Improvements relating to testing of medical devices

Abstract

A test system (1) comprising: a) a mounting rig (2) for clamping a first medical device (3); b) a dummy device (4); c) a transmission (5) for operatively interlinking the first medical device (3) when clamped in the mounting rig (2) with the dummy device (4) such that an actuation force applied to the dummy device (4) is transferred via the transmission (5) to the first medical device (3) to actuate the first medical device (3); and d) one or more sensors for generating an actuation profile of the first medical device (3).

Description

[0001] Improvements relating to testing of medical devices

[0002] The present disclosure relates to improvements in the testing of human actuation parameters of medical devices. The results may be applied in a laboratory environment to simulate 'real world' usage testing of medical devices. In particular, the disclosure relates to testing of human actuation parameters of medical devices including, for example, nasal spray devices, pressurised metered dose inhaler (pMDI) devices, dry powder inhaler (DPI) devices and soft mist inhaler (SMI) devices.

[0003] Background to the Disclosure

[0004] Some medical devices require an actuation process to be undertaken when used. Examples of such medical devices include nasal spray devices, pMDI devices, and other inhalation devices, for example DPI and SMI devices. Therefore, the design of medical devices may involve designing the actuation process so that they can be operated reliably and consistently by users.

[0005] In addition, a wide range of users may operate such medical devices. Users may vary, for example, in their age and manual dexterity. Therefore, the design of medical devices may involve designing the actuation and delivery process so that they can be operated by a range of users having different capabilities.

[0006] In addition, with some medical devices the actuation process itself may affect the delivery of the medicament to the user. For example, with manually actuated nasal spray devices the force and timing applied during actuation may affect the spray pattern and droplet size of the delivered medicament. The timing of inhalation versus actuation may also affect deposition of the medicament in the nasal passages of the user. Similarly, for pMDI, DPI and SMI devices the timing of inhalation versus actuation may affect deposition of the medicament in the oral or nasal passages of the user.

[0007] It would therefore be useful to obtain accurate and reliable data on how users actuate such medical devices to inform the design of the devices, for example in respect of the functionality, ergonomics and accessibility of their actuation mechanisms.

[0008] Summary of the Disclosure A first aspect of the present disclosure provides a test system comprising: a) a mounting rig for clamping a first medical device; b) a dummy device; c) a transmission for operatively interlinking the first medical device when clamped in the mounting rig with the dummy device such that an actuation force applied to the dummy device is transferred via the transmission to the first medical device to actuate the first medical device; and d) one or more sensors for generating an actuation profile of the first medical device.

[0009] A second aspect of the present disclosure provides the combination of the test system of the first aspect and a first medical device; and optionally wherein the first medical device is a nasal spray device, a pMDI device, a DPI device, a SMI device or a patch pump device.

[0010] A third aspect of the present disclosure provides a method of testing a first medical device, the method comprising: clamping the first medical device; operably interlinking the first medical device with a dummy device using a transmission; actuating the dummy device to thereby actuate the first medical device by transmitting an actuation force applied to the dummy device to the first medical device via the transmission; and using one or more sensors to generate an actuation profile of the first medical device.

[0011] A fourth aspect of the present disclosure provides use of the test system of the first aspect to perform the method of the third aspect.

[0012] A fifth aspect of the present disclosure provides a method of testing the actuation of a second medical device, comprising the steps of: a) actuating a first medical device while using one or more sensors to generate an actuation profile of the first medical device; b) repeating step a) a plurality of times to generate a plurality of actuation profiles of one or more first medical devices; c) generating an average actuation profile of the first medical device(s) by averaging the plurality of actuation profiles; d) using the average actuation profile to derive operating instructions for a testing apparatus; e) mounting the second medical device in the testing apparatus; f) controlling the testing apparatus using the operating instructions to actuate the second medical device; and g) during actuation of the second medical device, measuring at least a force variable based on the force applied to the second medical device.

[0013] The use of a dummy device allows for improved interaction of the user since the ergonomics and feel of the dummy device may closely resemble that of the actual first medical device. In this way the sensor data obtained may be of a higher quality and more representative of the forces, displacements, velocities and accelerations likely to be seen during real life usage outside the laboratory. In particular, the use of the dummy device allows the user to still manually actuate a device but without adding additional components that would significantly alter the ergonomics, shape, and feel of the device.

[0014] Obtaining data by users manually actuating the dummy device may allow for improved data to be obtained that is more representative of how individual users would actuate the first medical device outside the laboratory. In addition, each user will differ in how they actuate a device, the test system and methods of the present disclosure allow for the collection and use of a plurality of data sets from different users that allows for a more comprehensive average actuation profile of the first medical device(s) to be obtained.

[0015] The actuation profile and / or the average actuation profile may describe one or more characteristics of the actuation of the first medical device. Examples of such characteristics include but are not limited to: actuation force magnitude, actuation force acceleration, peak actuation force, actuation time, actuator displacement, actuator velocity, and actuator acceleration.

[0016] The mounting rig functions to hold the first medical device in place when an actuation force is applied to the dummy device. The mounting rig may also hold the dummy device so as to control alignment and position and / or orientation of the dummy device relative to the first medical device.

[0017] The mounting rig may be configured to allow manual actuation of the dummy device to thereby actuate the first medical device by transmitting an actuation force applied to the dummy device to the first medical device via the transmission. Using manual actuation may allow for improved data to be obtained that is more representative of how individual users would actuate the first medical device outside the laboratory.

[0018] The mounting rig may comprise one or more clamps for clamping the first medical device. The mounting rig may comprise one or more clamps for clamping the dummy device.

[0019] The mounting rig may comprise an upper bracket which clamps the first medical device. A lower bracket may also be provided for clamping the dummy device. The upper bracket and the lower bracket may be interlinked by one or more, optionally a plurality of, support bars. The support bar or bars may function to control alignment and position and / or orientation of the dummy device relative to the first medical device. In some examples a pair of parallel support bars may be provided interlinking the first medical device with the dummy device by, for example, interconnecting the upper bracket and the lower bracket.

[0020] The upper bracket may be provided with a quick release mechanism for clamping the first medical device. This allows to mount and dismount first medical devices from the mounting rig when testing a plurality of first medical devices quickly and easily. Likewise the lower bracket may comprise a quick release mechanism if desired. However, typically the dummy device may be configured to be resettable and therefore may remain mounted to the mounting rig.

[0021] For example, the upper and / or lower bracket may comprise two clamp parts (e.g. front and back clamp parts) that may be held together by magnets to apply a clamping force to a device retained in between the clamp parts. The clamp parts may be prised apart to release the device by overcoming the magnetic attraction force of the magnets.

[0022] The one or more sensors may comprise one or more sensors for measuring or determining: - a force variable based on the force applied to the first medical device during the actuation of the first medical device; and / or

[0023] - one or more of a displacement, speed, velocity, and acceleration variable based on a movement during the actuation of the first medical device.

[0024] The force variable may, for example, be a measurement of or indicative of the force applied to a part of the first medical device, for example to the actuator of the first medical device.

[0025] The displacement, speed, velocity, and / or acceleration variable may, for example, be a measurement of or indicative of a displacement, speed, velocity, and / or acceleration of a part of the first medical device, for example of the actuator of the first medical device.

[0026] The force variable and / or the displacement, speed, velocity, and / or acceleration variable may be measured or determined over a time period. The time period may extend over a whole of an actuation time of the first medical device.

[0027] The one or more sensors may comprise a force transducer. The force transducer may measure the force variable. The force transducer may be, for example, any sensor that converts an input mechanical load, weight, tension, compression, or pressure into an electrical output signal. The force transducer may be, for example, a load cell or a force sensing resistor (FSR). The load cell may be, for example, a piezoelectric loadcell, a capacitive load cell, an optical force sensor, e.g. a fibre optic load cell, or a strain gauge load cell.

[0028] The one or more sensors may comprise a displacement / position sensor and / or a speed sensor and / or an accelerometer. The displacement / position sensor may be any suitable sensor for measuring the displacement variable. The displacement / position sensor may be, for example, any sensor that converts an input movement into an electrical output signal.

[0029] The displacement / position sensor may be a contact sensor, for example a rotational or linear encoder or a linear variable differential transformer. However, the displacement / position sensor may be a non-contact sensor. Use of a non-contact sensor does not impart any additional resistance to the actuation of the first medical device, such that the actuation profile obtained will be more accurate. In addition, the feel of actuating the device by the user is less affected and the data obtained is more reliable. The displacement, speed, velocity, and / or acceleration variable may be based on a movement of the transmission (or a part thereof) during the actuation of the first medical device. Alternatively, the displacement, speed, velocity, and / or acceleration variable may be based on a movement of another suitable part that moves during actuation relative to a part that remains stationary.

[0030] The non-contact displacement / position sensor may be, for example, a linear displacement sensor. Examples of suitable sensors include, capacitive sensors, laser beam sensors, optical encoders, hall effect sensors, inductive sensors, and ultrasonic sensors. The laser beam sensor may use end to end or time of flight sensing. The laser beam sensor may, for example, be of a diffuse reflective, a specular reflective or a through beam type.

[0031] The speed sensor may be any suitable sensor for measuring or determining the speed and / or velocity variable. For example, a magnetic sensor, hall effect sensor, wheel speed sensor, or laser speed sensor.

[0032] The accelerometer may be of any suitable type. For example, piezoelectric, capacitive, or MEMS accelerometer.

[0033] The first medical device may be a manual medical device. The first medical device may be a manually-actuatable medical device.

[0034] Examples of the type of device for the first medical device include a nasal spray device, a pMDI device, a DPI device, a SMI device or a patch pump device. Indeed the first medical device may be any medical device where a user has to apply a displacement to force to actuate the device, in particular medical devices that comprise an actuator, e.g. an actuator button or trigger, that is pressed to actuate the medical device.

[0035] The first medical device may comprise an actuator that is operated to actuate the device. The actuator may comprise, for example, a button, trigger or switch. Alternatively, the actuator may comprise, for example, a vial or canister that may hold the medicament and may be directly pushed upon by the user. The actuator may be actuated, for example, by a linear movement, e.g. a sliding movement when pushed. Alternatively, the actuator may be actuated by a pivoting or rotational movement.

[0036] The first medical device may be a device capable of delivering a dose of medicament and the dummy device may be incapable of delivering a dose of medicament.

[0037] The first medical device may be configured to contain a product such that actuation causes delivery of the product to the user. The product may be a medicament, or a placebo or other inactive product. Alternatively, the first medical device, even though capable of delivering a product on actuation may not contain a product when tested. For example, the first medical device may be configured to be ‘dry-fired’ wherein an actuation mechanism of the device is fully functioning but no product is delivered, for example because a vial, canister or similar of the device is empty.

[0038] By contrast, the dummy device is optionally incapable of delivering a dose of medicament.

[0039] The dummy device may correspond to the first medical device. The correspondence may be one or more types of correspondence. For example, the dummy device and the first medical device may correspond by having the same, or substantially the same, external size and shape. Alternatively or additionally, the dummy device and the first medical device may correspond in that the ergonomics of an actuator of the dummy device functionally replicates the ergonomics of the actuator of the first medical device. Alternatively or additionally, the dummy device and the first medical device may correspond because the dummy device replicates at least those portions of the first medical device that would be manually contacted by a user when actuating the first medical device. In some examples, the dummy device may replicate the actuator of the first medical device. The actuator of the dummy device may comprise, for example, a button, trigger or switch, or a canister or vial.

[0040] The transmission functions to operatively interlink the first medical device when clamped in the mounting rig with the dummy device such that an actuation force applied to the dummy device is transferred via the transmission to the first medical device to actuate the first medical device. The transmission may comprise one or more transmission members that transmit the actuation force applied to the dummy device (e.g. to the actuator of the dummy device) directly or indirectly to the first medical device. In some examples the transmission comprises one or more transmission members that transmit the actuation force applied to the dummy device directly or indirectly to a force transducer which in turn transmits the actuation force directly or indirectly to the first medical device, optionally via one or more additional transmission members.

[0041] The one or more transmission members may be a rigid member, an articulated linkage, an hydraulic fluid (for example contained in one or more hydraulic lines), or a flexible line (for example a wire).

[0042] One or more of the transmission members may comprise a shaft, rod or tube.

[0043] The transmission may comprise the one or more sensors. For example, the one or more sensors may be located above, below or in between one or more transmission members of the transmission.

[0044] In some examples the one or more of the transmission members may be configured to receive one or more of the sensors in a transmission path of the transmission. For example, a transmission member may comprise a mount, e.g. a cavity, for mounting a force transducer.

[0045] In some examples a first end (e.g. a lower end) of a transmission member may contact an actuator of the dummy device and a second end (e.g. an upper end) of said transmission member may contact a first end (e.g. lower end or surface) of the force transducer. A second end (e.g. upper end or surface) of the force transducer may contact the actuator of the first medical device.

[0046] One or more parts of the transmission may extend through an interior of the dummy device. For example, one or more transmission members may be slidable mounted within the interior of the dummy device. A transmission member may extend out of an outlet end of the dummy device in order to make contact with the force transducer or an additional transmission member. The test system may further comprise a controller and / or computer for generating the actuation profile.

[0047] The test system may further comprise a timer for measuring a time variable. The time variable may be measured or determined during the actuation of the first medical device, for example throughout the whole actuation. The time variable may be measured by a separate timer. Alternatively a clock or cycle count of the controller and / or computer may be used to generate the time variable.

[0048] An average actuation profile may be derived from a plurality of actuation profiles, the plurality of actuation profiles being obtained from separate actuations of one or more first medical devices. The separate actuations may be performed by multiple users. The separate actuations may, for example, comprise greater than 20, or greater than 50, or greater than 100 actuations.

[0049] Data from the plurality of actuation profiles may be relativised by aligning an actuation point of each actuation profile with each other.

