Combinate Podcast - Med Device and Pharma

By Subhi SaadehScience Life Sciences

Combinate Podcast - Med Device and Pharma episodes

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
November 03, 2021 005 - “Compassionate Product Development” with Cameron Jones
On this episode we had Cameron Jones PhD, Co-Founder and CEO at Avasys. Cameron holds a PhD from University of Kentucky and did Post-Doctoral work at John’s Hopkins University. He has a passion for innovation and trying to find and address unmet clinical needs by working with the clinicians to craft fit for purpose solutions. In this episode we discuss the relationship between academia and innovation, how he pursued industry in graduate school, his upbringing, compassion and his zest for life. Cameron can be reached at http://www.avasysmedical.com/services/.
59 min
October 27, 2021 004 - “Until They Know How Much You Care” with Andy Robertson
I’m truly happy I discovered Andy Robertson before I took my own CQE exam. His tools, lessons and strategies were crucial in passing the exam on my first try. His passion and love for quality engineering jumped out and after becoming more familiar with his content and style, I thought “I have to meet this guy”. On this episode we discuss study habits, mastery, learning styles, applying CQE principles, and caring as a pillar of leadership.
Andy Robertson is a CQE’s CQE. Andy is a career engineer and learner who worked in the medical device industry in various roles in R&D, Operations and QA. He has spent the last decade teaching and mentoring his students to pass the CQE exam and recently moved to drive CQE Academy full time. Andy can be reached at cqeacademy.com and has a YouTube channel as well.
Hope you enjoy and as always, if you’d like to help the show, feel free to share.
#quality #qa #medicaldevice #leadership
1 hr 2 min
October 20, 2021 003 - “Standard Understanding” with Mark Swanson
In this episode I sit down with Mark Swanson.
We discuss Mark’s background and early career, his entrance into QA, his participation on standard work groups for ISO13485 and ISO9001, the standards process and more.
Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and a Principal Consultant of Quality and Regulatory Expert Partners (QRx Partners); a partnership consulting firm focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge as the large medical device companies. Mark has more than 20 years of experience in the medical device industry including all quality roles. He is a senior member of ASQ, corporate AAMI member (serving on several AAMI committees) and a RAPS member.
Mark has spent several years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) that published the revision of ISO 13485 in 2016 and was the project co-lead for the guidebook on ISO 13485. Mark is the chair of AAMI mirror committee for WG6 on post-market surveillance, member of the US mirror committee for JWG1 for ISO 14971/TR 24971 and has also participated with ISO TC176, on ISO 9000:2015 & ISO 9001:2015 as well as IWA31 on the application of risk management. This work includes discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how to effectively integrate these various international standards and other regulations into a single management system.
55 min
October 14, 2021 002 - “Seeing David in the Stone: Predictive Quality Management” with Larry Mager
Excited to drop episode 002- “Seeing David in the Stone: Predictive Quality Management” with Larry Mager from Mgmt-Ctrl. I hope you enjoy this episode!
Apple Podcasts: https://tinyurl.com/7y9k5kj8
Spotify: https://tinyurl.com/3w5chwhf
Larry and I discuss a lot in this episode, most notably what Predictive Quality Management is and how “Quality is Free”.
Larry Mager is the author of the books “The Quality Journey” and “Management Control Quality plan”. 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]
#qualityassurance #quality #leanmanufacturing #medicaldevice #riskmanagement
59 min
October 06, 2021 001 - “Learning Never Exhausts the Mind” with Rick Doe
I wanted the first episode to be very special so I invited someone who was instrumental in my development as an engineer and a person. I’d like to introduce you to Episode 001 - “Learning Never Exhausts the Mind” with Rick Doe! https://www.linkedin.com/in/rick-doe-aa312330
1 hr 30 min