Episodes
091 - Combination Products Handbook Part 1: Foundation, Learning from…
On this episode, I was joined by Susan Neadle, Principal Consultant and President of Combination Products Consulting Services LLC. Susan and I discuss: Part 1 of The Combination Products Handbook: A Practical Guide to Combina...
090 - Software Validation, Automation, No-Code Quality Tools and QMS …
On This Episode, I was joined by Harsh Thakkar, CEO of Qualtivate. Harsh walks through: - Automating Quality with No Code Tools - Software Validation - Infrastructure Software - Out of the Box - Configured Software - Custom S...
089 - Talking HealthTech Podcast, Consistency, Australian Innovation …
On this episode, I was joined by Peter Birch, CEO and Host of Talking HealthTech. Peter walks through: - Talking HealthTech Podcast with 350+ Episodes - HealthTech Innovation in Australia and audience building - Working Quiet...
088 - Production Part Approval Process(PPAP) with Subhi Saadeh
On this episode, I outline an introduction to one of my favorite APQP tools: Production Part Approval Process(PPAP): - What is PPAP - Inputs, Process, Triggers and Interactions - PPAP Elements and Tools - The difference betwe...
087 - From Crime Reporting to Regulatory Affairs and On/Off The Recor…
On this I was joined by Ferdous Al-Faruque, Senior Editor at RAPS. Danny discusses: • Landing in Medical Devices and Pharma Regulatory Affairs • Rules of engagement • On the record, Off the record, On Background • Dann...
086 - Elastomers - Stopper and Plunger Manufacturing, Processing and …
On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions. Fran and I discuss: (0:00) Component Machinability (3:47) Stopper/Plunger Coating vs Lamination (13:22) Stopp...
085 - Digital Innovation, Proteomics, Core & Non-Core Innovation, Con…
On this episode I was joined by Jacob Laporte, Co-Founder of the Novartis Biome. Jacob discusses: (1:56)Harvard PhD to Consulting in Innovation Management (11:50)Core & Non-Core Innovation (21:09)Digital Technologies in Pharm...
084 - Drug Discovery, Candidate Selection, Pre-Clinical Development, …
On this episode, I was joined by Marta New, the CEO of Radyus Research. Dr. New discusses: (0:00) Intro (1:37) Pre-Clinical Planning (7:15) What's the purpose of an IND? (14:10) Administration Route Selection (19:00) Candidat...
083 - Holistic Approach to Container Closure Integrity, Capping/Crimp…
On this episode, I was joined by Derek Duncan, Director and VP of Product Management at Lighthouse Instruments. Derek walks through: - (2:30) Holistic Approach to CCI - (5:50) Risk Management and CCI - (7:30) Lyophilized vs. ...
082 - CTD Structure for Combination Products, US vs. EU Submissions a…
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: Common Technical Document Combination Prod...
081 - ISO TC 84, ISO11608, Committee Work and Advancing the State of …
On this episode I was joined by Bob Nesbitt, Chair of ISO TC 84 and Director of Combination Products R&D at Abbvie. Bob discusses: ISO TC 84: Needle Based Injectors, Insulin Syringes, Auto Disable Syringes, On Body Injector...
080 - 9 CCI Tests in 10 Minutes, Probabilistic vs. Deterministic, and…
On this episode, I was joined by Derek Duncan, Director and VP of Product Management at Lighthouse Instruments. Derek walks through: CCIT vs. Sterility Testing Difference between Deterministic and Probabilistic Methods 9 CCI ...
079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmon…
On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD). Rumi walks through: How FDA Reviews Combination Products Industry's role in shaping policy Essential Performance Requirement...
078 - Preventation is Not New, Incentives in Health Care, and Integra…
On this episode, I was joined by Ramin Rafiei PhD, CEO of Unleash Health. Ramin discusses: Experiences in Integrating Combination Products and Digital Health Prevention + Intervention in Health Care Incentives and Outcomes Un...
077 - 8 Databases and How To Use Them with Michelle Lott
On this episode, Michelle Lott of LeanRAQA walks the listeners through 8 FDA Databases and how to use them! If you'd like to hear more about Michelle checkout episode 031 "The 5 stages of Regulatory Grief" and checkout Michel...
076 - GMP Training, Competence, Human Error and Mentorship with Joann…
On this episode, I was joined by Joanna Gallant of JGTA. Joanna walks through: Training programs at companies that had consent decrees The difference between good training and bad GMP training Competence in knowledge work Hum...
075 - Shortages, Pricing, Mastering New Skills, and Building Deep Und…
On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: - FDA Drug Shortages Report - Drug Shortages and Drug Pricing - How he approaches Mastering new skill set...
074 - Article 117, EU MDR extension, Notified Body Opinions, Timing a…
On this episode, I was joined by Christiana Hoffman, Executive Consultant & Business Development Manager at anteris medical GmbH. Christiana walks through: - Article 117 requirements for Combination Products in EU - Notified ...
073 - Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Man…
On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal of Creative Analytics Solutions and ExceedQM. Naveen discusses: The Anatomy of a Hazard Hazard Source(HS), Initiating Mech...
072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epic…
On this episode, I was joined by Dan Formosa, legendary designer and founder of ThinkActHuman. On this episode, Dan walks through: The importance of eliminating the need for instruction through good design His experience w...
071 - "Running in my Steel toes" with Etienne Nichols
On this episode, I was joined by Etienne Nichols, who is a Medical Device Guru and Host of the Global Medical Device Podcast. Etienne Discusses: Translating lessons from the Steel Industry into MedTech His experience on combi...
070 - "Humbled and Surprised" with Paul Jansen
On this episode, I was joined by Paul Jansen, who's a drug/device consultant, advisor, and board member in the combination products space. Paul discusses: - His experience leading combination product focused organizations at ...
069 - "EU MDR Extension" with Michelle Lott
On this episode, Michelle Lott discusses the EU MDR Extension that was formalized by the European Commission and what it means for industry. If you'd like to hear more about Michelle checkout episode 031 "The 5 stages of Re...
068 - "What's the Benefit?" with David Rutledge
On this episode I was joined by David Rutledge, author of Mythical Medical and CEO of Global Strategic Solutions. David Discusses: · His book Mythical Medical · Benefit (As part of Benefit/Risk) · PRRC Role and EU MDR David R...