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 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.

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.

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.

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.

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.

Which medical technology, product, or device are you focused on bringing to market that will positively impact and improve the quality of life? What are the obstacles and challenges you can expect to experience? How will you overcome those?

In this episode of the Global Medical Device Podcast, Jon Speer and Devon Campbell discuss a “Value Equation” for MedTech companies to consider when elevating and escalating quality to improve value.

Early-stage startups often wonder when the right time is to consider a quality management system (QMS)? Is it ever too soon to start a QMS? In this episode of the Global Medical Device Podcast, Jon Speer and Devon discuss the importance of timing when starting a QMS for medical device companies.