Have you ever wondered what your medtech company looks like from the point of view of a U.S. Food and Drug Administration investigator? Well, this is your chance to find out.

Greenlight Guru invited Vincent Cafiso, a former FDA investigator, to the Global Medical Device Podcast to share his experiences from three decades of working in medtech. After leaving the FDA, Cafiso worked as a quality engineer and then moved into consulting. His current role is director of quality and regulatory services at Creo Consulting, so it’s fair to say he’s just about seen it all.

It’s worth listening to the entire conversation, but here we’ve pulled out three major pieces of advice that Cafiso would give any medtech company from his wealth of experience. 

1. Build a foundation of regulatory knowledge

One thing Cafiso has noticed over the years is that medtech companies often have more data on their designs than they actually document in their design history file. Sometimes, the lack of documentation is simply a matter of companies trying to do the least they can to meet the regulations or standards. Other times, he’s noticed a lack of knowledge about what needs to be documented or the tests that need to be performed during design and development.

That’s a problem, because medtech professionals need to be fully versed in the regulations and standards that apply to their business. It’s impossible to be truly excellent in medtech without strong foundational knowledge of regulatory requirements.

Think of building a house. Once you put your foundation in place, there are all kinds of interesting and creative ways to construct the rest of the home. But if that foundation isn’t solid, then it doesn’t matter if the rest of the house is an architectural marvel—you will have problems with it.

The advice here is simple but can be revolutionary: To the best of your ability, ensure everyone on your team understands the regulations and standards that apply to your product and can easily reference them.

2. Align R&D and production as much as possible

Another issue Cafiso sees in many medtech companies is their tendency to put a wall between R&D and production. Initially, this is great for R&D, because they get to tinker and experiment until they find something that works. But it can lead to trouble down the road.

That’s because regulatory requirements do apply to R&D activities. And if you want to use the data from those activities, then you must perform them in a compliant manner. What Cafiso has found, both as an investigator and as a consultant, is that R&D teams do a lot of great work and will even document it. The issue is with the usability of their data. Often, the tests they document aren’t performed in a controlled environment, or they can’t establish traceability for the products they used, or the equipment wasn’t calibrated or on a preventive maintenance schedule.

Whatever the specifics, the result is the product development team must then re-create everything that was done in R&D to properly document it. Not only does that double the work involved, it can also lead to tricky situations in which product development can’t replicate what happened in R&D (possibly because it didn’t happen in a controlled environment).

Cafiso advises companies to avoid all of this by aligning their R&D with production and quality control, and ensuring that the R&D environment is the same as the environment where the products would be tested by quality control. This could mean using gowns, PPE, a clean room, and calibrated equipment on a routine preventive maintenance schedule.

It may seem like a lot of work but, as is so often the case, taking the time initially will save you even more time later on.

3. Break down silos for cross-departmental collaboration

When companies are small, there’s often a lot of cross-functional collaboration. The quality team may sit a few feet away from product development or marketing. There’s a natural sense that everyone is in it together, and that leads to a lot of cross-departmental conversations and collaboration.

As companies grow, however, it’s easy to lose that collaborative startup spirit. Walls start to rise between departments, and it’s harder to find the right person in another department, schedule time with them, and get any work done together.

Cafiso has seen this happen over and over again, and it leads to his last piece of advice: Break down silos.

You’re all in this business to create amazing, life-changing products, and that simply can’t be done when there are walls between departments. There must be collaboration, and if you sense that your company is missing that, you need to make an individual effort to break down walls and increase cross-functional interaction. 

Honestly, you’ll find that people want to help when you ask. You may occasionally run into a cranky colleague in another department who drags their feet, but more often than not, you’ll be surprised at how willing people are to help. It’s just that as companies grow, people naturally tend to lose touch with other departments and stop nurturing those relationships.

Published Feb. 21, 2025, on the Greenlight Guru blog.