Shows
Life of Flow78. 5 Experts & 1 Episode. Unfiltered Moments You Won’t ForgetFrom entrepreneurial leaps to the future of bypass, the most powerful moments from the past months are here.In this best-of episode, we revisit conversations with some of the sharpest minds in MedTech, vascular surgery, cardiology, and education, including ICHOR Founder and CEO Tim Blair, interventional cardiologist Dr. Jaafer Golzar, interventional angiologist Dr. Michael Lichtenberg, bilingual parenting expert Michelle Bruni and Scott Addonizio, COO of BrosMed Medical and President of BrosMed US.Each guest shares something unforgettable: what it really takes to build a company from scratch, when to...2025-07-3056 min
The Med Device Cyber PodcastFDA Cybersecurity Gets Real with Monica Montañez of NAMSAHow have medical device cybersecurity requirements changed since 2023, and what does this mean for your product development?In this episode, Christian and Trevor welcome Monica Montañez from NAMSA to unpack the evolving landscape of FDA cybersecurity requirements. From new laws introduced in 2023 to the ambiguous language in FDA guidance, they dig into what it really takes to meet expectations for cyber device submissions. (0:32) NAMSA and Industry Shifts* Monica introduces NAMSA’s role in regulatory and quality consulting.(5:12) FDA Guidance vs. Legal Mandate* The...2025-07-2932 min
The Inspired Stories PodcastDuane Mancini & Rich Mazzola Discuss How the Project Medtech Team Created a Life Science Consulting Powerhouse🎙️ Duane Mancini & Rich Mazzola: From Pandemic Startup to MedTech Empire - Building Project MedTech's Fractional Consulting NetworkIn this dynamic episode, Duane Mancini (CEO) and Rich Mazzola (CFO), co-founders of Project MedTech, share their remarkable journey from launching a podcast during the 2020 pandemic to building a comprehensive medtech consulting ecosystem serving 80+ startups. Through candid stories about starting a business while becoming first-time fathers, navigating founder communication challenges, and helping startups avoid catastrophic regulatory mistakes, Duane and Rich reveal how they created the "one-stop shop" fractional solution the industry desperately needed. From FDA pathway strategy to cap table negot...2025-07-021h 03Life of Flow71. The #1 Mistake Founders Make With Their StartupsTimothy Blair has spent more than 30 years inside some of the most influential companies in MedTech. But when he was offered a multimillion-dollar deal that could have accelerated everything, he walked away.In this episode, Tim shares why he turned down funding that most founders would have taken. He explains how early-stage deals can quietly dismantle a company’s future and what it takes to grow without losing control. From managing investor pressure to building a high-performance team culture, this is a real look at leadership inside a startup committed to doing things differently....2025-06-1359 min
The MedTech Experience#16 - Chris Rupp: Navigating Global MedTech Marketingwww.lifeblood.comHosted by Giovanni Lauricella, in this episode we interview Chris Rupp, VP of Global Marketing at NAMSA. Chris shares his story of navigating from Chemistry to Marketing for a CRO. Giovanni and Chris explore business development, networking and partnerships, when to make your first marketing hire, Antarctica, South Africa, and more.You can learn more about NAMSA and their CRO services at www.namsa.comThis episode is sponsored by Zapyrus, a business development and business intelligence software company based out of Toronto, Canada. To learn more about Zapyrus and...2025-05-173h 03
State of Medtech274. This Month in Medtech: Edwards’ Big Move, $200M Robotics Bet & AI ShiftsEpisode breakdown:00:00 – Intro: Why April Was a Pivotal Month for Medtech01:52 – Supira Medical Raises $120M for pVAD Innovation05:34 – CMR Surgical’s $200M Robotics Bet09:12 – Edwards Lifesciences Gets CE Mark for Sapien M313:01 – Biolinq’s $100M Needle-Free Glucose Monitor15:27 – AI + Imaging: Anumana and Conavi Raise Big18:40 – The Numbers: 3 Fastest-Growing Procedure Segments21:45 – The APAC Expansion Opportunity for Medtech24:15 – NAMSA, FDA, and the New Clinical-First Strategy27:00 – Closing Thoughts: What to Watch Going into May Meet me in NYC this May at MD&M East May 20-22...2025-05-0855 min
State of Medtech273. Family Office: How Ivanny Franklin Uses Her NAMSA Experience to InvestEpisode breakdown:00:00 – Intro: From NAMSA to MedSite Capital01:52 – Who Is Ivanny Franklin? Her $B Exit Story03:33 – Why She Started a Medtech Family Office05:04 – MedSite’s Investment Strategy: SPVs, Syndicates, Direct07:17 – Where She’s Investing: IVD, Cardiovascular, Health Tech10:50 – How NAMSA’s Scale Gives Her Market Pattern Recognition13:40 – Top Red Flags in Pitch Decks (Founders, Listen Up)16:30 – 510(k) vs PMA: Why Your FDA Path Can Kill a Deal18:55 – Clinical Trial Design: $1M vs $10M and What Drives It20:50 – The Most Overlooked Statement in Regulatory Strategy23:00 – Balancing Legacy with Risk: Family Office Rea...2025-05-061h 01
Tales from the Truth SeekersMaybe God's in Arizona, with Thomas Leo CurleyWelcome to Season One, Episode 3 of Tales from the Truth Seekers. You may have heard that juniper trees hold significance in the Bible, or that they can be traced back to the ancient goddesses of Canaan or Greece. You may have heard talk of spiritual energy vortexes in and around Sedona, Arizona and that they are mysteriously linked to the juniper that grows there. But it's another thing altogether to hear a story first-hand from a modern, American, financial analyst who just happened to have a life-changing spiritual experience for himself, while sitting next to one of these trees.2025-01-291h 02
Project MedtechEpisode 195 | Don Pohl and Sheri Krajewski at NAMSA | Tips to Successfully Navigate Biocompatibility Testing of Medical DevicesIn this episode, Don Pohl and Sheri Krajewski at NAMSA and Duane Mancini discuss ISO 10993 and biocompatibility testing for medical devices, the history of the standard and how it has evolved, why following the risk-based approach is becoming more important, tips to avoid having your submission delayed with various regulatory bodies across the globe, common mistakes and so much more.
