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Verification and Validation on the Horizon?
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.
IVDs and LDTs and Companion Diagnostics, Oh My!
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.
Turning Tables
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.
Humility. Key to startup success?
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.
Let’s get personal
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.
Digital Health, SaMD, and AI in Medical Devices for Startups
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.
Becoming an Advisor to a Medical Device Company
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.
Preparing for Medtech Startup Due Diligence
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.
Why risk practitioners must build empathy muscle
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.
Navigating IP and Trade Secrets issues for Medtech startups
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.
Regulatory Considerations for Medtech Startup Growth
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.
Medtech Funding and Preparing for Due Diligence
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.
Best Practices for Early Stage Founders
“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.
Using Quality and Risk as Tools, not Hurdles
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.
Project Management for Product Development of Medical Devices
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.
'Who, What, When' of Quality in the Medical Device Industry
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.
Building Startup Quality Culture
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
Preparing for Post-Approval
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.
Building your Medical Device Startup Team
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.
Voice of the Customer
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.