Global Medical Device Podcast powered by Greenlight Guru

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 your processes more efficient and supercharge the quality management engine for your medical device.

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.

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 regulating these emerging medical device technologies.

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 insights and knowledge from working in the global regulatory sector of the medical device industry and offer best practices and tips that will help you prepare for FDA inspections and other audit events.

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 and Jon discuss the ways in which EU MDR impacts a quality management system and best practices medical device companies can follow to maintain compliance with new requirements.Some highlights from this episode include:Medical device manufacturers have several QMS standards, regulations, and frameworks to follow, such as ISO 9001, ISO 13485, and FDA 21 CFR Part 820. Rumor has it that the FDA is harmonizing its Quality System Regulation (QSR) with ISO 13485:2016. Why? FDA’s QSR and ISO 13485:2016 offer significant similarities toward harmonization depending on where medical device companies, manufacturers, and products are located (in the United States or European Union). EU MDR implementation involves a complex transition process, it’s not about simply updating a technical file.What are the differences between ISO 13485:2016 and EU MDR? Refer to Article 10.9 for process requirements and Easy Medical Device courses. Research notified bodies to determine and verify authenticity, authorization, and accreditation. QMS changes related to EU MDR place greater emphasis on clinical and post-market surveillance as well as risk/benefit management. Be proactive!When everything goes well, nobody rechecks what you are doing. As soon as there is an issue on the market or there is a competitor that may want to raise some concerns, then the authorities can come and visit your site.EU MDR: Will it be delayed or postponed again due to COVID, remote audits, or because it’s too difficult to implement? MDR is a chance to level up and raise the bar in the medical device world. Memorable quotes from Monir El Azzouzi:“A quality management system is not just a bunch of documents.” “When you are, for example, manufacturing some medical devices, you have to respect some rules, some regulations.” “Don’t pay something twice (choose certification vs. notified bodies wisely).” “EU MDR is a regulation that is...raising the bar in terms of requirements and things that you need.” “When everything goes well, nobody will recheck what you are doing. But as soon as there is an issue on the market, as soon as there is a competitor that maybe wants to raise some concerns, then the authorities can come and visit your site.”

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 engaging in virtual auditing and navigating the post-COVID digital world of compliance.

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 insights from his work developing the latest version of the international risk standard and offers recommendations for companies that will help strengthen their product risk management practices.

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 is on the market.

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 being made by RADx teams. Listen as Jon and Devon share five actionable lessons learned from Devon’s involvement with RADx, each of which can be applied by medical device companies across the board.

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.