Global Medical Device Podcast Powered By Greenlight.guru

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 to bringing a device to market, like taking advantage of reimbursement opportunities and leveraging a QMS to support all efforts along the way.

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 sim

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.

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.

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 and how industry professionals are responding.

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 former FDA deputy associate commissioner and COO for the agency’s Office of Regulatory Affairs currently serves alongside Eric as the Quality Systems and Compliance lead consultants in the FDA and Life Sciences practice of their law firm. With more than 50 years of combined industry experience between Steven and Eric, the insights and knowledge of this episode’s guests, specifically as it relates to this topic is a MUST listen for any medical device professional. Some of the highlights of the show include: Steven and E

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 consultancy. Bassil offers expert advice on how device companies need to prepare for these regulatory deadlines and transition to meeting the requirements of EU MDR/IVDR sooner rather than later. Some of the highlights of the show include: COVID-19 is an additional burden by impacting implementation, increasing requirements, and not being transparent about limited notified body capacity. EU MDR/IVDR Readiness: Under the new legislation, every device needs to receive re-certification by notified bodies to keep market a

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 from FDA, as influenced by the Emergency Use Authorization (EUA) response to address the current health crisis caused by the COVID-19 pandemic.

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 final submission outcomes of these devices by leveraging Pre-submissions to FDA, which involves meeting the agency's applicable regulatory guidelines and pre-sub expectations.

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 about the Delta Development Team’s journey designing their latest product the Autonomous Portable Refrigeration Unit (APRU) that provides a cooling and heating systems for extreme environments. Some of the highlights of the show include: APRU is medical refrigeration for medical professionals. It provides constant cooling of blood products, vaccines, virus samples, and temperature-controlled medications. APRU applications include military operations, disaster relief response, and emergency medical systems (EMS) because

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 show include: Story Behind Business Name: Enqual is a combination of Devin’s background in engineering plus quality to provide a balance between both. A picture (or graph and diagram) is worth a 1,000 words to describe product development and design controls for medical devices. A challenge that medical device companies tend to miss is the establishment of well-defined requirements during the product development process. Best Practices: Open communication between internal and external customers and the product development

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 services, such as tests, masks, and ventilators. Some of the highlights of the show include: EUA and PPE: Erica comes from a regulatory background and describes how the huge influx of EUA applications for ventilators and masks to in-vitro diagnostic device (IVD) and lab developed tests affect FDA tiers that reach consumers and companies. The FDA is government-funded and has a limited amount of resources. As a result, it’s scrambling to allocate people to review EUA submissions and 510(k)s for COVID-19 related tests to be leg