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NAMSA Website
Duane Mancini LinkedIn
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Project Medtech Website
Mittal Consulting
Rook...2024-10-0148 min
BiocompCHATibilityNavigating Biocompatibility in Early Feasibility StudiesIn this episode of NAMSA’s BiocompCHATibility Podcast, our hosts discuss early feasibility studies and the scope of biocompatibility necessary to get started. They highlight the importance of controlling device response in a small patient group and how this approach shapes biocompatibility considerations within the framework of risk management.“The control measure of just having a few patients is definitely used as a reason why, in part Biocompatibility doesn't need to be as extensive as it needs to be for a pivotal where you have hundreds of people and commercialization where you lose practically all control.” – Don Pohl...2024-07-2222 minBiocompCHATibilityExploring Equivalency in Biocompatibilityn this episode of NAMSA’s BiocompCHATibility podcast, we welcome back Dr. Phil Smiraldo (Principal Toxicologist, NAMSA) for his third appearance as an honorary host. The discussion centers on the complexities of equivalency in biocompatibility, examining how equivalency can range from simple to complex and how a predicate device does not always equal equivalency.Listen in as we explore these topics with Dr. Smiraldo and gain insights into the intricate world of biocompatibility and the challenges faced when trying to establish equivalence between medical devices. “The world of equivalency runs the spectrum from incre...2024-07-0839 min
ExpertCast - Inovação em Saúde34- From Local Sucess to Global Impact: Key Insights into Device Innovation and Market Expansion - part 2Dr. Gustavo Meirelles leads the second part of the episode with guests Jasper Van De Sande, senior business consultant and partner at Suazio and Namsa, and José Leovigildo Coelho, CEO and co-founder of IONIC Health.Through their experiences and knowledge, they offer valuable guidance for companies looking to reach new markets and make a positive impact on global health. The journey of global expansion requires meticulous planning and a deep understanding of the inherent challenges at each stage. Jasper and Leo highlight the importance of assessing scalability and relevance, selecting strategic markets, conducting pilots and local validations, seeking s...2024-06-2626 min
The RA QA CaféHuman Factors: Real Life Testing for Real Life ExperiencesIn this episode of the RAQA Café podcast, our host explores the rapidly expanding field of human factors testing with two renowned experts—Dr. Caoimhe Duffy (Assistant Professor, Anesthesiology and Critical Care) from the Hospital of the University of Pennsylvania and Dr. Victoria Barnosky (Clinical Outcomes Consultant) from SUAZIO, now part of NAMSA. Tune in to learn about the vital importance and the intricate challenges involved in assessing how users interact with medical devices._“We all know that processes or workflows we’re doing here in the US are very different in other areas. There might be differe...2024-06-2538 min
ExpertCast - Inovação em Saúde34 - From Local Sucess to Global Impact: Key Insights into Device Innovation and Market Expansion - part 1The episode explores the challenges and strategies that medical device companies face in expanding their products and achieving a significant impact on a global scale. Dr. Gustavo Meirelles talks with Jasper Van De Sande, senior business consultant and partner at Suazio and Namsa, and José Leovigildo Coelho, CEO and co-founder of IONIC Health. The discussion delves into the main challenges companies encounter when trying to globally expand their healthcare innovations, such as rising healthcare costs that hinder the adoption of new technologies, constant changes in regulatory environments requiring continuous adaptation, and intense competition that necessitates distinction and dif...2024-06-1922 minThe RA QA CaféEpisode 13: Updates on the IVDRIn this episode of the RAQA Café Podcast, our host engages with Warren Jameson (NAMSA’s Sr. Manager, Regulatory & Quality) and Christele Perrin-East (NAMSA’s Sr. Regulatory Consultant, IVD), to explore the extension of the EU IVDR deadline and its implications for the industry.Our experts highlight the importance of maintaining progress towards IVDR compliance and registration despite the delay. The discussion also reflects on lessons learned from the EU MDR and examines how the IVDR extension might impact both new product registrations and updates to existing products previously regulated by the EU IVDD.“I think m...2024-04-2440 minThe RA QA CaféEpisode 12: The Relationship among Risk Management, Clinical Evidence and Post Market ReportsJoin us as we welcome two esteemed members of NAMSA’s Medical Writing team, Dr. Beatriz Rodriguez Grande and Dr. Sean Bird, for an insightful conversation on the intricate relationship between Risk Management, Clinical Evidence and Post-Market reports.Dr. Beatriz Rodriguez Grande, who began her career in the medical device industry as a Preclinical Research Scientist in 2010, joined NAMSA via AKRN Scientific Consulting in 2021. She now leads as Team Leader for Medical Writing Services and Manager Consulting GTC. Dr. Sean Bird started his career at Cook Medical as a Regulatory Scientist in 2012 and transitioned to NAMSA in 2021, wh...2024-03-0543 min
