Episodes
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...
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...
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...
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...
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...
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...
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...
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...
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...
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 ...
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...
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...
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...
015 - "Would You Use it on a Family Member?" with Monir El Azzouzi
On this episode of the podcast we had Monir El Azzouzi of Easy Medical Device. Monir and I focus on EU MDR and discuss the difference between EU MDR and US regulations, the history of the MDD being updated to MDR in 2017, Not...
014A - "The First P: Product" with Larry Mager
This Episode is with Larry Mager of Mgmt-Ctrl. In this episode Larry and I continue where we left off in 002 - "Seeing David in the Stone". In that episode he walked the audience through the importance of having Predictive Qu...
014B - "The Second P: Process" with Larry Mager
In Part 2 of this episode, Larry and I discuss the Second P: Process. I start the episode by asking Larry to explain the difference between a Quality System and a Quality Management System(QMS) to set the foundation. Larry th...
014C - "The Final P: People" with Larry Mager
In this final segment of the episode with Larry, we discuss the Final P: People. In this episode we discuss skillsets, training and competency, communication for teamwork, establishing a culture of trust and accountability an...
013 - “Big Rocks and Little Rocks” with Jumha Abu-Razeq
This episode of the podcast was with Jumha Abu-Razeq of Stoopid Fit. I wanted to bring Jumha on in preparation for 2022. Jumha was the first coach I hired and I did so after losing 100 lbs and finding that despite my success ...
012 - "Asking then Seeing" with Sara Waxberg Mcnew
Happy Holidays everyone! On this episode of the Combinate Podcast, we had Sara Waxberg McNew, Chief Scientific Officer at Design Science. Sara and I talk about her interest in Human Factors and her career, we discuss who is a...
011 - “Long Story Short” with Margot Leitman
Have you ever wondered what goes into a good story? Enter Margot Leitman. Margot and I talk about why people fear story telling, what people can do if they feel they have no good stories, the anatomy of a good story, and the ...
010 - "Don't Make Assumptions" with David Simoens
On this episode of the Combinate Podcast, we had David Simoens, COO at cGMP Consulting Group. David and I discuss his career, and dive deep into commissioning, qualification, and validation. David outlines the activities in i...
009 - “Cutting Through the Noise” with Charles Ventura
On this episode, we had Charles “Chuck” Ventura. Chuck is a the CEO of Hemotek Medical and President of Ventura Solutions. He has extensive product development, commercialization, and business management experience in the Med...
008 - "Follow the Opportunity" with Marta New
On this episode, I had Marta New PhD MBA. Marta and I talk about how business school changed her perspective, depth vs. the value of information when it comes to decision making, mentors in her career and their influence on h...
007 - "Beyond The Obvious" with Miiri Kotche
On this episode we had one of my most impactful engineering professors, Miiri Kotche PhD. In this episode we discuss: Starting as a Validation Engineer and making the decision to go back into academia Teaching engineering stu...