Monica Burt on Why Most MedTech Companies Are Doing Quality All Wrong—and How to Fix It Before It Breaks You
Interview by Javier Perez
Director at BlackPoint Capital and Chief Strategic Advisor, The MedTech Digest
Javier Perez: Monica, thank you again for being with us. Let’s start at the beginning—how did you find your way into the MedTech industry?
Monica Burt: It really started in my DNA. I come from a family steeped in manufacturing—my father worked at Smith & Nephew, and I followed in his footsteps. I began there as an administrative assistant, moved into packaging, and ultimately landed in quality systems. But even earlier, I was that kid obsessed with puzzles and legos—problem-solving was how I played. That mindset carried through into my engineering education and career. I fell in love with untangling complexity and designing systems that actually work.
Javier: And that passion eventually led to launching MB&A?
Monica: After years at companies like Smith & Nephew, Medtronic, and Wright Medical, I saw a persistent problem: companies treating quality and regulatory as barriers instead of business enablers. I founded MB&A to challenge that mindset. Our mission is to help companies build systems that are not only compliant but actually support innovation and scale.
Javier: What sets MB&A apart from the typical consulting firm?
Monica: We’re not drive-by consultants. We’re embedded partners. Our team is 100% ex-industry—regulatory, quality, operations, and sourcing professionals who have sat in our clients’ seats. And unlike the typical corporate grind, we offer flexible schedules and meaningful work. That means our consultants bring their full energy, passion, and focus to every engagement. Clients feel that. It’s why they keep coming back.
Javier: You’ve said before that “fulfilled people do better work.” That feels radical in a regulatory context.
Monica: It shouldn’t be. Quality work demands clarity and focus. When our team members have control over their schedules and feel connected to purpose-driven projects, they bring their best thinking. That’s our edge—and it’s one of the reasons our client outcomes are consistently strong.
Javier: What are you most proud of?
Monica: Two things. First, the tangible results—helping clients exit successfully, fixing broken systems, accelerating product launches. But second, and maybe more importantly, I’m proud of the lives we’ve impacted. We’ve built a space where seasoned professionals get to rediscover why they love this industry. That matters.
Javier: Walk us through your services. What does MB&A actually do?
Monica: Our work falls into four categories:
- Regulatory Compliance & Strategy – We help companies navigate FDA, EU MDR, and global submissions, often managing full product launches.
- Quality Systems & Audits – This is our wheelhouse. We prep companies for inspections, manage mock audits, and clean up CAPA chaos.
- Operations & Supply Chain – From manufacturing transfers to strategic sourcing, we build scalable and sustainable supply chains.
- Talent & Leadership – We help clients know when to hire, who to hire, and even place leadership talent ourselves—always from within our trusted network.
Javier: What’s the most complex or high-stakes work your team gets called in for?
Monica: We often joke that we’re the Green Berets of quality. When things go sideways—an FDA audit is imminent, a system is unraveling, or a product launch is on life support—we get the call. One client described us as “mission-critical firepower.” Whether we’re running a back room during an inspection or untangling legacy processes, we bring calm, strategy, and execution. And we always leave the system stronger than we found it.
Javier: You’ve worked across the spectrum—startups to strategics. What’s something MedTech still gets wrong?
Monica: Great question. Too many companies are afraid to question their own processes. They inherit systems, stack on controls after bad audits, and keep patching instead of reimagining. They mistake “more paper” for “more compliance.” What they need is clarity, agility, and alignment. That’s what we bring—permission to simplify without compromising safety or quality.
Javier: Beyond tariffs and AI, are there bigger market shifts your clients should be thinking about?
Monica: Absolutely. There’s a major reassessment of global supply chains underway. With rising costs, regulatory convergence, and geopolitical risk, more companies are exploring reshoring—but not just to the US. Places like Turkey and Malaysia are becoming serious manufacturing hubs. That shift will demand smarter sourcing strategies and earlier collaboration between quality and procurement teams. The companies that navigate this well will have a competitive edge in both compliance and cost.
Javier: If you could give one piece of advice to early-stage CEOs, what would it be?
Monica: Start regulatory strategy early. Too many startups treat it like a box to check—and it costs them. And second: lean into fear. You don’t have to know everything. But you do need to act. Surround yourself with people who’ve been there, and trust your instincts. Fear usually shows up right before growth.
Javier: Final question. How do you personally keep momentum going?
Monica: Discipline and focus. Every morning, I make a short list—three to five things I will accomplish that day. That habit has carried me from being a junior quality engineer to running my own firm. It’s about consistent forward motion, even when the day feels chaotic. Add value every day—that’s the rule I live by.
Javier: Monica, this has been incredible. Your insights are razor-sharp and refreshingly human. Thank you for showing our readers that quality and compliance can be powerful levers—not just obligations.
Monica: Thank you, Javier. It’s been an honor.
Want to connect with Monica and the MB&A team?
👉 Visit: https://www.burtandassociates.com
📧 Contact: monica.burt@burtandassociates.com
This interview is part of Experts in Motion—an exclusive series from The MedTech Digest featuring bold insights from the leaders shaping tomorrow’s healthcare technology.
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