Let's Talk Risk! with Dr. Naveen AgarwalLTR 40: A guest podcast with NAMSA - Part 1Recently, I was invited by Richard Granquist and Linford Leitch from NAMSA to talk about risk management as part of their monthly RA QA Cafe podcast. In part 1 of a 2 part series, we discussed the following topics in a very open and engaging conversation!* How I got into risk management.* How I think about risk management in a small vs. large organization.* Why risk management is not a paper exercise, it is a process.* Why risk management approach should align with business goals.* A leadership opportunity for...2024-02-1642 minThe RA QA CaféEffective Communication with your Notified BodyIn this episode of NAMSA’s RAQA Café Podcast, we are excited to welcome back two esteemed members of the NAMSA team—Paul Risborough, B-Eng (Hons) (Principal Regulatory Consultant) and Matt Royle, PhD (Principal Regulatory Consultant)—to discuss aspects of effectively communicating with Notified Bodies.Both Paul and Matt bring a wealth of experience to the table, having previously worked for Notified Bodies themselves. They have since leveraged their knowledge to aid numerous NAMSA clients in navigating the nuanced interaction process with their respective reviewers.“You know the review system should be you get the first rou...2024-01-3141 min
The Medical Alley Podcast (Presented by MentorMate)The Best of 2023We had so many great guests on the podcast in 2023 and enjoyed all the conversations with leaders from Medical Alley who are all working to help make this region the epicenter of health innovation and care. Thank you to all of our guests on the podcast this year, and to all of you who tuned in to listen.As we look ahead to the new year, we first look back at the most-listened-to episodes of the Medical Alley Podcast in 2023. The top five episodes included:Relieving Lower Back Pain: A Conversation with Tyler Binney, President and...2023-12-1831 minThe RA QA CaféEpisode 10: Talking Risk with Dr. Naveen Agarwal - Part 2In the tenth installment of NAMSA’s RAQA Café Podcast, our hosts continue their conversation from the previous episode, “Talking Risk with Dr. Naveen Agarwal – Part 1,” with guest speaker Dr. Naveen Agarwal (Principal and Founder of Creative Analytics Solutions, LLC). This episode focuses on how to maintain a Risk Management System and shares industry best practices that our experts have acquired over their years in the MedTech sector. As a passionate advocate for risk management, Dr. Agarwal’s mission is to uplift the overall capability in risk management within the MedTech industry to accelerate innovation and launch highly safe and effecti...2023-12-1319 min
Healing Out Lao'dE36: Sabaidee Fest Reflections (Part 2) ft. Somlit, Joy, and SusanOn this week's surprise episode of Healing Out Lao'd, we released PART 2 of the Sabaidee Fest Reflection Series!!! [Sabaidee Fest is the largest Southeast Asian music and cultural festival]Part 2 takes a deep dive and highlights the POV of 4 Lao-identified diaspora attendees of Sabaidee Fest: Somlit, Joy, and Susan!!! Individually and collectively, all reflect on the festival's scenery, food, culture, music, and the ultimately question: what does it mean to be a part of the Lao American diaspora community??!If you missed out and have FOMO and want to know what went down during the...2023-12-0129 minThe RA QA CaféEpisode 9: Part 1: Talking Risk with Dr. Naveen AgarwalRisk management is an essential requirement for all medical device organizations when developing, manufacturing, and commercially distributing medical products. In the ninth episode of NAMSA’s RAQA Café Podcast, our hosts sit down with guest speaker Dr. Naveen Agarwal (Principal and Founder of Creative Analytics Solutions, LLC) to discuss valuable insights into Risk Management Systems and best practices for maintaining a Risk Management System. Dr. Agarwal’s mission is to help elevate the collective capability in risk management throughout the medical device industry to accelerate innovation and launch highly safe and effective products for patients and doctors....2023-11-2242 minBiocompCHATibilityChemistry with the MFDSIn this episode, our hosts are joined by Charles Ducker, PhD (NAMSA's Senior Director of Analytical Services) who recently returned from Korea, where he provided training to the MFDS (Ministry of Food and Drug Safety) about ISO 10993-18. Throughout this discussion, we review the use of the standard and how it is adopted by Korean authorities. We also explore the challenges that lie ahead for device developers and testing labs.“I think they [MFDS] were maybe surprised at the complexity. Laying out the information you have on your materials and the knowledge that you already have that ma...2023-11-1435 minThe RA QA CaféClinical Investigations: Collecting Proof that your Device is Safe and EffectiveClinical investigations play a crucial role in supporting regulatory submissions and must encompass the intended user and intended use environment. The U.S. Food and Drug Administration (FDA) refers to these pivotal studies as the definitive means of generating data that demonstrates the safety and effectiveness of a device for its intended use.Join our hosts for the eighth installment of the NAMSA RAQA Café Podcast, where they sit down with Wendy Schroeder (NAMSA Principal Product Development Strategist–IVD, Clinical) to discuss valuable insights into clinical investigations and clinical evaluations and examine the advantages and risks associated wit...2023-09-1341 min
Middle East Monitor ConversationsCan language and photography bring us together? MEMO in Conversation with Fadi BouKaram 'Cedrusk'Ever wondered why certain words cross borders and are used the world over? Fadi BouKaram has made it his business to find out whyDid you know the Arabic word for Austria - An-Namsa - comes from Proto-Slavic language and means 'mute' or someone who doesn't speak and this was applied to anyone who could not speak a Slavic language? Why is the loquat fruit in Turkish called yeni dunya or 'new world' while in Arabic it's called akideneh and iskidenya derived from...2023-09-0855 minThe RA QA CaféThe EU IVDR: What do you need to know?In the seventh episode of the NAMSA RAQA Café Podcast, our hosts sit down with Warren Jameson (NAMSA Senior Manager of Regulatory and Quality) and examine the European Union (EU) In Vitro Diagnostic Regulation (IVDR). IVDR 2017/746 was published in the Official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017, gradually replacing the EU’s former Directive on in vitro diagnostic medical devices (98/79/EC).