindex. In the example shown in Figure 7, all specific sensor output values A'index have been shifted by the phase difference Pi, i.e. the time span between time points t(Ai) and t(Bi) before shifting. Here, a punctuation mark ', i.e. an apostrophe, is used to indicate that the sensor output values Aindex and Bindex of the first and second sensor output signals A and B have already been shifted and are not the same anymore as of the original sensor output signals A and B. Still, the switch incidents Si have not been shifted.

[0139] Due to the shifting, the specific sensor output values A'i and Bi are now aligned in Figure 7. Further, specific sensor output values A'2 and B2 are now aligned since P2 had the same time span as Pi as can be noted from Figure 6A. Still, however, the further specific sensor output values A'a to A's and B3 to B5 are not aligned. Nevertheless, using a fixed time offset, which may be a phase difference Pindex, at least reduces some of the phase differences Pindex. If, for example, P3 had been used instead of Pi, i.e. if all specific first sensor output values Aindex had been shifted by P3, the specific sensor output values A'3 and B3 would now be aligned in Figure 7 and the other specific sensor output values would not. Instead of shifting all specific first sensor outdoor values Aindex also all specific second sensor output values Bindex or all specific first sensor outdoor values Aindex and all specific second sensor output values Bindex may be shifted. If all specific first sensor outdoor values Aindex and all specific second sensor output values Bindex may be shifted, shifting may be conducted for each of the specific first or second sensor output values A or B by half the size of a fixed time offset, for example.

[0140] Adding a phase difference Pindex to all specific first or second senor output values Aindex or Bindex in order to align all specific first sensor output values Aindex with all corresponding specific second sensor output values Bindex would be more effective if the phase differences Pindex were the same or at least more similar before shifting, i.e. before adding the fixed time offset or a phase difference. The reason why Pindex in Figure 7 was not uniform or leveled before shifting may have to do with the fact that the dispense speed was not uniform, for example. In other words, and as can be seen from Figures 5A and 5B, for example, the dispense speed may

[0141] September 22, 2025 S 100 P 549 WO have increased during the dose delivery and the phase differences Pindex have thus become shorter.

[0142] In this respect, normalizing first and second time intervals tintA and tints between the specific first sensor output values Aindex and the specific second sensor output values Bindex as shown in Figures 8A to 8C may be used. Therefore, the processor unit 114 may be configured to normalize second time intervals tints of specific second sensor output values Bindex by setting all second time intervals tints between two consecutive specific second sensor output values Bindex to a second equal value t*nts. The normalized specific second senor output values B*ndex all comprise a same time interval. In other words, the second time interval tints between two consecutive normalized specific second sensor output values B*ndex has been set to a second equal value t*nts and is thus the same.

[0143] Further, the processor unit 114 may be configured to normalize first time intervals tintA between two consecutive specific first sensor output values Aindex to a first equal value t*ntA. A resulting normalized first sensor output signal A* and a normalized first sensor output signal B* are shown in Figure 8B. Here the first equal value and the second equal value are at least essentially the same. In order to normalize each first time interval tintA between two specific first sensor output values Aindex, a normalized second time point t(B*ndex) of a corresponding specific second sensor output value B*ndex is used. In addition, a phase difference Pindex divided by a second time interval tints is added to the normalized second time point t(B*ndex) in order to normalize each first time interval to an equal value t*ntA.

[0144] For example, in Figure 8B a normalized second time point t(B*i) of a corresponding specific second sensor output value B*i is used to which a phase difference Pi , i.e. a phase difference between specific first sensor output value Ai and specific second sensor output value Bi, divided by a second time interval tints, for example a second time interval tints between Bi and B2, is added to the normalized second time point t(B*i) in order to receive a normalized first time point t(A*i). Consequently, in order to normalize each first time interval tintA between two specific first sensor output values Aindex to a first equal value t*ntA, the aforementioned procedure may be repeated for each first time point t(Aindex).

[0145] However, as can be noted from Figure 8B, although all phase differences Pindex have the same value, phase differences Pindex between the specific senor output values A*ndex and B*ndex still exist. Thus, although the processability of the sensor signals A* and B* shown in Figure 8B may have already been improved, the processability may be further improved if the phase differences are eliminated.

[0146] September 22, 2025 S 100 P 549 WO Thus, in order to further improve processability and in order to eliminate phase differences Pindex shown in Figure 8A, instead of using the sensor output signals A and B shown in Figure 8A, a fixed time offset may first be added to all specific first sensor output values Aindex as known from Figure 7. Afterwards, and with the sensor output signal A', normalizing may be conducted. Figure 8C shows sensor output signals A'* and B* with eliminated phase differences Pindex. Here, the normalizing was conducted with the sensor output signals A' and B shown in Figure 7 or in other words with the sensor output signals A and B shown in Figure 8A, wherein the specific first sensor output values Aindex have been shifted before normalization.

