Combinate Podcast - Combining Drugs and Devices Subhi Saadeh
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- Science
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Hello Combi-Nation!
Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on.
My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers.
Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!
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135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson
On this episode, I was joined by Tony Watson, Vice President of Regulatory and Quality at Windgap Medical.
On this episode, Anthony discusses:
03:11 The Formation and Impact of the Office of Combination Products
04:16 Challenges and Changes in the Regulatory Landscape for Combination Products
07:53 Understanding FDA Titles and Organizational Structure
11:03 From FDA to Biogen: Transitioning to Industry and Building Medical Device Competency
16:41 Insights into FDA and Industry Dynamics: Conferences, Regulations, and Mindset Shifts
20:05 Combination Product Mindset in Large Organizations vs. Startups
21:54 Navigating Small Company Dynamics and Supply Chain Management
22:29 The Importance of a Combination Product Mindset
25:14 Challenges and Evolution of Combination Products
26:42 Global Perspectives on Combination Products
27:30 Digital Health: The New Frontier
35:02 Quality Culture and Open Communication
Anthony started his career as a naval officer on ships before transitioning to the civilian side of government. He served nearly 20 years at FDA as a reviewer, branch chief, and division director. In his time at FDA, he was one of the original regulatory policy-makers for combination products on the CDRH side. He has led the development of sevral guidance documents that are still in use more than 10 years after he left FDA. He has been active in industry advocay groups and standards efforts related to combination products for nearly 20 years. Since leaving FDA in 2013, Anthony has been developing and leading device and combination product teams in biotech, biopharma, and digital health companies from startups to global scale. He is presently the Vice President of Regulatory Affairs and Quality at Windgap Medical, a drug delivery device startup in Watertown, Massachusetts. He is also an adjunct professor at Northeastern University in the Regulatory Affairs Program and advises companies in the digital health field.
LinkedIn url: https://www.linkedin.com/in/anthony-w-77abaa3?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=android_app -
134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch
On this episode, I was joined by Richard Koch, Founder of KochSaMD. Richard discusses:
00:29 Exploring Software's Role in Medical Devices
02:29 Deep Dive into Cloud-Based Medical Devices
06:29 The Intricacies of Software Development in Medical Devices
26:33 The Future of Medical Devices in the Cloud Era
32:56 The Potential Impact of Tech Giants on MedTech
39:50 Embracing Digital Transformation in MedTech
40:50 Closing Thoughts and Where to Find More
Richard Koch is the founder of KochSaMD and is an expert in ISO62304, Medical Device Software and SaMD.
https://www.linkedin.com/in/richardkoch/
https://kochsamd.ch/
https://puriapp.com/ -
133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell
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/ -
132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner
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 -
131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer
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. -
130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder
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.