SPOT Radio

Listen in as we speak again with Bruce Anthenat founder and president of AWS Bio-Pharma Technologies. Bruce speaks on how the process of modular cleanrooms are specked out and delivered. We will also hear about emerging technology from AWS Bio-Pharma Technologies that will allow for the conversion of office space into a cleanroom.  

Guest  Description:

Bruce Anthenat earned his BS degree from the College of Engineering and Technology of Southern Illinois University.  He has also obtained the status of Certified Plant Engineer as recognized by the Association of Facilities Engineers (AFE). He is Past-President of AFE Chapter 126 and has made several presentations on a variety of topics to various professional organizations including AFE, ISPE, and the PDA.

Bruce has over 40 years of experience in facilities and process engineering, and management with the last 30+ years in pharmaceutical engineering and manufacturing management for a variety of well-known injectable drug manufacturers.  In February of 2000 he received the Engineer of the Year award from his peers in AFE Chapter 126. He has been a past member of the Board of Directors for the International Society of Lyophilization, a member of PDA Glass Handling Task Force, project manager, and lead technical authority for a number of new and renovated pharmaceutical manufacturing facilities.

He is the primary patent holder of US Patent# 831667 [a method and apparatus for high-velocity electromagnetic sealing of containers (primarily for Parenteral vials and cartridges].  Mr. Anthenat entered into the entrepreneurial world by founding AWS Bio-Pharma Technologies in 2005, where he continues to provide leadership to this growing company.  He is a proven leader, with a keen sense of observation and analytical skills, which provides him with the knowledge to administer and inspire others while developing a genuine understanding of their point of view. His vision includes helping others achieve very memorable accomplishments in his related areas of expertise.

877-297-7763

https://www.awsbiopharma.com

Best selling author and speaker Nick Webb discusses the art and science of managing a collaborative workgroup. Nick, a prolific writer and event speaker turns to digital platforms to reach out to his scattered and remote audience. Nick talks about the systems he uses to keep his innovation staff at a southern California medical School on task by focusing on the individual which he believes can foster better team performance.

Guest  Description:

Nick serves as the Chief Innovation Officer as well as an adjunct Professor of Health Sciences at Western University of Health Sciences in Pomona, California,

As an inventor, Nick Webb has been awarded over 40 patents by the U.S. Patent and Trademark Office for breakthrough technologies in a wide range of industrial and consumer products, including one of the world’s smallest medical device implants.

A prolific writer and bestselling author, his current breakthrough books include “The Innovation Mandate” and “What Customers Crave,” these books are used by top brands to design their customer experience and innovation strategies. Nick works closely with Fortune 500 companies throughout the world to help them lead their industries in innovation, strategy, and growth.

As one of the world’s leading innovation futurists, Nick Webb, is the CEO of LeaderLogic, a research and development project that is reinventing the way in which consumers access and engage with healthcare and other consumer products and services, and is dedicated to creating the next generation of wearable technologies.

Take a peek at his virtual event space: https://www.nickwebb.com/virtual-events/

Nick's Website: www.nickwebb.com

Our guest Gavin Smith a Chromatography scientist at SGS Polymer Solutions speaks on the role of independent Chromatography laboratory's in medical device manufacturing and packaging development. As medicinal embedded drugs seem to expand in our industry, Chromatography will help us understand the interplay and compatibility of drug chemistry in the presents of our delivery polymers.

Guest  Description:

Gavin Smith is a Chromatography scientist at SGS Polymer Solutions Incorporated with 6 years of experience in polymer and pharmaceutical testing in a laboratory setting. Gavin holds degrees in chemistry and biology from Radford University and Leads the size exclusion chromatography group at SGS PSI. Polymer Solutions is an independent testing laboratory specializing in polymers and pharmaceutical products, including medical devices, packaging, consumer product, and characterization and analysis.

https://www.polymersolutions.com

(877) 961-4341

As the medical device industry continues to speak the new mantra of "Patient Outcomes", device safety and sterility has become an enhanced topic of discussion. In this episode, our guest Michael Matthews of the Beyond Clean Podcast speaks on issues that must be addressed in the SPD departments in order to assure the safe and sterile delivery of surgical instruments to the OR. The interplay of People, Processes and Products must be understood to better manage the complicated work environment in the SPD.

Guest  Description:

Michael Matthews, MBA, CLSSGB, CRCST, CIS, CHL currently serves as the Director for Clinical Education and Training for Northfield Medical, where he previously served as a Territory Manager for the Little Rock, Arkansas area, and a Clinical Education Manager for the southeast region.  Before working at Northfield, Michael served as the manager for sterile processing at Baptist-Health Medical Center-Conway, a new $200 million facility in Arkansas.

During this time Michael also served as an Infection Preventionist on a PRN basis to consult on reprocessing services throughout the Baptist-Health system. Michael has previously served as a Sterile Processing Technician at Jewish Hospital & St. Mary’s Healthcare (Catholic Health Initiatives) (2012-2013), Baptist East Hospital (2011-2012), both in Louisville, KY, and system manager for sterilization and high-level disinfection at Conway Regional Medical Center (2013-2016).

