What is the role of the importer, according to EU MDR? The requirements for this role have changed since the new regulation went into effect in May 2021 and it's important to understand the extent and impact of these changes. In this episode of the Global Medical Device Podcast, Jon Speer talks to René Van De Zande with MedEnvoy Global, a specialty solution for European regulatory compliance that offers importer representation services. In addition, René founded EMERGO in 1997, later becoming wh...
Jul 01, 2021•35 min•Ep 217•Transcript available on Metacast A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can use to guide product development and marketing submission planning. There is an art to preparing a Pre-submission, though, so it's important to include the necessary contents (and avoid common pitfalls) that will yield the best possible results. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about Pre-submissions. Listen as the two share re...
Jun 23, 2021•36 min•Ep 216•Transcript available on Metacast What can you still do to help in response to the COVID-19 pandemic? The National Institute of Biomedical Imaging and Bioengineering (NIBIB) announced that its Point-of-Care Technology Research Network (POCTRN) is soliciting proposals to further advance SARS-CoV-2 testing technologies to fill specific unmet national needs through RADx Tech II, a fast-track program that leverages POCTRN. In this episode of the Global Medical Device Podcast Jon Speer talks to Mark Marino, Vice President of Growth a...
Jun 21, 2021•27 min•Ep 215•Transcript available on Metacast Hungry for medical device industry knowledge? Greenlight Guru has you covered — now, medical device professionals can enjoy additional, sought-after training courses in the already popular educational platform, Greenlight Guru Academy, through a new partnership with Medical Device HQ. In this episode of the Global Medical Device Podcast, Jon Speer talks to Peter Sebelius, the founder and CEO of Medical Device HQ. Together, Peter and Jon discuss the importance of online learning and providing acc...
Jun 16, 2021•15 min•Ep 214•Transcript available on Metacast What did FDA report as the most-cited issues during medical device inspections for the fiscal year of 2020? Understanding the data can help you prepare against making these common, avoidable mistakes during your next quality system inspection. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences. Together, Mike and Jon discuss the FDA FY2020 data for medical device quality system inspections and evaluate the top three most cited QSR clauses t...
Jun 14, 2021•34 min•Ep 213•Transcript available on Metacast Close your eyes, take a deep breath in, and imagine your team operating at peak performance, exceeding goals and each member feeling and working at their best. Now, breathe out, letting out a sigh of relief knowing that's fully within the realm of possibility — through mindset training. In this episode of the Global Medical Device Podcast, Jon Speer talks to Kevin Bailey, mindset coach and founder of Dreamfuel, a mindset coaching solution for high growth companies. Kevin is the mindset coach for...
Jun 10, 2021•29 min•Ep 212•Transcript available on Metacast 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, imaging systems, infusion pumps, and ventilators. Some highlights of this episode include: In January 2...
Jun 07, 2021•37 min•Ep 211•Transcript available on Metacast 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 Guru, to join the show and explain to listeners what Greenlight Guru Academy is and how the eLearnin...
Jun 02, 2021•32 min•Ep 210•Transcript available on Metacast 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 bestselling author who is creating a sales revolution. Together, Chip and Jon chat about the importance of a...
May 31, 2021•37 min•Ep 209•Transcript available on Metacast 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 into the life of a medical device guru at Greenlight Guru, how the guru team engages with customers bey...
May 26, 2021•32 min•Ep 208•Transcript available on Metacast 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 Speer talks to Etienne Nichols, a Medical Device Guru at Greenlight Guru, to learn more about his e...
May 24, 2021•30 min•Ep 207•Transcript available on Metacast 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 learned along the way. Some of the highlights of this episode include: Laura gained hands-on manufacturi...
May 19, 2021•28 min•Ep 206•Transcript available on Metacast 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 former FDA reviewer who is an expert in regulatory submissions, quality systems, and biocompatibility eva...
May 17, 2021•48 min•Ep 205•Transcript available on Metacast 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's such a high demand right now for regulatory and quality roles and how you can find your next care...
May 12, 2021•32 min•Ep 204•Transcript available on Metacast 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 and Safer Technologies Program and how manufacturers can determine if one or either is worth pursuin...
May 11, 2021•41 min•Ep 203•Transcript available on Metacast 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 on EU IVDR transition concerns and the challenges the medical device industry faces, like the notifie...
May 07, 2021•38 min•Ep 202•Transcript available on Metacast 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 approach and manage business risk, which systems and tools can help, and advice on how to review con...
May 03, 2021•34 min•Ep 201•Transcript available on Metacast 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 Podcast, host Jon Speer and his guest Devon Campbell, founder and CEO at Prodct, discuss the waterf...
Apr 28, 2021•39 min•Ep 200•Transcript available on Metacast 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 at Greenlight Guru. Sara loves to talk about internal audits. She shares her valuable wisdom of int...
Apr 27, 2021•34 min•Ep 199•Transcript available on Metacast 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 the two types of devices. Milton also offers some helpful recommendations for IVD manufacturers to ...
Apr 21, 2021•34 min•Ep 198•Transcript available on Metacast 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 Global Medical Device Podcast, Jon Speer talks to John Kapitan, CEO at Kapstone Medical, about the differ...
Apr 20, 2021•32 min•Ep 197•Transcript available on Metacast 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 provide personal protection during the coronavirus pandemic. Some of highlights of this episode include...
Apr 14, 2021•28 min•Ep 196•Transcript available on Metacast 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, entrepreneur, and inventor of reusable, physiologic medical products to eliminate unnecessary pain. ...
Apr 13, 2021•49 min•Ep 195•Transcript available on Metacast 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 them. Some highlights of this episode include: Three systems for medical device risk from FDA: product ...
Apr 08, 2021•40 min•Ep 194•Transcript available on Metacast 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 implementation training. Joanne offers valuable insights on the topic of managing quality for in vitro diagnostic...
Apr 05, 2021•42 min•Ep 193•Transcript available on Metacast 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 investigational device to be used in a clinical study to collect safety and effectiveness data, and...
Mar 31, 2021•57 min•Ep 192•Transcript available on Metacast 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. Bassil discusses QUNIQUE’s Quality Engine (QE) solution for supplier management, which helps manufactur...
Mar 30, 2021•22 min•Ep 191•Transcript available on Metacast 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 bringing a Class III medical device to market in the United States....
Mar 25, 2021•46 min•Ep 187•Transcript available on Metacast 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 through an entire lifecycle. Dan gives listeners an update on Project V, an initiative involving the mass ...
Mar 24, 2021•37 min•Ep 190•Transcript available on Metacast 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 new, voluntary program, helping manufacturers with eligible devices leverage STeP for easier, faste...
Mar 21, 2021•33 min•Ep 189•Transcript available on Metacast 
