Let's CombinateL Drugs + Devices

Episodes

June 29, 2022

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

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 Technologi...

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June 22, 2022

038 - "Clinical Trials" with Dan Sfera

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 Acc...

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June 15, 2022

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

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

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June 8, 2022

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

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 Opera...

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June 1, 2022

035 - “Safety is Safety” with Khaudeja Bano

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 Post...

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May 25, 2022

034 - "Agent" with Mitch Robbins

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) - I...

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May 18, 2022

033 - "Specialization" with Erik Barkley

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 Roast...

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May 11, 2022

032 - “Quality is Free”

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 ---------------------------------...

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May 4, 2022

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

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 observe...

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April 27, 2022

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

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 discover...

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April 20, 2022

"Purpose" with Marla Phillips

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 O...

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April 13, 2022

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

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 connotati...

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April 6, 2022

027 - "Become a Historian of the Problem" with Duane Mancini

On this episode, I was joined by Duane Mancini, CEO and Managing Partner of Project Medtech and host of the Project Medtech Podcast. Duane and I discuss: Why he enjoys working with Startups Reimbursement considerations for...

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March 30, 2022

026 - "Quality" with H. James Harrington

This is Part 1 of the episode with H. James Harrington PhD of Harrington Management Systems. On this part of the episode Dr. Harrington and I discuss: His first experience in Quality at 6 years old The evolution of Quality ov...

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March 23, 2022

025 - “The Frying Pan to the Fire” with Edwin Bills

On this episode of the podcast we had Edwin Bills, a Risk Management Expert that was on the committees for ISO14971:2019, ISO TR24971:2020 and AAMI TIR 105:2020. Ed and I discuss Combination Products Risk Management including...

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March 16, 2022

024 - "Operating Under Constraints "with Naveen Agarwal

On this episode of the podcast, Naveen Agarwal PhD from Creative Analytics Solutions. Naveen and I discuss: Running almost 1500 miles and the importance of constraints Risk Management Vigilance vs. Surveillance Customer Exper...

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March 9, 2022

023 - "The Best is Yet to Come" with David Albert

On this episode of the podcast we had Dr. David Albert of AliveCor, a medical doctor, scientist and entrepreneur who has founded several successful companies and ventures in MedTech like AliveCor and others that have been acq...

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March 2, 2022

022 - "What Chapter are you in?" with Susan Neadle

On this episode, we were joined by Susan Neadle. If you work on Combination Products, Susan is someone you need to know. Her and I discuss: Her career starting in consumer health and pivoting into Medical Devices then Pharma...

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Feb. 23, 2022

021 - "Options" with Karandeep Singh Badwal

On this episode of the podcast we had Karandeep Singh Badwal. Karandeep and I discuss: Why QA/RA is the place to be (if you're so inclined) Intended Use, Indications and Use cases Where software startups struggle Eudamed Cybe...

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Feb. 16, 2022

020- "The Right Words" with Kathy Walsh

On this episode we had Kathy Walsh, Director and Principal at Quality Systems. Kathy and I discuss: Her Book: "Eliminating the Gobbledygook: secrets to writing plain language procedures" Her background starting as a PhD Micr...

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Feb. 9, 2022

019 - "Carrying The Bag" with Omar M Khateeb

On this episode of the podcast we had Omar M Khateeb, the host of the State of MedTech, and Founder of Khateeb&Co where he Helps MedTech Companies Grow Sales & Drive Product Adoption Using Social Media. Omar and I talk about ...

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Feb. 2, 2022

018 - "The Optimist Plans for Forever" - with Sarfaraz Niazi

On this episode of the podcast, we had Professor Sarfaraz Niazi, a "Renaissance Man" if I ever met one. We discuss what biosimilars are and how they differ from generics, how he predicted biologics and biosimilars would be th...

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Jan. 26, 2022

017 - "Feet First" with Ahmed Zobi

On the podcast this week, we had Ahmed Zobi, CEO of Syntr Technologies. Ahmed and I talk about jumping into Syntr Technologies feet first, what bootstrapping in medtech looks like, the grant submission process for funding, be...

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Jan. 19, 2022

016 - "Be More Specific" with Joe Hage

This episode of the Combinate Podcast is with Joe Hage. Joe and I talk all things medical device marketing. We discuss how storytelling is even more important for medical devices than other industries, how he helps clients cl...

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