koji

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.

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.

Our 510k is definitely a sliver of the various forms of requirements that may be needed depending your product space and classification.

We're hoping this repo will grow as other contribute, and be a space where people can find references for various types of regulatory support.

If you'd like to contribute, we'd be happy to give you access.

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.

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!

Hello! I'm CTO of Shift Labs. Happy to answer anyone's questions about making the FDA process more accessible to startups.

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 [email protected].

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