Let's Combinate - Drugs + Devices

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 sets and building deep understanding in new areas Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in med...

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 Body Opinions, Timelines, and Interactions\ -Reporting for Combination and when does Eudamed Apply Christiana is a medical device and combination product professional with...

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 Mechanisms (IM) and Target-Threat Outcome (TTO) Clifton Ericcson How concepts/tools like these fit into the ISO14971 and ISO TR 24971 framworks Naveen Agarwal PhD is an Engineer by t...

On this episode, I was joined by Dan Formosa, legendary designer and founder of ThinkActHuman. On this episode, Dan walks through: - Eliminating the need for instruction through good design - Drug/Device Combination Product Usability - Collaborating with OXO on a Pre-Filled Syringe - Creating the worlds first toothbrush designed for children - Usability and his book on simplifying baseball Dan For...

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 combination products  - What is the most important quality system element?  Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning an...

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 Eli Lilly & Sanofi  - The first autoinjectors and the history surrounding ISO 11608  - Managing a product line, owning P&L and the product development...

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 Regulatory Grief" and checkout Michelle's Blog @ LeanRAQA.com) and Michelle's Podcast RAQA Today. Michelle Lott is the founder and principal of leanRAQA, which has supported 100+...

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 Rutledge, Pharm. D., FCCP, FAHA is a results-oriented consultant for clinical evaluation and investigation, clinical risk management, regulatory, and quality. He brings 25 ye...

On this episode I was joined by Jane M. True, VP, mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead at Pfizer. • Following career tracks, "experience", and non-linear career progression • Practical tips for presenting and nerves • Storyboarding and the Minto Principle • How Flu Vaccines are developed globally • mRNA and what it may mean for product development and org str...

On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions. Fran and I discuss: Her career at West Pharmaceuticals starting in the lab and retiring as Chief Scientific Officer Becoming experienced in Marketing, QA and RA What the C-Suit expects from individual contributors How to recognize opportunities and when to say yes Fran DeGrazio....

This solo episode walks through 8 of the quality lessons I learned by losing 100lbs over the last 10 years. They are: Change takes time Change starts from a small decision  More pain does not equal more pain/Quality is free. Prevention is part of performance Environment is as critical as habit Managing constraint changes as the quality journey evolves Quality is conformance to requirements Da...

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...