bkolko

9 ms·

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by bkolko 10y ago
I'll send you the info we have on internal FDA contacts for startups -- they can be extremely helpful.
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by bkolko 10y ago
We had downloaded several 510(k)s early in our process, but found them so heavily redacted that they didn't really give the overview we needed. That's why we worked so hard to redact as little as possible in our own docs. I'l
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by bkolko 10y ago
This is beth, also of Shift Labs. I've been offline in Haiti for the past several days, but am happy to answer questions as well. Thanks to all for the support for the repo -- we're excited to expand the content.
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by bkolko 11y ago
I'm a YC founder (current batch; Shift Labs) and also a tenured full professor at an R1 university. I've got a pretty good view from both sides of this fence. I've spent over 20 years as a faculty member at research universit
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by bkolko 12y ago
Great points in why things are complex, and why so often complex=expensive. While each of the items you mention are totally relevant, we've also found that it's possible to mitigate a lot of these risks and costs with careful stra
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by bkolko 12y ago
Just a quick comment to add: In many ways, what we're doing would probably not have been possible ten years ago. The markets were different, and so was the technology that enables us to implement changes to support and training. In add
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by bkolko 12y ago
We do indeed. And we've done FMEA. We're in the midst of FDA clearance, so all the required quality work for product development is totally part of our process. We're working on the assumption that regulatory processes establ
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by bkolko 12y ago
Thanks for great feedback. The lack of transparency is definitely something that keeps the system broken, and we want to drive some change in that direction. Also, let us know what kind of devices you want to see! We like to build things pe
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by bkolko 12y ago
When we started, we really didn't have a good estimate of how hacking in the medical space would be different from other kinds of hacking we'd done. But it's really not that bad once you get the hang of it. If we could say an
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by bkolko 12y ago
It's more about positioning of the solution, and thinking of new markets, not replacing existing markets. We also have a business model that allows us to leverage software in ways that lower costs of doing business -- some traditional
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by bkolko 12y ago
I can't say the FDA process is the most fun thing I've ever done, but it's been a great opportunity to bring the rock-solid engineering framework to our product development. We use a combination of in-house testing and extern
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by bkolko 12y ago
robbiep -- thanks for reaching out. It's pretty amazing that there's no middle ground between those super-expensive infusion pumps and hand counting. We used 3D printing for our early prototypes, and it was great for quickly figur
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by bkolko 12y ago
CEO of Shift Labs Beth here as well!
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by bkolko 12y ago
That comment wasn't originally about breast pumps, so I can't speak to that specific market. But the comment about sales force costs was about selling products like ultrasound into emerging markets. And if you have products that r