On this episode of the Spot Radio Podcast, host Charlie Webb CPPL sits down with Elon Goldbaum from the Network Partner Group to delve into the intricacies of performing a Corrective and Preventive Action (CAPA). They discuss the framework that underpins the CAPA process, highlighting its crucial role in ensuring product quality and compliance in the medical device industry.

Charlie and Elon explore the vital importance of the CAPA process, shedding light on how it helps organizations identify, address, and prevent potential issues. They also share valuable tips and strategies to make the CAPA process more manageable and effective, ensuring that businesses can maintain high standards of safety and quality.

Tune in to gain insights from industry experts and learn practical advice that can be applied to your own CAPA initiatives. This episode is a must-listen for anyone involved in quality assurance, regulatory affairs, or medical device manufacturing.

About our guest:

As Vice President, Client Solutions for Network Partners Group, Elon (Lon) brings over 20 years of experience in the medical device field specializing in packaging, labeling, quality management systems, CAPA and sterilization. 

Lon’s multifaceted background provides support and leadership to Network Partners’ packaging consulting, quality assurance, labeling, and the Apprentice Leadership Program.

Prior to joining Network Partners, Lon held various roles with Baxter Healthcare, Edwards Lifesciences, Endologix and Danaher with a wide range of responsibilities. Lon earned his Bachelor of Science degree in Packaging from Michigan State University.

Elon Goldbaum e-mail: [email protected]

On this episode of the Spot Radio Podcast, Charlie Webb, CPPL, speaks with Michael Geanous and Doug Stallard both experts in VHP ( vaporized hydrogen peroxide) The discussion is centered around the movement to perform in-house sterilization at the MDM's location in order to streamline distribution.

About Our Guests: 

Michael Geanous 
Michael Geanous has worked in the industry for 42 years, the last 20 of which have been using Hydrogen Peroxide technology. Michael has developed several commercially successful pieces of DECON equipment with STERIS and his current independent company. He has been the lead engineering manager in developing DECON chambers, Deep Vacuum hydrogen peroxide sterilizers, and the interface of VHP with freeze dryers. His expertise is in steam, Eto, chemical sterilization, and decontamination methods.

Doug Stallard
For the past 25 years Doug Stallard has been working as an independent consultant in business development, marketing, and sales management. Doug represented and consulted with several companies over his career primarily in the pharmaceutical, biotech, and medical device industries. Many of his clients over the years have been start-ups, smaller domestic manufacturers without internal sales and marketing resources, or companies based in Europe wanting to penetrate the US market.

His experience and expertise have been with capital equipment such as H202 decontamination, liquid and powder aseptic fill finish machines, WFI water systems, sterilization and autoclave equipment, inspection equipment, cleanrooms, isolators, and material handling.

For more information on VHP e-mail me: [email protected]

On this episode of the Spot Radio Podcast Charlie Webb CPPL speaks with Cord Burnham CKF about his observations of both healthy and unhealthy cleanroom cultures. Over the past 10 years, Cord has visited hundreds of cleanrooms throughout the United States and abroad.

About Cord Burnham: 

As a Van der Stahl Scientific's ISO 17025 laboratory manager, Cord oversees all of the functions of the calibration and their empirical Laboratory. Cord is certified as a CKF (certified kaizen facilitator) and he co-authored the quality system manual for Van der Stahl Scientific. Cord is hands-on with all of the machinery that Van der Stahl Scientific offers and is also an SME for regulatory processes surrounding the ISO 17025 standards

Email: [email protected]
Website: www.vanderstahl.com

On this episode of the Spot Radio and the Sterile Aware Podcast Charlie Webb CPPL speaks with Missy Travis a certified Infection Preventionist about her role in managing contaminants and healthcare-acquired infections.  

About Missy Travis: 

As a certified Infection Preventionist with over two decades of experience in acute care, long-term care, public health, and professional sports, but most importantly being a wife, mother, sister, daughter, and friend, She has learned the importance of living the life you want while doing something you love.

She is passionate about spreading the message of creating a safe environment for people, young and old, using infection prevention principles. I use evidence to support my recommendations while applying Her own experience, including some interesting stories, for application.