“In regards to the IVDR you have three things that you have to formalize, you have scientific validity, clinical performance and analytical performance. ” – Warren JamesonDiscussion topics include:What is...2023-08-0954 minHealing Out Lao'dE35: Sabaidee Fest Reflections (Part 1) ft. Saengthong DouangdaraLONG TIME NO SPEAK P'NONG!!! On this week's surprise episode of Healing Out Lao'd, we are reflecting and reminiscing our experiences of the largest Southeast Asian music and cultural festival-- Sabaidee Fest!!!This episode is PART 1 of a 2 PART SABAIDEE FEST REFLECTION SERIES that is intentional in highlighting the POV of 2 Lao-identified diaspora attendees of Sabaidee Fest. Saeng and Rita unpack raw emotions from attending the festival's scenery, food, culture, community growth, and most importantly-- LAO JOYYY. If you missed out and have FOMO and want to know what went down during the first Sabaidee...2023-08-0330 minThe RA QA CaféCompliance Pitfalls (Animal Study)In our sixth episode of the NAMSA RAQA Café Podcast, we sit down with guest speaker Jack Risdahl, NAMSA Principal Product Development Strategist and Doctor of Veterinary Medicine.During our discussion, Jack delves into common mistakes that are observed when conducting In Vivo studies, ways in which to mitigate these mistakes and variances pertaining to In Vivo study expectations in different global markets.“We reach out to other experts and bounce ideas. Am I missing something based on your experience?” – Jack Risdahl (Principle Product Development Strategist)Discussion topics include:Institutional Animal Care and Use...2023-07-1233 min
Let's Talk Risk! with Dr. Naveen AgarwalLTR14: The most important question for risk management: who is taking the risk?In this episode, Adam Saltman reminds us to not consider risk as an absolute concept; rather think about it in the context of the end user or the patient who is being asked to take the risk in return for a benefit to their health. There is a disconnect in the medical device industry between patients, manufacturers and regulators. By considering the question “who is taking the risk?”, we can stay focused on the end user or patients as we build and launch medical devices. About Dr. Adam SaltmanDr. Adam Saltman started his...2023-07-0133 minThe RA QA CaféRAQA Café Live! - RAPS EU Convergence and effective MDR-compliant Periodic Safety Update ReportsNAMSA and the Regulatory Affairs Professionals Society (RAPS) are delighted to host the first live edition of the RAQA Café!In this episode, our hosts will sit down with NAMSA UK-based Medical Device Regulation (MDR) experts, Matt Royle (Principal Regulatory Consultant) and Paul Risborough (Principal Regulatory Consultant) to discuss all things RAPS, including:Highlights and takeaways from the RAPS EU Convergence ConferenceBest practices for writing effective MDR-compliant Periodic Safety Update Reports (PSURs)Lessons learned when documenting benefit-risk in recent projects… and much more!2023-06-271h 00The RA QA CaféIVD Special - Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and ExpectationsIn our fourth episode of NAMSA's RAQA Café Podcast, our hosts are joined by NAMSA guest speakers, Sonia Lecce (Principal IVD Regulatory Consultant) and Duan Threats (Senior IVD Regulatory Consultant).During the discussion, Sonia and Duan delve into the differences between SiMD and SaMD for In Vitro Diagnostics (IVD), as well as FDA criteria deemed important during evaluation of safety and effectiveness of IVD software with one or more device functions.“Things have changed in diagnostics tremendously; they have brought diagnostics to the forefront as a norm rather than an afterthought” – Sonia Lecce (Principal IVD Regulat...2023-06-1435 min
Medsider: Learn from Medtech and Healthtech Founders and CEOsWhat it Takes to Bring a Medical Device to Market: Interview with Tim Blair, CEO of ICHORIn this episode of Medsider Radio, we sat down with Tim Blair, CEO of ICHOR, an early-stage company developing a novel approach to thrombectomy in the peripheral vascular system.With a rich, 30+ year career in the medtech industry, Tim Bhas held diverse roles spanning sales, marketing, and strategy development, both in multinationals and startups. In 2009, Tim brought his strategic vision to NAMSA, shaping it into one of the world's first Medical Research Organizations (MROs). Currently, as CEO and co-founder, Tim is leading ICHOR on its quest to transform thrombectomy in the peripheral vascular system.2023-06-1337 min
The Leading DifferenceDuane Mancini | CEO of Project Medtech | From Podcast to Consultancy to Hosting Events, Science, & FamilyDuane Mancini is the CEO managing partner and founder of Project Medtech. In this episode, he shares how Project Medtech quickly evolved from one industry podcast to two, then to consulting for medtech startups, and now to hosting events. He also discusses his passion for the industry, his background as a scientist, and how his family, friends, and the startups he helps motivate him and always prompt him to smile.
Guest links: https://www.projectmedtech.com/ | https://www.linkedin.com/in/duanemancini/
Charity supported: Save the Children
Interested in being a guest on th...2023-05-1938 minThe Leading DifferenceDuane Mancini | CEO of Project Medtech | From Podcast to Consultancy to Hosting Events, Science, & FamilyDuane Mancini is the CEO managing partner and founder of Project Medtech. In this episode, he shares how Project Medtech quickly evolved from one industry podcast to two, then to consulting for medtech startups, and now to hosting events. He also discusses his passion for the industry, his background as a scientist, and how his family, friends, and the startups he helps motivate him and always prompt him to smile.
