Let's Combinate - Drugs + Devices with Subhi Saadeh

By Subhi SaadehScience Life Sciences

Let's Combinate - Drugs + Devices with Subhi Saadeh episodes

January 05, 2022 014B - "The Second P: Process" with Larry Mager
In Part 2 of this episode, Larry and I discuss the Second P: Process. I start the episode by asking Larry to explain the difference between a Quality System and a Quality Management System(QMS) to set the foundation. Larry then moves on to explain have a control environment should be well established(policies, standards, procedures, governance, etc), Risk Management for processes and poking holes in your organization's ways of working, control activities, flow of information, monitoring, management review and continuous improvement.
Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes beyond compliance only. He has three decades of experience in the medical device industry, and has held responsible positions within medical device manufacturing companies ranging from start-ups to multisite, highly matrixed organizations. He has held executive management responsibilities in both quality management and operations management roles and is experienced in interrelated quality disciplines, such as quality systems, management control, CAPA, supplier control and management, risk management, quality assurance/control, lean manufacturing, product development engineering, and results-oriented management for continuous improvement. You can reach Larry at [email protected]
51 min
January 05, 2022 014A - "The First P: Product" with Larry Mager
This Episode is with Larry Mager of Mgmt-Ctrl. In this episode Larry and I continue where we left off in 002 - "Seeing David in the Stone". In that episode he walked the audience through the importance of having Predictive Quality Management or PQM. That it's not an afterthought, but rather a beforethought. It should be intentional.
In this episode, Larry and I chop it up about the well where PQM starts: Product. As Product is the output of the existing Process and People, before an organization moves to attempt to remediate systematic issues like QMS or Competency/Training/Development, it should ensure that it's product is Safe and Effective. We go over a quick overview of PQM, Sources of information to feed into risk assessment, Safety Signal Identification and Confirmation, Risk Control, and ensuring the State of the Art(SOTA) benefit of Patient Safety.
Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes beyond compliance only. He has three decades of experience in the medical device industry, and has held responsible positions within medical device manufacturing companies ranging from start-ups to multisite, highly matrixed organizations. He has held executive management responsibilities in both quality management and operations management roles and is experienced in interrelated quality disciplines, such as quality systems, management control, CAPA, supplier control and management, risk management, quality assurance/control, lean manufacturing, product development engineering, and results-oriented management for continuous improvement. You can reach Larry at [email protected]
1 hr 13 min
December 29, 2021 013 - “Big Rocks and Little Rocks” with Jumha Abu-Razeq
This episode of the podcast was with Jumha Abu-Razeq of Stoopid Fit. I wanted to bring Jumha on in preparation for 2022. Jumha was the first coach I hired and I did so after losing 100 lbs and finding that despite my success in weight loss, my relationship with food still needed a lot of work. I still didn't feel in control. I believe for us to be the best professionals we can be, it’s important to be healthy physically and mentally and in that way health is not defined as the absence of sickness but something that’s more positive than that. I found great success in working with him and I hope you find value in this interview.
Jumha and I talk about his thoughts on New Years resolutions, goal setting, fat loss, sleep, stress, health and his recommendations for who should get coaching. I hope you enjoy the episode with Jumha!
Jumha Aburezeq is Owner and Operator of lifestyle nutrition coaching brand Stoopidfit. His mission is to help as many people as possible break free from complexity and restriction, by embrace simplicity and freedom to live happier and healthier lives.
1 hr 2 min
December 22, 2021 012 - "Asking then Seeing" with Sara Waxberg Mcnew
Happy Holidays everyone!
On this episode of the Combinate Podcast, we had Sara Waxberg McNew, Chief Scientific Officer at Design Science. Sara and I talk about her interest in Human Factors and her career, we discuss who is a user and how to get close to them, how to read the ANSI/AAMI HE75:2009 (R2018) and IEC 62366-1:2015 standards, the design validation process and how human factors formative and summative evaluations fit in, human factors considerations for combination products, and figuring out what users need vs. want.
Sara Waxberg McNew is the Chief Scientific Officer at Design Science, a human factors firm that specializes in healthcare. Sara has held roles previously in user centered design leadership at Eli Lilly and Company, Philips Healthcare, and Baxter Healthcare. Throughout these experiences, she has led cross functional teams, selected and managed human factors consultants (and now is one), interacted with the FDA and international regulatory agencies, and executed on created corporate level strategic plans for human factors. At each of these organizations, she was accountable to ensure intended end-users are effectively represented and their needs are considered throughout the product lifecycle in order to reduce the potential for use error, satisfy target customers, and comply with regulatory requirements.
Sara has a B.S. in Human Factors Engineering and Biomedical Engineering Design from Tufts University, where she has also completed her M.S. course work. She is an active member of the Association for Advancement of Medical Instrumentation (AAMI) where she has contributed to the development and revision of human factors technical information reports and international standards.
Design Science is retained by the world’s leading companies to assure that their products fit user needs. Design Science conducts rigorous research and design user interfaces to optimize usability, safety, and customer appeal of products. Founded in 1991, Design Science was one of the first consultancies to focus on the person/product interface. They have deep roots in those product categories where usability is mission critical—particularly medical devices, but also other products that are tools: commercial, industrial, or consumer.
1 hr 17 min
December 15, 2021 011 - “Long Story Short” with Margot Leitman
Have you ever wondered what goes into a good story? Enter Margot Leitman. Margot and I talk about why people fear story telling, what people can do if they feel they have no good stories, the anatomy of a good story, and the importance of good story telling in business.
