Originally I set up separate tabs for each of these projects, but I found the sight of all those tabs so intimidating, I decide to consolidate them into a single page.
510(k) Development Costs
I plan to estimate the average cost of taking a 510(k) device from prototype to FDA clearance.
I'm a transparency fanatic. Like the rest of FDA and other government agencies, CDRH appears to practice a fair amount of it, but appearances can be deceiving. I want to take a closer look at some of its efforts at transparency. I think the place to start is with the question of what purpose is supposed to be served by the transparency effort, who does it serve, and how well.
I spend a lot of time reading decision summaries posted to CDRH's database, so I plan to start with them. I want to look at what types of information are included in the decision summaries. Is the information presented in the summaries consistent across reviewing divisions? Does it seem to be adequate to support the decisions? What does the information tell us about how FDA reviews the different types premarket submissions? Is this the purpose of making them transparent? If not, what might that purpose be?
Who starts them? Why?
What happens to start-ups after they start-up? Why?
What organizations are active in the medical device space? What is their mission, how are they organized, how are they funded, what do they do to pursue their mission, and what is their impact?
I'm going to start with the two organizations I know best, the Regulatory Affairs Professional Society (RAPS) and the Association of Clinical Research Professionals (ACRP). I will eventually look at AdvaMed and MDMA, but first....I've been itching to take a deep dive into the Medical Device Innovation Consortium for years now. Plus the National Venture Capitalist Association (NVCA). And, thanks to the pandemic, BARDA. Can't hardly wait. Meow.
What publications cover the medical device industry? What aspects of the industry do they cover and how well do they cover it? To what purpose?