bkolko

I'll send you the info we have on internal FDA contacts for startups -- they can be extremely helpful.

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'll dig deeper into that set of links to see if there are some that have more info in them. Thanks!

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.

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 universities, produced PhD students, raised millions in grant money, written dozens of articles, yadda yadda yadda.

Universities are really great for many things. They are even really great at commercializing some kinds of technologies. But they are not great for all things, even all things related to bio or tech transfer. Sometimes crazy bets are the only way breakthroughs happen, and generally academia cultivates incremental more than transformational.

I started my company because I wanted to make affordable medical devices. The incentive systems for both med device companies and university commercialization offices are almost completely misaligned with building a business model that works for affordable medical devices.

So I went the entrepreneurial route.

Being in academic research is not the same thing as building a company. They're not the same skill sets, or even the same language. Lots of academics become technical advisers to startups built around their research. That's not the same thing as building a company. YC is about building a company.

I wrote about being a med device company in YC here: http://bit.ly/1LlmZjk, but I think really what I was writing about was being a researcher learning to build a startup.

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 strategy.

For example, we're building devices that don't require animal or human clinical trials. That saves a tremendous amount of time and money in development costs -- but there are still large, lucrative markets to tackle.

IP is hugely interesting, and our approach to developing simpler technologies means we're not neck deep in the kinds of cutting-edge technology that comes out of research labs. That affects our IP exposure.

The regulatory hurdles are absolutely there, and for a long time we found them daunting -- almost paralyzing. But once we dove in, especially with a great expert on our side -- it became manageable.

This is all to say, you're right: it's hard, and it's complex, and it can be expensive. But we're really enjoying figuring out where the spaces are in between all these hard things and finding new ways to make things happen.

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 addition, technologies that are facilitating rapid prototyping in other industries are just as essential to cutting down development time and costs for medical devices.

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 establish benchmarks for performance, but they don't need to dictate how one makes things -- ie, design considerations can be front and center, not an afterthought.

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 people want...

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 anything to other people considering taking the plunge, it would be to not be afraid of the medical space. Sure, it's a regulated space and some things are more complicated, but the difficult problems are the more interesting ones to solve!

More along those lines: http://www.shiftlabs.com/blog/on-being-a-medical-device-comp...

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 areas like sales and support, and some non-traditional ways as well.

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 external testing labs to get the rigor required by regulatory agencies.

Probably the most important part of startup culture that's letting us innovate differently is the ability to create product development processes that prioritize human centered design. It means we develop and test in a different order, and our failure criteria for tests are not just about function, but also about form.

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 figuring out which physical designs made people's eyes light up. Now we're doing injection molding to get the quality control for the medical sector. And sure -- let's talk about Australia!

CEO of Shift Labs Beth here as well!

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 require lots of training and servicing, and lots of high-touch sales to get to acceptability -- yup, that's gonna cost you! And regardless of the price point of the product, you still have the associated overhead with reaching those markets. There are things you can change about that 'associated overhead' but that's a totally different story.

My gut instinct is that I don't think sales costs are really a huge driver of how companies have been approaching innovation in the breast pump space. There is indeed consumer psychology around how to price products, but the thing that really came across during the hackathon was the frustration people felt about the design and engineering of the pumps -- not the price point.