Here is something we have been working on. We have been thinking about a framework for managing “digital medical devices” from conception to destruction. Interested in peoples views about whether it covers the conversation adequately. Our starting point was the thought that data is probably becoming the most important part of digital medical devices, either to support decision making (glucose meter) or to take action (insulin pump).Pharmac conversation v1_1.pptx (7.7 MB)
Nice! I like the pyramid of needs!
I am curious what is the definition of “digital medical devices” and the framework scope? Here is the “Software as a medical device” and is interesting (risky IMHO in terms of security and privacy) what is out of scope:
The supply chain slide at the end will depend on identity, provenance and interoperability standards - keen to know if there are others here seeing blockchains as a good hammer for these types of nails…
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Interesting question about the “software as a medical device”. Think about it as a concept as opposed to a physical construct? A server underpinning “medical software” is an example maybe?
Maybe… Depends…
Doing a medical device certification in the past I know the definition/classification will influence the whole life-cycle.
Anyway, conceptually all good!