Shows
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 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 minBiocompCHATibilityNew FDA Biocompatibility Guidance – Let’s DiscussOn the latest installment of the BiocompCHATibility podcastis episode, our hosts are joined by Dr. Phil Smiraldo for his third feature3-peat episode on the podcast.The conversation throughout this episode focuses and we discuss on the new recently published FDA biocompatibility guidance document —issued onn September 7, 2023.“My favorite nuance is that annex A has slightly been updated because now the X’s and O’s are almost all gone.” – Don Pohl“Of these materials, you touch them every day, and your clothes are made out of them... Why would we need to do biocompatib...2023-10-0438 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 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 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 minBiocompCHATibilityDon’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 minBiocompCHATibilityBiological 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 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 minBiocompCHATibilityBiocomp and BeerIn its third year, the North American Biocompatibility Summit (NABS) is a limited-seating event that provides industry insights and expertise sharing on the biocompatibility of medical devices. This year, sessions will include the latest regulatory updates, biological evaluation strategies, and best practices that lead to successful biocompatibility programs in 2021 and beyond. In this episode, our hosts discuss this upcoming event and what attendees can expect. This includes details on the NABS Scientific Advisory Board, abstract submissions, and how the Board determined what educational opportunities to offer. Listeners will learn more about featured topics, including the overall theme t...2021-08-0920 minBiocompCHATibilityNAMSA 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 minBiocompCHATibilityBiocompatibility FAQOver the last year, the BiocompCHATibility Podcast hosts have been compilingquestions asked by our listeners and training series attendees. In this episode, wewill answer your frequently asked questions about all things biocompatibility—andno, we did not answer why Don is funnier than Sheri (it is definitely a growthopportunity for her).Highlights include:The use of clinical data in the biological evaluationCompleting chemistry testing before in vitro/in vivo studiesGathering historic data -and how much is useful to the evaluationU.S. FDA and DBT (dose ba...2021-05-2732 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 minBiocompCHATibilityIntact Skin Contact Devices: To Test or Not to TestIn this episode, our hosts are joined by Allison C. Komiyama, Ph.D., R.A.C., Owner and Consultant at AcKnowledge Regulatory Strategies and former U.S. FDA reviewer, to discuss the U.S. FDA’s latest draft guidance, “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.” The FDA has determined the biocompatibility risk of various polymers and fabrics to be low based upon a safe history of use in medical devices for this categorization. Our hosts dive into the list of materials as well as the nuances of this guidance that will ideally help manufac...2020-11-2340 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 minBiocompCHATibilityThe Facts About In vitro IrritationIn this episode, our hosts are joined by Dr. Joe Carraway, co-author of the new research paper, “The suitability of reconstructed human epidermis models for medical device irritation assessment: A comparison of In Vitro and In Vivo testing results,” which discusses in vitro irritation assays and their viability for medical device testing. The three Rs in this type of experimentation, which stand for Replacement, Reduction and Refinement, are a concept always considered for new test development. In vitro irritation is one of the latest to reach the normative text of the ISO standards and manufactures and laboratories will need to be...2020-09-2843 minBiocompCHATibilityISO 10993-4: The Second Most Misunderstood Section of 10993In this episode, two esteemed colleagues from Abbott, Tim Schatz and Ken Grove, join our hosts discuss ISO 10993-4:2017 Biological Evaluation Of Medical Devices - Part 4: Selection Of Tests For Interactions With Blood. Our experts highlight the general requirements of this very important and sometimes misunderstood segment of biological evaluations, including how to classify products requiring this test and how various products and scenarios may call testing evaluations. “We are discussing specifically contact with circulating blood directly or contact with circulating blood indirectly at its most basic element.” –Don Pohl“When assessing blood damage, we really use...2020-08-241h 06BiocompCHATibilityFDA and ISO 10993-18: 2020In this bonus episode, our hosts discuss the new FDA Supplementary Information Sheet (SIS) on ISO 10993-18:2020 and their extent of recognition. On July 6, 2020 the FDA released this document to help clarify how manufacturer’s should utilize ISO 10993-18:2020 for US submissions. With this release, may come more questions than answers, so we decided to try to clarify this document and highlight the items that have the most impact to manufacturers and their upcoming submissions. “There’s certainly a lot to