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Two stereotypes have persisted for decades: the Quality person who says no to everything, and the R&D person who shows up with a deadline they set without asking anyone.
Both are also learned, and that’s the more interesting problem we wanted to interrogate. People fall into these roles because previous experiences taught them to, and once both sides are braced for a fight, the fight is what they get, regardless of whether anyone actually disagrees about patient safety.
Nick Capman sat down with Shawn Fuller to work through why cross-functional teams default into these adversarial positions and what it takes to break the pattern. Shawn spent over 24 years at Surmodics, rising from regulatory manager to Vice President of Quality, Regulatory and Clinical Affairs, and she’s upfront about where Quality contributes to the problem.
She wanted to talk about this subject specifically because she saw plenty that could be done differently.
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Shawn’s key insights and practical takeaways
If you’re short on time, here are the most important lessons from the discussion.
Role-based identities are learned behavior, and they’re self-reinforcing. Shawn’s framing is that it’s easier to fall into learned behavior than to do anything else, and that behavior comes from years of experience. Most people have worked with someone who lived up to the stereotypical Quality roadblock, which that person would say was a response to the stereotypical R&D cowboy trying to hit a deadline they’d just announced to Quality. We carry those experiences internally, and when a similar situation comes up, we reproduce the same responses. Nobody starts out distrusting their own colleagues. You end up there.
The partnership-versus-dictatorship problem usually comes down to timing. Quality’s input typically arrives after the project has already started, which means the recommendation lands as a verdict rather than a contribution. That’s the difference between a partnership and a dictatorship, with Quality cast as the dictator. Keep patient safety as the actual goal and the posture changes, because you become willing to listen to different ways of getting there. Partnerships are easier to handle than dictatorships.
If Quality is afraid of the FDA, imagine what R&D is feeling. Shawn described her early years as a regulatory person: terrified the agency would show up, issue a 483, and hand out warning letters if the company wasn’t doing exactly what the Federal Register said. Live in it long enough and you learn FDA isn’t scary. They’re people, and they work for patient safety, which is the same thing you’re working for. Nick pushed the point further. If the Quality person signals fear, R&D takes the cue. If your posture is “I don’t want to talk to FDA about this,” the obvious question is why. He drew a useful line: don’t ask FDA what you should do, but you can share what you plan to do, particularly if you’re worried you’ve missed something.
Be ready all the time, and there’s nothing to prepare for! Shawn’s standard with her team was that she was happy when they didn’t have to prepare for an inspection, because you should always be prepared for one. Her group did well on that measure, and she’s clear about what it cost: time, effort, and a genuinely collaborative team, R&D included.
A regulatory conclusion without the reasoning behind it guarantees a fight. When Quality hands down a conclusion with no risk logic, no regulatory precedent, and no alternative pathways, you end up defending a position instead of educating your team. Shawn’s view is that R&D people can be educated too, and they’d be more comfortable in their own roles if they understood why they were doing things. People will do the right thing when they know why it’s right and how it affects the project. Some QA professionals get nervous handing over information, worried it’ll be misinterpreted, which she treats as more reason to have the educational conversation, not less. Once R&D understands the requirements, you might find room to be flexible, or reach a conclusion nobody had considered, which makes both jobs easier.
The memo-to-file versus special 510(k) question is a good test case. Shawn walked through a real trade-off: the FDA has come down hard on companies with more memos to file than they should have, on the logic that after twelve iterations you’re not making the same product anymore, and companies have received 483s for it. Her view is that a special 510(k) contains the same information a memo to file should contain. Yes, you wait 30 days. But you also avoid the later inspection that examines the process or product changes you treated as a memo to file when they warranted a special 510(k). They aren’t that expensive and don’t take as long as people assume. On where the line falls, the FDA has a solid guidance document with a flowchart, but interpretation still varies among regulatory professionals. Shawn’s approach was to have the discussion openly: if we do a memo to file we probably won’t have a problem, so why wouldn’t we do the special 510(k)? Get it out in the room so everyone inside and outside the group understands the guidance exists and how it works.
Gatekeepers create defensiveness; strategic advisors create teams. Communication is the answer to nearly every question in this territory, and how you communicate determines which role you’re playing. A gatekeeper will almost always get a defensive posture from whoever they’re working with. A strategic risk advisor isn’t working on the defensive because they’re part of the team. Shawn wants to see more QA and regulatory people move into that advisory role. Practically, it means that when R&D wants a memo to file and you want a special 510(k), you have the conversation about why each side thinks what it thinks. That gives people a sense of involvement in the decision. You may not get the answer you want, and part of the job is accepting that you won’t always get what you want, having the conversation anyway, and living with the outcome.