[0050] The average actuation profile may be obtained by averaging velocity data from the plurality of actuation profiles.

[0051] The method may further comprise using the average actuation profile to derive operating instructions for a testing apparatus to test fire a medical device.

[0052] The operating instructions may comprise or consist of displacement-velocity data pairs.

[0053] In the fifth aspect actuating the first medical device may comprise clamping the first medical device, operably interlinking the first medical device with a dummy device using a transmission, and actuating the dummy device to thereby actuate the first medical device by transmitting an actuation force applied to the dummy device to the first medical device via the transmission. In particular, the test system of the first aspect may be used to perform the method of fifth aspect.

[0054] The testing apparatus may be computer controlled using the operating instructions. Brief Description of the Drawings

[0055] One or more embodiments of the disclosure will now be described, by way of example only, with reference to the accompanying drawings in which:

[0056] Figure 1 is a front elevation of a combination of a test system and a first medical device in accordance with an embodiment of the present disclosure;

[0057] Figure 2 is a side elevation of the combination of Figure 1 ;

[0058] Figure 3 is a cross-sectional view of the combination of Figure 1 ;

[0059] Figure 3a is an enlarged view of a portion of Figure 3;

[0060] Figure 4 is an extract of data output from the test system of Figure 1 ;

[0061] Figure 5 shows graphs of force, displacement and velocity against time for the test system of Figure 1 ;

[0062] Figure 6 shows the graphs of Figure 5 relativised by the actuation point of each data set;

[0063] Figure 7 is an average actuation profile derived from the data of Figure 6;

[0064] Figure 8 is a truncated version of Figure 7 where the average actuation profile terminates at the actuation point;

[0065] Figure 9 is the profile of Figure 8 overlaid with manual displacement data;

[0066] Figure 10 is an extract of G-code for instructing a computer-controlled testing apparatus;

[0067] Figure 11 is a perspective view of an embodiment of a computer-controlled testing apparatus according to the present disclosure; and

[0068] Figure 12 is a schematic view of another embodiment of test system and first medical device in accordance with the present disclosure.

[0069] Detailed Description

[0070] Unless defined otherwise, all technical and scientific terms used in this specification have the same meaning as is commonly understood by the reader skilled in the art to which the claimed subject matter belongs. It is to be understood that the foregoing summary of the disclosure and the following examples are exemplary and explanatory only and are not restrictive of any subject matter claimed.

[0071] The following description is directed to embodiments of the disclosure. The description of the embodiments is not meant to include all the possible embodiments of the disclosure that are claimed in the appended claims. Many modifications, improvements and equivalents which are not explicitly recited in the following embodiments may fall within the scope of the appended claims. Features described as part of one embodiment may be combined with features of one or more other embodiments unless the context clearly requires otherwise.

[0072] The test system 1 comprises a mounting rig 2 for clamping a first medical device 3 which is in the form of a device capable of delivering medicament, a dummy device 4, a transmission 5, and one or more sensors.

[0073] An embodiment of the test system 1 is shown in Figures 1 to 3a. In the example of the embodiment of Figures 1 to 3a the first medical device 3 is shown as a nasal spray device of the general type described in WO2015 / 008048 A1 , the contents of which are incorporated herein by reference. However, it will be appreciated that the configuration of the nasal spray device may differ, e.g. in size, shape and the actuation mechanism. In addition, the first medical device 3 may take different forms, for example as a pMDI device, a DPI device, a SMI device or another inhaler device rather than a nasal spray device.

[0074] In the example of the embodiment of Figures 1 to 3a the mounting rig 2 holds the first medical device 3 in place. The mounting rig 2 comprises an upper bracket 10 which clamps the first medical device 3. A lower bracket 11 is also provided. The lower bracket 11 clamps the dummy device 4. In other embodiments the position may be reversed with the upper bracket 10 clamping the dummy device 4 and the lower bracket 11 clamping the first medical device 3. The upper bracket 10 and the lower bracket 11 are interlinked, for example, by one or more support bars 12, e.g. one, two or four support bars 12 that extend vertically between the brackets 10, 11. The support bars 12 are fixedly attached to one of the brackets 10, 11 and slidably mounted to the other of the brackets 10, 11. For example the support bars 12 may be fixedly attached to the lower bracket 11 and configured to slide within mounting bores 14 provided in the upper bracket 10, see Figure 3. The position of the upper bracket 10 along the support bars 12 is adjustable. The upper bracket 10 is retainable at various positions along the support bars 12 to allow the mounting rig 2 to accommodate devices of different sizes.

[0075] The upper bracket 10 comprises a plurality of magnets 13 as shown in the example of Figure 3 for clamping the first medical device 3. The upper bracket 10 is provided with a quick release mechanism for clamping the first medical device 3. Likewise for the lower bracket 11 and the dummy device 4. The upper bracket 10 and / or lower bracket 11 comprises two clamp parts (e.g. front and back clamp parts) that are held together by the magnets 13 to apply a clamping force to the respective device 3, 4 retained in between the clamp parts. The clamp parts can be prised apart to release the respective device 3, 4 by overcoming the magnetic attraction force of the magnets 13. In other embodiments other clamping arrangements may be provided, for example by use of bolts, sprung clamps, etc.

[0076] In the example of the embodiment of Figures 1 to 3a the first medical device 3 comprises a housing 20 defining an outlet end 21 provided with an outlet 22 through which medicament can be delivered. The housing 20 comprises a pair of shoulders 23 to either side of the outlet end 21 . The first medical device 3 further comprises an actuator button 24, at a lower end that is operated to deliver a medicament. The actuator button 24 is actuated by a linear upward movement, e.g. a sliding movement when pushed upwards (when viewed in the orientation of Figure 3). The housing 20 in use contains a medicament vial 25. In the example medicament vial 25 of Figure 3, a stopper 26 and a needle 27 for piercing the stopper 26 in use are provided.

[0077] In the example of the embodiment of Figures 1 to 3a the lower bracket 11 is provided for clamping the dummy device 4 and maintaining its alignment with respect to the first medical device 3. As noted above, the upper bracket 10 and the lower bracket 11 are interlinked by one or more, optionally a plurality of, support bars 12. In the illustrated example of Figures 1 to 3a two support bars 12 are provided that are parallel to each other. A lower end of each support bar 12 is fixedly attached to the lower bracket 11 . The upper end of each support bar 12 is free to slide through mounting bores 14 in the upper bracket 10, as shown in Figure 3 to accommodate differing device dimensions. The upper bracket 10 is secured in position on the support bars 12 by tightening a number of retaining bolts 15. It will be appreciated that the purpose of the one or more support bars 12 is to fix the relative positions of the first medical device 3 and the dummy device 4 in use, and that a variety of alternative configurations can be used. For example, in some embodiments one or both of the upper bracket 10 and / or lower bracket 11 may releasably engage with the one or more support bars 12 to facilitate adjustment of the relative positions of the first medical device 3 and the dummy device 4 before actuation.

