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Author: Charlie Webb

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Welcome to Sterile Device Packaging on Track podcast. Listen in as we speak with the nation’s leading experts in medical device packaging.The goal of this Podcast is to engender a community of packaging and manufacturing engineers that can pose questions to our panel of SME’s. We will cover all corners of medical device packaging from trending medical device packaging regulatory issues, new packaging technologies, and techniques as well as a host of case studies designed to make your medical device packaging program more robust.We would love to hear your feedback about our program and receive your input and suggestions on how we may improve this podcast. We are working to build a community of enlightened medical device packaging professionals. If you would like to be included in an upcoming episode please feel free to contact us at our website - www.spotradiopodcast.com, or send us an email to info@spotradiopodcast.com.
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On this episode of SPOT radio, Charlie Webb speaks with Don Alip about "Sterile Packaging Day"  Listen and learn about this exciting day of awareness that takes place on March 10th, 2021.  Please follow the link at the bottom of this Podcast description to view valuable infographics that highlight this event. Don also shares ways that you and/or your company can participate. Guest Description:Don Alip is currently Director of Product Excellence, at Amcor, and is responsible for driving the product growth strategy and leading Amcor’s product management and field service teams. Since 2019, Don has served as Marketing Committee Chairman for the Sterilization Packaging Manufacturer’s Council (SPMC), an industry organization dedicated to developing consensus on test methodology among industry-leading sterilization packaging manufacturers and publishing guidance documents for healthcare packaging validations.Under Don’s leadership, the SPMC will be sponsoring the inaugural Sterile Packaging Day event on March 10, 2021, to create awareness of sterile packaging’s vital role in healthcare and keeping patients safe.Don AlipContact:Website: https://www.sterilizationpackaging.org/sterile-packaging-dayContact: https://www.sterilizationpackaging.org/members/amcor.
Podcast Episode Description: On this episode of SPOT radio, Charlie Webb speaks with Ryan Erickson and Ryan Ott of Packaging Compliance labs about the needed step to conform to the UDI (Unique Device Identification) printing requirements. Also discover how SMEs can provide a valuable link to conform to the heightened expectations of the new regulatory girth of the ISO-11607-2019 and the UDI (unique device identifier) printing directive.Guest Description:Ryan Erickson is a co-founder and Vice President of Packaging Compliance labs; he serves as the technical expert on the team, guides trainings, and runs lean events. Erickson formed PCL with partner Matthew Lapham with the mission to help medical device and pharma clients speed their products to market by breaking down the barriers that relate to packaging. Ryan has 12 years’ experience in medical device packaging engineering, beginning as a Packaging Engineer at Cardinal Health in Chicago. At Cardinal Health, Ryan served as a packaging engineer as he developed his skills in packaging validation and testing. Upon returning to his hometown of Grand Rapids, Erickson became the Packaging Engineering Manager for Vention Medical, a large contract manufacturer.Contact:Website: https://pkgcompliance.come-mail: rerickson@pkgcompliance.comRyan Ott is the Director of Quality and Principal Packaging Engineer at Packaging Compliance Labs; he is PCL’s resource for all things quality related including, but not limited to, executing supplier agreements, answering questions about test standards, and scheduling audits. Ott earned a degree in Packaging at Michigan State University and began his career in Packaging at Vention Medical. In 2016, Ott joined Packaging Compliance Labs as a Senior Packaging Engineer.Website: https://pkgcompliance.come-mail: rott@pkgcompliance.comUDI Links for reference: Here’s the Primary GS1 site (You can go to the U.S. or Global sites from here): https://www.gs1.org/Download the GS1 General Specifications Guide here:https://www.gs1.org/standards/barcodes-epcrfid-id-keys/gs1-general-specific…FDA website for UDI: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-…
Podcast Episode Description: On this episode of SPOT radio, Charlie Webb speaks with Ryan Erickson and Ryan Ott of Packaging Compliance labs about the needed step to conform to the UDI (Unique Device Identification) printing requirements. Also discover how SMEs can provide a valuable link to conform to the heightened expectations of the new regulatory girth of the ISO-11607-2019 and the UDI (unique device identifier) printing directive.Guest Description:Ryan Erickson is a co-founder and Vice President of Packaging Compliance labs; he serves as the technical expert on the team, guides trainings, and runs lean events. Erickson formed PCL with partner Matthew Lapham with the mission to help medical device and pharma clients speed their products to market by breaking down the barriers that relate to packaging. Ryan has 12 years’ experience in medical device packaging engineering, beginning as a Packaging Engineer at Cardinal Health in Chicago. At Cardinal Health, Ryan served as a packaging engineer as he developed his skills in packaging validation and testing. Upon returning to his hometown of Grand Rapids, Erickson became the Packaging Engineering Manager for Vention Medical, a large contract manufacturer.Contact:Website: https://pkgcompliance.come-mail: rerickson@pkgcompliance.comRyan Ott is the Director of Quality and Principal Packaging Engineer at Packaging Compliance Labs; he is PCL’s resource for all things quality related including, but not limited to, executing supplier agreements, answering questions about test standards, and scheduling audits. Ott earned a degree in Packaging at Michigan State University and began his career in Packaging at Vention Medical. In 2016, Ott joined Packaging Compliance Labs as a Senior Packaging Engineer.Website: https://pkgcompliance.come-mail: rott@pkgcompliance.comUDI Links for reference: Here’s the Primary GS1 site (You can go to the U.S. or Global sites from here): https://www.gs1.org/Download the GS1 General Specifications Guide here:https://www.gs1.org/standards/barcodes-epcrfid-id-keys/gs1-general-specific…FDA website for UDI: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-…
