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
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 began as a biomedical engineer in the post-manufacturing industry. Listen as Sara offers valuab...
Mar 17, 2021•20 min•Ep. 188
What does it take to build a successful MedTech startup? It’s a multi-million dollar question and the answer involves strong execution of a highly strategic plan. In this episode of the Global Medical Device Podcast, Jon Speer talks to Duane Mancini, president and founder of Project Medtech, and host of the Project Medtech Podcast. Listen as Jon and Duane talk about building a startup in the MedTech industry and why it’s so important for MedTech startups to be strategic in their approach t...
Mar 10, 2021•30 min•Ep. 186
What makes Greenlight Guru unique? It’s 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 Karen Schuyler, a Medical Device Guru at Greenlight Guru with nearly 15 years of experience working in the medical device industry. Listen as Karen offers value advice to medical device professionals on how to establish important system connections that coincide with regulations so that you can make ...
Mar 08, 2021•26 min•Ep. 185
Imagine using medical illustrations, animations, and other types of artwork to tell the story of a medical device, its procedures, or its manufacturer. In this episode of the Global Medical Device Podcast, Jon Speer talks to Annie Campbell and Emily Holden from Now Medical Studios, where they create medical illustrations and animations for the healthcare industry. Listen to Annie and Emily explain how their unique artwork is transforming the way we see and understand medical devices....
Mar 04, 2021•43 min•Ep. 184
Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are interested in entering the SaMD space, what do you need to know when it comes to FDA regulations and guidance? In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, “Mr. Regulatory”, who has nearly a decade of firsthand experience working for FDA. Listen to Mr. Regulatory and Jon discuss all things related to SaMD from the perspective of FDA and how the agency is r...
Mar 01, 2021•46 min•Ep. 183
How can medical device companies be better prepared for remote and on-site inspections or audits? Practice, practice, practice so that you’re always audit-ready. In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry, lead consultant and senior advisor for Quality Systems and Compliance, respectively, within the FDA and Life Sciences division of their law firm, King & Spalding LLC. Listen to this episode where Steven and Eric share their keen...
Feb 24, 2021•51 min•Ep. 182
The new medical device regulation in the European Union (EU MDR) has introduced a host of new challenges for medical device companies. One challenge, in particular, has to do with the quality management system of a medical device. In this episode of the Global Medical Device Podcast, Jon Speer talks to Monir El Azzouzi, founder and CEO of Easy Medical Device. Also, Monir is a prolific podcaster, blogger, and YouTuber that helps medical device companies achieve compliance. Together, Monir a...
Feb 22, 2021•36 min•Ep. 181
What do auditing and compliance protocols look like during a pandemic? Medical device companies continue to adjust to changing circumstances in an attempt to maintain business as close to normal as possible. In this episode of the Global Medical Device Podcast, Jon Speer talks to Colleen Hittle, founder of ProVeritas Partners, who brings years worth of knowledge and experience in the regulatory environment of healthcare and life sciences. Colleen provides listeners with guidance and support for ...
Feb 18, 2021•31 min•Ep. 180
Keeping a constant pulse on current medical device industry standards for risk management, like ISO 14971:2019 and its companion documents, while also adhering to the recommended guidelines is one of the most important things a medical device company can do to be successful. In this episode of the Global Medical Device Podcast, Jon Speer talks to Ed Bills, risk management consultant and technical committee member of the working group for ISO 14971:2019 and ISO TR 24971:2020, who shares key insig...
Feb 10, 2021•40 min•Ep. 179
Medical device reimbursement is a key consideration that must be well researched, understood, and managed by companies in order to ensure no money, to which you’re entitled to, is left on the table. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the importance of medical device reimbursement and offers tips listeners can use to build a competitive reimbursement strategy that puts dollars back in the company’s pocket once a device ...
Feb 04, 2021•41 min•Ep. 178
Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Health (NIH) aimed at accelerating the development, commercialization, and implementation of COVID-19 testing technologies that shorten viral detection cycles and increase access to reliable, accurate testing on a widespread scale. In this episode of the Global Medical Device Podcast, Jon Speer talks to Devon Campbell, founder of Prodct, who has been a major contributor in supporting the efforts bein...
Jan 27, 2021•48 min•Ep. 177
What are the 2021 strategic priorities for FDA’s Center for Devices and Radiological Health (CDRH) and what impact will these initiatives have on the medical device industry? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about CDRH’s previous, current, and future strategic priorities, including those impacted by the COVID-19 pandemic.
Jan 20, 2021•47 min•Ep. 176
What’s the relationship between product feedback, complaints, and adverse events? In this episode of the Global Medical Device Podcast, Jon Speer talks to guest Isabella Schmitt, Director of Regulatory Affairs at Proxima Clinical Research (CRO). Jon and Isabella discuss some important processes and methods medical device companies should consider for soliciting, receiving, and handling feedback.
Jan 14, 2021•34 min•Ep. 175
What impact has artificial intelligence (AI) and machine learning (ML) had on the medical device industry thus far? Have the emergence of these new technologies created new, unanticipated regulatory and quality challenges for industry professionals? In this episode of the Global Medical Device Podcast, host Jon Speer and guest Mike Drues from Vascular Sciences revisit the topic of AI/ML to identify notable changes and technological advancements that have emerged as a result of these technologies...