Quality gets brought in late partly because they haven’t earned a seat. Shawn doesn’t let her own function off the hook here. Quality is brought in after key decisions in organizations where it isn’t seen as a partner, and sometimes Quality doesn’t make the effort to understand the business process. What changes is that someone is integrated enough with the business side to carry the QA and regulatory voice into those conversations, a VP of Quality or equivalent who can say that doing it one way misses this deadline but hits the next one, or that a different approach could speed things up elsewhere. Without that access, you default to keeping people from doing the wrong thing and following every regulation to the letter. In reality, few regulations are that specific. Most allow flexibility in how you meet them, which is where precedent comes in and where the judgment actually lives.
Quality always gets the last timeline, and it never gets extended. This is the structural reason speed appears to compete with Quality. Quality sits at the end of the project and has to have everything ready for submission. When R&D misses a deadline, it hits Quality, and Quality’s timeline usually doesn’t move. So you’re perpetually playing catch-up, and when Quality says something needs more time, R&D responds that there isn’t any. R&D often doesn’t see that moving one thing affects a long chain of documents and processes, particularly anything involving validation or testing. Nick related to it from his own first job in validation: you get told they’re ready, you walk in, everyone is panicking, the money is gone, and you’re the problem before you’ve started. Shawn’s example makes the consequence concrete. Why is Quality taking so long? Because you cut three validation runs to two, there’s no third data point, and now what happens if the validation fails?
Quality plans are prescriptive, which is both the argument for and against them. Shawn is refreshingly flexible here, and admits that when she led Quality she was the one asking whether they really needed a Quality plan for a given project. The good thing about QA plans is that they’re prescriptive and help track timelines and progress. The bad thing is the same: they’re prescriptive and they document exactly where you’re not meeting your timeline. Build one carefully, with the right milestones and real follow-up, because there’s nothing worse than an inspector pulling a Quality plan and finding items that were never finished or got abandoned when a bigger project came along. Her preferred solution is to stop maintaining a separate document. Call it the project plan and include the Quality group in it, so you don’t have two plans to keep aligned.
Trust breaks down before the meeting starts. Shawn’s answer to where trust fails is that it fails before you even begin, because of how the two sides treat each other. A QA person invited to an R&D meeting walks in already defensive, because in their experience nobody listens, and it’s nice to be asked but they’ll end up doing whatever they’re told in a compressed timeline anyway. Trust is built over time. You don’t get it when you start at a new company, you can’t assume people will extend it to you, and you can’t assume you’ll extend it to them. What builds it is the working relationship. You don’t have to marry these people, as she puts it, but you work with them 40-plus hours a week on projects that can cost the company millions. Get to know the R&D group and what makes them tick. Be respectful in meetings, which means saying the thing in the room rather than complaining afterward. Most of the work of establishing trust happens outside the meeting, which means you have to put yourself out there.
Nick’s formula and the communication half of the battle. Nick returned to a formula he uses often: trust is character times competence. Both are required, or people won’t trust you. He also made a point about their highly technical field. Knowing may be half the battle, but in this space, communication is half the battle, and letting poor communication continue indefinitely isn’t sustainable. Either you burn out, someone else does, or nobody reaches their goals because everyone is hyper-focused on their own objectives instead of the team’s.
Don’t blindly defend your own team, because that’s how leaders lose trust fastest. Shawn’s answer on the leadership behaviors that shift Quality from enforcer to partner starts with the intentional culture, then adds the willingness to challenge yourself and your own group, not just everyone else. She’ll have her Quality team’s back, but she won’t blindly declare they’re right. There’s a conversation, and hopefully everyone lands in the same place. A leader who sees their own team heading down the wrong road and lets them go to protect the Quality seat will lose trust faster than through any other action. The word she keeps coming back to is genuine.
One thing to bring back to your team
Look at when quality enters your projects, and be honest about what that timing communicates.
If Quality shows up after the technical and business decisions are locked, you’ve structurally guaranteed that its input arrives as an obstacle rather than a contribution, no matter how well anyone communicates.
And if Quality’s timeline is the only one that never moves when upstream work slips, you’ve built the speed-versus-quality conflict into the schedule itself.
Then ask the harder question Shawn keeps circling: is your Quality group making a real effort to understand the business, or is it defaulting to enforcement because it’s never been given a seat where anything else was possible? The answer usually implicates both sides, which is precisely why it’s fixable.
Shawn Fuller is a quality and regulatory professional who spent more than 24 years at Surmodics, a supplier of components and technologies to medical device and in vitro diagnostic companies. She joined as a regulatory manager and rose to Vice President of Quality, Regulatory and Clinical Affairs, building the quality and regulatory infrastructure that supported the company’s expansion into final manufacturing across Class I, II, and III devices, customer-driven products, and internal processes. She served as both a quality and regulatory representative to R&D and as program director for a Class III medical device, taking it from concept through commercialization. She holds a BS in Biology from Wingate University and is listed on a patent for wound-packing devices. She is now semi-retired and works independently.
Connect with Shawn on LinkedIn here.
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