Podcast

February 12, 2025

175 – Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau

???? Stay ahead in combination products, pharma, and medical devices ???? https://www.letscombinate.com????️ Listen to more expert discussions on regulations, drug delivery, and quality ???? https://www.letscombinate.com/ Get expert insights on FDA

February 5, 2025

174 – How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin

Ben Locwin discusses the science, quality, and future of GLP-1 receptor agonists, revolutionary drugs used in diabetes and obesity treatment. The episode explores the history and development of GLP-1s, their

January 29, 2025

173 – Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women’s

In this episode of Let’s Combinate, host Subhi Saadeh interviews Shelly Amster, a trailblazer in reproductive health with over 45 years of experience. Shelly shares her journey from being one

January 22, 2025

172 – Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead

In this episode of Let’s Combinate, host Subhi Sadeh welcomes regulatory expert Doug Mead. Doug, who brings extensive experience in regulatory affairs for medical devices and combination products, discusses the

January 13, 2025

171 – Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?

In this episode of 'Let's Combinate,' host Subhi Saadeh delves into the challenges and complexities of working with prefilled syringes in regulatory, quality, and product development settings. Subhi, who has

January 8, 2025

170 – The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)

By viewing ISO 13485 through the lens of interconnected Plan-Do-Check-Act (PDCA) cycles, Subhi offers a fresh perspective that simplifies the implementation of this quality management standard. He explains the structure

January 1, 2025

169 – Should You Study Bioengineering in 2025? My Decade-Long Perspective

In this episode, Subhi Saadeh, a seasoned professional in the pharma and medical device industry, shares his insights on whether choosing bioengineering is the right career path. Drawing from his

December 25, 2024

168 – Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth

In this episode of Let's Combinate, host Subhi Saadeh discusses the significance of audits as a key appraisal activity and draws parallels with personal self-assessment inspired by Peter Drucker's book,

December 18, 2024

167 – Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst

In this episode of Let's Combinate, host Subhi Saadeh dives into the world of digital transformation in healthcare with Dr. Timothy Aungst, a visionary pharmacist and digital health expert. Dr.

December 11, 2024

166 – Sync or Sink: 3 Levels of Harmonization for Combination Product Success

Subhi proposes a broader definition of harmonization, not just aligning regulations but also fostering synergy among drug and device teams. Subhi emphasizes the importance of creating seamless ecosystems for operational

December 4, 2024

165 – Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New

In this episode of Let's Combinate, host Subhi Sadeh is joined by Marta New, CEO of Radyus Research, to discuss the importance of Target Product Profiles (TPPs) in drug development

November 27, 2024

164 – Tiny Particles, Big Impact: Breaking down USP 788 & USP 790

In this episode, Subhi Saadeh delves into the specifics of USP chapters 788 and 790, which focus on the testing and acceptance criteria for sub-visible and visible particles in injectable

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