194 - Drug Delivery Innovation, Networking in Pharma, and Building a Career That Matters with Mike Denzer

194 - Drug Delivery Innovation, Networking in Pharma, and Building a Career That Matters with Mike Denzer

In this episode I sit down with Mike Denzer, a mechanical engineer, inventor, and trusted leader in the combination product space. We talk about the power of networking not just as a tool for finding your next job, but as a foundation for building a meaningful and resilient career in pharma and medtech.Mike shares what it’s like to develop life-changing devices like Amgen’s Auto Click autoinjector, how he built credibility across R&D and regulatory teams, and why asking good questions and being generous with your time pays off more than any formal title. If you’ve ever struggled to balance technical depth with approachability or you’re trying to navigate CROs, design controls, or cross-functional chaos, I hope you enjoy this conversation! ⏱️ Timestamps00:00 Welcome and introduction00:56 Why networking matters01:57 Life-changing moments in engineering09:45 Challenges and innovations in autoinjectors14:47 CROs, sponsors, and collaboration18:22 Mike’s favorite projects and final thoughtsAbout Mike Denzer:Mike Denzer is a mechanical engineer, inventor, and combination product leader with over 20 years of experience in drug delivery system development. He’s held leadership roles at companies like Amgen, Teva, Bristol Myers Squibb, and Kymanox, and is credited as an inventor on five U.S. patents related to autoinjector platforms and delivery technology.He’s the founder of Combo Products LLC, where he now consults on combination product design, human factors strategy, and technical development. Mike is widely respected for his collaborative style and clear communication across engineering, clinical, regulatory, and quality functions.Contact Mike: mdenzer@comboproductsllc.comSubhi Saadeh is a Quality Professional and host of Let’s Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large Medical Device and Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee.

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

Episoder(258)

I'm Changing The Podcast

I'm Changing The Podcast

After 250 straight weeks of publishing Let’s Combinate every Wednesday, I’m making a change.Starting now, new episodes will go live Mondays at 5:00 AM CT.To everyone who watches, listens, shares, or h...

18 Aug 2min

250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?

250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?

PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualific...

12 Aug 11min

249 - The Best Audit Advice Nobody Told Me

249 - The Best Audit Advice Nobody Told Me

Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitable, effective, and adequate and where it may n...

5 Aug 14min

248 - What Is a Quality Unit? QA vs. QC Explained

248 - What Is a Quality Unit? QA vs. QC Explained

What is a Quality Unit and how do Quality Assurance and Quality Control fit within it?In this episode, I explain the practical differences between the Quality Unit, QA, and QC across pharmaceutical, m...

29 Jul 8min

247 - Why Everyone in Pharma and MedTech Should Work in Quality

247 - Why Everyone in Pharma and MedTech Should Work in Quality

Quality is often treated like a necessary function rather than an exciting career path. But working in quality can give professionals in pharma, biotech, and MedTech a much broader understanding of ho...

22 Jul 8min

246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)

246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)

Most discussions about One QMS focus on harmonization.But before deciding whether a single global Quality Management System is the right approach, it's worth understanding the three primary ways organ...

15 Jul 8min

245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector

245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector

In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh talks with Julia Anthony, founder and chief strategy officer of Solution Medical, about adrenal crisis, emergency hydrocortisone, and ...

8 Jul 45min

244 - 5 Critical Quality Differences Between Drugs and Devices

244 - 5 Critical Quality Differences Between Drugs and Devices

Download the free Drug vs. Device Quality comparison guide here: https://letscombinate.kit.com/216fbfc6c2In this Let’s Combinate episode, Subhi explains why drug and device quality are not the same an...

1 Jul 8min

Populært innen Vitenskap

fastlegen
tingenes-tilstand
rss-nysgjerrige-norge
romkapsel
jss
villmarksliv
rekommandert
liberal-halvtime
rss-paradigmepodden
tomprat-med-gunnar-tjomlid
dekodet-2
sinnsyn
fjellsportpodden
vett-og-vitenskap-med-gaute-einevoll
abels-tarn
rss-rekommandert
rss-overskuddsliv
diagnose
nordnorsk-historie
rss-lundqvist-podden