He holds three International Association of Healthcare Central Service Materiel Management (IAHCSMM) certifications for sterile processing. Michael has also served as a subject matter expert and participated in exam development for IAHCSMM. Michael holds an MBA and has also been certified as a Lean Six Sigma Greenbelt.  He has published articles in Infection Control Today, Becker’s Hospital Review, Healthcare Purchasing News, as well as several LinkedIn articles in the sterile processing community.

Michael is a co-host of the Beyond Clean podcast, the premier podcast for sterile processing professionals throughout the world, and the lead host for Beyond the Headlines, which examines news related to the medical device reprocessing industry.  

https://www.beyondclean.net/

Shifting trends in medical product innovation may mean that innovation will come from unexpected organizations like Google and Amazon. Healthcare based on patient contributions to treatment may shape 3rd partly reimbursements as we move to the next level of managed care. As we move to a prevention model of healthcare, device makers will likely focus on wellness devices. Listen in as our Guest Nick Webb speaks on the future of Healthcare Innovation. 

Guest  Description:

Nick serves as the Chief Innovation Officer as well as an adjunct Professor of Health Sciences at Western University of Health Sciences in Pomona, California,

As an inventor, Nick Webb has been awarded over 40 patents by the U.S. Patent and Trademark Office for breakthrough technologies in a wide range of industrial and consumer products, including one of the world’s smallest medical device implants.

A prolific writer and bestselling author, his current breakthrough books include “The Innovation Mandate” and “What Customers Crave,” these books are used by top brands to design their customer experience and innovation strategies. Nick works closely with Fortune 500 companies throughout the world to help them lead their industries in innovation, strategy, and growth.

As one of the world’s leading innovation futurists, Nick Webb, is the CEO of LeaderLogic, a research and development project that is reinventing the way in which consumers access and engage with healthcare and other consumer products and services, and is dedicated to creating the next generation of wearable technologies.

www.nickwebb.com

https://www.goleaderlogic.com/

In this episode, we speak with sterile packaging influencers Rod Patch and Jennifer Benolken, CPPL from the Kilmer group. The Kilmer Conference community is a forum for select sterility assurance professionals. This group shares knowledge and best practices, poses questions to colleagues, and through their conversations, they spark the innovations that will shape the future of sterility assurance. Listen and learn about the valuable charter of the Kilmer innovation in packaging group.

Guest  Description:

Rod Patch is Senior Director, Package Engineering & Product Labeling for Johnson & Johnson Vision.  In his role, Rod serves the needs of J&J’s Vision Franchise with packaging strategies, innovation programs, talent, regulations and supply chain improvements.  Rod is responsible for both J&J Vision Care and J&J Surgical Vision within the J&J Vision Franchise.     

 Rod is an accomplished leader with a broad base of experience in sterile barrier package design and labeling systems. He has a track record of implementing innovative packaging systems and packaging strategies that elevate the quality; compliance, and business value as well as improving the customer delight experiences for Johnson & Johnson products.   Rod has supported packaging his entire career working in operations, supply chain, and R&D functions where he has led and managed teams supporting the package design, package process, package delivery as well as product label designs.    

Rod is an industry-recognized expert in sterile barrier packaging.   Rod is J&J’s primary delegate to ISO/TC198 WG7 Packaging and is an approved consensus U.S. Expert at international meetings.  Rod is also J&J’s primary voting member for ASTM F02 and D10, supporting packaging standards.

Our 2nd guest:

Jennifer Benolken, CPPL, is the Western Region Medical Device and Pharmaceutical Manufacturer and Regulatory Specialist with DuPont Tyvek® Medical Packaging; she works with downstream customers at medical device and pharmaceutical organizations, providing education and answering questions about Tyvek® packaging and sterilization. Jen has worked in the medical device community since 1991 in a variety of packaging related roles - packaging/labeling/sterilization engineer (in both operations and R&D roles), flexible packaging sales representative, and manager of packaging engineering and labeling groups.

 While Jen earned her undergraduate degree in Manufacturing Systems Engineering at Kettering University (Flint, MI), she came to love packaging through her collegiate co-operative work experience at CPI/Guidant. Jen furthered her education by obtaining a Masters of International Management degree from St. Thomas University (St. Paul, MN). She is currently the sub-committee chairperson for ASTM F02.50, Package Design and Development, as well as co-chair for AAMI’s ST/WG 7, Packaging Working Group, the US’s mirror group to ISO TC198/WG7.

