Let's Combinate - Drugs + Devices

On this episode, I was joined again by Skip Creveling. During the last episode, Skip walked through Design for Six Sigma(DFSS), and finding/measuring what's important(critical parameters and tolerancing).  In this episode, he discusses: Design and Development processes in Pharma and MedTech How DFSS can be integrated into lifecycle management Design Review strategies Clyde "Skip" Creveling is the...

On this episode, I was joined by Niedre Heckman, MPH, PhD, FRAPS, Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda. Niedre discusses: - Challenges with global regulatory strategies for combination products - Impact of regulatory strategies on patients and product adoption - Becoming an FRAPS, and building wide expertise in QA & RA - Being a great teamma...

I love talking to fellow podcasters and on this episode, I was joined by Dr. Stefan Walzer, the CEO of MArS Market Access & Pricing Strategy.  Stefan discusses: Discounts, Rebates, and how Co-Payment is different in Europe How data is presented to payers in Europe and European Reimbursement Germany/AMNOG Process Negotiation Dr. Stefan Walzer is a healthcare economist, podcaster, and CEO of MArS Ma...

On this episode, I was joined by Skip Creveling, President and Founder of PDSS Inc. Skip walks through: Learning from Genichi Taguchi and Stuart Pugh The 7 Steps to Robust Design Design for Six Sigma(DFSS) Six Sigma in Marketing Tolerancing and Critical Parameters Clyde "Skip" Creveling is the President & Founder of PDSS Inc. Skip has led the DFSS initiatives at Merck, Motorola, Carrier Corporatio...

Elena Kyria, CEO of Elemed joins the podcast and discusses: - Why People stay in roles and why they leave -Starting Elemed -The trusted advisory role that recruiters play -Community work on EU MDR and RAPS Elena Kyria is an award-winning talent acquisition specialist in the Medtech industry. She is the CEO of Elemed and in charge of executive placements across Europe. Elena runs one of the largest...

On this episode, I was joined by Ethan Drower, of Citemed. Ethan is a prolem-driven, software engineer and fellow Chicagoan who's focused on making literature review for EU MDR Clinical Evaluation Reports(CER) more efficient, traceable and robust. Ethan and I discuss: - A problem-driven career - Challenges with EU MDR Clinical Evaluation Reports(CER's) - Literature Search and Literature Review Eth...

On this episode, I was joined again by Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen. On this episode Khaudeja and I discuss: - PMSR and Risk Management  - Patient Safety, Pharmacovigilance, Medical Affairs, Clinical Affairs in Medical Device and Pharma companies. - PMSR Regulatory Landscape Globally (Outside of the US) Dr. Khaudeja Bano is the VP of Combination Product...

On this episode, I was joined by Rizwan Chaudhrey, of RSK Life Sciences Media. Rizwan and I discuss: Launching Chats with Chaudhrey during the Pandemic Conferences and Expos How to use LinkedIn to build your personal brand Getting Started Rizwan is a blogger on Life Science/ Pharma Bio-Pharma from Drug Discovery to Drug Delivery and all things in between. He aims to connect and Inform those workin...

On this episode I was joined by Darshan Kulkarni, Host of DarshanTalks, Attorney at the Kulkarni Law Firm and Adjunct Law Professor at Drexel University. Darshan and I discuss: - Non-Promotional Speech and Scientific Discussion - Medical Affairs vs. Sales and interaction with HCP's - Free Speech in Tech and what it might mean for Pharma Darshan Kulkarni is an FDA regulatory lawyer, author, profess...

On this episode, I was joined by Alexandra Benbadis, Usability Leader at Sanofi. Alexandra and I discuss: - Critical Tasks: What the guidance says , how to select them and what it means for HF study design - Knowledge Tasks: Meeting regulatory expectations and evaluation the IFU - Usability, HF Studies and Residual Risk Prior to joining Sanofi as Usability Leader, Alexandra Benbadis was a Senior H...

On this episode, I was joined by Richard Houlihan, CEO of Eirmed. Richard and I discuss: - History of Eudamed (Starting with EU Legislation in 2010) - The 6 modules of Eudamed (PMS, Vigilance & Post-Market Surveillance, Clinical Investigations, Certificates, Market Surveillance, Actor Registration) - Responsibilities for Economic Operators (Manufacturers, Importers, Authorised Representat...

On this episode I was joined by Chris Tsai from Boothroyd Dewhurst, Inc. Chris and I discuss: Value Engineering at Eastman Kodak in the 1990's Inventing and Deploying Concurrent Engineering Defining Design Robustness  QFD and Design Control in Non-Regulated Industries Verb/Noun Pairs and Product Development Design for Manufacturability and Assembly Chris Tsai is the Director of Implementation...

