

Shift Labs (YC W15) Makes Medical Devices for Healthcare’s Future - koji
http://techcrunch.com/2015/03/16/shift-labs-medical-devices-dripassist/

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northern_lights
What's this? A medical device company that publishes prices and actually tries
to make low-cost, high-value products?? I will be watching this very closely!

I am in medical school now, but I used to be an EE in the medical device
space; my experience was that so many device makers sell through one or
several layers of intermediaries that prices have to be jacked up
substantially to make any money at all. We're talking selling products with a
BOM <$150 for $3000+ (these weren't highly specialized med products either -
you'd find similar devices in practically every doc's office). As a result,
the companies never moved enough units to justify a refresh of the design more
than once every 10-15 years.

I'm very happy to see someone trying a leaner approach, and I hope you guys do
well! Sell me some cool stuff in a few years :)

~~~
bkolko
Thanks for great feedback. The lack of transparency is definitely something
that keeps the system broken, and we want to drive some change in that
direction.

Also, let us know what kind of devices you want to see! We like to build
things people want...

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

~~~
toomuchtodo
No questions, just wanted to say thank you. The healthcare industry is in dire
need of having its costs driven down, and your team looks like its perfectly
positioned to capture a substantial amount of revenue with this.

~~~
koji
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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muaddirac
What are your testing methodologies like? Startups aren't what come to mind
when I think of rock-solid engineering - but as a medical hardware company I'd
expect a thorough and rigorous testing practice. What sort of automated or
manual testing do you do? Is there any formal verification of the software?

~~~
bkolko
I can't say the FDA process is the most fun thing I've ever done, but it's
been a great opportunity to bring the rock-solid engineering framework to our
product development. We use a combination of in-house testing and external
testing labs to get the rigor required by regulatory agencies.

Probably the most important part of startup culture that's letting us innovate
differently is the ability to create product development processes that
prioritize human centered design. It means we develop and test in a different
order, and our failure criteria for tests are not just about function, but
also about form.

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lnanek2
Pretty cool they got the price so low. I've consulted as an Android developer
on the app side of medical software and for every day we actually wrote
features we spent something like four testing. Unit tests, integration tests,
UI automation tests, moving the app up from local dev, to integrated dev, to
staging, to production (unused servers), then production (used servers). You
can imagine how much that inflates the the time required and cost.

~~~
bkolko
When we started, we really didn't have a good estimate of how hacking in the
medical space would be different from other kinds of hacking we'd done.

But it's really not that bad once you get the hang of it. If we could say
anything to other people considering taking the plunge, it would be to not be
afraid of the medical space. Sure, it's a regulated space and some things are
more complicated, but the difficult problems are the more interesting ones to
solve!

More along those lines: [http://www.shiftlabs.com/blog/on-being-a-medical-
device-comp...](http://www.shiftlabs.com/blog/on-being-a-medical-device-
company-in-yc)

~~~
jes
Do you work to comply with IEC 62304?

Do you do FMEAs for risk analysis, or some other technique?

Grateful for any insights you wish to share.

~~~
bkolko
We do indeed. And we've done FMEA. We're in the midst of FDA clearance, so all
the required quality work for product development is totally part of our
process.

We're working on the assumption that regulatory processes establish benchmarks
for performance, but they don't need to dictate _how_ one makes things -- ie,
design considerations can be front and center, not an afterthought.

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ryanx435
hi. project manager at a major medical device manufacturing company here.

the reason medical devices are so expensive is a lot more complicated than
what this article suggests.

1) upfront costs. you have to complete the development of the product before
you can conduct clinical trials. this is a huge risk: if you say the device is
ready, but the fda or eu says it's not, then all that work is gone or has to
be redone and you have to foot the bill.

2) clinical trials and animal testing are insanely expensive. I'm talking 50k+
for 1 dog to test your device on. don't even get me started on human centric
trials.

3) risk of litigation. look at the current mess with vaginal meshes: boston
scientific, medtronic, and others are paying out huge sums of money over
faulty tech that was approved by the fda.

4) regulatory overhead. navigation of the fda and ce mark beaurocracies is
complicated enough that it is an entire industry in itself. we have a full
team working on our project full time just to make sure we stay within the
law, to meet with the fda and eu, and to do all our governmental paperwork.

5) ip law. medical companies sue eachother for patent infringement all. the.
time. if you aren't checking to make sure you aren't violating patents, you
are exposing yourself to huge amounts of risk. hundreds of millions of dollars
of risk.

sigh.

plus all the overhead to navigate each hospital's unique purchasing process,
dealing with different regulatory requirements in different countries,
different radio spectrum requirements (if your tech uses any type of emitors)
in different countries, traceability requirements in manufacturing, certified
manufacturing sites, and all the rest.

sigh.

but the good news is that I'm an expert at navigating these treacherous waters
and am looking for a new job. if anyone at shift labs (or other medical device
manufacturer) is interested in a chat, feel free to reach out.

~~~
bkolko
Great points in why things are complex, and why so often complex=expensive.

While each of the items you mention are totally relevant, we've also found
that it's possible to mitigate a lot of these risks and costs with careful
strategy.

For example, we're building devices that don't require animal or human
clinical trials. That saves a tremendous amount of time and money in
development costs -- but there are still large, lucrative markets to tackle.

IP is hugely interesting, and our approach to developing simpler technologies
means we're not neck deep in the kinds of cutting-edge technology that comes
out of research labs. That affects our IP exposure.

The regulatory hurdles are absolutely there, and for a long time we found them
daunting -- almost paralyzing. But once we dove in, especially with a great
expert on our side -- it became manageable.

This is all to say, you're right: it's hard, and it's complex, and it can be
expensive. But we're really enjoying figuring out where the spaces are in
between all these hard things and finding new ways to make things happen.

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InfiniteRand
The press release is a bit contradictory. It says the reason things are so
complex is because of a profit motive, but also the reason that they will
succeed where others did not is because they are working for a profit. Also,
they are going to trim all the bells and whistles but they are not going to be
strictly functional.

All that being said I do think this venture is fitting into an emerging niche
in the market place due to the low cost of designing/re-designing devices.
Things like 3-D printers for prototyping, etc. means that the cost to develop
a medical device does not require the profit margin of a high-end medical
device in order to get back costs.

~~~
koji
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!

~~~
bkolko
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.

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bkolko
CEO of Shift Labs Beth here as well!

~~~
robbiep
As a Doctor, just have to say that this looks great. I've often thought about
how ridiculous our infusion pumps and syringe drivers cost, and have thought
about playing around with 3d printers and working out my own. I think it's a
great way to drive down healthcare costs. If you have any interest in
developing an understanding of the Australian market then please reach out ( I
have experience selling apps as a service to the clinical side of the public
system here)

~~~
bkolko
robbiep -- thanks for reaching out. It's pretty amazing that there's no middle
ground between those super-expensive infusion pumps and hand counting. We used
3D printing for our early prototypes, and it was great for quickly figuring
out which physical designs made people's eyes light up. Now we're doing
injection molding to get the quality control for the medical sector. And sure
-- let's talk about Australia!

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nanl2053
Is the drip assist connected?

~~~
koji
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.