[0078] In the example of the embodiment of Figures 1 to 3a the dummy device 4 also comprises a housing 20’ defining an outlet end 21 ’. The housing 20’ comprises a pair of shoulders 23’ to either side of the outlet end 21 The dummy device 4 further comprises an actuator button 24’, at a lower end. As with the first medical device 3, it will be appreciated that the configuration of the dummy device 4 may differ, e.g. in size, shape and the actuation mechanism.

[0079] In the example of the embodiment of Figures 1 to 3a the dummy device 4 corresponds to the first medical device 3. In the illustrated example the dummy device 4 and the first medical device 3 correspond by having the same, or substantially the same, external size and shape. Additionally, the ergonomics of the actuator button 24’ of the dummy device 4 functionally replicates the ergonomics of the actuator button 24 of the first medical device 3. Additionally, the dummy device 4 replicates at least those portions of the first medical device 3 that would be manually contacted by a user when actuating the first medical device 3, e.g. the shape, size and position of the actuator button 24’ that would be pushed by the user’s thumb and the shape, size, position and spacing of the shoulders 23’ of the housing 20’ that would be gripped by the user’s fingers are designed to correspond to the respective parts of the first medical device 3.

[0080] In the example of the embodiment of Figures 1 to 3a a first sensor 30 is provided that is configured to measure or determine a force variable based on the force applied to the first medical device 3 during the actuation of the first medical device 3. A second sensor 31 is provided that is configured to measure or determine a displacement, speed, velocity, and / or acceleration variable based on a movement during the actuation of the first medical device 3.

[0081] In the example of the embodiment of Figures 1 to 3a the first sensor 30 comprises a force transducer. The first sensor 30 may be, for example, a load cell or a force sensing resistor (FSR). In the illustrated example as shown in Figures 3 and 3a the force transducer is a piezoelectric loadcell. Other types of suitable load cell may also be used, e.g. capacitive, optical, or strain gauge.

[0082] In the example of the embodiment of Figures 1 to 3a the second sensor 31 is a displacement / position sensor. In the illustrated example the displacement / position sensor is a laser distance sensor. In other embodiments a different type of displacement / position sensor may be used. The laser distance sensor 31 is rigidly mounted, for example to the upper bracket 10, so that it is in fixed spatial relationship to the housing 20 of the first medical device 3. A tab 40 shown in Figures 1 and 2 projects from a portion of the transmission 5. The tab 40 is located in the path of the laser of the laser distance sensor to provide a reflector to enable the laser distance sensor to measure or determine the displacement of the actuator button 24. In other embodiments the location of the tab 40 may be different.

[0083] The transmission 5 functions to operatively interlink the first medical device 3 when clamped in the mounting rig 2 with the dummy device 4 such that an actuation force applied to the dummy device 4 is transferred via the transmission 5 to the first medical device 3 to actuate the first medical device 3. As will be appreciated by the skilled person, depending on the type of first medical device 3 and corresponding dummy device 4, the transmission 5 may comprise a wide range of components suitable for transferring an actuation force applied to the dummy device 4 to the first medical device 3.

[0084] In the example of the embodiment of Figures 1 to 3a the transmission 5 comprises one or more transmission members, for example, one or more rigid members, an articulated linkage, a hydraulic fluid (for example contained in one or more hydraulic lines), or a flexible line (for example a wire). In the example of Figures 3 and 3a the transmission members are rigid members.

[0085] In the illustrated example the transmission 5 comprises a first transmission member 51 configured to transmit the actuation force applied to the actuator button 24’ of the dummy device 4 to the first sensor 30 via a second transmission member 52 and a sensor mount 53. The first transmission member 51 comprises a rigid rod that extends within an interior of the dummy device 4 between the actuator button 24’ and the second transmission member 52. The second transmission member 52 comprises a rigid rod and a mechanism for adjusting the spacing of the second transmission member 52 from the first transmission member 51. The mechanism is, for example, a releasable coupling 41 shown in Figures 1 and 3 that allows the second transmission member 52 to be loosened and tightened with respect to the first transmission member 51 to allow mounting of the second transmission member 52 on an upper end 51b of the first transmission member 51 at a range of locations.

[0086] The sensor mount 53 as shown in Figures 3 and 3a comprises a rigid cup-shaped cavity in which is mounted the first sensor 30. The first sensor 30, e.g. the loadcell, is supported by a pair of O-rings 54 within the sensor mount 53 to reduce vibrations and movements that might otherwise be imparted from movement of a sensor lead 56 connected to the first sensor 30. In other embodiments an alternative shock-absorber or anti-vibration mount may be provided. The O-rings 54 also allow upward deflection of the first sensor 30, e.g. the loadcell, when loaded by the second transmission member 52. In the example embodiment of Figures 3 and 3a a lower projection 57 on a lower surface of the first sensor 30 provides a contact point which is aligned with a contact point of the sensor mount 53 formed by an upper projection 58 that is raised relative to a remainder of a base of the cupshaped cavity of the sensor mount 53. The tab 40, for example, projects from the sensor mount 53.

[0087] In the example of the embodiment of Figures 1 to 3a the second transmission members 52 and the sensor mount 53 are push-fit together of otherwise connected so that they move in unison. In alternative embodiments, the second transmission member 52 and the sensor mount 53 are configured as a single integral transmission member.

[0088] A third transmission member 55, which is in the form of a short rod, may optionally be present to transmit force between an upper surface of the first sensor 30 and the actuator button 24 of the first medical device 3. The third transmission member 55 is rigidly connected to the upper surface of the first sensor 30, e.g. by adhesive. Alternatively the upper surface of the first sensor 30, for example a projection thereof, may make direct contact with the actuator button 24.

[0089] The releasable coupling 41 allows for any tolerance gap between the first sensor 30 (or the optional third transmission member 55) and the actuator button 24 to be taken up prior to testing.

[0090] In consequence, in the example embodiment of Figures 1 to 3a a transmission path for the actuation force is established from the actuator button 24’ of the dummy device 4 through a lower end 51 a of the first transmission member 51 that contacts the actuator button 24’ of the dummy device 4, then via the upper end 51 b of the first transmission member 51 , the second transmission member 52, and the sensor mount 53. The transmission path then passes via the contact point between the upper projection 58 and lower projection 57 to the first sensor 30, and then the optional third transmission member 55 to the actuator button 24 of the first medical device 3. In the example of the embodiment of Figures 1 to 3a the transmission 5 is aligned with the support bars 12, in particular parallel to the support bars 12.

[0091] In the example of the embodiment of Figures 1 to 3a the transmission members 51 -53 are made of light, rigid materials such as rigid plastics, aluminium, carbon fibre or glass fibre.

[0092] In the example of the embodiment of Figures 1 to 3a the first transmission member 51 and / or the actuator button 24’ are slidably mounted in a low-friction bearing 28’ within the interior of the dummy device 4. In alternative embodiments, for example dependent on the internal configuration of the dummy device, the low-friction bearing 28’ may be omitted.