Jen is also an active member of the Institute of Packaging Professionals (IoPP) where she attained her lifetime Certified Packaging Professional (CPPL) certification in 2012. As part of IoPP, Jennifer has recently been elected to the Board of Directors and is also Vice Chair on its Medical Device Packaging Technical Committee (MDPTC) board. Jennifer is currently working with industry leaders as the editor for the upcoming 3rd edition of the Medical Device Packaging Handbook.

kilmer innovation in Packaging

https://www.linkedin.com/groups/12301596/?msgConversationId=6592084813891596289&msgOverlay=true

Rod Patch

Human error is known to be the primary cause of quality and production losses in many industries including medical device manufacturing and medical packaging. In this episode of Sterile Packaging on Track (SPOT) radio host Charlie Webb speaks with Dr. Ginette Collazo a leading Industrial-Organizational Psychologist about how human errors develop and what can be done to manage the human failure risks.

Guest  Description:

Ginette Collazo, Ph.D is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.

Nine years ago, Dr. Collazo established Human Error Solutions (HES), a Florida based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development and effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.

Ginette Collazo, Ph. D. is the author of the book Human Error: Root Cause Determination Model, published in 2008. She is also a speaker at significant events like Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, and of course, Pharmaceutical Industry Association.

Contact Dr. Collazo

[email protected]

Professor Michael Cima chats with host Charlie Webb about his Drug and Medical device development course offered through the xPRO program at MIT. The course goals are to help participants gain a “big picture” perspective of the entire drug and medical device development process, from day one strategic planning through product commercialization. Also, students will understand the critical interplay between strategy and development and how they affect each other. This online program helps you explore the process of discovering, developing, testing, and bringing a medical product to market.

Guest  Description:

Dr. Michael J. Cima is a Professor of Materials Science and Engineering at the Massachusetts Institute of Technology and has an appointment at the David H. Koch Institute for Integrative Cancer Research. He earned a B.S. in chemistry in 1982 (phi beta kappa) and a Ph.D. in chemical engineering in 1986, both from the University of California at Berkeley. Prof. Cima joined the MIT faculty in 1986 as an Assistant Professor. He was promoted to full Professor in 1995. He was elected a Fellow of the American Ceramics Society in 1997. Prof. 

Cima was elected to the National Academy of Engineering in 2011. He now holds the David H. Koch Chair of Engineering at MIT. He was appointed faculty director of the Lemelson-MIT Program in 2009 which is a program to inspire youth to be inventive and has a nationwide reach.

Prof. Cima is author or co-author of over two hundred and fifty peer-reviewed scientific publications, fifty-eight US patents, and is a recognized expert in the field of materials processing. more on his Bio https://cima-lab.mit.edu/people/cima

Learn more about the Drug and Medical device development course. 

We visit with Greg Jones from SGS North America and gain insight into the ISO 13485 certification process from a seasoned auditor. Start-ups or established medical device manufacturers can benefit from this discussion as we speak about potential pitfalls that could jeopardize accreditation. 

Guest  Description:

Greg Jones is the Technical Director at SGS in North America. In that capacity, Greg is responsible for all technical and operational aspects of medical device certification including ISO 13485, MDSAP, MDR and IVDR. Greg brings over 15 years of experience in Medical Device Certification and prior to that spent over 10 years in Research & Development as a Process Engineer with a leading Medical Device manufacturer. He is a certified lead auditor for ISO 9001 and ISO 13485. Greg earned his Bachelors at Belmont University.

201.296.5353

www.sgs.com

Email [email protected]

Listen in as we speak with the founder and president of AWS Bio-Pharma Technologies. Bruce speaks on how the process of a modular cleanroom is specked out and delivered. Bruce has great insight into the process of controlled environments from his 40 years of experience in facilities and process engineering, and management.

Guest  Description:

Bruce Anthenat earned his BS degree from the College of Engineering and Technology of Southern Illinois University.  He has also obtained the status of Certified Plant Engineer as recognized by the Association of Facilities Engineers (AFE). He is Past-President of AFE Chapter 126 and has made several presentations on a variety of topics to various professional organizations including AFE, ISPE, and the PDA.

Bruce has over 40 years of experience in facilities and process engineering, and management with the last 30+ years in pharmaceutical engineering and manufacturing management for a variety of well-known injectable drug manufacturers.  In February of 2000, he received the Engineer of the Year award from his peers in AFE Chapter 126. He has been a past member of the Board of Directors for the International Society of Lyophilization, a member of PDA Glass Handling Task Force, project manager and lead technical authority for a number of new and renovated pharmaceutical manufacturing facilities.

He is the primary patent holder of US Patent# 831667 [a method and apparatus for high-velocity electromagnetic sealing of containers (primarily for Parenteral vials and cartridges].  Mr. Anthenat entered into the entrepreneurial world by founding AWS Bio-Pharma Technologies in 2005, where he continues to provide leadership to this growing company.  He is a proven leader, with a keen sense of observation and analytical skills, which provides him with the knowledge to administer and inspire others while developing a genuine understanding of their point of view. His vision includes helping others achieve very memorable accomplishments in his related areas of expertise.

877-297-7763

https://www.awsbiopharma.com