Let's Combinate - Drugs + Devices

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...

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, Notified Bodies(their role and how they are formed), CE Marking and medical device clearance, considerations for CMO’s and private label, the role of Authorized Representatives,...

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 Quality Management or PQM. That it's not an afterthought, but rather a beforethought. It should be intentional. In this episode, Larry and I chop it up about the well where PQM...

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 then moves on to explain have a control environment should be well established(policies, standards, procedures, governance, etc), Risk Management for processes and poking holes...

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 and all of this culminating into the creation of a strong Culture of Quality. Larry ends the episode by giving an example of how he's seen people and the soft science surroundin...

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 in weight loss, my relationship with food still needed a lot of work. I still didn't feel in control. I believe for us to be the best professionals we can be, it’s important t...

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 user and how to get close to them, how to read the ANSI/AAMI HE75:2009 (R2018) and IEC 62366-1:2015 standards, the design validation process and how human factors formative a...

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 importance of good story telling in business. Margot Leitman is an award-winning storyteller, best-selling author, speaker and teacher originally from Matawan, New Jersey. A l...

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 including discussing URS, DQ, FAT/SAT, IQ, OQ and PQ. David outlines the a risk based approach for streamlining commissioning and qualification activities, highlights some...

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 Medical Device industry. Chuck is a seasoned Medical Device leader with successful experience in Commercialization, R&D, Project Management, and Manufacturing Support. He also ha...

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 her development, her experience starting a new company, her time in venture capital and the due diligence process, lessons during the pandemic and some of the influences that i...

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 students during the pandemic Answering the age old question: "Do you use your degree?" Moving to Finland and her experience as a Fullbright Scholar at VTT STEM Progra...

On this episode of the Combinate Podcast we have the runner that needs no introduction, John Bingham. John is the best selling author of the books, “The Courage to Start”, “No Need for Speed” and “Marathoning for Mortals”. He is also the man behind the famous Runner’s World Magazine column “The Penguins Chronicles”. On this episode John and I discuss starting running in his 40’s, his favorite of h...

On this episode we had Cameron Jones PhD, Co-Founder and CEO at Avasys. Cameron holds a PhD from University of Kentucky and did Post-Doctoral work at John’s Hopkins University. He has a passion for innovation and trying to find and address unmet clinical needs by working with the clinicians to craft fit for purpose solutions. In this episode we discuss the relationship between academia and innovat...

I’m truly happy I discovered Andy Robertson before I took my own CQE exam. His tools, lessons and strategies were crucial in passing the exam on my first try. His passion and love for quality engineering jumped out and after becoming more familiar with his content and style, I thought “I have to meet this guy”. On this episode we discuss study habits, mastery, learning styles, applying CQE princip...

In this episode I sit down with Mark Swanson. We discuss Mark’s background and early career, his entrance into QA, his participation on standard work groups for ISO13485 and ISO9001, the standards process and more. Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and a Principal Consultant of Quality and Regulatory Expert Partners (QRx Partners); a partnership consulting firm focused on helpin...