Let's Combinate - Pharma + Medical Devices with Subhi Saadeh12 Feb 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 regulations, risk management, quality systems, and the latest trends in drug-device combination products.

In this episode of Let's Combinate, host Subhi Saadeh interviews Bill Facteau, President and CEO of Earlens Corporation, who has over three decades of experience in the medical device industry, focusing on hearing innovations. Bill discusses his journey in the ear, nose, and throat field, including his motivation to improve hearing aid technology due to personal experiences and unmet needs in the market. The conversation covers the limitations of traditional air conduction hearing aids, the unique advantages of Earlens' technology, and the broader industry challenges such as lack of education and reimbursement issues. Bill also highlights the critical importance of treating hearing loss to prevent cognitive decline and other health issues.

The episode concludes with leadership advice and a discussion on books that have influenced Bill's career.

00:00 Introduction and Guest Welcome

00:42 Bill Facto's Career Journey

03:01 Challenges in Hearing Aid Technology

08:15 Preventing Hearing Loss

12:05 Ear Lens Innovation

33:03 Hearing Loss and Cognitive Health

35:01 Leadership and Personal Insights

39:36 Conclusion and Contact Information

Bill Facteau is the President and CEO of Earlens Corp, which is focused on transforming the hearing aid industry with its novel and proprietary light-based technology. Prior to joining Earlens, Mr. Facteau served as President and CEO of Acclarent, the company that created Balloon Sinuplasty, which was ultimately acquired by JNJ for $800M. Mr. Facteau has served as a Board Director on a number of successfully acquired ventures including Acclarent, Neotract, CVI, Cabachon and ExploraMed.

Subhi Saadeh is a Quality Professional and host of Let's Combinate. 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.

For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Denne episoden er hentet fra en åpen RSS-feed og er ikke publisert av Podme. Den kan derfor inneholde annonser.

Episoder(266)

258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin

Combination product quality with Ben Locwin: why drug and device quality systems differ, how human factors studies are designed, what to do when a CDMO's clean audit doesn't match its performance, and...

12 Okt 34min

257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products

21 CFR Part 4 sets the CGMP requirements for combination products. If your product has a drug and a device in it, you're on the hook for both sets of regulations. In this video, I walk through Part 4 ...

5 Okt 12min

256 - The New FDA Inspection Playbook: Where to Start with QMSR

QMSR became effective on February 2, 2026. Alongside that change, FDA retired the Quality System Inspection Technique (QSIT) and began using the inspection process described in Compliance Program 7382...

28 Sep 9min

255 - Audit Interview Techniques: How Good Auditors Get Better Evidence

A huge part of the job is knowing how to interview people, understand how work is actually performed, and corroborate what you hear against records, observations, and other objective evidence.In this ...

21 Sep 11min

254 - Saying No Is the Easy Part of Quality

Quality has a reputation for saying no.Sometimes that’s exactly the right call. Other times, “no” is just the easiest answer.In this episode, Subhi breaks down four situations where Quality should abs...

13 Sep 12min

253 - FDA Is Making Big Changes to Its Inspection Approach

FDA is changing how it organizes and deploys its investigators but it isn’t simply returning to the old generalist model.Eric Pittman spent more than 20 years at FDA, conducted approximately 800+ insp...

7 Sep 45min

252 - Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)

Acceptance sampling is one of the most commonly used and commonly misunderstood tools in quality.In this video, I break down the fundamentals of acceptance sampling: what it is, what an AQL actually m...

31 Aug 13min

251 - The Future of Drug Delivery: Orals, Injectables, Sustainability & Device Strategy

In this episode, Subhi Saadeh sits down with Steven Kaufman, Founder of Combination Product Solutions, Inc. and fractional Chief Commercial Officer at Portal Instruments, to discuss where the drug del...

24 Aug 49min