Global Medical Device Podcast Powered By Greenlight.guru

In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Carmen Brown, the regulatory and quality affairs manager at Proxima Clinical Research. They delve into the specifics of In Vitro Diagnostics (IVDs) and explore the challenges and considerations faced by medical device manufacturers in the IVD pathway. Whether you're an industry veteran or new to the field of medical diagnostics, this conversation will enlighten you about the nuances of IVD regulatory compliance, risk assessment, and FDA interactions.Episode Highlights:IVDs are a Specialized Medical Device: Learn how IVDs, which include reagents, instruments, or systems for diagnosis, differ from other medical devices and what specific regulatory pathways they follow.Risk Levels in IVDs: Understand the significance of classifying IVDs into class one, two, or three based on the risk of false or inaccurate results, and how this impacts regulatory strategy.Pitfalls in Performance Characteristic Evaluation: Discover

In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Morven Shearlaw, co-founder of Fearsome, in a thought-provoking discussion on the essence of human-centered design in medical devices.Delve into the importance of understanding user needs beyond surface-level assumptions and learn how Fearsome's approach to product development is setting new standards in MedTech. From Glasgow's design desks to global market impacts, this episode is a deep dive into making MedTech better by truly connecting with the end-user experience.Noteworthy Points:The Pitfalls of Premature Solutions: Morven emphasizes the need for extensive user understanding before jumping to design conclusions, challenging the common industry haste to offer solutions.The Evolution of Fearsome: Morven shares the growth story of Fearsome from a broad design firm to a specialized MedTech developer, emphasizing the value of a diverse industry background.The Nuances of Usability: The conversation reveals the s

This episode of the Global Medical Device Podcast delves into the world of FDA submissions, specifically focusing on the eSTAR program. Host Etienne Nichols leads an insightful discussion exploring the intricacies, benefits, and strategies for using eSTAR effectively in medical device regulatory submissions.To discuss this topic, we brought in the following experts:Patrick Axtell, Ph.D., the Senior Tools & Templates Engineer for the Office of Regulatory Products at CDRHLisa Pritchard, Vice President of Regulatory, Quality, Clinical and Engineering at DuVal & AssociatesKathy Herzog, Senior Regulatory, Quality & Compliance Consultant at DuVal & AssociatesAs of now, all 510K submissions must use the eSTAR program. eSTAR is designed to streamline the FDA submission process, making it more efficient and standardized. This episode is a must-listen for anyone in the medical device industry looking to navigate the complexities of FDA submissions with a focus on the evolving eSTAR program.Expert Insigh

In this episode, we delve into the burgeoning world of artificial intelligence in MedTech. Listen as we discuss the skepticism and opportunities associated with AI, the revolutionary impact on product development, and provide practical advice for professionals looking to harness AI's potential. Wade Schroeder, Medical Device Guru for Greenlight Guru, shares his expertise on MedTechs AI-powered tools that are redefining risk management and compliance. With a keen focus on the AI in MedTech Trend report, this conversation is a must-listen for those ready to lead at the forefront of medical device innovation. Check out the full report and explore the resources mentioned in this episode by visiting the Reference Links below.Episode Highlights:AI is still in its early stages within the MedTech industry, with potential to save time and improve efficiency.There is a noticeable skepticism about AI, with 65% of respondents doubting the accuracy of AI data.Corporate executives are the highest users of AI at 60%, with m

In this episode, we delve into the multifaceted aspects of advisory roles within medical device startups. These discussions explore the nuanced differences between consulting and advisory work, the intricacies of the advisor-startup relationship, strategies for growth, and the delicate balance of equity and compensation in these roles. Devon Campbell shares invaluable advice and experiences, focusing on mentorship, relationship-building, risk management, and navigating the challenges of the MedTech startup ecosystem.Some of the highlights of this episode include:The distinction between consulting and advisory roles, highlighting the long-term, relationship-focused nature of advisory work.The critical role of experience and mentorship in guiding startups, enhancing their growth and success.Strategies to transform challenges into opportunities, fostering innovation and resilience in the MedTech industry.The importance of understanding and respecting employment contracts and avoiding conflicts of interest in adv