[0147] In summary, the present disclosure may thus allow to use phase differences Pindex between specific first and corresponding second sensor output values Aindex and Bindex in order to decide how to use or manipulate the sensor data. In one example, the phase differences Pindex are reduced or eliminated to improve processability of the sensor output signals A and B. In other examples, the phase differences Pindex are used to decide whether a first and / or a second dose count may be used as a general dose count. The present disclosure thus allows to provide an improved electronic module 100 which is configured to work with two sensor output signals A and B of two different sensor arrangements 112 and 113, wherein each sensor arrangement is configured to detect incidents during a same dose event. The electronic module 100 may thus allow to improve determining a general dose count.

[0148] September 22, 2025 S 100 P 549 WO Reference Numerals

[0149] 1 drug delivery device

[0150] 10 housing

[0151] 11 dose button

[0152] 12 dose dial grip

[0153] 13 drive sleeve

[0154] 14 display window

[0155] 15 container

[0156] 16 needle

[0157] 17 inner needle cap

[0158] 18 outer needle cap

[0159] 19 number sleeve

[0160] 100 electronic module

[0161] 101 first portion

[0162] 102 auxiliary dose dial grip

[0163] 103 second portion

[0164] 104 proximal end surface

[0165] 105 push element

[0166] 106 spring element

[0167] 107 lever arm

[0168] 108 switch

[0169] 109 electric power source

[0170] 110 circuit board assembly

[0171] 111 distal surface

[0172] 112 first sensor arrangement

[0173] 113 second senor arrangement

[0174] 114 processor unit

[0175] A first sensor output signal

[0176] Ai initial specific first sensor output value

[0177] Ajnde specific first sensor output value

[0178] An final specific first sensor output value index shifted specific first sensor output value index normalized specific first sensor output value index shifted and normalized specific first sensor output value

[0179] September 22, 2025 S 100 P 549 WO t(Aindex) first time point (of a specific first sensor output value) t(A'index) first time point (of a shifted specific first sensor output value) t(A*jndex) first time point (of a normalized specific first sensor output value) t(A'*jndex) first time point (of a shifted and normalized specific first sensor output value) tintA first time interval t*intA first equal value (normalized first time interval)

[0180] B second sensor output signal

[0181] Bi initial specific second sensor output value

[0182] Bindex specific second sensor output value

[0183] Bmfinal specific second sensor output value

[0184] B*index normalized specific second sensor output value t(Bjndex) second time point t(B*jndex) second time point (of a normalized specific second sensor output value) tints second time interval t*intB second equal value (normalized second time interval)

[0185] Pindex phase difference (between Aindex and Bindex)

[0186] 51 first switch incident

[0187] 52 second switch incident t(Si) switch time point (of a first switch incident) t(S2) switch time point (of a second switch incident) tiimit predetermined threshold value for the time

[0188] Viimit predetermined threshold value for the voltage

[0189] Vp1 first voltage peak

[0190] Vp2 second voltage peak

[0191] September 22, 2025 S 100 P 549 WO

Claims

Claims1. An electronic module (100) comprising at least• an electric power source (109) configured to power electronic components of the electronic module (100),• a circuit board assembly (110) electrically connected to the electric power source (109),• at least a first sensor arrangement (112) configured to provide a first sensor output signal (A),• at least a second sensor arrangement (113) configured to provide a second sensor output signal (B), and• a processor unit (114) configured to perform a first dose count by processing specific first sensor output values (Aindex) of the first sensor output signal (A) and a second dose count by processing specific second sensor output values (Bjndex) of the second sensor output signal (B), characterized in that the processor unit (114) is further configured to detect phase differences (Pindex) between a specific first sensor output value (Ajnedx) and corresponding specific second sensor output value (Bjndex), wherein a phase difference (Pindex) is a time offset between a specific first sensor output value (Ajnedx) and corresponding specific second sensor output value (Bjndex), wherein the processor unit (114) is configured to detect an error in the phase differences (Pindex), and wherein the processor unit (114) is configured to decide based on the error• how the first dose count and / or the second dose count are to be considered when reporting a dose count to a user, and / or• to manipulate the phase differences (Pindex) to increase processability of the first sensor output signal (A) and / or the second sensor output signal (B).

2. The electronic module (100) according to claim 1 , wherein, before the error in the phase differences (Pindex) is detected, the processor unit (114) is configured to level the phase differences (Pindex) by dividing each specific phase difference (Pindex) by a time interval related to the phase difference (Pindex), and wherein the time interval is determined• from a first time point (t(Aindex)) of a corresponding specific first sensor output value (Aindex) or from a second time point (t(Bindex)) of a corresponding specific second sensor output value (Bindex) used to determine the phase difference (Pindex) and a following or preceding first or second time point (t(Aindex), t(Bindex)) of a further corresponding specific first or second sensor output value (Aindex, Bindex) , orSeptember 22, 2025 S 100 P 549 WO• from a following first or second time point (t(Ajndex), (t(Bjndex)) and a preceding first or second time point (t(Ajndex), t(Bjndex)) of further first or second sensor output values (Ain ex, Bin ex) following and preceding a corresponding specific first or second sensor output value (Aindex, Bindex) used to determine the phase difference (Pin ex).

