Let's Combinate - Drugs + Devices

By Subhi Saadeh

Hello Combi-Nation!

Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the l... more

4.9

1313 ratings

Download on the App Store

Download on the App Store

Get it on Google Play

FAQs about Let's Combinate - Drugs + Devices:

How many episodes does Let's Combinate - Drugs + Devices have?

The podcast currently has 243 episodes available.

Let's Combinate - Drugs + Devices episodes:

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
------------------------------------------------------------
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
...more
1h 4min
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.
------------------------------------------------------
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
...more
1h 43min
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
...more
1h 32min
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
...more
1h 30min
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.
...more
1h 8min
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/
...more
50min
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].
...more
1h 30min
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]
...more
50min
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]
...more
51min
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]
...more
1h 13min

FAQs about Let's Combinate - Drugs + Devices:

How many episodes does Let's Combinate - Drugs + Devices have?

The podcast currently has 243 episodes available.

More shows like Let's Combinate - Drugs + Devices

Planet Money by NPR

Planet Money

30,609 Listeners

The Audible with Stew, Bruce & Ralph: A show about college football by The Athletic

The Audible with Stew, Bruce & Ralph: A show about college football

1,227 Listeners

The Daily by The New York Times

The Daily

113,121 Listeners

Up First from NPR by NPR

Up First from NPR

56,944 Listeners

RAQA Today by Michelle Lott

RAQA Today

0 Listeners