Jan 07, 2021•44 min•Ep. 174
Are you prepared for the aftermath of the pandemic’s impact on the medical device industry? It may be time for device professionals to start bracing for a new normal. In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry from King & Spalding LLC about post-pandemic readiness for the medical device industry and how companies can prepare for and embrace the new medical device landscape that’s expected to take shape from 2021 onward. Steven, a form...
Dec 23, 2020•43 min•Ep. 173
The end of 2020 is near, which will close out a year that’s been fraught with challenges and difficulties. However, 2021 will bring its own set of new challenges for those implementing the European Union Medical Device Regulation/In-Vitro Diagnostics Regulation (EU MDR/IVDR). What do device companies still need to do to be prepared for the transition? In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-Owner of QUNIQUE Group, a quality and regulatory...
Dec 17, 2020•31 min•Ep. 172
Still seeking guidance to stay in the know when it comes to new and updated FDA requirements related to medical devices, especially during the ongoing pandemic? In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, senior director of regulatory affairs at ConvaTec and industry thought leader who has been coined the name “Mr. Regulatory.” Listen to this episode as Mr. Regulatory shares his predictions on potential policy changes or updates we may begin to see fro...
Dec 09, 2020•39 min•Ep. 171
Software as a Medical Device (SaMD) is one of the fastest growing segments of the medical device industry. How are regulators keeping pace with its growth? FDA has a set of specific requirements unique to SaMD that companies are expected to meet in order to market these devices in the United States. In this episode of the Global Medical Device Podcast, Jon Speer talks to Andrew Frink, regulatory affairs manager at Proxima Clinical Research (CRO) about the ways in which SaMD companies can improve...
Dec 02, 2020•31 min•Ep. 170
There’s one niche market within the device industry that rarely gets the attention it deserves: products designed for military applications and use in other emergency settings. In this episode of the Global Medical Device Podcast Jon Speer and his cohost, colleague and medical device guru Wade Schroeder, talk to guests Monti Leija and Robert Futch from the Delta Development Team, manufacturers of ruggedized thermal systems who specialize in military applications. Listen to this episode to learn ...
Nov 26, 2020•39 min•Ep. 169
Some sources claim that one-third of your product development project should be spent on defining good requirements. Why? Requirements are key determinants of success for any new product that’s being developed, especially a medical device. In this episode of the Global Medical Device Podcast, Jon Speer talks to Devin Mack, mechanical engineer and owner of Enqual, about the importance of spending enough time defining and managing requirements for medical devices. Some of the highlights of the sho...
Nov 18, 2020•36 min•Ep. 168
As the COVID-19 global pandemic continues, emergency use authorization (EUA) has become a highly utilized regulatory pathway to market in the United States. In this episode of the Global Medical Device Podcast, Jon Speer talks to Erica Loring, a medical device guru at Greenlight Guru. Jon and Erica discuss the positive and negative impacts of the EUA program on the medical device industry as well as the need for increased responsiveness to streamline distribution of in-demand products and servic...
Nov 12, 2020•38 min•Ep. 167
Should your medical device company address biocompatibility? The short answer is, yes. Every single medical device should conduct some level of biocompatibility testing. What’s important is that you understand to what extent. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about biocompatibility of devices, the applicable FDA and ISO guidelines companies need to follow, and the possible ramifications if you don’t. Some of the highlights of...
Nov 04, 2020•49 min•Ep. 166
What makes Greenlight Guru unique? It’s Guru edge—a team of medical device professionals with decades of industry experience whose primary role within the company is to enable customer success. In this episode of the Global Medical Device Podcast, Jon Speer talks to Erica Loring, a medical device guru at Greenlight Guru. Erica shares her unique career journey working in the healthcare sector, which ultimately led her to enter the medical device and in-vitro diagnostic device space where she now...
Oct 28, 2020•38 min•Ep. 165
What is a multiple function device? From a high level, it’s a product with at least one portion that meets FDA’s Code of Regulations’ (CFR) definition of a medical device and at least one other portion that does not. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about multiple function devices to help listeners gain a clear understanding of this increasingly popular device type.
Sep 30, 2020•41 min•Ep. 164
What could go wrong as more medical device products are used at home and in similar non-traditional environments outside of hospitals and healthcare facilities by non-medical professionals? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences. Jon and Mike discuss challenges related to safety, risk, and usability when medical devices intended for "at home" environments interface with untrained end-users.
Sep 10, 2020•31 min•Ep. 163
What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Special, and Abbreviated Premarket Notification 510(k) programs? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the Safety and Performance Based Pathway that's designated for certain types of medical devices only and what eligible companies should consider when using this pathway for submitting a 510(k) to receive FDA clearance.
Sep 02, 2020•45 min•Ep. 162
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 Jon and Mike are passionate about the world of medical devices, particularly design controls, regulat...
Aug 26, 2020•41 min•Ep. 161
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 unique approach to medical device product development and complying with regulations. He also shares a fe...
Aug 19, 2020•26 min•Ep. 160
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 tips on one of her favorite topics—audit etiquette. She explains her beliefs around how practicing a hi...
Aug 12, 2020•36 min•Ep. 159
