
APPLY HN: organize and make accessible the world's data on medical devices - lordumoh
Hey guys, our vision is to be Google for all medical device data.<p>Why: starting with the FDA, the regulatory process for evaluating and approving medical devices is lax especially when compared to pharmaceuticals. The majority of devices are fast tracked through a process called 510k which requires minimal data&#x2F;clinical trials from manufacturers. This culminates in over 8k increasingly expensive devices flooding the US market with limited clinical data. Currently, a proliferation of organizations are attempting to fill the data gap by conducting their own trials, collecting post-market data, or sharing data across health systems. But they all remain in silos and often are hard to access.<p>Looking at post-market monitoring of devices, our national system is a joke. There&#x27;s no efficient framework by which the FDA monitor and manage the performance of devices after use with patients. So instead, we have hospitals and manufacturers manually submitting recalls and failures way after the fact.<p>How: aggregate from datasets including Medical journals, the FDA, vendors, research organizations, deidentified patient data crossed identified device in use. Layer on top tools to automate creation of data reports based on a few key search words.<p>Initial application: repository of evidence-based data for hospitals to evaluate medical devices before purchase--we realize this is a lot to tackle so we initially want to focus on hospitals who are looking for robust clinical data before buying devices, hence our current website on managing this process and giving access to all available data.<p>Stage: we&#x27;re about four weeks from a prototype and have interest from hospitals but no signed pilots. It&#x27;s a lot but it&#x27;s just the beginning. We welcome all questions and would love to hear more applications for the data!! Thanks.<p>Our website: amplehealth.us
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kumarski
I have some tough questions:

Help me understand the incentivization for the "proliferation of
organizations" to want to share their private trials data?

On aggregation, I recommend checking out SuperFeedr.

How many hospital systems have you spoken with? I'm well aware of the myriad
of ways in which surgical device sterilization documentation is poorly
tracked, but even when I've seen entrepreneurs fix it, the hospitals don't
purchase the systems.

Understanding why/how hospitals purchase data is where I'd start before ever
opening up the terminal on this venture.

Also, check out BaseHealth.com.

Onwards & Upwards!

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kumarski
What about your team? Who are you?

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graeham
The FDA does a fair bit of this already, both through their open API
[https://open.fda.gov/device/enforcement/](https://open.fda.gov/device/enforcement/)
and through MAUDE
[https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/s...](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm)

Maybe I'm missing what you're doing on top of this?

What data leads to purchasing decisions - I don't know I follow the data
you're looking to collect mapping to the initial application? For implants
I've worked with, surgeon preference often plays a big role and cost. Surgeons
keep up to date with journal articles, reports on failures, and compare notes
with colleagues.

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lordumoh
You're right, the fda's open API is a great new tool that they're building as
well as the Maude database. But it's very limited in collection and
accessibility of clinical data. For example, 510ks are redacted and require
manual requests for full information each time. The problem with Med journals
is their exclusivity in publishing research and often times doctors only read
certain journals, leaving out smaller, lesser known research. I've experienced
this as a pharma rep with first to market clinical data that was ignored
because we weren't in a certain journal. To overcome the trouble with late and
in-frequent submission of data like adverse events from manufacturers, we want
to position an access point for our data capture software at the point of
surgery/device usage where we combine device id with patient id for tracking.
At this point, adverse events or device failure is detected at the point of
hospital intervention.

Looking at the data that triggers purchase, there's actually a huge shift
occurring. More hospitals are moving to committee based decisions rather than
submitting to physician preferences. As prices for devices skyrocket in
conjoncution with the known relationship of physician and vendors, hospitals
are looking to base purchasing decisions across clinical evidence, financial
data, and comparative analysis. So we think these trends are favor our
thinking and strategies initially.

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lifeisstillgood
This seems like one of the few US based healthcare ideas that will cross
international borders easily. The US healthcare world is surprisingly insular
but the efficacy of medical devices is the same no matter your GOS co
ordinates.

If you can track device and patient outcome directly, that's amazing. But it
sounds fraught

If you are "just" converting trial data to accessible format, that's great too
but does seem more ... Going to get taken over by the FDA in about five years.

But even if the FDA don't buy you but just replace you, it's worth doing for
the value in those intervening years

Good luck

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lordumoh
Great point. The devices do not change in efficacy across borders but the
regulatory system that monitors safety and effectiveness certainly does
between the US, EU, and East Asia, for example. And we're (the US) at the
bottom of that assessment.

As for tracking direct patient outcomes, take a look here:
[http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/)

the fda is actually creating something really really awesome but the question
after is the applications and how (tech-wise, what's powering the mediums
through which multiple applications are implemented?) So we aim to be in those
conversations.

