One week into my first large-scale R&D leadership role, I was feeling good. I had gone from leading a team of five or ten to inheriting a group of about seventy. I was still learning names, still building trust, still figuring out where everyone’s strengths were. Then the front desk called.
An FDA auditor had arrived unannounced. I was the highest-ranking person in the building.
I remember the moment the blood left my brain. I stopped moving. I walked into the opening meeting carrying the full weight of a role I had held for exactly one week, leaning on direct reports who were still largely strangers to me. That experience, and the two and a half years that followed before the matter was fully closed, is probably where my actual leadership style was forged. My motto ever since: never waste a good audit.
What most leaders get wrong about regulatory risk
Leaders who come from outside the medtech world often underestimate how much latitude actually exists within the regulatory framework, and how much judgment is required to navigate it well.
The regulations allow for more flexibility than most people assume. Where standards exist for routine testing, such as IEC 60601 for electrical safety, manufacturers can often offer rationale-based data to justify a change, as long as the baseline risk analysis is thorough and clearly documented. It is allowed. It is not easy. But it is an option that well-prepared teams can use to their advantage.
One of the more important distinctions in this space is the difference between gaining market clearance and maintaining compliance after you are on the market. Clearance is primarily about verification and validation. Post-market compliance is primarily about complaints, records, and demonstrating that your manufacturing process is in control. When you submit for clearance, you build a ‘Design History File’. Once you are on the market, attention shifts almost entirely to the ‘Device History Record’ and whether production is running cleanly. If complaint excursions appear with any frequency, something is off. The question is whether you find it first, through internal audits and disciplined CAPA management, or whether an auditor finds it by pulling the thread on your highest-volume products.
In my experience, every company has issues with their top runners. Old products, older documentation, workarounds that accumulated over years. The best companies I worked for had standardized quality systems that everyone understood, sustaining teams that were genuinely good at remediation, and a discipline around documentation that gave them something solid to stand on when a complaint arrived. They called it building a bookend: running and re-running tests whenever documentation was touched, so there was always a defensible record on either side of any change. Without a bookend, responding to field issues becomes very difficult, very fast.
When you are managing a crisis
On the day the auditor arrived, I made the decision to pull all sustaining resources and pause new product development entirely to manage the response. In the end, we had to rebuild the remediation strategy from scratch. We got through it, and we launched new products simultaneously, supported in part by an acquisition that was already in motion. I would like to say that was brilliant planning. It was not. It was good timing and the right people executing under pressure.
If you find yourself in a similar situation, start with a history of safe use. Understand the full scope before you act. If complaints are forming a pattern, do the root cause analysis properly: fishbone diagrams, five whys, and Ishikawa. Push your teams to complete the full analysis even when they resist it. They will see it as overhead at first. It is not. Consider changepoint analysis to understand what may have shifted in the process over time. Raw material changes from suppliers, humidity, and small process drift. These things can quietly make your flagship product impossible to manufacture, and you will not know why until someone does the work.
Why this closes the loop on sustaining engineering
The auditor does not arrive to check your strategy deck. She arrives to follow the thread on your highest runners, your most complained-about products, and your oldest documentation. Whether that thread leads somewhere manageable or somewhere catastrophic depends almost entirely on what your sustaining engineering team has been doing for the past several years.
The best companies I have seen handle this well share a few things in common: standard work, a common language for addressing issues, close relationships between engineering, quality, and operations, and leadership with the judgment to know when a product or system has drifted too far from acceptable risk to be managed incrementally.
That judgment is not something you can build in a crisis. You build it before one arrives.
Read the previous article, The Human Reality of R&D Leadership: Part 6, where Terri explores how sustaining engineering keeps existing products compliant and competitive while balancing the demands of future growth.
Terri Kapur is a seasoned R&D executive with more than 20 years of experience driving innovation in the medical device industry. She has led global, multidisciplinary teams across the full product lifecycle, from early research through development, commercialization, and post-market support.
