Mobile Medical Platforms - How to deal with Supplier Hardware/Software Changes?

[mshupe]

We are developing an app to that will turn a mobile plateform (i.e., iphone, blackberrty, etc.) into a mobile medical plateform. Our concern is how we deal with what we know will be hardware and software changes by the manufacturers to ensure that the safety and effectiveness of our app is not compromised.

Does anyone have thoughts on this?

 

[yodon]

Worst case: you (re)test on every platform / software configuration.

You may be able to reduce the effort with some kind of (documented) compatibility / risk analysis. Have you looked at the latest FDA guidance on the subject (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm)?

You MAY be able to limit your liability by limiting the platforms / configurations on which the app is verified. That may be a marketing limitation but if people's lives / health are at risk, it may be a smart move.

It's a VERY good and timely question as these platforms get smarter and are used in more situations like this. These are just my thoughts; hopefully others will chime in with their thoughts.

 

[mshupe]

Thanks for the reply yodon. I have read the new draft guidance and agree with your train of thought. It's pretty much what we came up with as well.