On this special episode of the podcast, I was joined by Larry Mager. As the 52nd episode, I wanted to thank Larry for being my first interview a little more than a year ago!  On this episode, Larry and I discuss:  - His experiences with Pharma and CRO clients vs. Medical Device  - Predictive Quality Management across both medical device and pharma  - Management Review and Compl...

On this episode, I was joined by Bassil Akra, the CEO of AKRA Team. Bassil and I discuss: EU MDR and Implementation Timeframe Notified Bodies, Competent Authorities, MOH's and the EU Commission Article 117 & Drug/Device Combination Products Differences between MDD and MDR for Economic Operators His Favorite Book: EU MDR Dr. Bassil Akra spent the last year supporting medical device, in-vitro di...

On this episode, I was joined by Dr. James Somauroo of SomX and The HealthTech Podcast. James and I discuss: HealthTech Communication  Growing a Passion The HealthTech Podcast Healthtech Pigeon Delegating vs. Creating Systems James is the founder of SomX: The Healthtech Agency and supports the best healthtech companies in the world. He covers healthtech for Forbes as a contributor, hosts...

On this episode of the podcast, I was joined by Shannon Hoste, President of Agilis Consulting. Shannon and I discuss: - FDA Human Factors Review for Combination Products (CDRH, CDER/DMEPA, OCP) - Human Factors vs. Usability Engineering vs. Design Validation - Risk Management and User Risk - Summative HF Evaluation and Sampling Shannon is the President of Agilis Consulting Group, an assistant profe...

On this episode of the podcast, I was joined by Hsinjin Yang of Pioneer Scientific Solutions. Hsinjin and I discuss: - Materials for Biomedical Applications - Mechanical Properties, Physical Properties, Biocompatibility, E&L and Sterilization - Commercialization Considerations - 4 Major Factors for the appropriate selection of materials Dr. Hsinjin Yang PhD is a Materials Engineer with more th...

On this episode I was joined by Darshan Kulkarni, Host of DarshanTalks, Attorney at the Kulkarni Law Firm and Adjunct Law Professor at Drexel University. - Free Speech and Promotional Compliance - Misbranding - Regulatory vs. Legal Compliance - From Congress to the FDA - the flow from legislation to regulations - Sunshine Act Darshan Kulkarni is an FDA regulatory lawyer, author, professor, and spe...

On this episode of the podcast, I was joined by Sarfaraz Niazi. Dr. Niazi and I disucss:  - The Inflation Reduction Act  - Out of Pocket Costs  - Part B and Part D Drugs  - Price Negotiation vs. Price Control  Prof. Sarfaraz K. Niazi, Ph. D., SI, FRSB, FPAMS, FACB, founder of Pharmaceutical Scientist Inc. and Adello Biologics (acquired by Kashiv Biosciences), is an adjunct...

On this episode, we were joined again by Susan Neadle! This episode was focused on the current state of Combination Products globally. Susan and I discuss: - CPC Summit and Updates from FDA - Essential Performance Requirements(EPR's) - ASTM Harmonization for an International  Combination Products Terminology Standard -Different Approaches to Combination Products Globally : US, EU, UK, Canada, Japa...

On this episode, I was joined by Dr. Kasem Akhras, Senior Director, Translational Access, Geneconomics & Outcomes Research - New Products  at Novartis. Dr. Akhras and I discuss: -His Book "Frontiers in Market Access" -History of Market Access from the 1980's to now -Where the Market Access function fits in within Product Development -Market Access and Clinical Trials -Over-Utilization -Value Based...

On this episode of the podcast, I was joined by Shadeed Salem, the Founder and President of Synergy Bioscience. Shadeed and I discuss: -War Stories in method validation and NCR/OOS's -What is it that you're going to test and what are you testing for? -Differences between drug and device methods including Analytical, Physical, Mechanical and Visual methods -Method Development vs. Method Validation...

On this episode of the podcast, I walk through some of the takeaways I got from reading "Statistical Method from the Viewpoint of Quality Control" by Walter A. Shewhart. ----------------------------------------------------------  Who Was Walter Shewhart? Link

On this episode of the podcast, I was joined by Jane Sarasohn Kahn of Health Populi and THINK-Health. Jane and I discuss: - US Healthcare System - Healthcare economics before Healthcare economics - Her Book: Health Consuming - Health Consuming vs. Health Citizenship - US vs. European Healthcare systems Jane is a health economist, advisor and trend-weaver to organizations at the intersection of hea...

On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: - Behavioral Neuroscience and the soft skills of Quality - Quality, Compliance and Risk Management - Pharmacogenomics and Orwell - Combination Products Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, phar...