5 ms·

I could certainly see the FDA obstructing novel products without prohibitively expensive studies, but wouldn't it be significantly cheaper to demonstrate equiva

• HeyLaughingBoy 14y ago
  Yes, it would. Problem is that "significantly cheaper" means it costs $1 million instead of $5 million.
  • WiseWeasel 14y ago
    $1M+ might be in the realm of the attainable for a Kickstarter project, assuming the device has a sufficiently wide usage. The estimated cost of approval would need to be included in the funding goal. [If the same studies might be used to seek approval in several countries at once, then it might make such an approach to funding medical devices more attainable for the size of their market. The missing piece of the puzzle seems to be an affordable method for conducting studies to get medical devices approved. It seems like the industry is highly vertical, with difficult access to financing and compliance infrastructure. This might be an opportunity for a service provider to come in, establish a selection process for clients, partner with universities around the world to conduct studies to the specifications of US FDA, and its EU, Canada, Japan, etc. equivalents' approval, and help store and file the needed paperwork in exchange for a cut of sales. Maybe it's also time for the UN to create a world body for standards of approval of medical technology which all these nations should recognize; or maybe ISO should take that role.]