recognize or not recognize when it comes to part 18.” – Don Pohl “What you’re hoping to see...2020-07-2027 minBiocompCHATibilityListener Mail Bag – We Answer Your QuestionsIn this episode, our hosts answer your questions about biocompatibility. After 15 episodes of discussing what we think is important surrounding this topic, we asked for your questions and created this special episode to answer them. “A toxicological risk assessment is the process of focusing on the risk associated with the chemicals that are in or may come out of a device, that’s your primary focus.” –Don Pohl “The first step to investigation is trying to understand root cause […] what went into to my device that might cause this response.” - Don Pohl “I love the ever...2020-07-2033 minBiocompCHATibilityFinding the Qualified Biocompatibility UnicornIn this episode, our hosts are joined by Nicole Soucy, PhD, DABT from Boston Scientific to discuss qualifications of expert assessors and other personnel qualified to make biological evaluation decisions for medical devices. Documents including ISO 10993-1, Medical Device Regulation (MDR) documentation submissions and BSI best practice guidelines recommend having a qualified individual make decisions for the biocompatibility of medical devices.While many testing organizations claim to perform this work, what does “qualified” really mean and how do companies determine this qualification?In this episode, our experts discuss hiring and training processes utilized to identify and...2020-06-2240 minBiocompCHATibilityBiocompatibility and the Pre-sub meeting – the Devil is in the DetailsIn this episode our hosts are joined by 2 esteemed colleagues from Abbott: Deanna Porter, Kent Grove to discuss the US FDA pre-sub meeting process as it pertains to the biocompatibility of Medical devices.The group will review the current procedure for a pre-sub meeting and how this opportunity to obtain FDA feedback prior to an intended submission can be very useful, especially for programs containing chemical characterization or other complex testing protocols.It’s a great opportunity to receive feedback and responses to specific questions, although not guaranteeing approval, the guests show today how using th...2020-05-2537 minBiocompCHATibilityA Start-Up Biocompatibility Story – Prescient SurgicalIn this episode our hosts are joined by Jeremy Koehler, Director of R&D for Prescient Surgical. Prescient Surgical is a small medical device company in the San Francisco area, with a biocompatibility story to tell.Their first product submitted to the FDA, although not a high risk device, encountered delays directly related to some biocompatibility testing and the program. As a young start-up this can be very time consuming and most of all expensive.“As a small company, speed is everything and time is a precious commodity.” Jeremy Koehler“Externally communicating, limited contac...2020-04-2135 minBiocompCHATibilityCovid 19 Topic: Biocompatibility of Ventilators and Other Respiratory DevicesIn this special release episode, our hosts are joined by Dr. Phil Smiraldo, Toxicologist at NAMSA.During this episode the team discusses the current pandemic situation of Covid 19 and the production of ventilators and respirators to help treat and prevent spread of this virus. With companies like Dyson, Ford, GMC and others discussing the design and/or manufacture of ventilators to meet the growing need of infected patients, how do we insure biological safety on a very short term?Hosts will discuss some guidance put in place by the UK and USFDA alike that address...2020-04-0343 minBiocompCHATibilityReusable devices and the challenges with biocompatibilityOur hosts are joined this week by Stephanie Taylor, Staff Scientist - Toxicology and Biocompatibility at DePuy Synthes Companies. During this episode the team discusses the reprocessing of reusable devices and the challenges of the ever- changing landscape of the biological evaluation of such devices.There is activity requested both by the USDA and the EU that greatly impacts the timelines and costs of evaluating these devices for biological safety, so the team shares some strategies and practices used by manufacturers today to meet high regulatory expectations.“The end goal is a defensible position.” -Stephanie Tayl...2020-03-2329 minBiocompCHATibilityWebinar questionsDuring this episode, our hosts are joined by Andy Wyen, Toxicologist at NAMSA, to answer questions received during NAMSA’s live Webinar on the new ISO 10993-18:2020. As this new standard is a complete re-write from the 2005 version, it is stirring up industry and leaving many manufacturers confused and searching for the most efficient adoption methods.Topics include:Triplicate testing and how to determine if there is low variability in a sample before extraction has occurredAET: How to calculate the number of devices used in clinical use for a chronic device that can be used during someo...2020-02-1437 minBiocompCHATibilityThe biological evaluation plan and a manufacturers perspective, with guest Dave Parente of Ecolab.Our hosts are joined this week by David Parente, Director of Global Sterilization at and Biological Safety at Ecolab. During this episode the team discusses Dave’s chapters in the new book, Biocompatibility and Performance of Medical Devices. Dave has a long history with the biological evaluation process, including founding NAMSA’s first biological safety consulting team, NAMSA Advisory Services. For many years Dave has been teaching and writing about the importance of a plan. Additionally, Dave has years of experience as a manufacturer facing the challenges of meeting biological evaluation expectations from regulators.