The Combinate Podcast

Episodes

051 - "EU MDR" with Bassil Akra

Sept. 21, 2022

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 Comb…

050 - "When No One is Listening" with James Somauroo

Sept. 14, 2022

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

Sept. 7, 2022

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 …

048 - "Materials" with Hsinjin Yang

Aug. 31, 2022

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

Aug. 24, 2022

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 …

046 - "Inflation Reduction Act" with Sarfaraz Niazi

Aug. 17, 2022

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. N…

045 - "Combination Products around the Globe" with Susan Neadle

Aug. 10, 2022

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 Re…

044 -“Mindset is Everything” with Kasem Akhras

Aug. 3, 2022

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" -Histor…

042 - “Half Knowledge Can Hurt” with Shadeed Salam

July 27, 2022

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 w…

042 - “Reproducible within Limits”

July 20, 2022

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

July 13, 2022

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 Consumi…

040 - “Good Science is Good Science” with Ben Lockwin

July 6, 2022

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 - Pha…

039 - "The Camera Didn't Make the Artist Obsolete" with John Nosta

June 29, 2022

On this episode of the podcast, I was joined by John Nosta of NostaLab. John and I discuss: -Pharmaceutical Innovation in the last several decades -Patient-Centricity in Pharma -Innovation vs. Implementing Existing Technolog…

038 - "Clinical Trials" with Dan Sfera

June 22, 2022

On this episode, I was joined by Dan Sfera, aka "The Clinical Trials Guru". Dan and I discuss: Clinical Trials from the View of the Patient and the link to Primary Care Institutional Review Boards Informed Consent Patient Ac…

037 - Reflections #1 - (Episodes 001-25)

June 15, 2022

On this episode I go through the lessons I've learned through the podcasting process, and reflect on the first 25 episodes of the Combinate Podcast. Constructive Feedback or Guest Suggestions can be made at letscombinate.com

036 - "Those Moments Keep You Grounded" with Yousef Arman

June 8, 2022

On this episode of the podcast, I was joined by Yousef Arman, Founder of The Vial Store. Yousef and I discuss: His background growing up around Pharmacists and Pharmacies What starting a Pharmacy Requires and Day to Day Oper…

035 - “Safety is Safety” with Khaudeja Bano

June 1, 2022

On this episode, I was joined by Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen. On this episode Khaudeja and I discuss: - Safety function (Drug vs. Device) - 21 CFR Part 4 Subpart B - Specific Pos…

034 - "Agent" with Mitch Robbins

May 25, 2022

On this episode, I was joined by Mitch Robbins, founder of the Anthony Michael Group based in Denver, Co. Mitch and I discuss: - How he got into recruiting - The business model for recruiting (contract, retained, engaged) - …

033 - "Specialization" with Erik Barkley

May 18, 2022

On this episode of the podcast, we go off our normal topics within BioTech and MedTech and discuss a topic that is near and dear to me; Coffee! I was joined by my friend Erik Barkley, Founder and Owner of Tugboat Coffee Roas…

032 - “Quality is Free”

May 11, 2022

In this episode I walk through some of the concepts of the book "Quality is Free" by Phillip Crosby. ------------------------------------------------------------ Amazon Link to the Book: Link --------------------------------…

031 - "The Five Stages Of Regulatory Grief" with Michelle Lott

May 4, 2022

On this episode of the podcast, I was joined by Michelle Lott of Lean RAQA. Michelle and I discuss: - Her background starting at a manufacturing site and moving into QA and RA - Being Outspoken and Honest - What she's observ…

030 - "Why Don't I Try?" with Marc Koska

April 27, 2022

On this episode of the Combinate Podcast, I was joined by Marc Koska, Founder of Apiject. Marc and I discuss: The Importance of Understanding a Problem Developing Models for Courtrooms in the US Virgin Islands How he discove…

"Purpose" with Marla Phillips

April 20, 2022

On This Episode, I was joined by Marla Phillips of Pathway for Patient Health. Marla and I discuss: Pathway for Patient Health Training the Next Generations - What students can do? Quality for the 21st Century Chief Quality …

028 - "How Much Does Poor Quality Cost?" with H. James Harrington

April 13, 2022

This is Part 2 of the episode with H. James Harrington PhD of Harrington Management Systems. On this part of the episode Dr. Harrington and I discuss: His Book - Poor Quality Costs(PQC) Why Cost of Quality has a bad connotat…