Insights

The FDA’s new Quality Management System Regulation (QMSR), set to replace the longstanding Quality System Regulation (QSR) in 2026, is a seismic shift for MedTech companies. It aligns FDA requirements with ISO 13485:2016 and underscores the importance of ISO 14971:2019, reinforcing a risk-based approach to quality management. But beyond the technical updates, the QMSR sends a clear message: risk management isn’t just about compliance—it’s about culture.

Enzyme’s March 4, 2025 post “Tiny Tentacles of Risk” highlights this shift and features insights from Christie Johnson, co-founder at Prodct Studio.

Christie emphasizes that risk management shouldn’t be a standalone function—it needs to be deeply woven into every aspect of a company’s operations, from product development to post-market activities.

For medtech developers, the words “verification and validation” can evoke a mix of anticipation and uncertainty, especially if you’re new to the field. What lies on the horizon for your medical device? Are your foundations strong enough to navigate the road ahead?

In episode 392 of the Global Medical Device Podcast, Devon Campbell joined host Etienne Nichols to explore the realities of verification and validation (V&V). Their conversation focused on simplifying these critical processes, avoiding heavy FDA or ISO jargon, and breaking down practical strategies in plain, accessible terms.

Whether you’re grappling with regulatory compliance, medical device design controls, or user needs, this episode offers actionable insights to help you navigate V&V with confidence.

Throughout the discussion, Devon and Etienne made a point to avoid regulation-heavy language, focusing instead on what startups need to know in practical terms. Complex processes like design inputs, design outputs, and pre-verification testing were explained in ways that make sense for teams without years of regulatory experience.

In this 154th episode of the Combinate Podcast, host Subhi Saadeh is joined by Devon to venture into the complex world of in vitro diagnostics (IVDs), lab-developed tests (LDTs), and companion diagnostics. Much like Dorothy’s journey through the land of Oz, navigating IVD development requires courage, brains, and a heart for innovation. Devon shares insights drawn from his vast experience in both big pharma and startups, shedding light on the challenges and surprises along the way.

In this special episode of the Global Medical Device Podcast, Devon had the unique opportunity to interview the interviewer, Etienne Nichols, in celebration of his impressive milestone of producing nearly 100 podcast episodes.

Just as a joker card being played on the table symbolizes an unexpected twist, this episode flips the script, with Devon surprising Etienne by turning the tables on him. The result? 30 minutes of great tips and observations everyone in medical devices will benefit from listening to.

Previously, in episode 21 of Dr. Naveen Agarwal’s “Let’s Talk Risk” (LTR) podcast, Christie Johnson discussed the intersection of Risk Management and empathy. Building on that foundation, this milestone 50th LTR episode brings Devon and Naveen together to openly explore the critical importance of humility, meticulous planning, and the thrilling highs yet daunting low experiences inherent in medical device development.

This discussion sheds light on what it takes for innovative medical device startups to thrive in today’s fast-paced and resource-constrained environment.

In Episode 133 of Subhi Saadeh’s Combinate Podcast, Devon shares the transformative journey behind the founding of Prodct and our unique advisory approach. Following a successful IPO, he embarked on a reflective period dedicated to maximizing impact and embracing joy, while generously sharing his experiences with startups. This pivotal time not only reshaped his professional path but also reignited his passion for helping others thrive and achieve their own success.

Our friend Etienne Nichols and the good people over at Greenlight Guru hosted a wonderful discussion between Christie Johnson (Prodct) and Edwin Bills (Edwin Bills Consulting, also a member of the Prodct Advisory Board) to discuss risk, ISO 14971, and QMSR.

Our favorite comments in the chat? “Now I’m hungry!” because Christie kept talking about how “delicious” it is to read ISO/TR 24971:2020 (Guidance on the application of ISO 14971). Give it a listen. You’ll know what we mean.

Edwin Bills, Christie Johnson, and Jayet Moon describe how the new QMSR was shaped by ISO13485:2016 while still retaining its core. They explore how risk management is a key focus, with an emphasis on integrating risk-forward thinking throughout the QMS.

Dive deep into the revolution brought by digital technologies in medicine… topics like the integration of AI and machine learning, Software as a Medical Device (SaMD), and Digital Health are unpacked and explored in Episode 29 of "Let's Talk Risk!" featuring Pascal Werner as the guest.

While these technologies hold the promise to address some of our toughest medical challenges, they also bring a wave of regulatory uncertainties. Join Naveen and Pascal as they explore both the potential and the hurdles of digital health, shedding light on what the future holds for medical devices and healthcare at large.

Thinking about dipping your toes into advisory waters and doing some work with startups? Feel like you can help guide them through trails you’ve already traveled? Great! They need all the help they can get. Start-up life is hard.

