Let's Combinate - Pharma + Medical Devices with Subhi Saadeh9 Helmi 2022

019 - "Carrying The Bag" with Omar M Khateeb

On this episode of the podcast we had Omar M Khateeb, the host of the State of MedTech, and Founder of Khateeb&Co where he Helps MedTech Companies Grow Sales & Drive Product Adoption Using Social Media. Omar and I talk about him leaving medical school to pursue his purpose, intuition vs. ego, the death of the existing medtech sales process and where it's going post-pandemic, MedTech and the Metaverse, and the power of reading & taking action. Omar M. Khateeb is a marketing leader who has developed marketing strategies at two publicly traded surgical robotic companies through their IPOs as well as co-founded and successfully launched a consumer product for men’s fashion. Having successfully crowdfunded and launched a consumer product, Omar brings his knowledge of B2C marketing through digital channels to a B2B world. His areas of focus are category design, driving adoption of new technologies, and developing strategies to channel attention towards generating demand. Currently he is principal at Khateeb & Co, a strategic advisory firm whose mission is to help medtech companies grow revenue through social media. In his spare time, he enjoys teaching, mentoring young professionals, and donating his marketing expertise to non-profits. He also spends time speaking at various industry conferences on topics around digital marketing, business development, and market engineering. Omar can be reached on Linkedin at https://www.linkedin.com/in/okhateeb/. You can follow with him on Facebook, Instagram, Twitter (@OmarMKhateeb) or Youtube (Mind Loom with Omar M Khateeb). I implore you to listen to his podcast here: https://open.spotify.com/show/5NVrQLfLk0EXDeKDdX7BB6?si=ZrdzqZImQR6Y66RuVi1kjg

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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 Loka 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 Loka 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 Syys 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 Syys 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 Syys 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 Syys 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 Elo 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 Elo 49min