[0093] It will be appreciated that a wide range of suitable transmissions 5 may be used to transmit the actuation force from the actuator button 24’ of the dummy device 4 to the actuator button 24 of the first medical device 3. The example of Figures 1 to 3a is for use with the example nasal inhaler shown. However the transmission may be adapted dependent on the design of the first medical device 3.

[0094] In use of the test system 1 of the example embodiment of Figures 1 to 3a, the first medical device 3 is clamped in the upper bracket 10 of the mounting rig 2 and the dummy device 4 is clamped in the lower bracket 11 . The transmission 5 is configured to operably interlink the first medical device 3 with the dummy device 4 as shown in Figure 3. The dummy device 4 is then actuated by a user by the user holding the housing 20’ of the dummy device 4, e.g. with their fingers on the shoulders 23’ and a thumb on the actuator button 24’ and placing the outlet end 21 of the first medical device in a nostril or in the air.

[0095] The actuator button 24’ is then pushed upwards using a squeezing action. Upward force applied to the actuator button 24’ causes the actuator button 24’ and the transmission 5 to move upwards relative to the housing 20’ of the dummy device 4. This upward movement of the actuator button 24’ and the transmission 5 transmits an actuation force to the actuator button 24 of the first medical device 3 via the first and second transmission members 51 , 52, the sensor mount 53, first sensor 30 and the optional third transmission member 55. The actuation force causes the actuator button 24 to be displaced upwards relative to the housing 20 of the first medical device 3 causing the first medical device 3 to be actuated and medicament to be dispensed out of the outlet 22 at the outlet end 21 . (The medicament may be dispensed into the nasal passage of the user or may be dispensed into a suitable measurement device, as known in the art, for measuring and recording the spray pattern and plume geometry of medicament produced on actuation). Alternatively, the first medical device 3 may be dry-fired without the dispensation of a product.

[0096] During the actuation, the first sensor 30 measures or determines a force variable based on the force applied to the first medical device 3 during the actuation. In addition, the second sensor 31 measures or determines a displacement, speed, velocity, and / or acceleration variable based on a movement of the transmission 5 and / or the dummy device 4 during the actuation of the first medical device 3. For example, the laser distance sensor may measure movement of the tab 40 relative to the upper bracket 10 which allows for measurement or determination of the movement of the actuator button 24.

[0097] In the example of the embodiment of Figures 4 to 9 the force variable and / or the displacement, speed, velocity, and / or acceleration variable is used to generate an actuation profile of the first medical device 3 when actuated in the test system 1 . The generated actuation profile can be subsequently used to generate an average actuation profile for use in testing actuation of the same or a different medical device as will be discussed further below.

[0098] Each actuation profile describes one or more characteristics of the actuation of its respective first medical device 3. Examples of such characteristics include: actuation force magnitude, actuation force acceleration, peak actuation force, actuation time, actuator displacement, actuator velocity, actuator acceleration.

[0099] Generation of the actuation profile makes use of a controller and / or computer that are operably linked to the first sensor 30 and the second sensor 31 . For example, a microcontroller or microprocessor is used to capture and / or process the force variable and / or the displacement variable data.

[0100] In the example of the embodiment of Figures 4 to 9 a time variable is used as part of generating the actuation profile. The time variable may be measured by a separate timer. Alternatively a clock or cycle count of the controller and / or computer (e.g. microcontroller) may be used to generate the time variable and / or record a timestamp for each sample. In some examples, sampling of the force variable and / or the displacement variable may take place at set intervals (or may be assumed to be at set intervals), e.g. every 1 ms, 2ms, 3ms, 4ms, or 5ms or greater. A sample count number in the example of Figures 5 to 9 is used as an analogue for the time variable. In other examples the controller and / or computer may take samples and append a timestamp to each sample allowing, for example, samples to be taken at non-regular intervals and / or as fast as possible dependent on the loop time of the program.

[0101] In the example of the embodiment of Figures 5 to 6 the force variable is used to determine the force applied to the first medical device 3, in particular to the actuator button 24. The force may, for example, be a direct output from the first sensor 30 or derived from the output of the first sensor 30.

[0102] In the example of the embodiment of Figures 5 to 6 the displacement variable is used to determine the distance moved by the actuator button 24 during actuation. The distance moved may be a direct output from the second sensor 31 or may be derived from the output of the second sensor 31 .

[0103] In the example of the embodiment of Figures 4 to 6 the force variable and the displacement variable are sampled at discrete points in time throughout the actuation of the first medical device 3. The samples are recorded at regular intervals, e.g. every 1 ms, 2ms, 3ms, 4ms, or 5ms or greater. In practice, there may be some variation in sampling interval due to limitations of the apparatus. Therefore, the sampling interval may be assumed, in some examples, to be at fixed intervals, where the fixed interval is chosen as the average interval time or the preset interval time.

[0104] In the example of the embodiment of Figures 7 to 9 the velocity of the actuator button 24 of the first medical device 3 is calculated from the displacement variable and the time variable. Alternatively a speed or velocity sensor may be provided whose direct output may provide a velocity of the actuator button 24.

[0105] In some embodiments the actuation profile is based on the measurements recorded on a single first medical device by a single user. However, in other embodiments generating the actuation profile is based on multiple actuations, for example, >20, >50 or >100 actuations. In most embodiments the actuations would be performed by a range of users representative of the types of users expected to use the medical device, e.g. right handed, left handed, children, adults, infirm and able-bodied, etc. Alternatively, the range of users may be selected to represent those that are more likely to have an impairment that reduces their ability to apply an actuation force to the medical device. In some embodiments the actuations are carried out using the same first medical device 3 (in which case the first medical device 3 is optionally configured to be resettable). In other embodiments that are carried out using first medical devices of the same or similar type, e.g. samples from one or more batches made to the same design.

[0106] Figure 4 shows an example of an extract of data output from the test system 1 during an actuation of a first medical device 3 in the form of a nasal inhaler. The force and distance measurements are, in this example, direct outputs from the first sensor 30 and the second sensor 31 respectively. The velocity is a calculated amount based on change in distance between sample numbers divided by measurement time (time between samples).

[0107] In the example of the embodiment of Figures 1 to 3 the actuator button 24 of the first medical device 3 has an actuation point at which point actuation of the device will thereafter take place. For example, in cases where the actuation mechanism comprises a biasing force such as a spring, the actuation point may, for example, be the point at which movement of the actuator button 24 frees the biasing force to be able to displace the vial or container of product to move. Typically, the force to manually move the actuator button 24 will increase up to the actuation point with the peak force detected at the actuation point. In the example of Figure 4 the actuation point is at Sample Number 1129 where the force was 18.745N.

