Global Medical Device Podcast powered by Greenlight Guru

Reminiscing about past and present lessons learned from listening to conversations with this show’s most frequent guest, one important principle emerged: Teach others how to think, not what to think. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues, president of the medical device consultancy firm, Vascular Sciences. Anyone who’s listened to the show knows that J...

What sets Greenlight Guru apart from other quality management solutions? It’s Guru edge⁠—a team of medical device professionals with more than seventy years of combined industry experience. In this episode of the Global Medical Device Podcast, Jon Speer talks to Wade Schroeder, a medical device Guru at Greenlight Guru. As an electrical engineer and risk management enthusiast, Wade shares his uniqu...

Who looks forward to audits? Not most people except for maybe the actual auditor. Hold yourself accountable and stay audit-ready, so you can remove any pre existing concerns from the equation altogether. In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, a medical device guru at Greenlight Guru and certified Lead Auditor for ISO 13485. Taylor offers valuable tip...

What makes Greenlight Guru so unique, beyond its medical device QMS (MDQMS) software? Its Guru edge. In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rish, a senior medical device Guru at Greenlight Guru. Tom brings a breadth of knowledge to the Guru team with a biomedical engineering background and experience developing implant and instrument systems for one of the wor...

The current COVID-19 pandemic and its impact on clinical trials has created a sense of chaos amongst medical device companies worldwide. Are there creative ways to stay on track while ensuring the safety of those involved? In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Regulatory Affairs Consultant, and Stephanie Mull, Director of Clinical Project Manage...

Are you considering patent protection for your software as a medical device? Should you keep your secret sauce via the trade secret route? Perform due diligence to stay ahead of the competition. In this episode of the Global Medical Device Podcast, Jon Speer talks to Kevin Buckley and Neil Thompson from Torrey Pines Law Group. Their biotech-focused legal firm specializes in artificial intelligence...

What makes Greenlight Guru unique? It’s Guru edge, composed of a team of medical device experts with over seventy years of combined industry experience. In this episode of the Global Medical Device Podcast, Jon Speer talks to Jesseca Lyons, a senior medical device guru at Greenlight Guru, a self-proclaimed design control junkie with a mechanical engineer background. Listen as Jesseca shares her in...

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task that is often delayed until later stages of development. Don’t wait to implement a QMS; the consequences of waiting too long can lead to irreparable damage to your processes and, in some cases, product failures. In this episode of the Global Medical Device Podcast, Jon Speer talks to quality and re...

What makes Greenlight Guru unique? The Guru Edge⁠—a team of medical device professionals with over eight decades of combined industry experience. Greenlight Guru’s mission is to improve quality of life, and those of customers, through True Quality products managed through its medical device quality management system (MDQMS) software. In this episode of the Global Medical Device Podcast, Jon Speer...

What is regulatory due diligence? Why does it matter, and how does it differ from other regulatory strategies and pathways? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about the importance of and reasons for regulatory due diligence that all medical device professionals should understand. Some of the highlights of the show include: • Reg...

Are you discouraged by all of the negative news and sad stories about COVID-19? Let's shift the focus to a story centered on positivity and innovation that will reignite hope for a better, safer road ahead. In this episode of the Global Medical Device Podcast, Jon Speer talks to Dan Purvis, CEO and co-founder of Velentium. Dan shares some much needed positivity through the uplifting stories and ex...

There is a spectrum of feelings someone may experience in the midst of a career transition. For some, however, being laid off can turn out to be one of the best things to ever happen to them. In this episode of the Global Medical Device Podcast, Jon Speer talks to Aaron Moncur, owner of Pipeline Design & Engineering and host of the Being an Engineer podcast, as they both reflect on the twists and...

Most of us have read about, observed, participated in, and spoke with healthcare providers and medical device professionals collaborating during the COVID-19 crisis.  Creativity within reason can be an opportunity. Like many things in life, it’s not what happens to us that counts, it’s how we choose to respond. COVID-19 is not an excuse to cut corners. In this episode of the Global Medical Device...

