
064 - Pharma and Medical Device Development Processes, DFSS and Design Reviews 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 toleranci...
21 Des 202254min

063 - Combination Products Regulatory, Going Wide, and Patient Impact 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 glo...
14 Des 202248min

062 - Reimbursement in Europe, Access, Rebates, and Negotiation 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-Paymen...
7 Des 202237min

061 - Taguchi, Pugh, DFSS, Robust Design and Tolerancing 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 Si...
30 Nov 202244min

060 - Why People Leave, Starting Elemed and 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 an...
23 Nov 202242min

059 - Literature Review, EU MDR CER’s, and Being Problem Driven 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 Rep...
16 Nov 202241min

058 - PMSR Globally, Different Clinical Roles and Risk Management 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, ...
9 Nov 202244min

057 - Conferences, Expos, LinkedIn and Launching a Podcast with Rizwan Chaudhrey
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...
2 Nov 202246min



















