Removing compliance as an engineering bottleneck

For MedTech companies, quality and compliance can become a major bottleneck in product development, particularly when teams rely on information spread across multiple systems. Instead of treating compliance as a separate exercise at the end of development, Infera is taking a different approach by using AI to draft compliance records from the engineering work teams are already doing.

MedTech World interacted with Harry Blumsack, CEO and co-founder of Infera, to discuss the challenges his team encountered in bringing regulated medical devices to market and how those experiences led to the development of Infera.

Asked about his experience as an engineering leader working through quality and compliance requirements, Harry said: “As the VP of Engineering at the startup that got me into medical devices, I had an incredibly talented, super technical team with the know-how to build cleared MedTech — that hit the wall every day we did quality and compliance.” He explained that the pressure became particularly intense when it was time to prepare a submission.

“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?’ And that was just the bare minimum.”

The process also took a personal toll. “Personally, I lost tons of sleep, not just leading up to submission, but also waiting for the result.”

For the team, addressing compliance also meant investing heavily in external expertise and tools.

“We spent a small fortune building compliance muscle, hiring a series of consultants who all had different methods and paying for expensive tools that weren’t all that helpful.”

Traceability presented another major challenge, particularly because the team was working across multiple development systems. “Traceability was especially hard for us, since we had six development systems to tie together.”

Harry described the system they relied on as little more than a formatted collection of links.

“The tool we used was essentially a nicely formatted table that you could pop hyperlinks into, including ones pointing at information that was wrong, because nothing was connected.”

Checking that information could then become a lengthy manual exercise.

“To double check everything, I’d have to pore over paper printouts of 40-page Excel sheets for eight hours alone in a room.”

According to Harry, the problem went beyond simply having information in different places. Moving information between systems also introduced opportunities for errors.

“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.”

He said that when this process is repeated at scale, the risks increase. “Do this thousands of times and what begins as a clunky process becomes incredibly error-prone.”

That experience eventually led Harry and his team to a different understanding of where compliance information already exists within the product development process.

“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 regulators are asking for, just in a different form.”

Harry pointed to the information already generated by engineering teams throughout development.

“The answers are already written in your PRDs, engineering specs, project tracking, CAD, and code.”

He added that existing engineering practices can also contain the foundations of regulatory documentation. “Almost every well-engineered product has exception handling to prevent failure. Document those, and it’s a risk analysis.”

That realization became the foundation for Infera’s approach.

“That realization is what our whole company is based on. You connect the tools your team already works in, our agents draft the record, and your experts approve it.”

Importantly, Harry said the process is designed to keep human experts involved in reviewing the resulting documentation.

“Nothing enters your technical documentation without review.”

Rather than waiting until the end of development, the goal is to keep the compliance record moving alongside the product.

“The record comes together in real time, not at the very end of development, and what used to hold up every release becomes part of how you build better, safer products every day.”

Harry believes the need for this approach will become more pressing as software development accelerates and more AI and machine learning technologies enter regulated products.

“The mismatch between the speed of software development and regulated development is widening the regulatory valley of death.”

He added: “That threat will only grow as we put more AI and ML in products, as more consumer tech companies enter the regulatory space, and as the bar rises in every jurisdiction you expand into.”

For Harry, the challenge is also about ensuring that compliance does not become a barrier that only well-funded companies can overcome.

“We were well funded enough to survive the compliance learning curve, but that’s the exception.”

He believes the process should allow strong products to progress based on their quality rather than the resources available to their developers.

“We believe quality and innovation should decide which products reach patients, not capital.”

As he concluded: “If you have the know-how to build a life-changing product, the leap to formalizing it shouldn’t be the thing that kills what you’re doing. With Infera, there’s no leap, just a record that keeps pace as you build.”

Infera eliminates the gap between engineering and compliance, helping MedTech teams take life-changing products from concept to clearance in one intelligent platform. Its AI drafts your compliance record from the engineering work you already do and keeps it audit-ready as you build your device. Your team signs off on everything. Built by veteran MedTech engineers and former FDA regulators.

Harry Blumsack is CEO and co-founder of Infera. Meet him at the Infera booth at MedTech World Asia in Hong Kong, or on the Day 1 panel, “Beyond APAC: Building a MedTech Expansion Strategy for Europe and the USA.”