Let's Combinate - Drugs + Devices with Subhi Saadeh

By Subhi SaadehScience Life Sciences

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

March 09, 2022 023 - "The Best is Yet to Come" with David Albert
On this episode of the podcast we had Dr. David Albert of AliveCor, a medical doctor, scientist and entrepreneur who has founded several successful companies and ventures in MedTech like AliveCor and others that have been acquired by companies like GE Healthcare. Dr. Albert and I discuss:
Pursuing a Career and Family Simultaneously
Becoming an Inventor Physician by Chance
The unexpected reception that started AliveCor
His inventions and Patents
The importance of being optimistic and opportunistic
The lessons he learned having created 4 businesses
His amazing fire alarm inventions under Lifetone Technologies
Artificial Intelligence in remote patient monitoring devices
David Albert, MD, an Oklahoma native, is a physician, inventor and serial entrepreneur who has developed life-saving technologies and products over the last 30 years, turning an number of those innovations into tech startups. Today, he is a founder of three technology companies, InnovAlaram, Lifetone Technology, and AliveCor. His previous startups include Carazonix Corop(sold to Arrhythmia Research Technology) and Data Critical(sold to GE). Dr. Albert left GE in 2004 as Chief Scientist of GE Cardiology to disrupt several new markets.
His latest invention, AliveCor's KardiaMobile personal ECG technology, became a global sensation via a Youtube Video in Jan 2011 around the CES show and was featured on ABC, CBS, CNN and Fox News and others. Dr. Albert has 75 issued patents and has lectured at the entrepreneurship programs at MIT and other universities. Dr. Albert graduated with honors from Harvard College and Duke University Medical Schools.
1 hr 7 min
March 02, 2022 022 - "What Chapter are you in?" with Susan Neadle
On this episode, we were joined by Susan Neadle. If you work on Combination Products, Susan is someone you need to know. Her and I discuss:
Her career starting in consumer health and pivoting into Medical Devices then Pharmaceuticals
Design to Value, Design Excellence and Process Excellence
The History of Combination Products regulation and what it was like implementing 21 CFR Part 4 as it was revealed.
Creating future plans using tools like the Merlin Exercise, and Future/Back
Vocabulary in Combination Products
AAMI TIR 48 and TIR 105
Her involvement in ASTM, AAMI, ISPE, FPIA, DIA, AFDA, TOPRA and RAPS
Prioritization, Passion and her upcoming book
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Susan Neadle, MS, BS, FAAO is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience. Networked, published, highly active in numerous industry groups and with links to a number of teaching institutions, Susan brings deep knowledge, and genuine passion for sharing that knowledge, with others. Susan’s leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, Johnson & Johnson’s highest honor for excellence in Research & Development, and most recently, as a Finalist in TOPRA’s 2021 Awards for Regulatory Affairs Excellence. She is Principal Consultant and President of Combination Products Consulting Services LLC, applying her extensive leadership and technical skills and experience to provide hands-on design-to-value, program management, quality & compliance, and regulatory consulting services, for pharmaceutical, biotech and medical device industries. Among her many significant industry affiliations and contributions, she serves as Chair of the ISPE Combination Products CoP, lead author on the ASTM International Combination Products Standard Committee, and teaches a Master’s Curriculum on Combination Products at University of Maryland Baltimore Campus.
Most recently, Susan served as Head of Combination Products, Medical Devices, Digital Health & IVD Regulatory Affairs at Amgen, providing strategic leadership in global combination products/ device regulatory development and portfolio/project management from initial clinical investigation through registration and commercial lifecycle. She served as an advisor for internal regulatory policy priorities, health authority engagement and submissions approaches through strategic engagement and mentoring of colleagues for individual projects and portfolio. She led interactions with multiple global health authorities, and served as a catalyst for external consortium deliverables and strategic direction.
Susan retired from Johnson & Johnson. Her distinguished career there of more than 25 years included integral leadership roles in R&D, Quality Engineering, Design-to-Value, Risk Management and Quality Systems, spanning pharmaceuticals, medical devices, and consumer health sectors, including strategic Enterprise leadership as Chair of J&J’s Design Council, advancing world-class practices in customer-centric product/process design and development. She led the team that defined and successfully implemented the globally integrated business model to meet Combination Products regulations for Janssen.
1 hr 24 min
February 23, 2022021 - "Options" with Karandeep Singh Badwal
On this episode of the podcast we had Karandeep Singh Badwal. Karandeep and I discuss:
Why QA/RA is the place to be (if you're so inclined)

Intended Use, Indications and Use cases

Where software startups struggle

Eudamed

Cybersecurity

Artificial Intelligence in Medical Devices

SaMD and Digital Health Considerations related to the MDR

Impact of Brexit on existing and future products within the EU and UK

Robert Green and his books

His Podcast: The Med Tech Podcast
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Karandeep is a QA/RA consultant and host of The MedTech Podcast with a mission to help you understand the Quality, Regulatory Affairs and Compliance of Medical Devices, Digital Health and Biotech.
Karandeep can be found at: Linkedin Profile
The MedTech Podcast: Podcast Link
1 hr 4 min
February 16, 2022020- "The Right Words" with Kathy Walsh
On this episode we had Kathy Walsh, Director and Principal at Quality Systems. Kathy and I discuss:
Her Book: "Eliminating the Gobbledygook: secrets to writing plain language procedures"

Her background starting as a PhD Microbiologist and moving into Quality Systems/Technical Writing

Where most companies have issues with their procedures

Plain Language Skills: Active voice vs. passive voice, Process Mapping, Inference Building, Sentence Parsing, document structure and more

The origins and history of "plain language"

