I agree Kris. I think the lack of innovation in the larger companies goes a long way toward answering the question of why we have not seen as much progress in the medical field as in other fields. The barrriers to entry are high which discourages startups and slows the pace of innovation.
While I can't talk about things like certification with any authority, I've seen many advances in things like 3d printing and low cost sensing. Some of the tech that has surfaced in the last couple years seems like it will have a fairly large impact in the near future.
I agree, long certification is a problem...but saying that "Larger companies have great financial backing, which in turn fosters developments in the industry and supports creative innovation" missing the point completely...large companies in my experience do very little innovation, they just watch technologies being developed by small companies and ocasionally buy them when they really feel something needs to be done in a given filed...Kris
Apart from the regulators and the long development and certification cycle , there is also a hanging sword of litigation and huge compensation claims if a medical device fails to perfrom its expected function because ofa hardware/software malfunction.
In my opinion , the medical fraternity has to take a lead in the development by joining hands with the electronics community.
One hard thing to do with medical devices is software certification. One solution i've read about is a modular software framework that pre certifies a large part of the needed design , thus simplifying the design.
Stevel Blank is the Grandfather of the Lean startup movement. The medical space is unique and if we are able to learn from other peoples experiences, read and follow these blog posts. You will learn how to innovate and succeed in the medical market.