Combinate Podcast - Combining Drugs and Devices Subhi Saadeh

On this episode, I was joined by Devon Campbell, Founder, Prodct LLC + CPO, myBiometry.
Devon discusses:

02:20 The Journey to Consulting: A Year of Saying No
03:09 Advising Startups: The Role of a Consultant
05:08 The Shift to Consulting: Embracing Joy and Impact
09:21 Navigating the Startup Ecosystem: Challenges and Opportunities
13:31 Building a Positive Team Culture and Avoiding Arrogance
19:12 The Philosophy Behind Prodct: Focusing on Medical Devices
20:55 A Personal Touch: The Impact of 'Born to Run'
21:59 Closing Thoughts and Where to Find Devon

Devon Campbell is the Founder, Prodct LLC and Chief Product Officer(CPO), myBiometry. He's launched and exited several MedTech ventures and has worked in large Pharma and large IVD companies in executive roles focusing on engineering and product development.
https://www.devonccampbell.com/

On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses:


00:56 Evolution of Industry Standards
02:00 The Impact of Standards on Medical Device Development
02:10 Standards and Regulatory Challenges
02:42 Standards in Medical Devices and Emerging Technologies
13:19 The Auditing Experience
17:59 The Challenge of Maintaining and Updating Standards
29:49 Concluding Thoughts and Where to Find More Information

Leo Eisner, founder and principal compliance and regulatory consultant of Eisner Safety Consultants (ESC), ESC provides the medical device industry with product safety compliance & regulatory support. Leo ensures his clients’ medical device compliance needs are met, provides his clients with practical assessments of their products and provides strategies & support to help them through the medical device product compliance maze based on his experience.

He has over 30 years of invaluable experience in the medical device industry. He worked at 3 notified bodies, and his career has spanned over 35 years of product safety certification test lab experience. He worked at 2 internationally recognized labs for 11 years. As an expert in the standards development process, Leo has been staying at the forefront of evolving medical device standards for over 20 years with standards such as the IEC 60601 series, ISO 15223, ISO 20417.



Links:


Website: https://eisnersafety.com/
Blog: https://eisnersafety.com/industry_news/ & Sign-up for newsletter on right side of
page (1/2 way down)
LinkedIn: linkedin.com/in/leoeisnersafetyconsultants
Contact Us: https://eisnersafety.com/contact_eisner_safety/
Schedule a call: https://eisnersafety.com/schedule-call/


U.S. TAG 62D - https://www.aami.org/detail-pages/opentext-gateway-standards-committee/u.s.-tag-62d---electromedical-equipment-committee
EV - WG 13 - Lens Removal and Vitrectomy Devices Working Group- https://www.aami.org/detail-pages/opentext-gateway-standards-committee/ev-wg-13---lens-removal-and-vitrectomy-devices-working-group
JWG 9 Lens removal and vitrectomy devices for ophthalmic surgery - https://www.iec.ch/dyn/www/f?p=103:14:612205979307807::::FSP_ORG_ID,FSP_LANG_ID:2472,25

On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting. Jeanne and I discuss:
- Assessing Drugs, Devices, and Combination Products for Sterility Methods
- Regulatory Frameworks and EMA's Decision Tree (Link)
- Novel Methods: liquid phase sterilization, ionization, physics based sterilization, high pressure sterilization, glass bead sterilization, infrared, microwave
Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has been very involved in the remediation of contamination issues including: sterility test failures, media fill failures, mold contamination, and Burkholderia cepacia. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. She has served on the Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board and was an Interest Group Leader for the Parenteral Drug Association (PDA) (1998-2016). Jeanne has also served on advisory committees for emerging technologies (rapid methods), aseptic processing and sterilization for FDA.

On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses:

00:58 Exploring the Impact of QMSR on Medical Device Companies

02:19 UDI Regulations

05:18 Understanding the FDA's Approach to QMSR and Compliance

18:02 The FDA's Inspection Techniques and the Future of QMSR

31:55 Where to Find Aaron and Closing Thoughts

Aaron Snyder is a quality management systems expert and is the VP of QA at Allotex. Prior to joining Allotex, Aaron served in roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. He has worked with a wide range of pharmaceuticals, medical devices and combination products. Aaron is a member of the AAMI Faculty and teaches several courses focused on various QMS topics. Aaron is also and avid content creator and dissects, presents and teaches on QMS and cGMP’s topics on his YouTube channel: Quality Systems Explained.

On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, expect to learn from Alan about how reliability engineering concepts can be used for single use combination products. Why infusion pumps are susceptible to recalls. Why people call Allen captain Allen Stevens. And the roles of standards and guidance in combination product approval.



03:32 The Story Behind 'Captain' Allen Stevens

06:52 The Challenges of Infusion Pumps and Recalls

13:34 The Intricacies of FDA's Rule-making and Guidance Process

21:44 The Future of Reliability in Combination Products

30:46 A Book That Changed Life: Systems Thinking in Safety

32:44 Wrapping Up: The Impact of Engineering on Public Health



Alan is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie within the RA Emerging Technologies, Devices and Combination Products team. Prior to joining AbbVie, Alan spent 20 years at the FDA/CDRH leading premarket review and policy development for drug delivery devices and combination products.

On this episode, I was joined by Former FDA Investigator and Managing Consultant of Practical Compliance Results, Vin Cafiso.

Vin discusses:

01:35 Journey from Premed to FDA Investigator: VIN's Story

07:25 Understanding the Impact of QMSR on Industry

16:24 The FDA's Approach to Inspections and Compliance

27:45 The Shift Towards Quality Culture in FDA Inspections

31:07 Real-World Insights

35:34 The Impact of Quality Culture on Inspections

44:22 Transitioning from FDA to Industry

49:51 Building a Career in Quality Engineering

Vincent (Vin) Cafiso, serves as the Founder and Managing Consultant of Practical Compliance Solutions. His professional journey commenced as an FDA investigator, after which he transitioned into the industry. Throughout his career, he has held diverse positions at well-established medical device companies such as BD, Smith & Nephew, BioArray Solutions, and Impulse Dynamics. He consults on medical device quality management and can be reached on linkedin here or via the web on https://practicalcomplianceresults.com/about