Let's Combinate - Drugs + Devices with Subhi Saadeh

On this episode I was joined by Chris Tsai from Boothroyd Dewhurst, Inc. Chris and I discuss:

Chris Tsai is the Director of Implementation at Boothroyd Dewhurst Inc. Chris is a Lean Six Sigma and Value Analysis/Value Engineering professional with a thirst for harvesting productivity and quality improvements and a passion for professional growth. He's worked in a diverse set of new product development (NPD) and manufacturing operations management experience. He's been recognized for his decisive, consistent leadership style, strong team building skills, focus on personnel & organization development, and the persistent and effective application of productivity and quality improvement tools. 

On this special episode of the podcast, I was joined by Larry Mager. As the 52nd episode, I wanted to thank Larry for being my first interview a little more than a year ago! 

On this episode, Larry and I discuss: 

- His experiences with Pharma and CRO clients vs. Medical Device 

- Predictive Quality Management across both medical device and pharma 

- Management Review and Compliance/Effectiveness/Efficiency 

- Prioritization, finding the right metrics and not measuring every process 

- His Books and what’s to come 

Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes beyond compliance only. He has three decades of experience in the medical device industry, and has held responsible positions within medical device manufacturing companies ranging from start-ups to multisite, highly matrixed organizations. He has held executive management responsibilities in both quality management and operations management roles and is experienced in interrelated quality disciplines, such as quality systems, management control, CAPA, supplier control and management, risk management, quality assurance/control, lean manufacturing, product development engineering, and results-oriented management for continuous improvement. You can reach Larry at [email protected]

On this episode, I was joined by Bassil Akra, the CEO of AKRA Team. Bassil and I discuss:

Dr. Bassil Akra spent the last year supporting medical device, in-vitro diagnostic, combination device companies preparing their strategy for the EU regulations MDR 2017/745 and IVDR 2017/746. Before that, he spent many years as a subject matter expert at the biggest notified body in Europe acting in the various roles and representing locally and globally the notified body association in the various European discussion and guidance documents preparation. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has long experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standard. He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving the relevant designation ensuring continuity of the healthcare system in the interest of the patient population.

On this episode, I was joined by Dr. James Somauroo of SomX and The HealthTech Podcast. James and I discuss:

James is the founder of SomX: The Healthtech Agency and supports the best healthtech companies in the world. He covers healthtech for Forbes as a contributor, hosts The Health-Tech Podcast, which has listeners in >120 countries and is the Editor-In-Chief of the Healthtech Pigeon newsletter. He is an anaesthetics and ICU doctor by training, has held roles in leadership, management and innovation at NHS England, Health Education England and the British Medical Journal and previously directed two healthtech accelerators; DigitalHealth.London, which provided startups with market access to the NHS, saving £48M for the UK health service and HS., which built, scaled and invested in deep technology companies. He has degrees in medicine, biomedical sciences and education and is a guest lecturer on healthtech innovation and entrepreneurship at academic institutions around the world.

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 Engineering vs. Design Validation

- Risk Management and User Risk

- Summative HF Evaluation and Sampling

Shannon is the President of Agilis Consulting Group, an assistant professor in the Quality Science Education program at Pathway for Patient Health and is active on several standards and conference committees for medical devices and combination products. Formerly, Shannon worked as Team Lead for Human Factors in FDA’s Center for Devices and Radiological Health (CDRH) and as human factors reviewer within the Center for Drug Evaluation and Research (CDER), Division of Medication Error Prevention and Analysis (DMEPA).

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 and Sterilization

- Commercialization Considerations

- 4 Major Factors for the appropriate selection of materials

Dr. Hsinjin Yang PhD is a Materials Engineer with more than 30 years of experience in the areas of Polymers/Materials Science and Engineering for infrastructure in renewable energy systems, biomedical devices/packaging, medication delivery system, optical ophthalmic lens, imaging materials and polymer blends. He has 25 patents (21 issued & 4 filed), and more than 50 publications in Journals or Book Chapter or Conference Proceedings.

On this episode I was joined by Darshan Kulkarni, Host of DarshanTalks, Attorney at the Kulkarni Law Firm and Adjunct Law Professor at Drexel University.

- Free Speech and Promotional Compliance

- Misbranding

- Regulatory vs. Legal Compliance

- From Congress to the FDA - the flow from legislation to regulations

- Sunshine Act

Darshan Kulkarni is an FDA regulatory lawyer, author, professor, and speaker, who takes a holistic approach to the healthcare and life sciences industries. Through the lens of patient centricity, including the underlying concepts of privacy, transparency, innovation, and access, Darshan looks at the broader implementation of programs by life sciences companies and healthcare professionals. With a background in creating companies, developing products, and helping guide finished products through the approval process where he has sold products as a pharmacist, Darshan has a unique perspective on how the pharmaceutical, regulatory, and life sciences industries intersect and function.

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. Niazi, Ph.D., SI, FRSB, FPAMS, FACB, founder of Pharmaceutical Scientist Inc. and Adello Biologics (acquired by Kashiv Biosciences), is an adjunct professor at the University of Illinois. A prolific inventor with scores of patents in a variety of fields to his name, Sarfaraz has developed the MayaBio® bioprocessing platform that allows faster development and manufacturing of biological products at the lowest cost. Sarfaraz has published extensively including consumer articles and books, refereed scientific research, technical handbooks, poetry translations, philosophic rhetoric, and technical textbooks that are required reading worldwide. He has written most books in the field of bioprocess engineering and biosimilars. His honors include the prestigious University of Illinois Alumnus of the Year Award, Inductee into Chicago Entrepreneurs Hall of Fame, the Star of Distinction—the high civil award from Pakistan; Forbes magazine has called him, “The Most Interesting Man Revolutionizing the Health World.” https://www.niazi.com/expertise