[0108] Figure 5 illustrates example graphs of force, displacement, and (calculated) velocity for 5 sample actuations by different users. As can be seen the actuations show varying actuation time, including slow and fast actuations. It is noted that the velocity that the user initially moves the actuator button 24 appears to affect the peak force measured, i.e. the force to reach the actuation point of the device. It is believed various factors may affect this, such as the velocity value at the point of initial displacement, the velocity value at the point of actuation, and how these velocities affect the stick-slip between the mechanical interactions of the actuator button 24. In addition, the force to displace the mass of the actuator button 24 at different velocities may play a role. As shown in Figure 6 it can be useful to relativise the graphs of Figure 5 so that the variables are plotted relative to their actuation point. In Figure 6, the actuation point is marked by the vertical broken line at relative time = 0 on the x-axis. Each data set is moved so that the actuation points (discernible as the point of peak actuation force) are all aligned. The samples before actuation are at negative time points on the x-axis.

[0109] An average actuation profile for the first medical device 3 is now obtained as shown in Figure 7. This is obtained, for example, by averaging the velocity data from the 5 actuations shown in the bottom graph of Figure 6. A smoothing process is optionally applied to the average to account for the discrete sampling period of the original data and subsequent shifting of the data to align their actuation points. For example, this may be achieved by averaging the data points using their sequential sample count number (rather than time) and assuming a fixed sampling interval. Additionally or alternatively, by increasing the number of sample actuations in the average, a smoother average actuation profile will be obtained.

[0110] Figure 8 shows the interval up to the actuation point for the data of Figure 7. In the example of the embodiment of Figures 9 and 10 this average actuation profile is used to derive suitable operating instructions for a suitable testing apparatus to test fire a medical device (for example a medical device from a different batch or of a modified design where it is desired to verify that the device will actuate with an acceptable peak actuation force).

[0111] In the example of the embodiment of Figures 9 and 10 a target actuation displacement for the medical device to be tested (which may be a pre-determined distance set during the design process), e.g. 3.5mm, is used with the average actuation profile to generate operating instructions for the testing apparatus. For example, the target actuation displacement of 3.5mm is overlaid on the average actuation profile of Figure 8 as shown in Figure 9. The target actuation displacement is selected to be a pre-determined maximum actuation distance (rather than an average) for actuating the medical device allowing for any manufacturing tolerances. This guarantees actuation when the generated average actuation profile is later applied to test other samples of the medical device as opposed to using an average actuation distance that would risk not actuating some devices.

[0112] Operating instructions for the testing apparatus can then be derived. For example, a series of displacement-velocity data pairs are derived that can then be used to instruct a suitable testing apparatus. Figure 10 shows an example of an extract of derived operating instructions in G-code, where variable Z is displacement and variable F is velocity. For the average actuation profile of Figure 8, the complete G-code comprises 250 lines - one for each sample count. Of course, the number of lines for a particular example will vary dependent on the sampling time, actuation stroke length, etc.

[0113] In the example of the embodiment of Figure 11 the testing apparatus comprises, for example, an apparatus under computer numerical control. The testing apparatus comprises a drive unit for example a stepper motor, for imparting the instructed displacements and velocities to the medical device to be tested. The testing apparatus is configured to accept operating parameters in a suitable coding language. For example the testing apparatus may be instructed in G-code. The lines of G-code are, for example, run at a fixed time interval that matches the sample count interval of the average actuation profile.

[0114] Figure 11 shows an example of a suitable testing apparatus 100. The testing apparatus 100 comprises a mounting rig 102 for clamping a medical device 103 that is to be tested. The mounting rig 102 comprises a bracket 110 for clamping the medical device 103 to hold a housing 120 of the medical device 103 stationary. A carriage 105 is provided that is movable in a linear direction along the mounting rig 102 under action of a drive 150 to actuate an actuator button 124 of the medical device 103. The carriage 105 is mounted to a leadscrew 126 that is driven in rotation by the drive 150. The drive 150 is, for example, a stepper motor under computer control. In alternative embodiments the drive 150 may be any suitable rotational or linear actuator, for example a hydraulic or pneumatic actuator or electromechanical actuator.

[0115] In the example of the embodiment of Figure 11 a first sensor 130 for measuring a force variable imparted on the actuator button 124 is provided as part of the carriage 105, for example at a front of, or as a part of, a transmission rod 106. In this way either the transmission rod 106 or the first sensor 130 itself contacts the actuator button 124 as the carriage 105 is advanced by the drive 150. The first sensor 130 comprises, for example, a force transducer, e.g. a load cell or a force sensing resistor (FSR). The load cell may, for example, be any of the types discussed above for the first sensor 30. The same type of sensor may be used for both the first sensor 30 and the first sensor 130. In the example of the embodiment of Figure 11 the testing apparatus 100 also comprises a second sensor 131 for measuring a displacement, speed, velocity, and / or acceleration variable based on a movement during the actuation of the medical device 103. The movement is for example a movement of the carriage 105 relative to the stationary housing 120, e.g. relative to a part of the bracket 110 holding the housing 120. The second sensor 131 is, for example, a displacement / position sensor. In the illustrated example the displacement / position sensor is a laser distance sensor. The same type of sensor may be used for both the second sensor 31 and the second sensor 131 .

[0116] In use of the example of the embodiment of Figure 11 the medical device 103 to be tested is mounted in the bracket 110 of the mounting rig 102. The carriage 105 is then advanced by the drive 150 under computer control using, for example, the G-code operating parameters of displacement and velocity to actuate the medical device 103 by moving the actuator button 124 using the transmission rod 106. The force imparted during the actuation stroke is measured or determined by the first sensor 130 and recorded by the computer to derive one or more operating parameters for the medical device 103. These may include, for example actuation force over time, peak actuation force, stoke length to reach the actuation point, etc. The first sensor 130 and / or the second sensor 131 allows for the testing apparatus 100 to provide for direct validation of the medical device 103 and / or confirmation that the average actuation profile has been correctly applied.

[0117] Another embodiment of the test system 201 is shown schematically in Figure 12. This embodiment functions in the same way as described above, except where discussed below.

[0118] In this embodiment the first medical device 203 is shown as a pMDI device. A mounting rig 202 holds the first medical device 203 in place. The mounting rig 202 comprises a lower bracket 211 which clamps the first medical device 203. An upper bracket 211 is also provided. The upper bracket 211 clamps the dummy device 204. The upper bracket 210 and the lower bracket 211 are interlinked by one or more support bars 212 that extend vertically between the brackets 210, 211. The support bars 212 are fixedly attached to one of the brackets 210, 211 and slidably mounted to the other of the brackets 210, 211. For example the support bar 212 may be fixedly attached to the upper bracket 210 and configured to slide within a mounting bore provided in the lower bracket 210. The position of the lower bracket 210 along the support bar 212 is adjustable. The lower bracket 210 is retainable at various positions along the support bar 213 to allow the mounting rig 202 to accommodate devices of different sizes.

[0119] The transmission 205 comprises a first transmission member 251 that passes through an aperture in the base of the dummy device 204 supported by a low-friction bearing 228’ and interlinks an actuator button 224’ of the dummy device 204 with the top of a canister 224 of the first medical device 203. The actuator button 224’ is sized and shaped to replicate the shape of a canister of a pMDI, in particular that of the canister 224 of the first medical device 203. The transmission 205 further comprises the first sensor 230 for example in the form of a force transducer as discussed above.

