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Monica Burt on Why Most MedTech Companies Are Doing Quality

Tariff Talks: One-on-One with Tim Sheehan, BlackPoint Capital Markets, Managing

Tariff Talks: One-on-One with Tim Sheehan, BlackPoint Capital Markets, Managing

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Monica Burt on Why Most MedTech Companies Are Doing Quality All Wrong—and How to Fix It Before It Breaks You

Apr 18, 2025

Tariff Talks: One-on-One with Tim Sheehan, BlackPoint Capital Markets, Managing Director – Episode 1, Part 2

Apr 15, 2025

Tariff Talks: One-on-One with Tim Sheehan, BlackPoint Capital Markets, Managing Director – Episode 1, Part 1

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The MedTech Digest > MedTech Leaders
18
Apr

Monica Burt on Why Most MedTech Companies Are Doing Quality All Wrong—and How to Fix It Before It Breaks You

  • Guillaume Viallaneix / 6 hours
  • 5 min read

“We often joke that we’re the Green Berets of quality,” says Monica Burt, founder of MB&A. “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.”In this candid conversation with The MedTech Digest, Monica Burt pulls back the curtain on why most MedTech companies are doing quality all wrong—and how her team is helping them fix it before it breaks them. From debunking the myth that more paperwork equals more compliance, to rebuilding systems that actually enable innovation, Burt’s insights are equal parts sharp, strategic, and human.

15
Apr

Tariff Talks: One-on-One with Tim Sheehan, BlackPoint Capital Markets, Managing Director – Episode 1, Part 2

  • Guillaume Viallaneix / 3 days
  • 6 min read

MedTech companies from both sides of the Atlantic kept reaching out to us since the beginning of the year, worried about what was happening in the U.S. with the new administration and how it might affect their business. They wanted guidance, insights, and most importantly, an educated path forward.

10
Apr

Tariff Talks: One-on-One with Tim Sheehan, BlackPoint Capital Markets, Managing Director – Episode 1, Part 1

  • Guillaume Viallaneix / 1 week
  • 10 min read

MedTech companies from both sides of the Atlantic kept reaching out to us since the beginning of the year, worried about what was happening in the U.S. with the new administration and how it might affect their business. They wanted guidance, insights, and most importantly, an educated path forward.

Cody Simmons
22
May

Exclusive Interview: A Look Inside DermaSensor’s Journey to Innovation with CEO, Cody Simmons

  • Guillaume Viallaneix / 11 months
  • 16 min read

I’ve learned and shared with people that whenever you have a major setback – whether study-related, study timeline change or product setback and timeline change, just reevaluate your whole approach and strategy because even with your well-laid plans, when one of the pieces of the plan changes, you realize other doors could open.

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