20 JAN 2021 · 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.

14 JAN 2021 · 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.

6 JAN 2021 · 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.

23 DEC 2020 · 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 Eric discuss how COVID is pushing the FDA toward a voluntary pilot program for agency investigators to conduct virtual facility inspections. Steven describes the current state of FDA inspections as challenging to work remotely and conduct follow-ups when appropriate. The FDA has established a paradigm to continue on-site mission critical inspections. Eric expands on the logistical challenge for inspections by explaining that since the FDA has put a hiatus on its inspection scheme, many organizations are following the Medical Device Single Audit Program (MDSAP). The Medical Device Coordination Group’s (MDCG) 2020-4 Guidance lists four circumstances where organizations under MDSAP or EU notified bodies have remote audits—surveillance, re-certification, change notification, and termination. Impact of the Emergency Use Authorization (EUA) program and the influx of requests on FDA. Some EUA submissions require pre-approval inspections. Before EUAs are revoked, build a remediated QMS, prepare for inspection, and decide whether to continue manufacturing a product after the pandemic. King & Spalding’s FDA and Life Sciences team offers a full-service approach, including cardiologists to help with health assessment risks, premarket and postmarket mergers and acquisitions, and warning letters. Pre-submission is an initial but formal way to build communication, collaboration with the FDA. A pre-submission can be an effective means for understanding regulatory requirements.

16 DEC 2020 · 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 access. EU MDR/IVDR Challenges: Additional guidance needed during transition to apply these regulations. Regulations put expectations that are not ready, such as EUDAMED. Increased requirements on clinical evidence via higher clinical and performance evaluation requirements. Continuous reporting increases expectations on resources for new and existing medical devices. EU MDR/IVDR Timeline: Number of notified bodies isn’t the most important part. How much capacity do those notified bodies have to address market needs? Tips for Medical Device and In-vitro Diagnostic Companies: Read the regulation(s). Understand implication(s) of regulation(s) on system(s). Identify/re-evaluate notified bodies that can address needs. Manage timeline/deadline for submission, implementation, certification.

9 DEC 2020 · 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.

2 DEC 2020 · 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.

25 NOV 2020 · 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 the device meets AABB guidelines and FDA regulations. The military provided end-user feedback on how it wants the APRU to function and perform. Therefore, the APRU is unique because it’s small and runs on a battery that can be charged. Power of Innovation: The biggest power consumers are refrigerators and air conditioners—both require refrigeration. Obstacles and Challenges: Every time somebody goes through the medical device journey it involves learning and becoming aware of regulatory guidelines. Recommendations: Find the right consultants, team members, and standards management tools. Wade Schroeder, Greenlight Medical Device Guru, has been a major asset to the Delta Development Team by providing regulatory guidance. Testing Methodologies: Motivation is to meet extreme environment requirements and standards. Some manufacturers choose to not meet some standards to make mobile medical devices that don’t work as well. APRU is the new standard. Root Cause and Right Configuration: Make minor adjustments to prototypes to reduce complexity, cost, and failure points via due diligence rather than rebuild.

18 NOV 2020 · 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 team as well as cross-functional involvement to define good requirements early in the process. Potential Pitfalls: What if stakeholders, engineers, and end users are not adequately considered in the development process? Everyone needs to voice their opinion to meet end user satisfaction and create a competitive edge to achieve goals. Stop Light, Agile, or Six Sigma Methodology? Track team’s progress versus focusing on customer specifications. Constantly evaluate where you are with respect to your requirements. Mantra: Invest time and money in useability/engineering models to get it right the first time to prove indications and meet proper requirements.

11 NOV 2020 · 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 legally marketed. Due Diligence: FDA’s review periods on other products have slowed down, but timelines still need to be met. Also, the quality of reviews has declined, not only with the EUAs but 510(k)s because of limited resources. FDA Statistics: A 510(k) review is supposed to take up to 90 days from the point of submission to an official response from the agency. However, EUA applications are being reviewed quickly to address a global public health crisis. Maybe too quick for regulatory quality and risks to be properly evaluated. Compare and Contrast: Erica describes the pros and cons of false-negative and false-positive results for COVID-19 and/or IVD tests. What risks do those results pose to the public? Research Use Only (RUO) to IVD: Companies that are not or have never been a medical device company need to have a quality management system (QMS), appropriate resources, and manufacturing transfers that can scale. This process takes time. FDA EUA Guidance: Proper development and design control provisions should not be viewed as optional. Companies should not cut corners but be expected to follow best practices and post-market challenges for quality events. EUA Impact Everywhere: Non-EUA products, procedures, and supplies were delayed, costs increased, and biocompatibility testing was affected due to the push for COVID-related products and services and eventual lift of those EUAs?