Let's Combinate - Drugs + Devices

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...

On this episode of the podcast, I was joined by John Nosta of NostaLab. John and I discuss: -Pharmaceutical Innovation in the last several decades -Patient-Centricity in Pharma -Innovation vs. Implementing Existing Technologies -Genius Being a Birthright & Mediocrity Being Self imposed -Telemedicine & Digital Health -Decentralized Clinical Trials - Artificial Intelligence, Wonder and Fear...

On this episode, I was joined by Dan Sfera, aka "The Clinical Trials Guru". Dan and I discuss: Clinical Trials from the View of the Patient and the link to Primary Care Institutional Review Boards Informed Consent Patient Accrual, Inclusion/Exclusion and Screen Failure Role of the Sponsor Sponsor/CRO/Study Site Dynamics Roadblocks in Clinical Research Decentralized Clinical Trials Dan Sfera is the...

On this episode I go through the lessons I've learned through the podcasting process, and reflect on the first 25 episodes of the Combinate Podcast. Constructive Feedback or Guest Suggestions can be made at letscombinate.com

On this episode of the podcast, I was joined by Yousef Arman, Founder of The Vial Store. Yousef and I discuss: His background growing up around Pharmacists and Pharmacies What starting a Pharmacy Requires and Day to Day Operations Pharmacy Pricing/Costs and how they make money Demand Planning, Formularies and how pharmacies always seem to have medications The role of Specialty Pharmacies in develo...

On this episode, I was joined by Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen. On this episode Khaudeja and I discuss: - Safety function (Drug vs. Device) - 21 CFR Part 4 Subpart B  - Specific Post-Market Safety Reporting Expectations - Industry Challenges with implementing PMSR Requirements - Working in Quality with a background in Safety - Self Marketing, Toastm...

On this episode, I was joined by Mitch Robbins, founder of the Anthony Michael Group based in Denver, Co. Mitch and I discuss: - How he got into recruiting - The business model for recruiting (contract, retained, engaged) - Interview Matrix - interview strategies for objective unbiased candidate selection - The overall recruiting/hiring process and some of the tools AMG uses to find the best candi...

On this episode of the podcast, we go off our normal topics within BioTech and MedTech and discuss a topic that is near and dear to me; Coffee! I was joined by my friend Erik Barkley, Founder and Owner of Tugboat Coffee Roasters. Erik and I discuss: - How Erik and I met a few years ago - How he works with coffee farms around the globe - The life of a coffee bean: growing, processing, roasting and...

In this episode I walk through some of the concepts of the book "Quality is Free" by Phillip Crosby. ------------------------------------------------------------ Amazon Link to the Book: Link ----------------------------------------------------------- Who Was Phillip Crosby(From ASQ): Philip B. Crosby was a legend in the discipline of quality. A noted quality professional, consultant, and author,...

On this episode of the podcast, I was joined by Michelle Lott of Lean RAQA. Michelle and I discuss: - Her background starting at a manufacturing site and moving into QA and RA - Being Outspoken and Honest  - What she's observed between large and small organizations - Her Experience being an industry rep on the FDA Device GMP Advisory Committee - Regulations vs. Guidance's and how they come ab...

On this episode of the Combinate Podcast, I was joined by Marc Koska, Founder of Apiject. Marc and I discuss: The Importance of Understanding a Problem Developing Models for Courtrooms in the US Virgin Islands How he discovered the problem with Syringe Re-Use and HIV The development of the K1 Syringe How he drove the outlawing of reusable syringes in India Some Problems of Pre-Filled Delivery Syst...

On This Episode, I was joined by Marla Phillips of Pathway for Patient Health. Marla and I discuss:  Pathway for Patient Health Training the Next Generations - What students can do?  Quality for the 21st Century  Chief Quality Officer Forum  FDA/Industry Collaborations  How Xavier Health Came to be and the Future of Xavier Health  Supply by Design  The importance...

This is Part 2 of the episode with H. James Harrington PhD of Harrington Management Systems. On this part of the episode Dr. Harrington and I discuss: His Book - Poor Quality Costs(PQC) Why Cost of Quality has a bad connotation to it Direct vs. Indirect Poor Quality Costs White Collar Poor Quality Costs and Process Ownership/Optimization Burying the problem vs. Putting it to bed Problems and...

On 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...

This is Part 1 of the episode with H. James Harrington PhD of Harrington Management Systems. On this part of the episode Dr. Harrington and I discuss:  His first experience in Quality at 6 years old  The evolution of Quality over the last century Quality in a service vs. a product  What the "Gurus" of Quality were like: Juran, Ishikawa, Feigenbaum, and Crosby  ISO:56002 and the...