In Episode 344 of the Global Medical Device Podcast, Etienne Nichols (host) and Devon Campbell delve into the challenges you’ll want to consider when it comes to advising leaders of medical device startups.

Together, they navigate the demanding and often isolating journey that startup founders may experience, exploring the enduring value of a relationship-driven approach when surrounding oneself with trusted advisors.

While the episode ostensibly targets those contemplating supporting startups as advisors, insightful startup leaders can glean profound insights, gaining a deeper appreciation for the contributions carefully selected advisors can make to personal and company growth.

Project Medtech Podcast episode 153, the final of a special three-part “Setting up your company to succeed” series, features Devon Campbell and Duane Mancini discussing the due diligence process for medical device start-ups, what you need to be prepared to answer as a startup company, common errors, recommendations, and more.

Risk management in medical devices is a strait-forward, cold, calculated process -- right? Nope. It requires ❤️ heart. It requires 💬 open communication. It requires 🙌 empathy.

Every Friday at 11:00 (ET) Naveen Agarwal, Ph.D. streams wonderful live "Let's Talk Risk!" conversations via LinkedIn Live. LTR! episode 21 features Christie Johnson as the guest talking about two of her favorite topics: risk management for medical device startups AND why empathy matters.

Give it a listen. We hope you find something useful in the conversation.

In episode 152 of the Project Medtech Podcast, Edward Steakley, Devon Campbell, and host Duane Mancini discuss intellectual property, patents, trade secrets, overall strategy around these topics, why they are important, and so much more.

In episode 151 of the Project Medtech Podcast, Nikki Batista, Devon Campbell, and host Duane Mancini discuss the merger of regulatory and business strategy, allowing business to lead decisions not regulatory, global regulatory strategy, how to communicate with the FDA, and so much more.

Join Devon Campbell and Global Medical Device Podcast host Etienne Nichols as they explore the current medical device start-up funding climate in episode 334. They try to spark glimmers of hope by sharing tips to help you know your weaknesses, fill the gaps, and increase your odds in finding funding.

Devon and Etienne dive into topics such as the importance of understanding the risk profiles, objectives, and expectations of different funding sources, product readiness, QMS maturity, avoiding smoke and mirrors by being fully authentic and transparent, and how to build unshakeable confidence.

In a world where investor confidence becomes your MedTech start-up currency… data integrity is key, risk management becomes your best friend, and quality is more than just a thing you do… it’s the whole point.

“It’s like jumping from the plane while sewing the parachute” says Devon.

Glasslab episode 15 is a lively video conversation between Devon Campbell and Glassboard’s Grant Chapman and Drew Westrick. Together, they share tips and best practices for early stage founders of physical product-centric companies to consider as they are creating new devices.

Topics include the balance between sparking creativity while creating documentation, simultaneous empathetic AND engineering mindsets, the art of managing vendors, best practices for data management, regulation nuance, and “the valley of death in product development”, among many other things.

Devon, Drew, and Grant are clearly having fun in this conversation. We hope you do too.

The most popular guest column of 2023 for Med Device Online! Edwin Bills and Christie Johnson describe the intersections of ISO 13485:2016 medical devices quality systems standard and ISO 14971:2019 medical device risk management standard, which the FDA believes is key to the new QMSR.

Do you come from a development background but are leaping into new waters with medical devices?

This podcast is recorded for you and provides a great overview of quality, product development processes, design controls, managing risk, and the importance of documentation in this unique industry.

Christie Johnson speaks with Grant Chapman and Ben Ettinger in episode 14 of the Glasslab Podcast and it’s full of great advice plus a few good laughs.

What is the best way to approach project management (PM) for medical device product development? Don't settle for the trial and error method, turn to the experts with proven best practices for managing your product development project.

In this 233rd episode of the Global Medical Device Podcast, Jon Speer talks to Devon Campbell and Christie Johnson about the things they all love to hate about Project Management for Product Development of Medical Devices, the appropriate time and place for PM practices and tools, following the Keep It Simple Stupid (KISS) philosophy, and plenty of “hot garbage” situations. It’s a fun listen.

There are many schools of thought when it comes to the 'who, what, and when' of quality management for medical devices. Who is responsible for quality? What does quality mean for me? When should I get started? These questions and many more are explored in episode 114 of the Global Medical Device Podcast where host Jon Speer and Christie Johnson offer their insights and guidance on medical device quality management best practices.

Season 1, Episode 30 of Quailo’s From Lab to Launch Podcast features Devon, Christie, and several other industry experts who work closely with medical device entrepreneurs and startups discussing tips related to fostering a culture of quality in medical device startups. They dive deep into the essential strategies for building a transparent, mistake-embracing environment. Learn how leveraging data-driven decisions can significantly impact the quality of your medical device, the importance of documenting every step for success, and the power of preventive actions. This conversation is a treasure trove for any early-stage medical device company aiming for excellence in quality.

