Reading the Water: Navigating What Matters in Regulatory and Quality

One of the most expensive mistakes I see is when companies start working from fear.  They are no longer asking what is required, what is justified, and what fits the product. They are asking what FDA might want to see.

That shift gets expensive fast.

I was brought in to work with a company that had been quoted more than $280,000 for biocompatibility testing to support a 510(k) and they wanted a second opinion. The proposal was full endpoint testing across the board. It probably would have supported clearance.



It also was not the best approach.

We stepped back and looked at the material, the patient contact, and the intended use. From there, we built a strategy around extraction work and chemical characterization. It still aligned with the standard. It still answered the safety questions. It also gave the company a better long-term framework for future product changes, not just the first submission. 

That approach saved roughly $150,000.  Nothing about that was cutting corners. It was using the tools in the standard in a thoughtful way.

That is the point. There is often more than one way to support a submission. A mature regulatory approach knows that and makes deliberate choices.

It also understands that it is okay to know where your submission may be weaker. That does not mean you ignore the issue. It means you understand your body of work, you know what you can defend, and you prepare for the questions that may come. That is very different from continuing to pile on work simply because no one wants to make a decision.

I see that happen all the time. More testing. More reports. More time. Not because the science demands it, but because the team is uncomfortable stopping and saying, this is enough, and this is why.

The earlier recommendation in this case was not wrong. It just was not the best use of the available tools or the company’s money.

That distinction matters.

The sponsor knows the product better than anyone. FDA knows the broader landscape better than anyone (don’t forget that they see failures and products that never make it). Good regulatory strategy sits in the middle. You need to know your product well enough to tell the story clearly, and you need to know the standards and the regulatory context well enough to defend your position.

That is where judgment comes in.

In fishing, you usually have a plan before you leave the dock: where to start based on satellite shots, what bait to run based on what’s been working, and when to go based on tide and season. If conditions change, you adjust. You do not try to fish every spot at once.

Regulatory strategy works the same way.

You make a plan based on the information you have. You understand where you are strong. You know where you may need to defend your position. You stay flexible if the facts change. What you do not do is try to cover every possible angle all at once just because it feels safer.  That approach usually costs more and teaches you less.

The goal is not to guess what FDA wants. The goal is to understand the requirements, understand your product, and use the right tools to answer the right questions. That is how you get to a defensible submission without wasting time and capital.

If you'd like to talk about a thoughtful, strategic regulatory approach for your novel MedTech company, please contact us.

Sam Murray

Head of Regulatory & Quality