Missy specializes in helping new Infection Preventionists develop an Infection Prevention Plan while managing their busy schedule. She also work with health departments, healthcare facilities (acute, post-acute, and long-term care), and sports teams to develop an Infection Prevention Program that promotes safety and excellence.

Email: [email protected]

Linkedin: https://www.linkedin.com/in/missy-travis-b8588b45/

On this episode of the Spot Radio Podcast Charlie Webb CPPL speaks with  Stan Gibson, JD. Listen in as Stan Uncovers the secrets to securing your medical device or packaging innovations. Stan Gibson is a leader in patent litigation and Chairman of the Patent Litigation Group at Jeffer Mangels Butler & Mitchell LLP. 

About the Stan Gibson: 

Stan is a seasoned trial attorney dedicated to helping innovators and entrepreneurs protect and monetize their ideas, transforming them into valuable business assets. With 30 years of experience and victories in dozens of trials, he has developed a specific strategy to shield clients' intellectual property from theft, ensuring they truly own their envisioned assets. His approach provides early peace of mind, allowing clients to focus on business growth. Stan's mission is to help 10,000 innovators secure and enhance the value of their intellectual property while avoiding costly trials and litigation. 

Contact Stan: www.ip-checklist.com 

On this episode of the Spot Radio Podcast Charlie Webb CPPL speaks with biomedical engineer Emily Graba about her scoring system for the visual features of a medical device Pouch or Tray sealing.

About the Emily Graba: 

Emily Graba is a biomedical engineering graduate from the University of Minnesota and a Process Development Engineer at QTS. Prior to joining QTS as a full-time engineer, Emily completed an R&D Co-op with the Cardiac Surgery group at Medtronic and a Project Engineering Co-op at QTS. At QTS Emily is heavily involved in the development and improvement of the sealing characterization and validation process for medical devices. Outside of work, Emily enjoys going to Society of Women Engineers (SWE) events and spending time outdoors!

Guest Email: [email protected]

Visual seal inspection app: https://vanderstahl.com/viu-system/

Visual seal inspection device: https://vanderstahl.com/seal-stats/

On this episode of the SPOT® Radio Podcast Charlie Webb CPPL speaks with Justin Paur the president of Achates about when and why to use a contract medical device packaging and consultancy firm.

About Justin Paur:

Justin Paur is the president of Achates (A-kate-ees), a medical device contract manufacturing and product development company in the Twin Cities focused on startup medical device technologies. Justin has undergraduate degrees in Mechanical Engineering and Aerospace Engineering from West Virginia University, and an MBA from the Carlson Medical Industry Leadership Institute at the University of Minnesota in the Twin Cities, where Justin is now a senior lecturer. Justin authored “The Core Chain”, a book on lean medical device development, which is available now on Amazon.

Email: [email protected]

Link to The Core Chain Book: https://a.co/d/7vBnVeu

Link to Achates: www.achates.com 

Link to Biodesign Book: https://a.co/d/hPq9Aun

On this episode of the Spot Radio Podcast Charlie Webb CPPL speaks with the Pack-Out founding members Sarah Rosenblum-Ptach and 

Kiley Djupstrom about what to expect at this years event. The event this year will be held in Coronado California.  

About the Pack-Out

This is not your average healthcare packaging conference. the PACK-Out is built for the industry, by the industry. Whether you are new to healthcare packaging or a seasoned healthcare packaging professional, join us to grow your expertise and knowledge of the industry.

Email: [email protected]

Website: https://thepackout.com

Linkedin: https://www.linkedin.com/company/thepackout/about/

On this episode of the SPOT® Radio Podcast Charlie Webb CPPL speaks on the topic of medical device packaging system innovation. Charlie asks the question, can we do better as innovators in sterile device packaging?

