Let's Combinate - Drugs + Devices

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 - Pharmacogenomics and Orwell - Combination Products Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, phar...

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 Technologies -Genius Being a Birthright & Mediocrity Being Self imposed -Telemedicine & Digital Health -Decentralized Clinical Trials - Artificial Intelligence, Wonder and Fear...

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 Accrual, Inclusion/Exclusion and Screen Failure Role of the Sponsor Sponsor/CRO/Study Site Dynamics Roadblocks in Clinical Research Decentralized Clinical Trials Dan Sfera is the...

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

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 Operations Pharmacy Pricing/Costs and how they make money Demand Planning, Formularies and how pharmacies always seem to have medications The role of Specialty Pharmacies in develo...

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-Market Safety Reporting Expectations - Industry Challenges with implementing PMSR Requirements - Working in Quality with a background in Safety - Self Marketing, Toastm...

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) - Interview Matrix - interview strategies for objective unbiased candidate selection - The overall recruiting/hiring process and some of the tools AMG uses to find the best candi...

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 Roasters. Erik and I discuss: - How Erik and I met a few years ago - How he works with coffee farms around the globe - The life of a coffee bean: growing, processing, roasting and...

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 ----------------------------------------------------------- Who Was Phillip Crosby(From ASQ): Philip B. Crosby was a legend in the discipline of quality. A noted quality professional, consultant, and author,...

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 observed between large and small organizations - Her Experience being an industry rep on the FDA Device GMP Advisory Committee - Regulations vs. Guidance's and how they come ab...

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 discovered the problem with Syringe Re-Use and HIV The development of the K1 Syringe How he drove the outlawing of reusable syringes in India Some Problems of Pre-Filled Delivery Syst...

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 Officer Forum  FDA/Industry Collaborations  How Xavier Health Came to be and the Future of Xavier Health  Supply by Design  The importance...

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 connotation to it Direct vs. Indirect Poor Quality Costs White Collar Poor Quality Costs and Process Ownership/Optimization Burying the problem vs. Putting it to bed Problems and...

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 Startups Importance of Regulatory Strategy for Startups Project Medtech and Medtech Money Podcasts Startup Symposiums Combination Products Startups Startup Symposium in Columbus...

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 over the last century Quality in a service vs. a product  What the "Gurus" of Quality were like: Juran, Ishikawa, Feigenbaum, and Crosby  ISO:56002 and the...

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: His background as an educator Entering Quality after being taught by some of the quality gurus in the 1980's The history of Risk Management in medical devices and what it wa...

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 Experience focused Quality Improvement and Post-Market Surveillance  Common Issues with P1/P2 Implementation   Data Based Decision Making Framework...

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 acquired by companies like GE Healthcare. Dr. Albert and I discuss: Pursuing a Career and Family Simultaneously Becoming an Inventor Physician by Chance The unexpected reception...

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 Pharmaceuticals Design to Value, Design Excellence and Process Excellence The History of Combination Products regulation and what it was like implementing 21 CFR Part 4 as it was rev...

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 Cybersecurity Artificial Intelligence in Medical Devices SaMD and Digital Health Considerations related to the MDR Impact of Brexit on existing and future products within the EU a...

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 Microbiologist and moving into Quality Systems/Technical Writing Where most companies have issues with their procedures  Plain Language Skills: Active voice vs. passive...

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 him leaving medical school to pursue his purpose, intuition vs. ego, the death of the existing medtech sales process and where it's going post-pandemic, MedTech and the Metave...

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 the future of medicine, his inventions starting from coffee mugs and hats to bioreactors that don't have an exhaust, how he passed the federal bar exam without attending law sch...

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, being a young CEO and figuring out where to trust your gut and where you need help, how Covid impacted his startup, leading with emotional intelligence, and where Syntr is going...

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 clarify their vision and messaging, the importance of being specific and concise, the medical device marketing process, hist start in the food industry and transitioning into Me...