Guest links: https://www.projectmedtech.com/ | https://www.linkedin.com/in/duanemancini/
Charity supported: Save the Children
Interested in being a guest on th...2023-05-1938 minThe RA QA CaféThe Role of Software in Healthcare - Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and ExpectationsWhat are the differences between Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD)? In this third episode of NAMSA's RAQA Café Podcast, our hosts are joined by NAMSA guest speakers, Lezlie Hynes (Principal Quality Consultant) and Monica R. Montanez (Principal Product Development Strategist).During the discussion, they delve into the differences between SiMD and SaMD, as well as FDA criteria deemed important during evaluation of the safety and effectiveness of device software with one or more device functions.“I get a lot of questions related to the FDA guidance document. Mos...2023-05-1035 minThe Medical Alley Podcast (Presented by MentorMate)Interacting with the FDA: A Conversation with Chris Mullin, Director of Global Strategy Services, NAMSANAMSA, a leading medtech contract research organization, has been a longtime partner of Medical Alley. On this week's episode of the Medical Alley Podcast, we're joined by Chris Mullin, the Director of Global Strategy Services at NAMSA, to learn more about what the organization does, NAMSA's relationship with the FDA, and much more. Send us a message!Follow Medical Alley on social media on LinkedIn, Facebook, X and Instagram. 2023-04-2426 min
NATO-TVLiving Without Fear - Part 1NATO is currently conducting a project in Ukraine with the aim of destroying weapons and ammunition inherited by Ukraine following the break-up of the Soviet Union. The population and local industries are playing a part in this program. Includes interview with Vasyl Lytvynchuk, NAMSA Project Supervisor in Ukraine; Lubov Borita; Galina Sobatchinski; Serhiy Brul, Director of Department for the Demilitarization, Ukraine; Anatoliy Yuschchyshen, Head of Demilitarization Center of Hrechany; Pertro Kravchuc, Chief of Engineering; and Rashid Saifulin, Chief of SAWL Demilitarization Center. Also available in high definition.2023-04-1704 minThe RA QA CaféRefuse to Accept Policy and the Future of FDA SubmissionsWhat is the FDA’s Refuse to Accept Policy? In this second episode of NAMSA's RAQA Café Podcast, we are joined by NAMSA’s Principal Product Development Strategist, Angela Mallery, to examine the procedures and criteria FDA use in assessing whether a premarket notification 510(k) submission meets a minimum threshold of acceptability, and if it should be accepted for substantive review. Also discussed during this podcast is FDA’s voluntary eSTAR (electronic Submission Template and Resource) program, which aligns with FDA’s internal review template and integration of guidance expectations.“When you are doing your 510(k), you should set...2023-04-1231 minThe RA QA CaféChoosing the Right ConsultantFinding the right consultant is crucial to the success of your project. In this first episode of NAMSA’s RAQA Café Podcast, our hosts, joined by two guest speakers, delve into the many aspects that must be considered when choosing the best consultant for your product development needs. Providing perspectives from both large-scale manufacturers and small startups, our guest speakers help highlight the different needs that each type of customer requires.“I think that communication is important with your consultant or CRO. Finding one that you can communicate with, that they understand your needs, that you can have...2023-03-1036 minBiocompCHATibilityWelcome to the RA QA CaféIn this first BiocompCHATibility Podcast episode of 2023, our hosts are happy to introducea new podcast to the NAMSA family, and talk a little bit to the hosts about the insightfultopics to come.This new, conversational podcast will feature a new set of hosts who dedicate eachepisode to trending regulatory and quality affairs topics within the MedTech industry.Future topics include:Refuse to Accept Policy for 510(k)s – This episode will delve into the proceduresand criteria FDA intends to use in assessing whether a...2023-02-0731 min
The Medical Marketing Executive"Adapting to Changing Times" with Anney PetersonKurt talks with Anney Peterson, Senior Global Marketing Operations Specialist at NAMSA. Anney talks upon marketing the right messages for each individual product and finding the clients who aren't utilizing the service. She explains how she rose to her position and the skills that she used to get there.2022-07-2526 minBiocompCHATibilityWhat Exactly is my Test Article?In this episode, Dr. Phil Smiraldo (NAMSA’s Senior Toxicologist) joins us to discuss the test article and the many challenges with identification and preparation. Throughout this discussion, we explore the many different types of test articles and help define what is considered patient contact and what is not? We also review how you can best work with your laboratory to define your test article preparation and make certain the test article definition is clear to the regulatory agencyListeners can expect to learn:How to easily define their test articleKey points to consider when separating pa...2022-07-2532 min
The Medical Alley Podcast (Presented by MentorMate)Webinar Replay: Global Regulatory and U.S. Reimbursement SeminarThe Medical Alley Association and its partners, Investissement Quebec and the Quebec Government Office in Chicago, present a seminar preparing new market entrants for global regulation and U.S. reimbursement. Medical Devices and Digital Health products face a range of regulations in the United States, primarily from the Food & Drug Administration (FDA). Further, reimbursement, or payment for various health services, in the U.S. differs significantly compared to most other countries.A mix of public and private, national and regional, and separate of medical, dental, vision, and pharmacy benefits means your path to securing payment can be complex and fraught...2022-07-181h 00Healing Out Lao'dE34: Somlit Inthalangsy on returning to his Lao name + embodying dad's legacy of community organizing & finding home away from home in Laos AngelesFINAL SZN 2.0 Episode 34 features a conversation between creator/host Rita Phetmixay and actor/co-host of Laos Angeles Deuan Sabaidee, Somlit Inthalangsy!During this episode, Somlit speaks on returning to his Lao name + embodying dad's legacy of community organizing & finding home away from home in Laos Angeles.As the co-host of the Laos Angeles Deuan Sabaidee, Somlit organizes monthly gatherings for LA/Orange County community members who have roots in Laos to connect and build sustainable relationships. Today, Somlit is taking a break from social media and acting to focus on personal development and...2022-04-171h 09
Let's Combinate - Drugs + Devices027 - "Become a Historian of the Problem" with Duane ManciniOn this episode, I was joined by Duane Mancini, CEO and Managing Partner of Project Medtech and host of the Project Medtech Podcast. Duane and I discuss:
Why he enjoys working with Startups
Reimbursement considerations for Startups
Importance of Regulatory Strategy for Startups
Project Medtech and Medtech Money Podcasts