About Charlie Webb CPPL:

 Charlie Webb CPPL is the founder and President of Van der Stahl Scientific; a medical device packaging and testing machine provider and packaging testing and calibration laboratories. He also hosts the popular Podcast "SPOT Radio" (sterile packaging on track)

 www.spotradiopodcast.com Charlie was recognized in the Rode Podcast awards as the top 100 ‘Highly Commended Podcasts for his Podcast "Antidote to Despair" Charlie earned his BS degree in Management at the University of Redlands and completed the medical device development program at the Andersen graduate school of management at UCLA. Charlie is a “lifetime” certified packaging professional “CPPL” certified through the institute of Packaging Professionals as well as a “Six Sigma Master Black Belt”. As a member of a scientific review board, he co-developed micro-surgical devices that broke away from the conservative innovation models. Charlie has been in sterile device packaging for 26 years and has been involved in numerous FDA and ISO audits as a regulatory advisor.
He is also a certified internal auditor and is the Quality Manager for Van der Stähl Scientific’s demanding ISO/IEC 17025 Laboratory accreditation. Under Charlie's quality management system, his lab received the MSI Continuous Improvement Award. Charlie is a member of the IOPP Medical Device Packaging Technical Committee, the Kiip group, and the ASTM F02 technical committee and has multiple granted and pending patents on medical device packaging machinery and pouch testing systems.

His current patent-pending technologies include a medical device tray sealer that will integrate pouch testing within the packaging machine to provide 100% real-time seal testing. Also, in development is his patented HTIP system (human tissue isolation pouch) this disposable system is designed to help avoid packaging machine contamination. His patented seal-through HTIP system isolates the donor tissue during the packaging process to help thwart cross-contamination between donor events. This system will help prevent machine contamination and increase packaging machine component life cycles, saving money while managing infection risks to donor recipients.

His company was also recently awarded a federal contract as a medical device packaging machine provider for the VA Hospital group and his laboratory client list includes NASA and the CDC (center for disease control). He continues to grow his company’s new product development program with the aim of reaching more users of their equipment in order to better manage healthcare packaging failures.

E-mail: [email protected]

Website: www.vanderstal.com

PTT-500-AV Video: https://vanderstahl.com/wp-content/uploads/2024/02/PTT-500-AV.webm

On this episode of SPOT Radio Podcast Charlie Webb CPPL speaks with Megan Frost PhD the founder and Chief Technology Officer and Kurt Yockey the CEO of Sterile State about their exciting new technology.  Could this sterilant be the future of medical device sterilization? Listen in and learn more about the emerging technology. 

Guest bio's:

Megan Frost PhD is the founder and Chief Technology Officer for Sterile State. She has worked on the development of medical polymers and their applications to devices for over 20 years.  She earned a BS in Biological Sciences from the University of Notre Dame, a BS in Chemistry with a minor in Mathematics and an MS in Analytical Chemistry from Purdue University - Indianapolis, and a PhD in Chemistry with a Graduate Certificate in Cellular Biotechnology from the University of Michigan - Ann Arbor. She was a post-doctoral researcher in the Department of Surgery at the University of Michigan Medical School. Her dissertation work focused on the development of implantable, real-time sensors for medical analytes such as oxygen, carbon dioxide, pH, glucose, etc.  Industrial experience gained prior to completion of graduate studies includes working at Dow Elanco (Indianapolis, IN) in the Technology Applications Group. She also has experience as an analytical chemist at Eli Lilly and Company (Indianapolis, IN) and was a professor for 16 years and department head for Michigan Technological University.

Kurt Yockey is the CEO of Sterile State, LLC and has worked extensively with physicians, hospitals, medical product manufacturers, and other healthcare professionals and entities for over 40 years. While practicing law, he was preferred counsel in complex litigation involving orthopedic surgery, emergency medicine, obstetrics, cardiology, and medical device matters. Kurt has been general counsel for innovative medical product development companies including Zip Pak Inc., J.M. Longyear, Pioneer Surgical, Frontier Medical Products, Samaritan Medical and Sterile State LLC. In 2005, Kurt was named a Michigan "Lawyer of the Year" by Michigan Lawyers Weekly for his role as hospital counsel in finding a defect in a medical device, leading to the manufacturer making a design change which avoided patient injury worldwide. He is AV rated by Martindale-Hubble. Kurt received his undergraduate degree from Michigan State University in 1977 and graduated with honors from the Detroit College of Law in 1981.

E-mail: [email protected]

Website: www.sterilestate.com

Phone: (906) 295-5250