Margot Leitman is an award-winning storyteller, best-selling author, speaker and teacher originally from Matawan, New Jersey. A leading expert in the growing field of storytelling, Leitman has written two books on the subject: the best-selling, Long Story Short- the Only Storytelling Guide You'll Ever Need and her latest What’s Your Story? A Workbook For the Storyteller in All of Us both from Sasquatch Books. Her comedic memoir, Gawky…Tales of an Extra Long Awkward Phase is available from Seal Press/ Perseus Books.
She has written for NBC, DreamWorks TV, the Hallmark Channel and the PixL Network and a variety of print and online sources including Cosmo and Backstage Magazine. In 2016 she worked as the west coast story scout for This American Life. Margot is a five-time winner of The Moth StorySLAM, and was the Moth GrandSLAM winner in New York City achieving the series' first ever score of a perfect 10. Her stories have been featured on NPR's “The Moth Podcast,” “Good Food," “Unfictional,” "Strangers," and is a frequent contributor to the popular podcast “RISK!" Leitman is the founder of the storytelling program at the UCB Theatre, where she has performed in dozens of shows over the years and is a frequent monologist at their flagship show "Asssscat."
Margot travels all over the world as a public speaker, storyteller and teacher. Internationally she has performed and taught at the SPOKEN FEST in Mumbai, India as well as a six-week teaching residency at the Blue Room Theatre in Australia. In her spare time Leitman is an amateur baker, avid yogi and a devoted bibliophile. A proud graduate of the Ithaca College Theatre Department, Leitman now resides in Los Angeles.
Margot can be reached at https://www.margotleitman.com/contact.
1 hr 19 min
December 08, 2021 010 - "Don't Make Assumptions" with David Simoens
On this episode of the Combinate Podcast, we had David Simoens, COO at cGMP Consulting Group. David and I discuss his career, and dive deep into commissioning, qualification, and validation. David outlines the activities in including discussing URS, DQ, FAT/SAT, IQ, OQ and PQ. David outlines the a risk based approach for streamlining commissioning and qualification activities, highlights some important things to watch out for and also gives some great book recommendations!
David Simoens is a certified Project Management Professional with over 7 years of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radio-pharmaceuticals and enterprise quality management systems. Mr. Simoens assisted in C&Q standardization and implementation on a global level guided by ASTM E2500 and assisted in development of content for the ISPE Baseline Volume 5 guide. He led an effort to assess, pilot, implement and go-live with an electronic engineering platform for several global sites. David has designed, installed, and tested several commercial size Freeze-Dryers and Automated Loading Systems. He managed a month shutdown for one of the largest products on market. Currently, David is supporting NPI launches for a large pharmaceutical company and operating a 100 person consulting company across multiple clients.
Founded in 2001, cGMP Consulting Inc. has strived to help our clients adopt new technologies and ensure that changes to your processes are compliant with current Good Manufacturing Practices (cGMP). Our experienced engineering and quality assurance consultants have helped many industry leading companies identify and remediate gaps, support international pharmaceutical manufacturing, and implement cGMP requirements.
1 hr 14 min
December 01, 2021 009 - “Cutting Through the Noise” with Charles Ventura
On this episode, we had Charles “Chuck” Ventura. Chuck is a the CEO of Hemotek Medical and President of Ventura Solutions. He has extensive product development, commercialization, and business management experience in the Medical Device industry. Chuck is a seasoned Medical Device leader with successful experience in Commercialization, R&D, Project Management, and Manufacturing Support. He also has start up experience in business development and investment management.
Chuck received his Bachelor’s degree in Bioengineering with a minor in Electrical Engineering from the University of Illinois at Chicago. He went on to earn his Master’s degree in Mechanical and Aerospace Engineering from the Illinois Institute of Technology.
Chuck and I talk about:
* His career entry and expectations vs. reality
* Starting at the bottom and trusting the process
* How working as a systems and risk engineer influences his style in leading his companies
* Building business acumen
* The clinical study process for medical devices
* Staffing advice for college juniors and seniors to land their first job
1 hr 31 min
November 24, 2021 008 - "Follow the Opportunity" with Marta New
On this episode, I had Marta New PhD MBA. Marta and I talk about how business school changed her perspective, depth vs. the value of information when it comes to decision making, mentors in her career and their influence on her development, her experience starting a new company, her time in venture capital and the due diligence process, lessons during the pandemic and some of the influences that inspire her. Happy Thanksgiving!
Marta is the CEO of Radyus Research. Before starting Radyus, Marta was the co-founding Partner at Agent Capital, a life sciences-focused venture capital firm based in Cambridge, MA. While at Agent, Marta participated in multiple deals in oncology, immunology and rare disease areas including Orchard Therapeutics (NASDAQ:ORTX), Precision Biosciences (NASDAQ:DITL), Pliant Therapeutics and Verge Genomics, among others. Prior to Agent Capital, Marta was a Principal investor at Baxalta Ventures, the corporate venture capital arm of Baxalta in Cambridge MA, where she was on the investment dilligence team and served as a board observer for Gadeta BV (acquired by Kite/Gilead, 2018), Syntimmune (acq. by Alexion, 2018), and Vitesse Biologics (early stage accelerator funded by Baxalta, Mayo Clinic and Velocity Pharmaceutical Development).
Marta started her investment career at Baxter Ventures, the corporate venture capital arm of Baxter in Chicago, IL, transitioning from the Global Renal Marketing franchise, where she was the commercial lead for multiple new products for the Chinese and European markets. She joined Baxter from Northwestern University’s Innovation and New Ventures Office where she was responsible for licensing negotiations, commercial assessment of patents, and industry alliance management.
She received her Ph.D. from the University of Illinois at Chicago in microbiology and immunology and completed her post-doctoral training at Northwestern University. She also received an MBA from Northwestern University Kellogg School of Management in Chicago, IL.
56 min
November 17, 2021007 - "Beyond The Obvious" with Miiri Kotche
On this episode we had one of my most impactful engineering professors, Miiri Kotche PhD.
In this episode we discuss:
Starting as a Validation Engineer and making the decision to go back into academia