The history of Fonts

How to make for more efficient document reviews and advice she has for writing technical documents and procedures
Dr. Kathy Walsh is a scientist, a PhD biochemist with post-doctoral work turned QS expert. She helps companies in regulated industries design & implement quality compliance solutions that increase productivity and master the quality challenges in their marketplace. She most recently wrote her book "Eliminating the Gobbledygook: secrets to writing plain language procedures" and is joined us from Melbourne, Australia.
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Links:
Kathy can be reached on LinkedIn HERE

QSN: https://www.qualitysystemsnow.com.au/

Eliminating the Gobbledygook: secrets to writing plain language procedures: Book Link
1 hr 43 min
February 09, 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
1 hr 32 min
February 02, 2022 018 - "The Optimist Plans for Forever" - with Sarfaraz Niazi
On this episode of the podcast, we had Professor Sarfaraz Niazi, a "Renaissance Man" if I ever met one. We discuss what biosimilars are and how they differ from generics, how he predicted biologics and biosimilars would be the future of medicine, his inventions starting from coffee mugs and hats to bioreactors that don't have an exhaust, how he passed the federal bar exam without attending law school, how he writes 4 to 5 books a year(with more than 50 books published), passions vs. hobbies, how he schedules his day and more.
Prof. Sarfaraz K. Niazi, Ph.D., SI, FRSB, FPAMS, FACB, founder of Pharmaceutical Scientist Inc. and Adello Biologics (acquired by Kashiv Biosciences), is an adjunct professor at the University of Illinois. A prolific inventor with scores of patents in a variety of fields to his name, Sarfaraz has developed the MayaBio® bioprocessing platform that allows faster development and manufacturing of biological products at the lowest cost. Sarfaraz has published extensively including consumer articles and books, refereed scientific research, technical handbooks, poetry translations, philosophic rhetoric, and technical textbooks that are required reading worldwide. He has written most books in the field of bioprocess engineering and biosimilars. His honors include the prestigious University of Illinois Alumnus of the Year Award, Inductee into Chicago Entrepreneurs Hall of Fame, the Star of Distinction—the high civil award from Pakistan; Forbes magazine has called him, “The Most Interesting Man Revolutionizing the Health World.”
https://www.niazi.com/expertise
1 hr 30 min
January 26, 2022 017 - "Feet First" with Ahmed Zobi
On the podcast this week, we had Ahmed Zobi, CEO of Syntr Technologies. Ahmed and I talk about jumping into Syntr Technologies feet first, what bootstrapping in medtech looks like, the grant submission process for funding, being a young CEO and figuring out where to trust your gut and where you need help, how Covid impacted his startup, leading with emotional intelligence, and where Syntr is going.
Ahmed Zobi is the Founder and CEO of Syntr Health with experience in microfluidics and biomechanics, and has headed research and development, management, and grant submissions. He has successfully attained all funding and has guided the company towards 510(K) clearance and commercialization of the SyntrFuge System. Ahmed received his BS in Biomedical Engineering, specializing in micro and nanotechnology, from the University of California, Irvine, and recently received his EMBA from Quantic School of Business and Technology.
Syntr Health Technologies, Inc is a start-up company that was founded by biomedical engineers and experienced surgeons. Together, we have developed and tested a processing device, the SyntrFuge™ System, for the microsizing of adipose tissue for body contouring. How microfat is processed is incredibly important to its viability. The SyntrFuge System utilizes the precision of automation to deliver dependable results every time. We are on a mission to empower practices to offer innovative and natural solutions for their patients.
1 hr 8 min
January 19, 2022 016 - "Be More Specific" with Joe Hage
This episode of the Combinate Podcast is with Joe Hage. Joe and I talk all things medical device marketing. We discuss how storytelling is even more important for medical devices than other industries, how he helps clients clarify their vision and messaging, the importance of being specific and concise, the medical device marketing process, hist start in the food industry and transitioning into MedTech, a single book recommendation and the 10x Medical Device Conference.
Joe Hage leads the Medical Devices Group(MDG) with more than 350,000 subscribers, the most useful website serving the medical device industry. Joe also runs his company, Medical Markom, where he provides medical device marketing services, and helps companies engage qualified prospects. He is the host of the 10x Medical Device Conferences where he unites Medical Devices Group members in fun and educational forums each year.
Medical Devices Group: https://www.medicaldevicesgroup.net/
Medical Marcom HELL List mentioned in the podcast: https://medicalmarcom.com/medical-device-marketing/selling-medical-devices-2019/
The 10X Medical Device Conference will be in San Diego, CA this year on May 10-12: https://medicaldeviceevents.com/
50 min
January 19, 2022 015 - "Would You Use it on a Family Member?" with Monir El Azzouzi
On this episode of the podcast we had Monir El Azzouzi of Easy Medical Device. Monir and I focus on EU MDR and discuss the difference between EU MDR and US regulations, the history of the MDD being updated to MDR in 2017, Notified Bodies(their role and how they are formed), CE Marking and medical device clearance, considerations for CMO’s and private label, the role of Authorized Representatives, books be recommends and the importance of thought and integrity in QA.
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses.
If you'd like to support the show, please share, subscribe and rate on Apple Podcasts and Spotify. If you have any feedback or requests please contact [email protected].
1 hr 30 min
January 05, 2022 014C - "The Final P: People" with Larry Mager
In this final segment of the episode with Larry, we discuss the Final P: People. In this episode we discuss skillsets, training and competency, communication for teamwork, establishing a culture of trust and accountability and all of this culminating into the creation of a strong Culture of Quality. Larry ends the episode by giving an example of how he's seen people and the soft science surrounding quality culture applied very well.
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]
50 min