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

Embedded Systems Engineer | Shift Labs (YCW15) | http://www.shiftlabs.com | Seattle, WA

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

Learn more at: http://www.shiftlabs.com/jobs.html To apply, email [email protected]

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!

Thanks for reaching out! AsthmaMD looks like a great product. Would love to connect in the future.

The device does not currently have the CE Marking, but it is something we recognize as very important to sell in certain markets. We're working on it!

Thank you! Every day we wake up wanting to work towards a better healthcare solution. There are many ways to solve it, and this is just one of many, but we feel this is where we can make our impact.

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.

CTO of Shift Labs Koji here. Happy to answer any questions!

Haven't looked at the app myself, but was curious to know if providing vet feedback was available? Can specific vets be requested to build a repertoire with your pet?

Additional information on the Hackathon: http://breastpump.media.mit.edu/