We must use technology’s strengths to reap its benefits and avoid its pitfalls. Theoretically, software can be patched quickly, and new insights from real-world evidence can be incorporated into feature updates. In the regulated medical world, we adopted connected cloud technologies without fully adopting connected cloud strengths; namely, fast software releases to patch vulnerabilities and produce feature updates.
Medtech must adopt continuous software releases to achieve the value of connected cloud services. To do that, medtech must continuously produce evidence of safety and effectiveness. How fast can you produce evidence of safety for a software release? Can you continuously produce clinical safety evidence? How do you know whether FDA will clear it?
I have spoken with a variety of medtech manufacturers about plans to speed up software releases. They have the following in common, either in plan or underway:
Over-the-air firmware updates for postmarket patching of software vulnerabilities
New Medical Device Development Tools (MDDTs) like simulation and modeling for evidence generation
Predetermined change control plans for FDA clearance
Postmarket real-world evidence collection and feedback loop
If you don’t have one of these, your product may struggle in the cloud-connected continuous update world that medtech is becoming. Don’t miss the boat!
~Shannon, the Optimistic Optimizer