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Description:In this episode, Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dives deep into the complexities of FDA submissions for medical devices. She sheds light on the nuances of different submission types, such as 510K, De Novo, and PMA, and underscores the criticality of timelines, strategic planning, and a robust Quality Management System (QMS). Reynolds also guides listeners through effective FDA interactions, the eSTAR system, and the significance of building relationships with review teams. Her expertise illuminates the path to successful FDA submissions, emphasizing preparation, organization, and proactive engagement with regulatory bodies.Some of the highlights of this episode include:Strategic alignment of clinical trials with market launch timelines is crucial for successful FDA submissions.Differentiating between submission types (510K, de novo, PMA) and how they are essential for navigating the regulatory landscape.Early interaction

Description:Dive into the enlightening world of FDA inspections with Etienne Nichols and Mike Drues. In this comprehensive episode, the duo decodes the essence of effective communication, the importance of managing expectations, and the art of proactive dialogue with the FDA. They reveal insights that every MedTech professional must know, breaking down the philosophy, challenges, and expectations surrounding inspections, all while blending unique "Mike Drues isms" and Etienne's candid takes.Some of the highlights of this episode include:Grasping the art of proactive communication with the FDA, laying the foundation for regulatory success.Delving into the essence of managing FDA's expectations during pivotal conversations.Exploring the unpredictability of FDA inspections and the mantra of always being prepared.Differentiating between inspections for class two/lower medical devices and class three devices.Unpacking the role of FDA registration in attracting the FDA's attention for inspections.Achieving the perf

Description:In this episode, host Etienne Nichols and Shannon Bennett, a regulatory affairs expert in the diagnostic testing space dive into the FDA's proposed rules for Laboratory Developed Tests (LDTs) and In Vitro Diagnostic products (IVDs). Shannon breaks down the past and present regulatory landscapes of LDTs, the differences between IVDs and LDTs, and what the FDA's changes could mean. They discuss the cost implications and the learning curve for labs new to FDA's processes. Shannon explains the FDA's four-year phased plan for labs to comply with the new rules, touching on the challenges at each phase, like the administrative burden and the influx of submissions the FDA might have to review. Focusing on the transition for new or modified tests, Shannon emphasizes the need for more guidance from the FDA and educational efforts to help labs understand the new terms and requirements. We also discuss the potential disruption to healthcare and urge labs to actively comment on the draft regulations to the FDA

Description:In this episode, we discuss the past, present, and future state of EUDAMED. EUDAMED is the European Database for Medical Devices, and is part of the European Medical Device Regulation. While the EUMDR may have been published in 2017, many companies are still unsure how to handle the submission of their UDI (Unique Device Identification) data.Joining us to discuss this topic is Richard Houlihan, an international speaker and guest university lecturer on EUDAMED. His time running the European Commission IT teams developing EUDAMED has given him unrivalled insights into how EUDAMED affects the MedTech industry. This EUDAMED experience and his 28 years in IT give him a real advantage when helping companies prepare for EUDAMED, FDA GUDID, and other regulatory submissions. His company EirMed with the website eudamed.com provides ongoing EUDAMED and regulatory submission support, training, an EUDAMED mobile search app, and software to help Manufacturers, Importers, European authorised reps, and Distributo

Description:In this episode, we discuss how to select a site for a Clinical Trial. Joining us for the conversation is Isabella Schmitt, MBA, RAC, the Vice President of Life Science Solutions at Proxima Clinical Research. Isabella brings a wealth of knowledge and experience in the intricacies of clinical study site selection, shedding light on the critical role it plays in MedTech product development.In addition, we're joined by Samantha Pickett, an Associate Director at Proxima Clinical Research. Melissa dives deep into the key considerations for site selection, emphasizing the significance of patient demographics, regulatory compliance, and technological access.This was a fun conversation as we discussed how to navigate the complexities of regulatory landscapes, explore collaboration strategies, share best practices, and draw insights from real-world case studies.Some of the highlights of this episode include: 1. Why Site Selection Matters:In the realm of MedTech product development, site selection is the li

