When a Quality System Catches the Problem and Still Can’t Fix It

For too long at one of my early companies, every engineering change order needed my signature before it could ship. I told myself the signature kept product and engineering aligned. The honest version is that it was mostly ego, and underneath the ego sat a mistake I now watch founders make at every size: I had confused my attention with a system. A signature is not a quality system. A quality system is the thing that catches a problem, fixes it, and proves the fix worked, whether or not the founder is in the room. I thought about that signature again this week reading the FDA’s warning letter to Medline, because it is the same mistake written at industrial scale.

What the FDA actually found

The device at the center of it is unglamorous: a NAMIC angiographic control syringe, the kind used to push contrast dye during imaging. In a warning letter dated March 25, the FDA said excess silicone was migrating to the connector and letting the syringe unwind off the manifold during a procedure, which can pull air into the line. Air in an arterial line is an embolism. The agency was blunt about how the company had scored that risk, writing that Medline’s “declaration of a low risk to health was inconsistent given the potential for air embolisms.”

Here is the part that should stop a founder. This was not a problem nobody saw. Medline opened a corrective action, CAPA-01872, back in June 2023 as disconnection complaints climbed. The response was to scrap affected inventory and clean the machines more often. By the FDA’s account that never amounted to a real root-cause investigation, and more than two years later the agency still found the corrective action inadequate, with 177 medical device reports, hundreds of complaints, and four serious injuries logged in the meantime. The detection worked. The closing of the loop did not.

The same letter flagged the housekeeping too. An investigator observed particulate accumulating on top of manufacturing equipment in the cleanrooms, and the last documented cleaning of that equipment was logged back in November 2023. A quality system was running the whole time. It was generating records, opening actions, and filing reports. What it was not doing was the one job that matters, which is making the defect stop.

Detection is the easy part

Almost every hardware founder I work with has the detection half handled. Complaints come in. A log fills up. Somebody opens a ticket. The half that fails is the second one: turning a found problem into a verified fix and proving the verification held. That is what a corrective action is for, and it is the single most common place I watch young device companies fake it. They open the action because the quality manual says to, they write down a containment step that looks like progress, and they never go find the cause. A year later the same defect is still shipping.

For a founder who is still pre-market, this is not abstract. When you file, and later if an acquirer runs diligence, your corrective-action history gets read like a credit report. An open action that never closed is worse than a clean record, because it is written proof that you knew about a problem and could not fix it. The FDA does not have to build a case that you were careless. Your own quality system already documented it for them.

This is why I now treat the quality system as product work and push founders to staff it as product work, not as a binder a consultant assembles before an audit. The signature I clung to for years felt like control, but it was one human standing in a doorway dressed up as a process. Medline had the process and still could not close the loop, which is the more expensive version of the same failure, because it scales. A bottleneck slows one company down. A quality system that detects and does not fix ships the defect by the case.

Dave Saunders is the founder of Base Reality Group and a Fractional CPO for hard-tech founders. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →