Global Medical Device Podcast powered by Greenlight Guru

What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS) proposal that impacts the medical device industry? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the HHS proposal, which focuses on down-classifying and exempting more than 80 types of devices such as exam gloves, thermometers, ima...

If you love learning and want to level up your medical device industry knowledge on topics such as audits, document management, design controls, risk management, and more, Greenlight Guru Academy is your education destination. In this episode of the Global Medical Device Podcast, Jon Speer invites colleagues Aaron Lucas, Training and Education Manager, and Jesseca Lyons, Operations and Enablement...

Have you ever had to “sell” your brand to someone? To do this effectively, you must master the art of networking and selling whatever it is that you bring to the table. In this episode of the Global Medical Device Podcast, Jon Speer talks to Chip Helm, a Dental School dropout turned National Sales Manager of a multi-billion-dollar medical device company. Also, Chip is a guest lecturer and bestsell...

Have you ever wondered, what does a medical device guru actually do? What role do they play within Greenlight Guru and what value do they bring medical device companies in the context of the QMS software? In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rish, a senior medical device guru and manager of the guru team at Greenlight Guru. Tom shares his unique insights int...

The Guru edge: it's what makes Greenlight Guru so unique and valuable to the medical device companies it serves. The Guru team is comprised of industry experts with a knack for helping companies succeed; each of whom have a specific skillset and knowledge base that companies can tap into and leverage throughout their medical device journey. In this episode of the Global Medical Device Podcast, Jon...

What makes Greenlight Guru unique? It’s the Guru edge⁠—a team of medical device professionals with a ton of industry experience. In this episode of the Global Medical Device Podcast, Jon Speer talks to Laura Court, a medical device Guru at Greenlight Guru, about her journey in the medical device industry, which ultimately brought her to Greenlight Guru, and Laura shares tips for success she's lear...

As some veteran FDA reviewers leave and new ones are hired, knowledge is not always passed on seamlessly... To that end, regulatory professionals are often left to their own devices to find the guidance, support, and resources they need to fulfill their important roles in the medical device industry. In this episode of the Global Medical Device Podcast, Jon Speer talks to Allison Komiyama, a forme...

Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles are one of the highest in demand in the medical device industry.  In this episode of the Global Medical Device Podcast, Jon Speer talks to Mitch Robbins, founder and managing director at The Anthony Michael Group.  Listen as Mitch shares his unique insights and perspectives into why there...

What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program (BDP) and Safer Technologies Program for Medical Devices (STeP) ? In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Director of Regulatory Affairs for Proxima Clinical Research (CRO). Together, Isabella and Jon discuss the FDA’s Breakthrough Devices Program...

Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many device professionals, the one year countdown to the IVDR deadline in May 2022 is almost here, causing much anxiety about whether compliance is even possible. In this episode of the Global Medical Device Podcast, Jon Speer and his guest Joanne LeBrun, VP of Quality Systems at MDC Associates, shine light o...

It's easy to get so wrapped up in the risk management of your medical device that you forget about managing your business risk with the same level of diligence and ongoing attention. In this episode of the Global Medical Device Podcast, Jon Speer talks to Michael Cremeans, Life Sciences Industry Practice Leader at Hylant.  Together, Mike and Jon talk about how medical device companies should...

Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice? The waterfall methodology used to be the industry norm for medical device product development until an alternative approach known as the agile methodology emerged, leading to competing opinions over which product development approach is best.  In this special 200th episode of the Global Medical Device...

Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me!” While it may not be everyone’s favorite pastime, internal audits are very important...especially if you have or want a true quality culture and mindset of continuous improvement.   In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru...

What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a medical device?   In this episode of the Global Medical Device Podcast, Jon Speer talks to Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions (ICS). Jon and Milton discuss practical pointers for determining and describing the similarities and differences between...

For medical device professionals, there are the “knowers” and the “doers.” One group is knowledgeable about quality best practices and product realization needs, but may not know how, or have the desire, to act upon it. The other group puts that knowledge into action by doing the best practices that are needed to realize the product needs and [seize all] opportunities. In this episode of the Globa...

Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, are you a customer who has benefited from using them?     In this episode of the Global Medical Device Podcast, Jon Speer talks to Alison Lee about her PPE startup Breathe99, which pivoted operations in developing its high-quality face mask product to meet respiratory needs and pro...

Do you fear needles and the associated pain? No one understands this fear more than physicians who see it firsthand with their patients day in and day out. And one physician in particular set out to do something about it. In this episode of the Global Medical Device Podcast, Jon Speer talks to Dr. Amy Baxter, CEO and founder at Pain Care Labs. Amy discusses the pros and cons of being a physician,...

Why does the FDA have three systems in place to address and handle risk related to medical devices? Each system serves a different purpose, but are all three actually necessary? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about FDA’s three systems of risk for medical devices and the unique interdependencies and distinctions between the...

How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD manufacturers approach quality management and other key elements based on these similarities and differences? In this episode of the Global Medical Device Podcast, Jon Speer talks to Joanne LeBrun from MDC Associates, which offers quality systems consulting, regulatory consulting, and implementatio...

Does your medical device qualify for an investigational device exemption (IDE)? What does this process involve and what does FDA expect of these manufacturers? There is plenty to consider when it comes to the IDE timeline and process. In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill “Mr. Regulatory” who sheds valuable light on the topic of IDE, which allows an...

Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself? There’s a supplier management solution that will make your job a whole lot easier. In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-owner of ‎QUNIQUE, a quality and regulatory consultancy. Previously, Bassil worked with the notified body, TÜV SÜD. Bas...

Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that has historically been known to evoke a fearful, negative response by medical device professionals. In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, known in the industry as Mr. Regulatory, about the reasons why the PMA process is so dreaded by manufacturers brin...

Why is design, manufacturing, quality, and culture so important in the medical device industry?  These key elements must exist and function in synchrony so that a medical device can save and improve patient lives. In this episode of the Global Medical Device Podcast, Jon Speer talks to Dan Purvis, CEO at Velentium—a design, development, and manufacturing firm that takes medical devices throug...

What do manufacturers need to know about the Safer Technologies Program (STeP) for Medical Devices from FDA? How is STeP different from similar programs, like the Breakthrough Devices Program? Which devices are eligible? In this episode of the Global Medical Device Podcast, host Jon Speer and his guest Mike Drues from Vascular Sciences offer answers to these questions and educate listeners on this...

One of the main differentiators that makes Greenlight Guru so unique is its Guru Edge. The medical device gurus ⁠are a team of medical device professionals with decades of combined industry experience and subject matter expertise. In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenlight Guru. Sara shares how her professional journey b...