We hired a consultant to help put together the paperwork and deal with the actual submission itself. They did not support us on putting our documentation together, and could not provide specific answers to questions we had.
What they did provide was a means to package our paperwork together in a way that is recognizable to FDA reviewers, and the resulting work is what you see in the StartupFDA repo.
We still had to produce all the work, and interpret the FDA guidelines on our own. It was a bit of a compromise on speed and cost, but worked for us.
We don't have any experience with food and supplements with the FDA, so don't have a lot to offer. The hope is that based on your experiences, you could contribute to github.com/Shift-Labs/StartupFDA as you learn the process.
Alex, happy to help. First thing would be to review our 510k documents we made available on the github repo, and see if there are any specific gaps. Start a conversation and submit an error request so we can start expanding on what's there!
Someone I know is working on a platform to help startups with FDA compliance (specifically the quality systems requirements), who I think would be complementary to this effort. Mind emailing me at brandon@cardiogr.am if you'd like to be put in touch?
This would be me. @koji, I think this is fantastic, as my startup's mission is precisely to demystify the process of getting (and maintaining) regulatory clearance/approval. Would love to connect. Just reached out over email.
Agreed. We'd like to expand fom just FDA specifically (and 510k specific), and get into maintaining quality standards. There are numerous different segments you can expand to as well.
It seems to me the big chunk of the problem is that my local hospital doesn't really have to compete with anyone and has rather free reign in setting prices.
There is also a very high overhead required for simply getting products to market. When the easiest way to proceed is by hiring high-priced consultants who hold all the keys, it makes it very difficult for new ideas to become available. Only established players really have the pockets deep enough to navigate the regulatory process.
There are numerous costs that you can't avoid, such as lab testing, clinical trials, and fees for acquiring certifications, but being able to do more on your own as far as documentation is a big first step.
> It seems to me the big chunk of the problem is that my local hospital doesn't really have to compete with anyone and has rather free reign in setting prices.
Yes, there is definitely lack of competition at the provider level which has gotten worse post-ACA. But in this context I'm talking about lack of competition among technology manufacturers. Really easy to set high prices for things when competitors can't enter your market without going through several hoops. That's how you get guys like Martin Shkreli.
Have you thought about including redacted copies of 510(k) submissions available from the CDRH FOIA Electronic Reading Room [1]? You could probably just provide a list of links to the PDFs.
Here's an example of one for a powered laser surgical instrument (warning: 57MB PDF):
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!
Shift Labs (YCW15) is looking for our first embedded systems hire in Seattle.
We’re a Y Combinator backed company creating innovative and simple devices for fast-growing healthcare sectors. Our customers range from home health care patients in the US to expectant mothers in emerging markets. That means we build devices that use creative design and engineering to develop technologies that help provide better care around the world. We’ve got ambitious goals and global plans. If you want to build technologies that make a difference in people's lives, we want to talk to you.
Job Description:
We’re a growing startup looking for a team member to take a leadership role on the embedded systems side of our product development. If you have a strong knowledge of product development, embedded electronics systems and programming (with an emphasis on power management), and the ability to anticipate product, engineering, and consumer needs, read on!
If you enjoy building tangible things, can think at a systems level, and want to do meaningful work that helps improve the world, email us at jobs@shiftlabs.com.
Location:
Seattle, WA
Qualities:
· You enjoy talking to customers and are able to explain technical concepts to non-technical users.
· You have worked in a startup-like environment (unstructured, ambiguous, resource constrained).
· You have experience with manufacturing products and scaling production.
· You work well with engineers, marketing, sales and other stakeholders at the company.
· You have exceptional organizational, collaborative and communication skills.
· You are curious and have the ability to learn quickly and become an expert in new technologies, markets, etc.
· You can engage in both tactical and strategic thinking.
· You’re open to participation in broad tasks related to the business, including recruitment, resource planning, marketing strategy, etc.
Required Skills:
· Expert at embedded software development
· Expert at electronics circuit design, testing, and PCB layout (digital and analog)
· Experience with electronics design for manufacture, dealing with suppliers, including putting together electronics manufacturing packages to get production quotes.
· Capable in ultra-low power design
· C and C++ experience
Help change medical devices. We're looking for an immediate electrical engineer with embedded systems knowledge to help improve Ebola patient care, and improve safety for Ebola health workers.
· Expert at embedded software development
· Expert at electronics circuit design, testing, and PCB layout (digital and analog)
· Experience with electronics design for manufacture, dealing with suppliers, including putting together electronics manufacturing packages to get production quotes.
· Capable in ultra-low power design
· C and C++ experience
This may just be a result of their maturity. The YC companies may seem "not very good" because they're closer to market and practical application.
When it comes to research, particularly in academia, it's much farther from market. This makes it much easier to expound on the broad possibilities. News headlines have a bad habit of doing this (think fusion and carbon nano-tubes).
Functionality will not be made less of a priority, but we are making design and usability equally as important. Doing so helps cut down on training and support required for equipment, which is where many companies make their real revenue (similar to enterprise software charging support subscriptions). Because this is where so many established companies make their margin, there is little incentive to make their equipment easier to use. They also have built up large support staffs for this purpose.
By removing the need to support large support staffs, and reducing our sales team requirements by aiming at markets outside of large hospital institutions, we are able to keep our overhead low compared to the competition.
I hope that makes thing a bit more clear, but happy to elaborate if you like!
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.
Not currently. The approach with the design was to focus on basic functionality and ease of use. We wanted to keep things simple. In addition, keeping things simple has allowed us to eek out 290 hours of battery life out of a single AA. Something our users have really appreciated.
We have already gotten strong feedback for more connectivity, so that's definitely something we're working on.
What they did provide was a means to package our paperwork together in a way that is recognizable to FDA reviewers, and the resulting work is what you see in the StartupFDA repo.
We still had to produce all the work, and interpret the FDA guidelines on our own. It was a bit of a compromise on speed and cost, but worked for us.