Episodes
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...
067 - "Brains, not activities" with Jane M. True
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 ...
066 - "I was asked" with Fran DeGrazio
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 O...
065 - "8 Quality Lessons from Losing 100 Lbs " with Subhi Saadeh
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. P...
064 - "Robust and Tunable" with Skip Creveling
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 ...
063 - "Walk into the fog" with Niedre Heckman
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 strategie...
062 - "Take the Hat of the Other Side" with Stefan Walzer
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...
061 - "Follow the Energy" with Skip Creveling
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 Market...
060 - "Trusted Advisory" with Elena Kyria
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...
059 - "Literature Review" with Ethan Drower
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,...
058 - "PMSR Globally" with Khaudeja Bano
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...