Description:In this riveting episode of the Global Medical Device Podcast, Etienne Nichols brings together the dynamic leaders from Greenlight Guru: David DeRam (internally known as DD) and Pall Johannesson. Together, they embark on a journey through the chronicles of Greenlight Guru and SMART-TRIAL, exploring its growth, trials, and moments that defined its course. The conversation is sprinkled with heartfelt personal anecdotes, emphasizing the brand's commitment to unwavering quality and the pivotal shifts during the COVID-19 pandemic.The trio delves into the intricate dance of nurturing a thriving work culture in the MedTech arena, especially amidst the waves of the changing remote work landscape. They share profound insights into navigating the maze of regulations in the medical device sector, underscoring the critical importance of resilience—captured by the evocative term "alligator blood"—to thrive in such a challenging environment.Drawing the curtain back on the transformative world of medical technol

Description:In this episode recorded in front of a live audience in Boston, MA, we speak with Christy Sheehy-Bensinger, the CEO & Founder of C-Light Technologies, Inc. about their recently cleared eye movement monitor. Listen as we unpack her journey from academia to startup life, explore the complexities of medtech communication, and delve into the intricate dance of securing FDA clearance. This was a fun conversation, with good Q&A at the end where we discuss the highs and lows of pioneering digital health solutions, the significance of a quality-first mindset in MedTech, and the art of crafting a passionate team.Some of the highlights of this episode include:Transitioning from academia to startup, and the demands of adaptability; navigating the real-world validation while staying solution-driven.Navigating the regulatory landscape, and the marathon that it is and how being FDA-cleared is just one of the many milestones.Building a quality-centric culture from day one to set the tone for long-term su

Description:In this episode, we explore the impact of software development methodologies in the medical device industry. With industry experts from HTD Health, we dissect the Agile approach to compliance, the intricacies of Quality Management Systems (such as Greenlight Guru), and go-to-market challenges for innovative medical devices.Zach, CEO of HTD Health, is a self-taught software engineer turned serial entrepreneur. His first venture, Fresh Corner Cafe, served fresh food in Detroit's food deserts for eight years. He then founded HTD Health to craft digital health solutions, pioneering the shift to virtual care. The company supports care providers, device makers, and life sciences. Zach also founded Exos, a governance SaaS, and sold it in 2022.Weronika Michaluk, a jack-of-all-trades in biomedical engineering, business, and public health, leads HTD's Software as a Medical Device unit. With degrees from Miami and Warsaw, plus a Doctorate in Public Health, she's worked on everything from wireless ECGs to dig

Description:Join Devon Campbell in MedTech funding. He unveils startup red flags, from data integrity to product maturity. His message? Know your weaknesses, fill the gaps.Considering cold-calling other Founders? It works. Understand your their investment landscape first. Recognize that VCs and Angels have different risk profiles. Devon says know your funding options and their strings. It’s about terms and expectations, not just money.Think a sleek exterior hides internal flaws? Devon focuses on product readiness and QMS. Be manufacturing-ready and optimize. No shortcuts in MedTech.In a red-tape world, paperwork matters. It's about confidence, not bureaucracy. Devon shifts focus to quality systems as confidence builders. His point? "Unquestionable, indelible data—that’s what I can trust." Get organized, and confidence becomes your MedTech currency.Some of the highlights of this episode include:Knowing your weaknesses. It's important to recognize your gaps and seek the right help.Maintain data integrity. Full