[0120] The second sensor 231 , for example a laser distance sensor, is mounted to the lower bracket 211 and a tab 240 acting as a reflector for the laser projects laterally from the transmission 205, for example from the sensor mount of the first sensor 230.

[0121] The actuation of the first medical device 203 is performed by depressing the actuator button 224’ relative to the housing 220’. The housing 220’ is firmly gripped by the upper bracket 210. The movement of the actuator button 224’ is transmitted to the canister 224 via the transmission 205. In the same way as discussed above, during the actuation, the first sensor 230 measures or determines a force variable based on the force applied to the first medical device 203 during the actuation. In addition, the second sensor 231 measures or determines a displacement, speed, velocity, and / or acceleration variable based on a movement of the transmission 205 and / or the dummy device 204 during the actuation of the first medical device 203. For example, the laser distance sensor measures movement of the tab 240 relative to the lower bracket 211 which allows for measurement or determination of the movement of the actuator button 224.

[0122] The force variable and / or the displacement, speed, velocity, and / or acceleration variable are used to generate the actuation profile of the first medical device 203 as discussed above.

[0123] It is to be understood that at least some of the figures and descriptions of the disclosure have been simplified to focus on elements that are relevant for a clear understanding of the disclosure, while eliminating, for purposes of clarity, other elements that the reader skilled in the art will appreciate may also be required. Because such elements are well known to the reader skilled in the art, and because they do not necessarily facilitate a better understanding of the disclosure, a description of such elements is not provided herein.

[0124] Additional aspects and embodiments of the present disclosure are set out in the following numbered clauses:

[0125] Clause 1 . A test system comprising: a) a mounting rig for clamping a first medical device; b) a dummy device; c) a transmission for operatively interlinking the first medical device when clamped in the mounting rig with the dummy device such that an actuation force applied to the dummy device is transferred via the transmission to the first medical device to actuate the first medical device; and d) one or more sensors for generating an actuation profile of the first medical device.

[0126] Clause 2. The test system of clause 1 , wherein the one or more sensors comprise one or more sensors for measuring or determining:

[0127] - a force variable based on the force applied to the first medical device during the actuation of the first medical device; and / or

[0128] - one or more of a displacement, speed, velocity, and acceleration variable based on a movement during the actuation of the first medical device.

[0129] Clause 3. The test system of clause 2, wherein the one or more sensors comprises a force transducer.

[0130] Clause 4. The test system of clause 2 or clause 3, wherein the one or more sensors comprises a displacement / position sensor and / or a speed sensor and / or an accelerometer.

[0131] Clause 5. The test system of any preceding clause, further comprising a timer for measuring a time variable.

[0132] Clause 6. The test system of any preceding clause, wherein the first medical device is a manually-actuatable medical device. Clause 7. The test system of any preceding clause, wherein the first medical device is a device capable of delivering a dose of medicament and the dummy device is incapable of delivering a dose of medicament.

[0133] Clause 8. The test system of any preceding clause, wherein the dummy device corresponds to the first medical device by having the same, or substantially the same, external size and shape as the first medical device.

[0134] Clause 9. The test system of any preceding clause, wherein the dummy device corresponds to the first medical device in that the ergonomics of an actuator of the dummy device functionally replicates the ergonomics of an actuator of the first medical device.

[0135] Clause 10. The test system of any preceding clause, wherein the dummy device replicates at least those portions of the first medical device that would be manually contacted by a user when actuating the first medical device.

[0136] Clause 11 . The test system of any preceding clause, wherein the dummy device replicates an actuator of the first medical device.

[0137] Clause 12. The test system of clause 11 , wherein the actuator comprises a button, or trigger, or switch, or canister, or vial.

[0138] Clause 13. The test system of any preceding clause, wherein the transmission comprises the one or more sensors.

[0139] Clause 14. The test system of any preceding clause, wherein the transmission comprises one or more transmission members that transmits the actuation force applied to the dummy device directly or indirectly to a force transducer which in turn transmits the actuation force directly or indirectly to the first medical device.

[0140] Clause 15. The test system of clause 14, wherein the one or more transmission members is / are a rigid member, an articulated linkage, an hydraulic fluid, or a flexible line. Clause 16. The test system of clause 14 or clause 15, wherein a first end of a transmission member contacts an actuator of the dummy device and a second end of the transmission member contacts a first end of the force transducer.

[0141] Clause 17. The test system of clause 16, wherein a second end of the force transducer contacts the actuator of the first medical device.

[0142] Clause 18. The test system of any one of clauses 14 to 17, wherein the transmission member is slidable mounted within an interior of the dummy device.

[0143] Clause 19. The test system of any preceding clause, further comprising a controller and / or computer for generating the actuation profile.

[0144] Clause 20. The test system of any preceding clause, wherein the first medical device is a nasal spray device, a pMDI device, a DPI device, a SMI device or a patch pump device.

[0145] Clause 21 . The combination of the test system of any preceding clause and a first medical device; and optionally wherein the first medical device is a nasal spray device, a pMDI device, a DPI device, a SMI device or a patch pump device.

[0146] Clause 22. A method of testing a first medical device, the method comprising: clamping the first medical device; operably interlinking the first medical device with a dummy device using a transmission; actuating the dummy device to thereby actuate the first medical device by transmitting an actuation force applied to the dummy device to the first medical device via the transmission; and using one or more sensors to generate an actuation profile of the first medical device.

[0147] Clause 23. The method of clause 22, wherein generating the actuation profile comprises using the one or more sensors to measure or determine:

[0148] - a force variable based on the force applied to the first medical device during the actuation of the first medical device; and / or one or more of a displacement, speed, velocity, and acceleration variable based on a movement during the actuation of the first medical device.

[0149] Clause 24. The method of clause 22 or clause 23, further comprising measuring or determining a time variable during the actuation of the first medical device.

[0150] Clause 25. The method of any one of clauses 22 to 24, wherein an average actuation profile is derived from a plurality of actuation profiles, the plurality of actuation profiles being obtained from separate actuations of one or more first medical devices; optionally wherein the separate actuations are performed by multiple users; optionally wherein the separate actuations comprises greater than 20, or greater than 50, or greater than 100 actuations.

[0151] Clause 26. The method of clause 25, wherein data from the plurality of actuation profiles is relativised by aligning an actuation point of each actuation profile with each other.

[0152] Clause 27. The method of any one of clauses 25 to 26, wherein the average actuation profile is obtained by averaging velocity data from the plurality of actuation profiles.

[0153] Clause 28. The method of any one of clauses 25 to 27, further comprising using the average actuation profile to derive operating instructions for a testing apparatus to test fire a medical device.

[0154] Clause 29. The method of clause 28, wherein the operating instructions comprise or consist of displacement-velocity data pairs.

[0155] Clause 30. Use of the test system of any one of clauses 1 to 20 to perform the method of any one of clauses 22 to 29.

