How design iterations reduce risk.

I am not a fan of Class III devices. I believe that you can build company value faster and with less risk in the Class II space.
Class III devices inherently have enormous company risk in cost and time (often 10 years and $100M investment).
But there is an overlooked risk with Class II versus Class III.
I want to bring light to the Getting-the-Product-Right Risk. The risk in Getting-the-Product-Right can be minimized with many iterations. Design iterations dramatically reduce risk around product performance and market acceptance.
If you can design/test/re-design rapidly (every week or at ...