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 Speec...
26 Okt 202233min
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 d...
19 Okt 202250min
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-M...
12 Okt 202228min
053 - "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 Defini...
5 Okt 20221h 4min
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 an...
28 Sep 202253min
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 Ar...
21 Sep 202244min
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 ...
14 Sep 202240min
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) - Huma...
7 Sep 202246min
