[da3da]

My guess would be this is more for capital reasons than legal ones. It is extremely expensive to form a company of either type. I think the standard drug pipeline costs somewhere between 10s of millions to billions of dollars per drug. I'd imagine that the cost for medical device development and approval is similar.

[rdl]

Medical devices are 1-3 years vs. 5-15 years (orphan drugs are actually pretty fast now), and 1-2 orders of magnitude less capital.

Medical devices would be just on the upper bound of what I think YC could do. The right way is probably to do an unregulated "fitness" or "convenience" product, which later has regulated-medical-device functionality. Defer the compliance parts until the product itself is proven.

There are plenty of "small business" ($1-5mm in personal-recourse debt) type medical device entrepreneurs. US and Israel seem to be the two big markets for developing them. Surprisingly, a lot come from people outside the medical professions.

[da3da]

Ah, thanks for that info, I wasn't aware that the time from development to deployment was that low now.

[rdl]

There are ways to fast-track in the US and other countries.

A medical device which had applicability to the military (specifically, IEDs, TBI, PTSD, eye/hearing protection or remediation of damage, traumatic amputations, or prosthetics) would largely avoid the FDA, too. There is going to be so much money in improving the lives of wounded veterans from Iraq/Afghanistan for the next 50 years, and it's going to be one of those cases where money you earn is also related to a societal benefit.

If I were in biotech/biomed or robotics, that'd be what I'd want to do; the only comparable-scale problems are reducing cost of care for everyone and dealing with an increasingly elderly population.

[malay]

For medical devices that are based on modern mobile platforms, the average FDA clearance time is down to 67 days. It's not nearly as capital-intensive as it used to be and there are going to be plenty of predicate devices to base your filings on.

The ubiquitous computing plus sensor environment is making healthcare hardware startups the norm—we're seeing more and more applicants in this space at Rock Health. We don't think the FDA process is that onerous, and just published a report outlining the process for entrepreneurs who are new to the space.