[0156] Clause 31 . A method of testing the actuation of a second medical device, comprising the steps of: a) actuating a first medical device while using one or more sensors to generate an actuation profile of the first medical device; b) repeating step a) a plurality of times to generate a plurality of actuation profiles of one or more first medical devices; c) generating an average actuation profile of the first medical device(s) by averaging the plurality of actuation profiles; d) using the average actuation profile to derive operating instructions for a testing apparatus; e) mounting the second medical device in the testing apparatus; f) controlling the testing apparatus using the operating instructions to actuate the second medical device; and g) during actuation of the second medical device, measuring at least a force variable based on the force applied to the second medical device.

[0157] Clause 32. The method of clause 31 , wherein in step a) the one or more sensors are used to measure or determine:

[0158] - a force variable based on the force applied to the first medical device during the actuation of the first medical device; and / or

[0159] - one or more of a displacement, speed, velocity, and acceleration variable based on a movement during the actuation of the first medical device.

[0160] Clause 33. The method of clause 31 or clause 32, wherein in step c) generating the average actuation profile comprises relativising the plurality of actuation profiles by aligning an actuation point of each actuation profile with each other.

[0161] Clause 34. The method of any one of clauses 31 to 33, wherein the average actuation profile comprises information on the velocity over time up to an actuation point of the first medical device(s).

[0162] Clause 35. The method of any one of clauses 31 to 34, wherein the testing apparatus is computer controlled using the operating instructions; and optionally the operating instructions comprise or consist of displacement-velocity data pairs.

[0163] Clause 36. The method of any one of clauses 31 to 35, wherein actuating the first medical device comprises clamping the first medical device, operably interlinking the first medical device with a dummy device using a transmission, and actuating the dummy device to thereby actuate the first medical device by transmitting an actuation force applied to the dummy device to the first medical device via the transmission. Clause 37. The method of any one of clauses 31 to 36, wherein step a) is performed using the test system of any one of clauses 1 to 20.

Claims

Claims:1 . A test system comprising: a) a mounting rig for clamping a first medical device; b) a dummy device; c) a transmission for operatively interlinking the first medical device when clamped in the mounting rig with the dummy device such that an actuation force applied to the dummy device is transferred via the transmission to the first medical device to actuate the first medical device; and d) one or more sensors for generating an actuation profile of the first medical device.

2. The test system of claim 1 , wherein the one or more sensors comprise one or more sensors for measuring or determining:- a force variable based on the force applied to the first medical device during the actuation of the first medical device; and / or- one or more of a displacement, speed, velocity, and acceleration variable based on a movement during the actuation of the first medical device.

3. The test system of claim 2, wherein the one or more sensors comprises a force transducer.

4. The test system of claim 2 or claim 3, wherein the one or more sensors comprises a displacement / position sensor and / or a speed sensor and / or an accelerometer.

5. The test system of any preceding claim, wherein the first medical device is a device capable of delivering a dose of medicament and the dummy device is incapable of delivering a dose of medicament.

6. The test system of any preceding claim, wherein the dummy device corresponds to the first medical device by having the same, or substantially the same, external size and shape as the first medical device.

7. The test system of any preceding claim, wherein the dummy device corresponds to the first medical device in that the ergonomics of an actuator of the dummy device functionally replicates the ergonomics of an actuator of the first medical device.

8. The test system of any preceding claim, wherein the transmission comprises the one or more sensors.

9. The test system of any preceding claim, wherein the transmission comprises one or more transmission members that transmits the actuation force applied to the dummy device directly or indirectly to a force transducer which in turn transmits the actuation force directly or indirectly to the first medical device.

10. The test system of any preceding claim, further comprising a controller and / or computer for generating the actuation profile.11 . The test system of any preceding claim, wherein the first medical device is a nasal spray device, a pMDI device, a DPI device, a SMI device or a patch pump device.

12. The combination of the test system of any preceding claim and a first medical device; and optionally wherein the first medical device is a nasal spray device, a pMDI device, a DPI device, a SMI device or a patch pump device.

13. A method of testing a first medical device, the method comprising: clamping the first medical device; operably interlinking the first medical device with a dummy device using a transmission; actuating the dummy device to thereby actuate the first medical device by transmitting an actuation force applied to the dummy device to the first medical device via the transmission; and using one or more sensors to generate an actuation profile of the first medical device.

14. The method of claim 13, wherein generating the actuation profile comprises using the one or more sensors to measure or determine:- a force variable based on the force applied to the first medical device during the actuation of the first medical device; and / or- one or more of a displacement, speed, velocity, and acceleration variable based on a movement during the actuation of the first medical device.

15. The method of claim 13 or claim 14, further comprising measuring or determining a time variable during the actuation of the first medical device.

16. The method of any one of claims 13 to 15, wherein an average actuation profile is derived from a plurality of actuation profiles, the plurality of actuation profiles being obtained from separate actuations of one or more first medical devices; optionally wherein the separate actuations are performed by multiple users; optionally wherein the separate actuations comprises greater than 20, or greater than 50, or greater than 100 actuations.

17. The method of claim 16, wherein data from the plurality of actuation profiles is relativised by aligning an actuation point of each actuation profile with each other.

18. The method of any one of claims 16 to 17, wherein the average actuation profile is obtained by averaging velocity data from the plurality of actuation profiles.

19. The method of any one of claims 16 to 18, further comprising using the average actuation profile to derive operating instructions for a testing apparatus to test fire a medical device.

20. Use of the test system of any one of claims 1 to 11 to perform the method of any one of claims 13 to 19.21 . A method of testing the actuation of a second medical device, comprising the steps of: a) actuating a first medical device while using one or more sensors to generate an actuation profile of the first medical device; b) repeating step a) a plurality of times to generate a plurality of actuation profiles of one or more first medical devices; c) generating an average actuation profile of the first medical device(s) by averaging the plurality of actuation profiles;d) using the average actuation profile to derive operating instructions for a testing apparatus; e) mounting the second medical device in the testing apparatus; f) controlling the testing apparatus using the operating instructions to actuate the second medical device; and g) during actuation of the second medical device, measuring at least a force variable based on the force applied to the second medical device.

22. The method of claim 21 , wherein in step a) the one or more sensors are used to measure or determine:- a force variable based on the force applied to the first medical device during the actuation of the first medical device; and / or- one or more of a displacement, speed, velocity, and acceleration variable based on a movement during the actuation of the first medical device.

23. The method of claim 21 or claim 22, wherein in step c) generating the average actuation profile comprises relativising the plurality of actuation profiles by aligning an actuation point of each actuation profile with each other.

24. The method of any one of claims 21 to 23, wherein the average actuation profile comprises information on the velocity over time up to an actuation point of the first medical device(s).

25. The method of any one of claims 21 to 24, wherein actuating the first medical device comprises clamping the first medical device, operably interlinking the first medical device with a dummy device using a transmission, and actuating the dummy device to thereby actuate the first medical device by transmitting an actuation force applied to the dummy device to the first medical device via the transmission.

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