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

“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.

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

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.

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

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.

2025 US Tariffs in the MedTech Space

Tariff Time Bomb: European and American MedTech Companies Can Act Now to Turn a Potential Crisis into Opportunity

In an era defined by geopolitical maneuvering and protectionist impulses, European MedTech companies now face a pivotal moment. The U.S. administration’s latest proposal to impose steep tariffs on multiple countries worldwide, including European imports, is not just a policy tweak; it is a signal of a return to a high-stakes trade environment reminiscent of history’s […]

Medtech marketing how to post

Turning PR into Results: Lessons from Unify Medical’s TIME Magazine Feature

In today’s noisy digital landscape, standing out isn’t just about having groundbreaking technology; it’s about ensuring the right people know about it. Public Relations (PR) have emerged as a key driver in connecting innovation with opportunity This article describes how, upon landing a coveted spot in TIME Magazine’s Best Inventions of 2024 with it’s innovative […]

The Pricing Problem: Are Conferences Outpricing Their Audience?

The State of Healthcare Conferences in 2024: Rebooting for the Future

Last week, I attended the North American Spine Society (NASS) conference in Chicago for the 24th year in a row. While the event retained its familiar warmth, I couldn’t ignore the challenges—lower attendance, fewer exhibitors, and a noticeable shift in energy compared to the pre-pandemic years. This isn’t just an issue unique to NASS; these […]

attract customers

The Lead Generation Problem No One Talks About in MedTech—and How to Solve It

Let’s face it—if you’re in the MedTech industry, lead generation is likely one of your biggest challenges. It’s no longer just about gathering contact information. The stakes are much higher for Medical Technology companies: regulatory complexities, extended sales cycles, and an ever-evolving industry make it increasingly difficult to attract and convert the right leads. So, […]

Cody Simmons

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

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.