“It all speaks to the imp...2020-01-2353 minBiocompCHATibilityDemystifying 10993:18 chemical characterization of medical device materials within a risk management processOur hosts are joined this week by Dr. Ted Heise, convenor of TC 194/WG 14 responsible for the re-write and release 10993-18 Biological evaluation of medical devices —Chemical characterization of medical device materials within a risk management process. This much-anticipated standard is expected to provide greater detail and guidance to the use of characterization within the biological evaluation of medical devices.“There are no technical changes allowed when FDIS is translated to International standard” – Ted Heise“The distinction between chemical information and analytical testing is one of the important changes in the new document.” -Ted Heise“You ca...2019-12-061h 03BiocompCHATibilityEditor Chat: Biocompatibility and Performance of Medical DevicesOur hosts are joined this week by Dr. Jean Pierre Boutrand, VP of North American Laboratory Services at NAMSA. During this episode the team discusses the new book, Biocompatibility and Performance of Medical Devices. Jean Pierre is the Editor of this collection of experiences by esteemed authors in the biocompatibility and medical device profession. This is the second edition of the book, originally published in 2012 and the focus of the new edition is how to accelerate a product to market and ways to plan for evaluation. From the book cover “Biocompatibility and Performance of Medical Devices, Second Editio...2019-12-0341 minBiocompCHATibilityNAMSA Training Series, Live from Frankfurt GermanyOur hosts are joined this week by NAMSA colleagues, Dr. Sylvie Framery and Dr. Nicolas Martin – LIVE from the NAMSA training series event in Frankfurt, Germany. Sheri, Dr. Martin and Dr. Framery have spent the week conducting NAMSA’s biocompatibility training, and discuss the week’s events, the specific questions that seemed to drive the training this week, and any new awareness received from hearing attendee stories and experiences. “The MDR mentions that the manufacturer must demonstrate, amongst other things, the safety of its device but does not provide any technical solutions.. that’s why we will use the ISO 1...2019-11-1330 minBiocompCHATibilityNAMSA Training Series, Live from PhiladelphiaOur hosts are joined this week by NAMSA colleague, Dr. Phil Smiraldo – LIVE from the NAMSA training series event in Philadelphia. Sheri, Don and Phil have spent the week conducting NAMSA’s biocompatibility training, and discuss the week’s events, the specific questions that seemed to drive the training this week, and any new awareness received from hearing attendee stories and experiences. Discussion points include:Material information and its usefulnessHow to use clinical data for biocomp evaluationMulti component devicesThe hosts each give a main takeaway from the weekAnd ...Dr Smiraldo joins on his first visit to bicompch...2019-10-2936 minBiocompCHATibilityWelcome to NAMSA: Lisa OlsonLisa Olson, NAMSA’s Global Director of Analytical Services joins Sheri and Don on this special episode. As Lisa is a recent addition to the NAMSA team, our hosts ask about her background, her thoughts on the future and present state of biocompatibility, and most specifically the use of chemical characterization in the biological evaluation strategy. The hosts also introduce a new game of 2 truths and a lie, for biocompatibility.To connect with Lisa, you can find her here athttps://www.linkedin.com/in/lisa-olson-09659511/Opinions are their own and do not refl...2019-10-0921 minBiocompCHATibilityExtractions: The How and WhyAccess NAMSA testing resources here at www2.namsa.com/csipodcast. There are many mentions of extractions throughout international testing standards and regulations. In this episode, ISO 10993-12 for sample preparations and extraction conditions is discussed. What happens to a sample when it’s received at a lab prior to testing? How does the lab actually extract a piece of plastic and when has the extraction gone too far?Opinions are their own and do not reflect that of their current or former employers.2019-08-2329 minBiocompCHATibilityCSI: Cracking the CaseCytotoxicity, sensitization and irritation, sometimes known as CSI, are three of the most common tests performed on medical devices. In this episode, our hosts discuss these tests, common pitfalls and how to address regulatory expectations. Opinions are their own and do not reflect that of their current or former employers.2019-08-2331 minBiocompCHATibilityWelcome to BiocompCHATibility!In this first episode of BiocompCHATibility, hosts Sheri Bibins (Product Marketing Manager) and Don Pohl (Principal Product Development Strategist) of NAMSA discuss this first-of-its-kind podcast dedicated to all things medical device biocompatibility.Access NAMSA podcasts and transcripts here at www.namsa.com/resources/podcastsOpinions are their own and do not reflect that of their current or former employers.2019-08-2313 min