Startup Symposiums
Combination Products Startups
Startup Symposium in Columbus, OH on 15-Jun-2022 - Register here
Book Recommendation: Your Life Depends on It: What You can do to make better choices about your health Link
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Duane Mancini is a chemist by training and holds a Master of Science degree in Medicinal...2022-04-0659 minBiocompCHATibilityFDA Thoughts On Chemical CharacterizationIn this episode, our hosts are joined by NAMSA Associate, Dr. Darin Kent, and second-time guest, Dr Ted Heise, to discuss the new paper released by the FDA and the American Chemical Society. The intention of this latest FDA publication is to examine specific topics that promote continuous discussion around the disparities between where the industry currently stands and how alignment and proper development may occur. Listen in as these industry experts explore the topics covered by the FDA within this document, as well as the challenges faced by medical device manufacturers and testing laboratories regarding chemical...2022-03-2835 minHealing Out Lao'dE33: Christy Innouvong-Thornton on experiences of growing up without her Lao Isan parents + moving beyond narratives of forced resilience & giving back through Southeast Asian foodwaysEpisode 33 features a conversation between creator/host Rita Phetmixay and founder of Courageous Kitchen & TukTuk Box enterprises, Christy Innouvong-Thornton!During this episode, Christy reflects on her painful experiences of growing up in a white household (w/o her Lao Isan parents) + moving beyond narratives of forced resilience & giving back through Southeast Asian foodways. Today, Christy is living her best life in North Carolina, while feeding, educating and creating socioeconomic advancement for Southeast Asian people through TukTuk Box, a specialty food retailer storytelling platform. ----------CONNECT WITH CH...2022-03-201h 06BiocompCHATibilityDon’t Forget Packaging!In this episode, NAMSA’s Senior Product Development Specialist, Ed Arscott, joins our hosts to examine the relationship between packaging and biocompatibility, including: how to evaluate primary packaging for biological safety. The discussion also focuses on the direction provided in ASTM F2475-05 Standard Guide for Biocompatibility Evaluation ofMedical Device Packaging Materials.Listeners can expect to learn:Where to look for guidance on packaging evaluation for medical devicesKey points to consider when looking at material contact to medical devicesEvaluating device/package interactionAssessing cases or primary packaging for reusable devices“I’m happy...2022-02-2234 minHealing Out Lao'dE32: Andrew David Vilaythong on growing up with a parent suffering from mental illness + therapy as a tool for addressing conflict-avoidant behaviors & music as self-explorationEpisode 32 features a conversation between creator/host Rita Phetmixay and music maker/DJ/audio editor of HOL– Andrew David Vilaythong!During this episode, Andrew reflects on his experiences of growing up with a parent suffering from mental illness + therapy as a tool for addressing conflict-avoidant behaviors & making music as self-exploration. Today, Andrew continues to thrive in his creativity thru DJing/producing beats and being the best plant dad he can be to his 15+ plant children in Los Angeles. ----------CONNECT WITH ANDREW @AndrewDavidV: Insta...2022-02-2054 min
The Med-Tech Talent LabMed-Tech Startup Challenges & Resources-Duane Mancini-Project MedTechI was so excited to host Duane Mancini, the Founder & CEO of Project Med-Tech, primarily because Duane and his team are adding so much value to the industry at large by way of the fantastic content they put out on a regular basis.Duane hosts the Project MedTech podcast where he interviews leading experts in the Medical Device industry on a variety of topics related to major successes, pitfalls, and trends.Recently, Project MedTech has morphed into a full-blown business of resources for Med-Tech startups at any phase the company is working through....2022-01-2427 minHealing Out Lao'dE31: #HealingTheHealer-- Stephanie Franco on writing as resistance + cultivating mental health equity for BIPOC across cali & tapping into radical imaginationEpisode 31 brings back the #HealingTheHealer series, which was first created in order to share the experiences of people in Rita’s lives that have empowered her healing process. In this first episode of 2022, Rita dives into a conversation with Stephanie Franco (aka “SPESH”), who is a creative writer, audio storyteller and sound designer/engineer based in Oakland, California. During this episode, Stephanie reflects on her experiences of growing up in the BAY AREA (Haywaaard), writing as resistance, cultivating mental health equity for BIPOC across Cali & tapping into radical imagination.----------CONNECT...2022-01-0957 minHealing Out Lao'dE30: Lina V Luangrath on overcoming domestic violence, finding inner liberation thru music, & meeting Lao ancestors for the first timeThis episode features a conversation between creator/host Rita Phetmixay and the talented Lao American musician and family woman, Lina V Luangrath. During this episode, Lina reflects on her experiences of growing up in an impoverished Lao/BIPOC community in Rockford, Illinois + overcoming domestic violence + finding inner liberation thru music, & meeting Lao ancestors for the first time. Today, Lina is living the dream by singing/performing on various stages across Los Angeles, as well as building community with hosting events. She also enjoys cheffing it up in the kitchen and cooks SAAP SAAP Lao food and Jamaican ox...2021-12-051h 14BiocompCHATibilityBiological Equivalency: When is “same” the same?In this episode, our hosts are joined by NAMSA Toxicologist, Michelle Kelly, to discuss the ever-elusive biological equivalency claim. The discussion focuses on how to maintain the balance of the risk and benefit of a medical device without stalling innovation. We also explore equivalency and how it is not only a key concept to the risk analysis but also a challenging concept to prove.“This is often a controversial topic.” – Sheri Krajewski“You not only have to think about equivalency per 10993-1, but also think about it as one aspect of equivalency that is sitting in the MD...2021-11-2245 minHealing Out Lao'dE29: Lao Womxn Healing CircleEpisode 29 features creator/host Rita Phetmixay with special guests Seraphina Lotkhamnga, Joy Ngaosivath, and Carole Chainon. Together, they dialogue and reflect on what it means to be daughters of Lao refugees who uniquely embody intergenerational ancestral strength.GUEST BIOs: Seraphina Lotkhamnga is Sr. Creative Manager of Sync at Nettwerk Music Group and has been in the music industry for over a decade. In addition, Seraphina is also known for documenting her favorite foods over at FoodiePhina and using her hand to show where she's originally from in Michigan. She is also...2021-11-141h 16
Bande à part148: Namsa LeubaWe talk about the fascinating photographs of Namsa Leuba and what we learned from her recent online conversation with Nomusa Makhubu, organised by London’s Photographers’ Gallery. See links below.
