SoylentNews

Fnord666 [soylentnews.org] writes:

The Food and Drug Administration approval process can be like navigating a minefield for health startups hoping to get through regulations and begin selling to the American public. YC company Enzyme.com [enzyme.com] hopes to help these small businesses by automating the process for them.

Biomedical engineer Jared Seehafer came up with the idea through his own experience consulting with health companies like Genentech. He found going through all the paperwork to get into compliance wasn't just tedious but also a big part of what's holding back small companies.

"You find you spend almost as much time documenting the work as you do doing the work," Seehafer told TechCrunch. "This is a multitrillion-dollar industry and I thought 'why isn't there software to automate the process?' "

[...] With Enzyme, Seehafer says startups don't need a background understanding in regulatory issues and don't have to duplicate the paperwork, either. They can just plug it in and have it ready to go when the FDA comes knocking.

[...] Seehafer hopes Enzyme helps founders not only navigate the process more smoothly but also educates the community so those with an idea can concentrate on innovating more and dealing with paperwork less.

Would something like Enzyme have helped Theranos navigate the process? Seehafer laughed, adding the beleaguered blood testing company "didn't follow FDA compliance 101."

Source: TechCrunch [techcrunch.com]

Original Submission