Episodes
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...
057 - "At Least, Try" with Rizwan Chadhrey
On this episode, I was joined by Rizwan Chadhrey, 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...
056 - "Non-Promotional Compliance" with Darshan Kulkarni
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 Discussi...
055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis
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: ...
054 - "EUDAMED" with Richard Houlihan
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, Clini...
"Duct Tape and Bubble Gum" with Chris Tsai
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 ...
052 - “All Work is Process” with Larry Mager
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 experie...
051 - "EU MDR" with Bassil Akra
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 Combi...
050 - "When No One is Listening" with James Somauroo
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 ...
049 - "What Does the Data Say?" with Shannon Hoste
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 E...
048 - "Materials" with Hsinjin Yang
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 ...
047 - "Truthful Not Misleading" with Darshan Kulkarni
On this episode, I was joined by Darshan Kulkarni, of - Free Speech and Promotional Compliance - Misbranding - Regulatory vs. Legal Compliance - From Congress to the FDA - the flow from legislation to regulations - Sunshine A...
046 - "Inflation Reduction Act" with Sarfaraz Niazi
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. Ni...
045 - "Combination Products around the Globe" with Susan Neadle
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: Topics: - CPC Summit and Updates from FDA - Essential Performance Req...
044 -“Mindset is Everything” with Kasem Akhras
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...
042 - “Half Knowledge Can Hurt” with Shadeed Salam
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 wh...
042 - “Reproducible within Limits”
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. -------------------------------------------------------...
041 - “Health Citizenship” with Jane Sarasohn Kahn
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 Consumin...
040 - “Good Science is Good Science” with Ben Lockwin
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 - Phar...