Methods for self-validation of hardware and software for safety-critical medical devices

Patent metadata

Field	Value
Publication number	US-11456076-B2
Application number	US-202016865152-A
Country	US
Kind code	B2
Filing date	May 1, 2020
Priority date	May 2, 2019
Publication date	Sep 27, 2022
Grant date	Sep 27, 2022

Abstract

Medical devices critical to patient health and safety that communicate with third party hardware and software, such as smart devices, require validation to ensure compatibility and correct performance. Disclosed are methods and systems to perform a self-validation of hardware and/or software components with a medical device to confirm that any combination of hardware and software are compatible and perform acceptably. If the self-validation passes then the user may safely use the system, and it may report to a cloud server that the particular configuration tested was successful. If the self-validation fails, the user will be prevented from using safety-critical aspects of the application and be notified of the incompatibility; and the results may also be reported to a cloud server.

First claim

What is claimed is:

1. A computer program product installable on a mobile communication device and configured for use with a peripheral electronic medical device, the computer program product embodied in a non-transitory computer readable storage medium and comprising computer instructions for:
verifying the presence of system minimum requirements of the mobile communication device;
verifying an electronic communication connection between the peripheral electronic medical device and the mobile communication device;
executing a connectivity test to evaluate electronic communication connectivity between the peripheral electronic medical device and the mobile communication device and subsequently disconnecting the electronic communication connection therebetween, wherein executing the connectivity test includes:
reconnecting the electronic communication connection and subsequently checking latency of the reconnection;
transferring data from the peripheral electronic medical device to the mobile communication device and checking a transfer rate of the transferred data; and
checking a data integrity parameter; and

assessing the result of the connectivity test.

2. The computer program product of claim 1 , wherein executing a connectivity test further includes at least one of:
verifying that a connection latency time value of the reconnection is below a predetermined threshold value; or
verifying that a connection bandwidth rate is above a predetermined threshold value.

3. The computer program product of claim 1 , further comprising computer instructions for:
upon determining that the result of the connectivity test is a pass, enabling full user access to the computer program product thereby enabling use with the peripheral electronic medical device; and
upon determining that the result of the connectivity test is a fail, disabling full user access to the computer program product thereby disabling use with the peripheral electronic medical device.

4. The computer program product of claim 1 , further comprising computer instructions for:
upon determining that the result of the connectivity test is a fail, repeating the connectivity test.

5. The computer program product of claim 1 , wherein the system minimum requirements comprise at least one of a compatible Operating System version, display properties, and wireless transceiver module.

6. The computer program product of claim 5 , wherein the display properties comprise at least one of display resolution and color capability.

7. The computer program product of claim 1 , wherein the computer program product is embodied in the memory unit of the mobile communication device.

8. The computer program product of claim 1 , further comprising computer instructions for:
transmitting the result of the connectivity test to an external computer.

9. The computer program product of claim 1 , wherein the communication device comprises at least one of a smartphone, a tablet computer, or a smartwatch.

10. The computer program product of claim 1 , wherein the peripheral electronic medical device comprises at least one of a medicine injection device and a monitoring device.

11. A method for self-validating compatibility of a peripheral electronic medical device, and a mobile communication device, comprising:
verifying the presence of system minimum requirements of the mobile communication device;
verifying an electronic communication connection between the peripheral electronic medical device and the mobile communication device;
executing a connectivity test to evaluate electronic communication connectivity between the peripheral electronic medical device and the mobile communication device and subsequently disconnecting the electronic communication connection therebetween, wherein executing the connectivity test includes:
reconnecting the electronic communication connection and subsequently checking latency of the reconnection;
transferring data from the peripheral electronic medical device to the mobile communication device and checking a transfer rate of the transferred data; and
checking a data integrity parameter; and

assessing the result of the connectivity test.

12. The method of claim 11 , wherein executing a connectivity test further includes at least one of:
verifying that a connection latency time value of the reconnection is below a predetermined threshold value; or
verifying that a connection bandwidth rate is above a predetermined threshold value.

13. The method of claim 11 , further comprising the steps of:
upon determining that the result of the connectivity test is a pass, enabling full user access to a computer software program associated with the peripheral electronic medical device on the communication device, thereby enabling use with the peripheral electronic medical device; and
upon determining that the result of the connectivity test is a fail, disabling full user access to the computer software program associated with the peripheral electronic medical device on the communication device, thereby disabling use with the peripheral electronic medical device.

14. The method of claim 13 , wherein the computer software program is embodied in a memory unit of the mobile communication device.

15. The method of claim 11 , further comprising the step of:
upon determining that the result of the connectivity test is a fail, repeating the connectivity test.

16. The method of claim 11 , wherein the system minimum requirements comprise at least one of a compatible Operating System version, display properties, and wireless transceiver module.

17. The method of claim 16 , wherein the display properties comprise at least one of display resolution and color capability.

18. The method of claim 11 , further comprising the step of:
transmitting the result of the connectivity test to an external computer.

19. The method of claim 11 , wherein the communication device comprises at least one of a smartphone, a tablet computer, or a smartwatch.

20. The method of claim 11 , wherein the peripheral electronic medical device comprises at least one of medicine injection device and a monitoring device.

21. A method for self-validating a medical device with a communication device, comprising:
verifying system minimum requirements of the communication device;
producing a wireless connection between the medical device and the communication device;
initiating a test sequence and subsequently disconnecting the wireless connection;
executing a test, comprising:
reconnecting the wireless connection between the medical device and communication device and subsequently checking latency of the reconnection;
transferring data from the medical device to the communication device and checking a transfer rate of the transferred data; and
checking a data integrity parameter; and

assessing a result of the test.

22. The method of claim 21 , wherein, when the result of the test is a pass, the method includes enabling a software application associated with the medical device on the communication device; or wherein, when the result of the test is a fail, the method includes disabling the software application associated with the medical device on the communication device.

23. The method of claim 21 , further comprising transmitting the result to an external computer.

24. The method of claim 21 , wherein the communication device includes a smartphone, a tablet, or a smartwatch.

Assignees

• Companion Medical Inc
• Medtronic Minimed Inc

Inventors

• Holmquist Arnold
• Cohen Eric
• Hampapuram Haripriyan
• Mensinger Michael

Classifications

• G16H20/17 Primary

  delivered via infusion or injection · CPC title

• H04L43/0811

  by checking connectivity · CPC title

• G16H40/67 Primary

  for remote operation · CPC title

• H04W24/08

  Testing, {supervising or monitoring} using real traffic · CPC title

• H04L43/0852

  Delays · CPC title