What is a regulatory strategy? What are the components involved? In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues of Vascular Sciences to provide listeners with practical and pragmatic tips on how to construct a meaningful, not misunderstood, misapplied, and misused regulatory strategy. Some of the highlights of the show include: • Pro Tip: Regulatory strategy is...

Does your software as a medical device (SaMD) function properly? Does it meet the needs of the end user? What are the expectations for post-market clinical surveillance and real world evidence for SaMD products in particular? In this episode of the Global Medical Device Podcast Jon Speer talks to Kevin Coker, co-founder and CEO of Proxima Clinical Research. Kevin shares tips and advice on what com...

What is artificial intelligence (AI) and machine learning (ML) and how do the two differ in the medical device industry? How can companies leverage AI and ML in their medical devices to improve the quality of life? In this episode of the Global Medical Device Podcast Jon Speer talks to Devon Campbell, founder of Prodct LLC, and Anthony Habayeb, co-founder and CEO of Monitaur.ai about how AI and ML...

What does the 510(k) process involve? How should medical device companies know if this is the right regulatory pathway to market? When should a premarket notification be submitted to FDA and how should it be prepared? What’s the Refuse To Accept (RTA) checklist? In this episode of the Global Medical Device Podcast, Mike Drues of Vascular Sciences joins host Jon Speer to tackle these and other comm...

Are you a medical provider or caregiver unable to find facemasks as PPE for COVID-19? Get one for free. In this episode of the Global Medical Device Podcast, Jon Speer talks to Sanjay Vakil and Devon Campbell from MasksOn.org to discuss the impactful efforts being made through the MasksOn initiative that’s providing personal protective equipment and relief at no cost during the coronavirus pandemi...

NOTE: This episode was recorded prior to the EU Commission Proposal and now EU Parliament approval; pending EU Council (member states approval) and publication in the official journal (OJEU) for the official postponement of EU MDR. Once official, the DoA would be amended by one year, so when referring to the DoA as 26 May 2020 this would now be 26 May 2021. This live episode of the Global Medical...

Why is verification and validation (V&V) confusing and challenging for many medical device professionals? In today’s new episode of the Global Medical Device Podcast, Jon Speer and his guest Brad Graves, Principal Project Manager at The RND Group explore key aspects of the verification and validation topic and provide helpful clarification to medical device professionals about V&V cloud-based soft...

In response to the COVID-19 pandemic, medical device companies are improving and saving lives through innovative technologies and methods to combat the virus. In this episode of the Global Medical Device Podcast, Jon Speer talks to Jeff Veenhuis and Quinn Leach from Surfacide, a company actively working in the fight against COVID-19 with their proven UV-C technology that destroys pathogens, includ...

What qualifies and what does not for Emergency Use Authorization (EUA)? What is the impact of this rare regulatory pathway during the COVID-19 pandemic? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences in a highly relevant discussion on considerations for medical device professionals regarding EUA as a proper pathway to bring a medical device...

Medical device usability is a critical, yet confusing component of medical device design, development, regulatory, marketability, and product success. Although three things are clear when it comes to your processes around usability for your medical device: do it early, do it right, and don’t try to cut corners. In this episode Isabella Schmitt, regulatory affairs consultant with Proxima Clinical R...

In this modern digital world, did you know that most medical devices are not connected to the Internet? This episode of the Global Medical Device Podcast is a special live recording from The Greenlight Guru True Quality Roadshow in San Jose, California and is moderated by Tom Rish, Medical Device Guru at Greenlight Guru. Chris DuPont, CEO of Galen Data, joins Tom as his guest to discuss with live...

How can the IEC 62304 standard serve as a framework for your Software as a Medical Device (SaMD) development processes? Today’s guest is Cathy Wilburn, Director of Quality Assurance and Compliance for The RND Group, a medical device software development company that helps clients write software, submission readiness, and compliance. Cathy joins Jon Speer to clarify the confusing parts of IEC 62304...