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 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

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 jobs@shiftlabs.com

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/

They are doing some things. They sponsor some startup events, and try to get people to use Windows Azure (which is actually quite nice) to compete with AWS (also Seattle). However, I think the reputation of Microsoft as the "Big Evil" is pretty hard for them to overcome. I think people tend to roll their eyes at them when they try to get into the startup space.

That being said, the other giant here, Amazon, seems to be doing just fine with their reputation.

Employees from both companies are common in the startup land here, having jumped ship to go on their own.

I've worked both in the Valley and in Seattle, and in my experience the startup mentalities have been pretty much the same. There may be a lot of former MS people working at the startup, but they don't seem to have any attachment to it. If iOS or Android are where the numbers are, that's where they go. I've also never met a startup in Seattle solely focused on developing something for MS, although there probably are some that exist. Whatever trend you saw in the northwest previously must have changed, from my limited perspective.

I agree with this. People ask me all the time what I thought about my experience at YC was like. And my answer usually comes down to being with the people. When everyone around you seems to be smarter, work harder, and be more driven, you really push yourself too. But, it was also a supportive community. Everyone wanted to see everyone else succeed. Basically, it was a good support group for those days (and there were many) where you just felt down in the startup dumps.

The good news is that you don't necessarily need YC to have much of that experience. If you build a good network around you, with lots of hard-working and positive people, it helps a lot.

Thanks for the feedback. We've actually been operating our largest program for over a year now. Also, many new, specialized bicycles designed for bikeshare use now exist. We definitely don't want to use $100 Walmart bikes. We make sure the bicycles are up to certain standards for durability and rider comfort, and perform regular and as-needed maintenance.

I'm always looking for ways to stay motivated and keep me focused. I've tried the Todo list before, but it always seems to fall by the wayside when the little things in life come up.

What have other's done that has worked for them personally?

This is a more succinct and elegant way of explaining what I was trying to say.

Being a mechanical engineer and a hardware guy myself, I may be biased, but I think hardware is alive and well. With rapid prototyping and open-sourcing of 3D printers, fabrications shops and the like, the opportunity to create new hardware devices is easier now than ever before.

The issue the article focuses on is commoditizing of hardware. Tablets all essentially have the same components and the economies of scale are exaggerated. When you have multiple manufacturers of very similar devices they all start reducing their margins to gain market share. This is a race to the bottom, and I believe the point the article is trying to make.

However, the innovators of hardware are the winners. New devices that create new markets, new functions, new possibilities for consumers have the potential to sell large volumes at high margins. This has the advantage of the added barrier of manufacturing. Competitors take longer to tool-up and compete, giving first-movers a larger advantage than software producers. The iPod, for example, still remains the leader to this day.

Hardware isn't dead, it just becomes a commodity over time. To avoid reaching the bottom, you have to be a company that's always innovating, just like software. Creating new products, vastly improving design, etc. Leave the copycats in China to turn it into a commodity, you should be onto your next big thing by the time that becomes an issue.

I recommend taking the time to use it, especially with friends. When you're not just passively sitting and staring, but contributing to the content, it turns it something else. You become part of a conversation that's surprisingly addictive, and not something you come across in 'post random pictures here' sites.

Let us know when it comes out! We'd love to give it a read.

We couldn't agree more! One of the things we're very excited about is the amount of data viaCycle's system can collect and organize. And because we're not tied to permanent infrastructure we can be flexible; adjusting to usage on demand, etc. Some of it may work, some of it may not, but we're looking forward to pushing the traditionally slow-moving transit world into the future.

There is definitely a lot of things we can do with the bicycles. viaCycle is actually bike agnostic. It's a modular device we can retrofit to secure onto numerous types of bicycles. It's easy to add features to bicycles as well, such as baskets, bells, etc. Customization is part of the offering. We're just showing off the bare-bones test bikes for the most part.

Current bike share programs do require redistribution of bicycles, often as often as twice a day. In large city operations viaCycle would likely be subject to this as well, but that leaves operation costs nominal.

On university campuses we have seen the traffic to be much more free flowing, as students do not follow standard commute patterns. During standard maintenance bicycles can be moved around as needed.

We have discussed the possibility of incentivizing riders to help redistribute bicycles, although the effectiveness of this has yet to be proven.