139 episodes

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!

Combinate Podcast - Combining Drugs and Devices Subhi Saadeh

    • Science
    • 4.9 • 10 Ratings

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!

    136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura

    136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura

    On this episode I was joined by Chuck Ventura, Founder of Ventura Solutions and CEO of HemoTek. On this episode Chuck walks through:

    00:29 Design Changes When No DHF Exists

    03:30 Challenges and Strategies in Document Management

    04:49 Improving Design Inputs and Risk Management

    21:37 Leveraging Tools for Better Traceability and Compliance

    Charles Ventura is the Founder of Ventura Solutions and CEO of HemoTek. Chuck is a leader in the Medical Device & Combination Products space with successful experience in Commercialization, R&D, Project Management, and Manufacturing Support.



    https://ventura-solutions.com/

    • 39 min
    135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson

    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

    • 41 min
    134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch

    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/

    • 41 min
    133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell

    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/

    • 22 min
    132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner

    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

    • 31 min
    131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer

    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.

    • 42 min

Customer Reviews

4.9 out of 5
10 Ratings

10 Ratings

lblake09 ,

Great content and knowledgeable guests

As a young biomedical engineer in BioPharmTech, this podcast is a good resource for pertinent topics in the medical device/pharmaceutical world. The only critique I have is the audio quality could be better. The sound cuts in and out sometimes for the guests. I'm guessing the audio is extracted from a zoom or teams interview. The host would serve himself well with a better mic and recording in a better studio-like room setting

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