This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru(Episode #380).
In this episode, Etienne and I discuss:
02:50 The Start of the Combinate Podcast
06:00 Efficiency and Tools in Podcast Production
08:40 Understanding Combination Products
09:43 Regulatory Frameworks and Definitions
13:46 Challenges and Misconceptions in the Industry
20:47 Evolution of Regulations: QMSR and Part 4
22:05 Exploring Unique Podcast Episodes
25:56 The Pyramid of Regulations
30:40 The Role of Coaching and Mentorship
32:59 Trends in Combination Products
35:23 Recommended Books and Final Thoughts
37:04 Encouragement for Lifelong Learning
Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market
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By Subhi Saadeh
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This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru(Episode #380).
In this episode, Etienne and I discuss:
02:50 The Start of the Combinate Podcast
06:00 Efficiency and Tools in Podcast Production
08:40 Understanding Combination Products
09:43 Regulatory Frameworks and Definitions
13:46 Challenges and Misconceptions in the Industry
20:47 Evolution of Regulations: QMSR and Part 4
22:05 Exploring Unique Podcast Episodes
25:56 The Pyramid of Regulations
30:40 The Role of Coaching and Mentorship
32:59 Trends in Combination Products
35:23 Recommended Books and Final Thoughts
37:04 Encouragement for Lifelong Learning
Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market
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