http://www.namsaleuba.com/
Artist Talk: Namsa Leuba, Photographers’ Gallery, London (12 October 2021): https://thephotographersgallery.org.uk/whats-on/artist-talk-namsa-leuba
Miss Rosen, ‘Namsa Leuba’s kaleidoscopic photographs explore the politics of the gaze’, Dazed (13 October 2021): https://www.dazeddigital.com/art-photography/article/54348/1/namsa-leuba-kaleidoscopic-photographs-explore-politics-of-the-gaze-crossed-looks
Namsa Leuba, ‘Crossed Looks’, Halsey Institute of Contemporary Art at The College of Charleston (27 August – 11 December 2021): https://halsey.cofc.edu/main-exhibitions/crossed-looks/
Helen Jennings, ‘Namsa Leuba’, Nataal (2016): https://nataal.com/namsa-leuba
Esther Ma...2021-10-1727 minHealing Out Lao'dE28: Phetmixay Sibling Reunion on Rupture & Repair Mid-PandemicEpisode 28 features three out of the four Phetmixay siblings: David, Rita, and Joseph Phetmixay, who come together to reflect on how this pandemic has impacted each individually and how family conflict & reconciliation have helped drive closer ties between each other. Together, they discuss ways on how to best support one another and make it through COVID-19 as they all live worlds apart. ----------SUBSCRIBE x FOLLOW x RATE x REVIEW! Healing Out Lao’d is created/hosted by Rita Phetmixay and manifested by a collective Lao diaspora voice. HOL is a podcast and virtual pra...2021-10-1041 minBiocompCHATibilityThe QB1 of GLPIn this episode, our hosts are joined by the QB1 (or 4 of them) of GLP (Good Laboratory Practice), NAMSA’s Study Directors. Throughout this podcast, the team delves into the role of the Study Director in biocompatibility and chemical characterization studies, discussing day-to-day activities, legalities, key factors manufacturers should know about working with a Study Director, and the qualifications needed to be an effective Study Director.Discussion points include:GLP and what it means for biocompatibility studiesThe role of the Study Director in the GLP programThe history of adopting GLP guidance from pharmaceutical studies and how th...2021-09-2841 minHealing Out Lao'dE27: Joseph Phetmixay on growing up as Lao GenZ in NC during era of Uprisings & COVID-19E27 features Joseph Phetmixay, baby brother to Rita Phetmixay AND youngest sibling of the Phetmixay family! Not only is Joseph the youngest child, he’s also the youngest guest on HOL and here to rep all the Lao GEN Z folx out there!! Rita gets to interview Joseph and explore his personal experiences of growing up as a Lao American high school kid in the south during the onset of political rising/anti-Asian hate and COVID-19 pandemic. Joseph’s critical self-reflection during last years of high school led him to confront an identity crisis and find Buddhist pract...2021-09-2649 min
Market PathwaysAppraising the Medtech Innovation Ecosystem with Nadim YaredNadim Yared is a medtech CEO who is not afraid of digging into the details—the regulatory details; the nooks and crannies of Medicare coverage, coding, and payment; the finer-points of p-values and novel clinical trial designs. He has dug in deep on these matters and more during his 15 years at the helm of CVRx Inc., which as recently transitioned to a commercial phase, public company with its Barostim Neo heart failure device. And he has also done so as part of his very active role in cross-industry endeavors on the boards of AdvaMed, the Medical Device Innovation Consortium, and, most...2021-09-2352 minHealing Out Lao'dE26: "The Right to Heal: Southeast Asian American Mental Health in CA" [SEARAC report launch]On behalf of the Laotian American National Alliance, creator/host Rita Phetmixay of Healing Out Lao’d was invited to be a part of a virtual launch event hosted by SEARAC + partners on March 25, 2021. This audio recording captured SEARAC’s debrief of their new report titled: "The Right to Heal: Southeast Asian American Mental Health in California,” which highlights both the challenges and the solutions for addressing mental health disparities among Southeast Asian Americans in California and across the country. The full report can be downloaded here.Other helpful links: Event recordingReport/factsheetsSocial media toolkitIf you...2021-09-121h 46Healing Out Lao'dE25.2: Lao Sibling Reconciliation (Part 2) on saving face, vulnerability and building compassionHealing Out Lao’d SZN 2.0 launches part two of the Lao Sibling Reconciliation episode, which explores the direct impact of saving face, vulnerability and building compassion. Facilitated by Wanda Pathomrit, this intimate conversation between HOL creator/host Rita and her older brother (Aiy David) further explores the questions of what it means to protect your family’s name/reputation, breaking free from family interpersonal conflict/violence/silenced oppression and so much more!SUBSCRIBE x FOLLOW x RATE x REVIEW! Healing Out Lao’d is created/hosted by Rita Phetmixay and manifested by a collect...2021-08-2955 minHealing Out Lao'dE25.2: Lao Sibling Reconciliation (Part 2) on saving face, vulnerability and building compassionHealing Out Lao’d SZN 2.0 launches part two of the Lao Sibling Reconciliation episode, which explores the direct impact of saving face, vulnerability and building compassion. Facilitated by Wanda Pathomrit, this intimate conversation between HOL creator/host Rita and her older brother (Aiy David) further explores the questions of what it means to protect your family’s name/reputation, breaking free from family interpersonal conflict/violence/silenced oppression and so much more!SUBSCRIBE x FOLLOW x RATE x REVIEW! Healing Out Lao’d is created/hosted by Rita Phetmixay and manifested by a collect...2021-08-2955 min