Teaching engineering students during the pandemic

Answering the age old question: "Do you use your degree?"

Moving to Finland and her experience as a Fullbright Scholar at VTT

STEM Programs and giving back
Dr. Kotche is the Associate Dean for Undergraduate Affairs and a Clinical Professor of Biomedical Engineering at the UIC College of Engineering. Her focus is on providing real-world experiences in education for bioengineering and medical students, by bringing industry experience in product development into the classroom. Miiri leads two programs—the Clinical Immersion Program for engineering and medical students, and the Bioengineering Experience for (High School) Science Teachers (BEST). Miiri is the Director of the Medical Accelerator for Devices Laboratory (MAD Lab) at the UIC Innovation Center, where an interdisciplinary student team of graduate-level engineers, designers, business and medical students provides early concept and business development of medical devices for clinicians across the campus.
Miiri has been recognized as a U.S. Fulbright Scholar, UIC Master Teaching Scholar, UIC College of Medicine Rising Star, UIC Teaching Award recipient and College of Engineering Faculty Teaching Award recipient.
Dr. Kotche can be reached at [email protected]
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PS - apologies for my mic coming in and out a few times. I've found the issue and addressed.
53 min
November 10, 2021 006 - “The Courage to Start” with John Bingham
On this episode of the Combinate Podcast we have the runner that needs no introduction, John Bingham.
John is the best selling author of the books, “The Courage to Start”, “No Need for Speed” and “Marathoning for Mortals”.
He is also the man behind the famous Runner’s World Magazine column “The Penguins Chronicles”.
On this episode John and I discuss starting running in his 40’s, his favorite of his 45 marathons, his books, owning his own race, the lessons he learned finishing races last or not finishing at all, his career and many more. John can be found at Johnbingham.com
For any feedback or recommendations of future guests feel free to reach me at [email protected]
1 hr 3 min