The biggest challenge to medical innovation is the regulatory compliance and the challenge adds an exponent to it when it comes to software validation. This article is very important and relevant in the present scenario
Wow there is a lot to think about. And when it comes to medical liability, I'm sure being "different" is not a competitive advantage, but a huge liability when it comes to review and certification. I appreciate that the article does a great job of dealing with multi-core development to expand the capabilities of small devices. But what of the cloud? While we continue to push the speed and number of processors and cores in individual devices, I wonder how feasible it would be to deploy a cloud-centric system. One that utilized fairly simple biometric transducers, a color touch screen and a crazy-fast wired or wireless modem. Send the raw data to a well controlled, extremely-capable redundant cloud server within the building. Allow the cloud to processes and send the results back to the not-so smart device.
At least when it comes to certification, I suspect validation would be a bit simpler when adding new components and modules to the cloud server rather than needing to manage a heterogeneous collection of smart remote processing units.
I'm wondering about the analogy between pharmaceutical development costs and medical devices. Namely, approval costs for drugs are a huge percentage of the go-to-market cost, often more than the research to develop the drug itself. I'm wondering if there's any kind of similar scenario with electronic medical systems. Perhaps it varies whether you're talking about consumer or professional. An ancillary consideration is potential liability. The latter might actually be the scariest, cost wise. Anyway, unique challenges in the medical sector and I'm wondering if in some sense this impedes engineers, putting more constraints upon the design process than in other market sectors.
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Good engineering designs are those that work in the real world; bad designs are those that don’t. If we agree to set our egos aside and let the real world be our guide, we can resolve nearly any disagreement.
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