3. The electronic module (100) according to claim 1 or 2, wherein the processor unit (114) is configured to compare a single phase difference (Pindex) and / or a difference between any two phase differences (Pindex) with a first predetermined threshold value to detect an error in the phase differences (Pindex).

4. The electronic module (100) according to claim 3, wherein the processor unit (114) is configured to compare a difference between two adjacent phase differences (Pindex, Pin ex±i) or a difference between an initial phase difference (Pi) and a final phase difference (Pn) with the first predetermined threshold value.

5. The electronic module (100) according to any one of the preceding claims, wherein, when an error in the phase differences (Pindex) is detected, the processor unit (114) is configured to decide at least one of the following• not to report a dose count to the user;• to report the first dose count and / or second dose count to the user together with a warning;• to determine a first number of specific first sensor output values (Aindex) and a second number of specific second sensor output values (Bindex), and to report the first dose count or the second dose count to the user, if the first number and the second number are equal;• to process the first and / or second sensor output signal (A, B) if the error exceeds a second threshold value.

6. The electronic module (100) according to any one of the preceding claims, wherein the processor unit (114) is configured to determine a first number of specific first sensor output values (Aindex) and a second number of specific second sensor output values (Bindex), wherein the processor unit (114) is configured to determine at least two phase differences (Pindex) between at least two different pairs of specific first sensor output values (Aindex) and specific second sensor output values (Bindex), andSeptember 22, 2025 S 100 P 549 WOwherein the processor unit (114) is configured to determine, depending on a ratio of the first number of specific first sensor output values (Aindex) and the second number of specific second sensor output values (Bindex) and a difference between the at least two phase differences (Pindex), whether the first number of specific first sensor output values (Aindex) or the second number of specific second sensor output values (Bindex) is to be considered as a general dose count or whether the first sensor output signal (A) or the second sensor output signal (B) is to be corrected.

7. The electronic module (100) according to claim 6, wherein• when the first number of specific first sensor output values (Aindex) is less than the second number of specific second sensor output values (Bindex) and the difference between the at least two phase differences (Pindex) exceeds a threshold value, the first number of specific first sensor output values (Aindex) is considered as the general dose count;• when the first number of specific first sensor output values (Aindex) is greater than the second number of specific second sensor output values (Bindex) and the difference between the at least two phase differences (Pindex) deceeds a threshold value, the first number of specific first sensor output values (Aindex) is considered as the general dose count;• when the first number of specific first sensor output values (Aindex) is less than the second number of specific second sensor output values (Bindex) and the difference between the at least two phase differences (Pindex) deceeds a threshold value, the first sensor output signal (A) is to be corrected;• when the first number of specific first sensor output values (Aindex) is greater than the second number of specific second sensor output values (Bindex) and the difference between the at least two phase differences (Pindex) exceeds a threshold value, the first sensor output signal (A) is to be corrected.

8. The electronic module (100) according to any one of the preceding claims, wherein the processor unit (114) is configured to shift all specific first sensor output values (Aindex) or all specific second sensor output values (Bindex) by a fixed time offset prior to detecting any phase differences (Pindex) .

9. The electronic module (100) according to any one of the preceding claims, wherein the processor unit (114) is configured to shift all specific first sensor output values (Aindex) or all specific second sensor output values (Bindex) by a phase difference (Pindex) determined between a specific first sensor output value (Aindex) and specific second sensor output value (Bndex) .September 22, 2025 S 100 P 549 WO10. The electronic module (100) according to any one of the preceding claims, wherein the processor unit (114) is configured to normalize second time intervals (tints) of second sensor output values (Bindex) by setting all second time intervals (tints) between two consecutive specific second sensor output values (B*ndex) to a second equal value (t*ntB), wherein the processor unit (114) is configured to normalize each first time interval (tintA) between two specific first sensor output values (Aindex) to a first equal value (t*ntA) by using a normalized second time point (t(B*index)) of a corresponding specific second sensor output value (B*ndex) and by adding a phase difference (Pindex) divided by a second time interval (tints) to the normalized second time point (t(B*index)).11 . The electronic module (100) according to any one of the preceding claims, wherein the electronic module (100) comprises a switch (108) which is actuated at the end of a dose delivery, and wherein the processor unit (114) is configured to manipulate the phase differences (Pindex) after the switch (108) has been actuated at the end of the dose delivery.

12. The electronic module (100) according to any one of the preceding claims, wherein the processor unit (114) is configured to perform a dose correction algorithm after the phase differences (Pindex) have been manipulated.

13. The electronic module (100) according to any one of the preceding claims, wherein the electronic module (100) comprises a communication unit configured to transmit the dose count to a signal generator to report the dose count to the user.

14. The electronic module (100) according to any one of the preceding claims, wherein the electronic module (100) is configured to be releasably attached to a drug delivery device (1).

15. The electronic module (100) according to any one of the preceding claims, wherein the at least one first sensor arrangement (112) comprises an acoustic sensor, and wherein the at least one second sensor arrangement (113) comprises at least one optical sensor.September 22, 2025 S 100 P 549 WO

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