Description:In this episode, Etienne Nichols and Ellie Reynolds explore FDA's Breakthrough Device designation. They discuss pursuing breakthrough status, aligning marketing strategies with FDA review, and navigating the medical device industry. This episode provides a roadmap for this complex regulatory terrain.Learn about the benefits and scrutiny of the breakthrough designation, hear examples that emphasize the need for precise data and quality in the application process, and listen as we explain the planning and considerations for success, and how innovation can thrive within regulation.Some of the highlights of this episode include:The changes in CMS reimbursement, and how breakthrough devices no longer guarantee automatic CMS reimbursement.Planning for FDA Submission, and how to align with FDA timelines.Competitive Landscape - how achieving breakthrough is still possible, even if competitors have it.Whether or not it's worth pursuing Breakthrough Designation.The benefits of Breakthrough Designation Benef

Description:In this episode of the Global Medical Device podcast, we discuss the intricate world of medical device regulations, design, and innovation. Hosted live in San Jose, the podcast features the esteemed Nada Hanafi, SVP - Regulatory Strategy at Veranex, who brings her rich experience of 12 years at the the FDA and Regulatory Strategy to discuss pressing issues and notable developments in the industry.Join us as we delve deep into crucial topics such as biases in medical device testing, the evolving approach of the FDA, and the importance of user-centric design. This episode offers a comprehensive look into the dynamic and ever-evolving realm of medical technology, emphasizing the balance of innovation and regulation.Highlights of the episode include:Skin Tone Bias in Medical Devices: Nada Hanafi spotlighted the biases in pulse oximeters, shedding light on how these devices often fail to perform efficiently across varied skin tones. A lack of diversity in validation tests, mostly relying on Caucasian y

Description:During the Houston leg of our True Quality Roadshow series, we had the opportunity to sit down with Dan Purvis, CEO of Velentium and author of "28 Days to Save The World." Dan tells the story of how his company weathered the early days of startup life, and how the pandemic - which took so many companies down - turned out to be the springboard that tested the culture that Dan and his co-founder had molded from the very beginning.If you're not familiar with our True Quality Roadshow - you should definitely check it out! It's a free half-day event at one of 6 cities across the world. Links below!Some of the highlights include:The role Velentium played in upscaling the production of ventilators during the pandemic - this was a significant achievement and showcases Velentiums leadership, collaboration, and company responsiveness during this worldwide crisis.Real-life challenges faced by companies, especially dramatic stories like the purchase of parts without a PO and the personal involvement of the le

DescriptionIn today’s episode, Shawnnah Monterrey discusses the 3P510k - which is short for the 510k 3rd Party Review Program. This is a lesser known program, but there can be significant benefits from using it, which we talk about during the episode. Some of the issues we discussed include:How utilizing this program can accelerate the submission process, or at least remove some uncertainty around the timelineWho this program is for - not just for small startups, but rather how even experienced Regulatory Affairs specialists working at large corporations can benefit from this program.Lastly, we don’t usually get into the specifics of cost and expenses, but we even discuss some of the differences in how much you’ll pay using the 3P510k route vs. the traditional submission route.Shawnnah Monterrey is the founder of BeanStock Ventures after nearly a 20-year career as a technical leader. Shawnnah was responsible for developing strategies and leading complex global product development programs and functional manag

DescriptionMost people in the world of Medical Devices know that they need a Quality Management System, but what is the best way to go about building that QMS, when should you start, and how do you know when you've built it to the point it can stand on this own?In this episode, Rob MacCuspie, PhD, Manager of Regulatory and Quality Affairs at Proxima Clinical Research, Inc., discusses the best practices of companies he has worked with to help implement their Quality Management System in a manageable way.Takeaways:What is the difference in your QMS and a Document Management System?What is the most important aspect of a QMS?Who really needs a QMS, and when?What are the phases of a QMS?How to start building a QMS.Quote:""If my SOPs and training process can bring in somebody that has no experience and they can hit the ground running, I'm not worried if the auditor has any experience now in my space, right. Because I now have everything in place to show somebody how they can teach themselves and learn and get up to