koji

6 ms·

1.
by koji 10y ago
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 pr
2.
by koji 10y ago
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. Onl
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by koji 10y ago
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 referen
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by koji 10y ago
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.
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by koji 10y ago
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 pro
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by koji 10y ago
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 t
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by koji 10y ago
Hello! I'm CTO of Shift Labs. Happy to answer anyone's questions about making the FDA process more accessible to startups.
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Shift Labs (W15) Is Hiring a Marketing Manager in Seattle(shiftlabs.com)
1 points by koji 10y ago
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Shift Labs (YC W15) Is Hiring Medical Device Director of Quality and Regulatory(shiftlabs.com)
1 points by koji 11y ago
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Shift Labs (YC W15) Is Hiring Market Development Reps to Help Change Healthcare(shiftlabs.com)
1 points by koji 11y ago
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This medical device startup just raised cash and is heading to Rwanda(geekwire.com)
2 points by koji 11y ago|0 comments
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by koji 11y ago
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
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by koji 11y ago
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 p
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Shift Labs (YC W15) is hiring an embedded systems engineer(shiftlabs.com)
1 points by koji 11y ago
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Shift Labs (YC W15) is hiring an embedded systems engineer in Seattle(shiftlabs.com)
1 points by koji 11y ago
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by koji 11y ago
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 fr
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by koji 12y ago
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 (s
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On Being a Medical Device Company in YC(shiftlabs.com)
6 points by koji 12y ago|0 comments
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by koji 12y ago
Thanks for reaching out! AsthmaMD looks like a great product. Would love to connect in the future.
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by koji 12y ago
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!
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by koji 12y ago
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.
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by koji 12y ago
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. Som
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by koji 12y ago
CTO of Shift Labs Koji here. Happy to answer any questions!
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Shift Labs (YC W15) Makes Medical Devices for Healthcare’s Future(techcrunch.com)
76 points by koji 12y ago|27 comments
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by koji 12y ago
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?
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Developers, doctors team up to create simulation of Ebola treatment center(geekwire.com)
3 points by koji 12y ago|0 comments
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Ebola Training Hackathon by Shift Labs(eventbrite.com)
1 points by koji 12y ago|0 comments
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Creating Digital Simulations to Supplement WHO Training Materials(openideo.com)
1 points by koji 12y ago|0 comments
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by koji 12y ago
Additional information on the Hackathon: http://breastpump.media.mit.edu/
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Hacking the Breast Pump(newyorker.com)
52 points by koji 12y ago|12 comments

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