DrsGreenandHollister

There is a lot that can be done for children with SMA I. Can you email me? GG

3D printing will be a challenge for the FDA as you obviously can make custom implants and can readily change design. This raises issues about how to implement FDA quality systems requirements (QSR). Also, how do you verify and validate such processes? These are challenges that we face and will require new approaches in regulatory science. I think the most interesting challenge is how to implement QSR for 3d printing. Thanks for your question. Scott Hollister

I agree, but maybe we could combine the two and make a movie about 3D printing medical devices! George Clooney could shave his head and play my role in the movie, LOL! Scott Hollister

It depends on whether you are talking about the cost of just making the splint, or all the research, development and regulatory costs that go into it. The cost for materials and machine time would be about $100, if you include R&D and regulatory costs, probably in the low thousands. Thanks for you question. Scott Hollister

Our estimate of total costs with all factors involved is about $40,000. The marginal cost is only $100. We expect this to be very cost effective in the future.