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Comment by idealmedtech | Hacker News Reader

There's a reason why we ended up putting our trials together essentially by trial and error! You learn a lot by writing your own clinical protocol, interacting with the FDA etc. It's an intimidating process at the outset, but if you can save $200k on a first-in-man study by not contracting a CRO, that's gonna extend your runway by a lot!

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I don't completely disagree with your point, but for one's clinical regulatory strategy, perhaps "trial and error" isn't the best branding to appeal to investigators, patients, regulators or investors.

Perhaps I was being too self deprecating! We worked closely with the FDA through multiple QSub meetings to make sure it was up to snuff, and did a lot of legwork on the backend to make sure we understood what they were asking for. 3 or 4 revisions later, we had an approval!

Are you under the impression that that's how they branded things?

A fair point, but with the FDA responses taking up to 30 days you burn a lot of runway.

They have a 180 day review commitment. A 30 day delay on their side would be unusual and burn a big chunk of that clock.

That's why you have several Type B or Type C meetings during development to work out the kinks before you submit a protocol.

If you are worried about $200k, do you have enough money to bring your product to market?

When we started putting the trial together, we were still self funded. In medical device, to get to series A you need human data, so by doing the trial protocol ourselves, we avoid the chicken and egg problem of needing money in order to raise money. Once you get human data, your valuation skyrockets.

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