Experiencing the Pain of Modern Compliance Firsthand: How Infera Was Born
A founding team that built cleared medtech the hard way shares what they learned — and how they're changing quality and compliance infrastructure.
Experiencing the Pain of Modern Compliance Firsthand: How Infera Was Born
Smart people, stuck
When I was VP of Engineering at the startup that got me into medical devices, we had an incredibly talented, super technical team — that hit the wall every day they did quality and compliance.
We had the technical know-how to build cleared medtech. In our case, that was the complex domain of EEG signal processing.
But when it came to the make-or-break task of formalizing our inventions for the FDA, we’d have to stop and spend time and money on learning what we didn’t know. At submission time, engineering would freeze for months and months so we could answer, “How do we do this? What are we missing? Who owns this piece?” instead of focusing on quality or standards adherence in their own rights. And that was really just to do the bare minimum. Personally, I lost tons of sleep, not just leading up to submission, but also waiting for the result.
Paying the big bucks to still feel dumb
Documenting the quality and safety of medtech is not a natural exercise, the asks puzzling enough to resemble the Sunday crossword. Take a risk analysis, for example: “Just imagine how your device can fail.” Developer: “What do you mean? I’ve already written all this exception handling.” The gap between the what and the why was maddening.
Even though we had some existing compliance expertise, we spent a small fortune building this muscle, hiring a series of consultants who all had different methods and paying for expensive tools that weren’t all that helpful.
Six systems, zero traceability
Traceability was especially hard for us since we had six different development systems to tie together. The tool we used was essentially a nicely formatted table that you could pop hyperlinks into — including information that was wrong — because nothing was connected. There was no verification of inputs. To double check everything, I’d have to pore over paper printouts of 40-page Excel sheets for eight hours alone in a room.
Information found in different systems has inherent gaps, so you’re going to have to do translation. And when people do translation, they miss things.
An Infera customer had all these issues because they were copy-pasting critical pieces of information — tolerances, tests, executions, history — from Jira and Confluence into basically a Word doc. Do this thousands of times, and what begins as just a clunky process becomes incredibly error-prone and hard to keep track of. At the startup, our first submission ran 400 pages. Modest, by industry standards.
The answers are in the code
Eventually learning the regulatory approval process from the development side, we came to recognize that if you’ve built a product, you’ve already done 90% of what the FDA is asking for, just in a different language. The answers are already written in the code.
In Infera’s world, you’re working with these answers in real-time, not the very end of development. Most every well-engineered product already has exception handling to prevent failure. Document those, and it’s a risk analysis. When you have a system that continuously connects what you do to the outputs you owe a regulator, what used to be a long pole becomes a natural part of your everyday.
Beyond compliance: safer products
The more our team thought about this opportunity, the more we realized that it isn’t just about saving medtech developers from being taken away from their mission by admin. It’s about preventing people from getting hurt.
Medtech isn’t as safe and effective when manufacturing happens in silos, which isn’t just an issue for startups that don’t know what they’re doing. As we started to do some discovery about this problem, we came to understand that it’s an issue for companies that do know what they're doing too, including enterprises who know what they're doing very well.
The problem is only going to get harder to ignore. Without rigorous and robust tooling to unify development information, these silos will only harden as we continue to put AI and ML in products, more startups and consumer brands enter the regulatory space, and the regulatory bar continues to rise.
Connecting the dots between development tools and teams doesn’t just bridge the compliance documentation gap, it makes for safer, stronger products that deepen impact and keep people coming back.
Walking the regulatory valley of death
Every medtech startup hopes and prays that they'll reach commercialization or acquisition before they run out of capital, something that’s a lot harder when there’s regulatory pushback. The fundamental mismatch between the speed of software development and regulated development is widening the regulatory valley of death — and preventing innovation from entering the market.
We were fortunate to be well-funded enough to survive the compliance learning curve, but that was an exception. Massive interests have created our current regulatory complexity, ostensibly to keep people safe. But it’s also made it hard to navigate, forcing a pay-to-play dynamic. A whopping 30% of submissions are rejected not because of product, but formatting or missing information.
Here at Infera, we believe that quality should be the barrier to entry, not capital. If you have the know-how to build something, the jump to formalizing it into documentation shouldn't be the thing that kills what you're doing. We hope to act as a catalyst for making medtech development more accessible, to be the trusted compliance coach in the corner of anyone who has the technical skills to improve and save lives.