Why is this important?

For starters, early stage companies enjoy a unique opportunity to create the culture they want internally right from the start!

However, if you’re financially motivated, consider the following future should your startup eventually grow into a mature company…

“A company with a highly developed culture of quality spends, on average, $350 million less annually fixing mistakes than a company with a poorly developed one.”

- Harvard Business Review article “Creating a Culture of Quality” by Ashwin Srinivasan and Bryan Kurey

What are you going to do after your medical device is approved? You just launch it, right? No. It takes careful planning! Project Medtech Podcast episode 49 offers Devon Campbell and Duane Mancini an opportunity to discuss preparation for commercialization, product launch, and tips to avoid what Duane calls “the valley of death” between approval and launch.

This is the final episode of a three-part series.

In Project Medtech Podcast episode 48, Devon Campbell and Duane Mancini explore what it takes to build a successful medtech start-up team, how using fractionalization vs. full time resources can benefit a start-up, red-flags, and more.

This episode is the second in a three-part series.

Project Medtech Podcast episode 47, features Devon Campbell and Duane Mancini discussing unconventional perspectives with respect to who the “customer” should be when thinking about VOC (Voice of the Customer) for medical devices. Newsflash - it’s not just the patient and their caregivers.

This episode is the first in a three-part series.

Ever wondered if your choice of medical device product development methodology could make or break your medical device success story?

In this special 200th episode of the Global Medical Device Podcast, brace yourself for a gripping debate. Are you Team Waterfall, clinging to tradition, or do you dare to embrace the innovation of Team Agile?

Here's the kicker: Does the name of your chosen methodology really matter, or is it the secret sauce within the processes that propels your project to victory? Join host Jon Speer and Prodct's founder, Devon Campbell, as they peel back the layers on these provocative questions, potentially reshaping the way you view medical device development methodologies!

Episode 177 of the Global Medical Device Podcast, host Jon Speer and Devon Campbell examine the groundbreaking Rapid Acceleration of Diagnostics (RADx) initiative, a visionary project initiated by the National Institutes of Health (NIH). RADx was designed to fast-track the development, commercialization, and deployment of cutting-edge COVID-19 testing technologies, with a focus on reducing viral detection cycles and enhancing widespread access to reliable testing.

Devon shares personal lessons learned while actively supporting RADx teams in their tireless efforts throughout the pandemic, distilling five actionable lessons that can be seamlessly applied by medical device companies to drive innovation and success across the industry.

One of the positive developments to unfold during the COVID-19 pandemic has been the incredible work to meet urgent needs for medical supplies. The non-profit MasksOn.org is one such effort, and it has taken a creative approach to filling gaps in personal protective equipment (PPE) supplies, in both device design and business strategy. The project also served as a blueprint for innovators and startups on how to innovate quickly while developing viable manufacturing and regulatory pathways to market.

Here in Episode 2 of the Let’s Talk Medtech Podcast, Sanjay Vakil, Devon Campbell, Ken Block, and Jon Speer talk with host Daphne Allen about the the MasksOn.org project and how they rapidly brought their unique skills and networks together to bring their modified snorkeling mask to caregivers without proper PPE — all with amazing speed. So many great lessons here about rapid creation, scale-up, and growth for early stage medical device companies.

The Being An Engineer Podcast is a meant to be a tool through which engineers learn other engineers about technologies, resources, and challenges that face engineers today.

Host Aaron Moncur of Pipeline Design and Engineering talks to Devon Campbell in Season 1, Episode 13 where they explore why photography appeals to engineers, truly understanding how things are made makes one a much better design engineer, the human side of engineering and balancing emotional intelligence (EQ) with intelligence quotient (IQ), taking a holistic view to meet the needs of downstream stakeholders while building value for your startup, and much more!

Trust and transparency can get murky when it comes to AI and ML decisions in medical devices. What’s really going on below the surface?

In episode 146 of the Global Medical Device Podcast Jon Speer talks to Devon Campbell and Anthony Habayeb, co-founder and CEO of Monitaur.ai about clearing the water a bit to explore how AI and ML can be utilized to produce better, safer, smarter, and faster medical devices.

MasksOn.org was an amazing grass roots, non-profit effort created to mass-produce reusable, sanitizable emergency masks and distribute it to those clinicians who did not have access to FDA-approved PPE at the start of the pandemic. Over 36,000 safe, reusable, sanitizable EUA face shields were shipped to clinicians in dire need… all without any cost to them.

In episode 114 of the Global Medical Device Podcast, host Jon Speer talks to Sanjay Vakil and Devon Campbell to discuss the impactful efforts being made at that time through the MasksOn.org initiative to providing personal protective equipment and relief at no cost during the coronavirus pandemic. All three were deeply involved in the effort and recorded this podcast with hopes that medical device startups may find valuable lessons within the story.