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 least every month) then you can quickly de-risk your product, and your company.
The Class II pathway is set up for rapid iterations.
The Class III pathway is constrained to one major iteration.
EXAMPLES
Ellipse Technologies‘ products were Class II. At Ellipse, we redesigned MAGEC almost weekly. Over 52 interation weeks these produces advanced dramatically.
50 iterations per year.
The STAR total ankle was a Class III product designed by Waldemar Link. The design had to be frozen before the large FDA clinical study was initiated in the 1990s. Once approved, the design was still frozen. After being sold to DJO, the STAR ankle is still a frozen design back in 1990s. Frozen in time.