Life Science TodayLife Science Today 063 – Medtronic, Sanofi, Adagio, Moderna, WCG, Inotiv, NAMSA, CenExelOriginally Published as The Niche PodcastDevice acquisitions, rare disease approvals, COVID success stories, and clinical research ups and downs. Find out more athttps://thenichepod.comStory Referenceshttps://tinyurl.com/Niche-063-1https://tinyurl.com/Niche-063-2https://tinyurl.com/Niche-063-3https://tinyurl.com/Niche-063-4https://tinyurl.com/Niche-063-5https://tinyurl.com/Niche-063-6https://tinyurl.com/Niche-063-7https://tinyurl.com/Niche-063-8https://tinyurl.com/Niche-063-9https://tinyurl...2021-08-0909 minHealing Out Lao'dE25.1: Lao Sibling Reconciliation (Part 1) on gender roles, birth order, and parentificationHAPPY RELAUNCH DAY P’NONG/FAMILY!!! Healing Out Lao’d SZN 2.0 is finally here!!! In this first relaunch episode, creator/host Rita Phetmixay engages in a (part 1) in a deeply personal and heartfelt conversation with her big brother David, facilitated by big sis Wanda Pathomrit. Together, they dialogue on the impact of gender roles, birth order, and parentification while growing up as children of Lao (Isaan) refugees in North Carolina. SUBSCRIBE x FOLLOW x RATE x REVIEW! Healing Out Lao’d is created/hosted by Rita Phetmixay and manifested by a collective Lao diaspora...2021-08-081h 01BiocompCHATibilityNAMSA Awarded ASCA AccreditationNAMSA is pleased to announce that the U.S. Food and Drug Administration (FDA) granted the organization Accreditation Scheme for Conformity Assessment (ASCA) status on July 23. The ASCA Pilot Program, a first-of-its-kind assessment created by the U.S. FDA, reduces the regulatory burden on medical device manufacturers through consensus of biocompatibility testing requirements for efficiency. In this episode, our hosts are joined once again by Lisa Olson, NAMSA’s Senior Vice President of Global Laboratory Operations to discuss the importance of this accreditation and what it means to NAMSA. But perhaps most importantly, what this status means fo...2021-07-2834 min
The Joe Ciccarelli Show#38 John Gorski - Former CEO of NAMSAThis Week’s Conversation: John Gorski
Former CEO of NAMSA (North American Science Associates)
What You’ll Get from this Episode:
Leading by Asking the Right Question.
The Importance of a Healthy Tension in Business - and Life.
An Actionable Approach to Servant Leadership.
And A Lot More.
Listen. Enjoy. Tell Us What You Think Below.2021-05-2649 minBiocompCHATibilityWhy biocompatibility cares about preclinical: NAMSA and APS discussIn this episode, our hosts are joined by APS’s Senior Director of Biocompatibility Services, Dr. Yan Chen, to discuss NAMSA’s acquisition of APS and the importance of preclinical studies in the biological evaluation of medical devices.This podcast discussion revolves around the many synergies of the combined companies, as well as a technical discussion regarding preclinical studies, preclinical study biocompatibility endpoints, and of course, an energetic game of ‘2 Truths and a Lie’ that will surely bring you a laugh.“We have expanded the possibilities of people who can join us now.”-Sheri Krajewski“We are...2021-03-2249 minBiocompCHATibilityWhen to Go with In Vitro: Your Irritation Questions AnsweredIn this episode, our hosts answer listener questions regarding the new ISO 10993-23:2021 from NAMSA’s February 3, 2021 webinar.The standard recommends that In Vitro testing be completed prior to In Vivo testing, warranting many questions about how to deal with legacy data, regulatory acceptance and timelines. Our hosts will provide podcasters a full episode of responses, possible scenarios and potential recommendations.“This is an extraction-based evaluation and you will be creating and dosing extracts in most cases. There is not a direct contact equivalent for the In Vitro like there is In Vivo.” Don Pohl“...2021-02-2235 minBiocompCHATibilityIs Your BioCompatibility Program Knocking Your Submission Off Track?In this episode, our guests are joined by Syntactx’s Dr. Valerie Merkle, Associate Director – Regulatory Strategy, to discuss NAMSA’s recent acquisition of Syntactx.During this one-hour installment, Dr. Merkle discusses her deep-rooted experience at the FDA and the importance of proper biological safety planning to achieve biomechanical efficiency and successful clinical trial execution. Examples will be provided regarding how and when biocompatibility programs go wrong, which often result in derailment of development efforts. How can manufacturers create biocompatibility programs that are observed favorably by the FDA? Learn helpful tips and strategies to help ensure a succes...2021-01-2542 minBiocompCHATibilityOh No, Another Failed CytoIn this episode, our guests are joined my NAMSA’s Melissa Cadaret to discuss the ever-confusing cytotoxicity failure. Manufacturers can have more questions created when encountering an unexpected cytotoxicity result and these podcast experts have seen thousands of various cytotoxicity results. The information provided from a cytotoxicity test can be useful and stressful, so what do manufacturers need to know to navigate the cyto failure, whether expected or unexpected.“I would say we generally see some type of cytotoxicity failure weekly.” –Melissa Cadaret “Cytotoxicity is not really an end point. It’s a screen.” – Sheri Krajewski-Bibins2020-12-2035 minBiocompCHATibilityWhat in the world is the FDA’s Lab Accreditation Program – ASCA?In this episode, our hosts are joined by Lisa Olson (NAMSA’s Vice President, North American Lab Services) to discuss the U.S. FDA’s new Accreditation Scheme for Conformity Assessment (ASCA). This pilot program, launched September 24, 2020 with a new guidance document, is designed to accredit laboratories for certain biocompatibility tests, allowing for decreased paperwork and time for certain regulatory submissions, among other things. Although this is not specific to the device manufacturer unless they have an in-house laboratory, it is important for manufacturers to understand what ASCA is, how it is implemented and how important it may be when...2020-10-2637 min