🧬 Magic or Medtech #3 - FDA compliance is easy 👍
Plus: Standards orgs are getting along, EHRs aren't getting along, and the best remote salary included jobs in medtech
FDA submissions.
😱
Scared yet?
You don’t have to be. As promised last week, I have more to say about Arash Samimi and Oleksiy Zaika’s panel discussion.
This week, we’re talking regulations. Or rather, they already talked. I’m just writing down what they said.
Safe and Effective
FDA compliance is a confusing, comprehensive, and stressful process that exists to ensure exactly two things:
That your product works the way you say it does.
That your product is safe.
Sounds like something you should do even if there was no FDA, eh?
Of course it’s more complicated than that. It’s always more complicated than that. But you can do it. Here’s how:
Avoid it if you can
This should go without saying, but if you have a valuable product without making any condition or diagnostic claims, find your product/market fit first and then consider wading into regulated water.
Even if you think you’ll ultimately have to be regulated, it’s never a bad idea to run your product through some strict parameters and see what comes out the other side.
Work with the process, don’t fight it
FDA requirements don’t have to be an extra pile of work you keep putting off. You can use them to make your life easier.
Quality Management Systems (QMS) can identify serious issues early on, before you have to perform surgery on your product. Risk Management Systems (RMS) can identify architectural flaws in your software.
Your product will have to meet the requirements eventually. Use them to guide your process from the start… it might feel like they’re slowing you down, but they can also dramatically reduce the distance you have to go.
Include regulatory milestones in your fundraising roadmap
Use presubmissions and submissions as checkpoints in your product development and fundraising cycle.
Where can you get with the runway you have?
Use classification as a competitive advantage
If you’re the only Class II medical device in a niche full of Class I devices, you have access to billing and reimbursement codes no one else does. You have access to indications and conditions no one else does. You are almost by definition ahead of the pack.
This is especially true you’re keeping on top of regulatory trends in your market. Are there new regulations coming? You should know if there are. Being Class II might set you apart in a new regulatory regime.
Bonus advice from the author
Get help. Seriously, don’t do this by yourself. People like Arash can save you months of wasted time and money. Talk to experts.
That being said - by the end of the process, you should be an expert too.
Alright, that’s probably enough for you to think about this week. Next week, we’ll cover what Arash and Oleksiy had to say about R&D.
Everything EHR integrations
This week on the podcast, I spoke with Alex Goel of Topology Health about EHR integrations.
It was a great conversation that I’ll cover in depth in the newsletter two weeks from now (blame Arash and Oleksiy for frontloading my writing schedule).
If you can’t wait that long, you can listen here or wherever you listen to podcasts.
The week in medtech
Epic makes a surprise move, Oracle makes a surprise move, Colorado makes a surprise move, and openEHR and HL7 work together to make a surprise move.
Epic goes open source
Epic has released a free and open source AI validation engine called Seismometer.
The software will allow Epic users to validate the models integrated to their EMR, including models developed by Epic itself.
The package includes templates to analyze model statistical performance, fairness across different cohorts, and the application and impact of interventions on outcomes for commonly used model types within healthcare.
Sounds great. The more companies spending actual money on developing AI monitoring and evaluation tools in general, the better. The risk surface with AI is enormous. IMO it encompasses literally “all of society.”
That said, I’m not sure what the motivation is for Epic here? This will be another gatekeeper in their integration process, but why open source it?
My best guess is this just gives hospitals and health systems an Epic-branded point of reference for model validation for any software they’re considering - not just Epic integrations.
Also this:
If you have any better ideas, I’d love to hear in the comments.
Oracle isn’t having any of it
One open source project doesn’t make an organization open.
Oracle Executive VP Ken Glueck wrote a blog post this week calling Epic CEO Judy Faulkner the “single biggest obstacle to EHR interoperability.”
Epic’s contracts expressly appropriate all patient EHR data as Epic’s own, stretching HIPAA beyond recognition, while Oracle/Cerner’s explicitly state medical centers must opt-in to any data sharing.
Oracle acquired Cerner, arguably Epic’s biggest competitor, in 2022.
I’m a software developer, so I’m instinctively predisposed to not believe anything anyone at Oracle says. That being said… fair point, Ken.
Colorado regulates healthcare AI
Colorado became the first US state to regulate AI in healthcare.
The legislation will bolster consumer protections when key health care-related decisions are made via AI, and require developers and deployers to address algorithmic bias based on reproductive health, genetic information and other data. Developers must also make disclosures about AI systems that make high-risk decisions.
The new legislation doesn’t kick in until 2026. Plenty of time for GPT-5 to make it all either totally insufficient or just irrelevant.
I don’t think anyone knows how to regulate AI. At best, you can set up requirements around the margins - set parameters around training data, create technical standards around interfacing with the model - but it’s hard to regulate fundamentally indeterministic systems.
Underneath every assertion of capability, there’s an unstated caveat:
"This seems to work at least as well as a human physician, but we don’t actually know why.”
I guess that’s fine?
Everyone is getting along
openEHR and HL7 announced their intention to cooperate and align their respective standards.
I’m not up to speed on the areas of friction between the two organizations, but cooperation in technical standards is always a good thing.
Competition is great for most categories of progress - open standards for highly technical interoperability is not one of them. Everyone here wants the same thing. The best ideas will come from discussion and collaboration between motivated communities.
Remote jobs with salaries
Medtronic is hiring a Director of Market Access, Business Development and Remote Sales for $176K - $264K CAD
Garner Health is hiring a Director of Product Design for $175K - $195k USD
Thirty Madison is hiring a Principle Product Manager for $185 - $278K USD
Big Health is hiring an Engineering Manager for $190K – $245K USD
If you’re looking for a job in medtech or digital health, let me know. I’m here to connect people!
That’s it for this week. Have a great weekend!
- Clark