On this episode of SPOT radio, Charlie Webb talks about expanding the show to cover topics deeper within medical device manufacturing as well as discussions surrounding challenges in the sterile processing departments at hospitals and clinics. As SPOT radio podcast expands the scope of the show packaging engineers will gain valuable insight into all aspects that affect their mission to deliver medical devices safe and sterile to the point of care. Welcome to season three.Host Description:Charlie Webb is the founder and President of Van der Stahl Scientific; He also hosts SPOT Radio (sterile packaging on track) www.spotradiopodcast.com Charlie earn 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 25 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 accreditation. Charlie is a member of the IOPP Medical Device Packaging Technical Committee, 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 the HTIP system (human tissue isolation pouch) this disposable system is designed to help avoid packaging machine contamination. The 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 increases 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. Contact:charlie@vanderstahl.com 
On this episode of SPOT radio, Charlie Webb speaks with Elon Goldbaum from Network partners about the IQ, OQ, PQ process for medical device packaging validation. Does you packaging validation plan meet the requirements for ISO-11607-2019? Listen in on the edifying discussion for a solid overview of the IQ, OQ, PQ process to evaluate possible shortcomings within your medical device packaging plan.Guest Description:As Sr. Director of Client Solutions, Elon (Lon) Goldbaum brings over 20 years of experience in the medical device field specializing in packaging, labeling, quality, CAPA systems and implementation of UDI requirements for Class II products. Lon’s multifaceted background provides support and leadership to Network Partners’ packaging consulting, quality assurance, labeling, and the Apprentice program. He also managed part of a 483, and 90 CAPAs, while rebuilding the CAPA system.Prior to joining Network Partners, Lon held various roles with Baxter Healthcare, Edwards Lifesciences, and Danaher with a wide range of responsibilities, covering everything from implementing and managing packaging and labeling processes to sterilization requalification and rebuilding a CAPA system. Lon earned his Bachelor of Science degree in Packaging from Michigan State University.Elon GolbaumContact:Website: http://www.networkpartners.com/e-mail: elon.goldbaum@networkpartners.com
On this episode of SPOT radio, Charlie Webb speaks with Elon Goldbaum from Network partners about the IQ, OQ, PQ process for medical device packaging validation. Does you packaging validation plan meet the requirements for ISO-11607-2019? Listen in on the edifying discussion for a solid overview of the IQ, OQ, PQ process to evaluate possible shortcomings within your medical device packaging plan.Guest Description:As Sr. Director of Client Solutions, Elon (Lon) Goldbaum brings over 20 years of experience in the medical device field specializing in packaging, labeling, quality, CAPA systems and implementation of UDI requirements for Class II products. Lon’s multifaceted background provides support and leadership to Network Partners’ packaging consulting, quality assurance, labeling, and the Apprentice program. He also managed part of a 483, and 90 CAPAs, while rebuilding the CAPA system.Prior to joining Network Partners, Lon held various roles with Baxter Healthcare, Edwards Lifesciences, and Danaher with a wide range of responsibilities, covering everything from implementing and managing packaging and labeling processes to sterilization requalification and rebuilding a CAPA system. Lon earned his Bachelor of Science degree in Packaging from Michigan State University.Elon GolbaumContact:Website: http://www.networkpartners.com/e-mail: elon.goldbaum@networkpartners.com
In this episode of SPOT radio, Charlie Webb speaks with Laura Palker about the future of tradeshows and Expos post-COVID. When will we come together again in close proximity to each other, or will human distancing be a constant to better manage the risk of infectious Disease?  The tradeshow and expo industry is developing solutions that will make venues safer and will also develop virtual meetups as a stopgap as the pandemic risk slowly wanes.Guest Description:Laura Palker is an accomplished business executive with more than 25 years of experience in the Trade Show Sales and Marketing industry. She is the founder and managing director of Trade Show Solution Center/Trade Show Studio and the Solution Center Network.Palker has developed a distinguished career working for some of the region’s top companies in the trade show industry where she was able to hone her marketing, logistics, and analytical acumen. Some of the firms that benefitted from her efforts include Exhibit Corporation of America, Exhibit Graphics, and Display Presentations.In 2002, she branched out on her own with a vision of building a company that did more than simply sell trade show displays – one that supported the entire sales cycle with tools that worked in tandem to grow her clients’ business. That resulted in the founding of Trade Show Solution Center, a full-service agency that offers sales and lead generation tools, marketing collateral, corporate communications, trade show displays and management, and promotional items – all with an eye to presenting a clear, consistent, and compelling message that drives sales and effectively builds your brand.Palker’s management style emphasizes strong communication, strategic planning, and internal controls to build relationships, revenues, and profits. And, with a reputation for being able to provide creative solutions for even the most complex problems, coupled with her commitment to exceptional customer service, Palker has amassed a loyal following of satisfied customers.Giving back to the community has always been a priority to Palker as evidenced by her involvement with a variety of philanthropic and professional organizations.  Palker serves as President of the Moxxie Mentoring Foundation.  She proudly supports her husband as First Lady of the Global Board of Directors for the Institute of Management Accountants.  Palker sits on the EAC Network Board and served as former Marketing Chair and the 2014 EAC Spring Luncheon Chair.  She served on the EAC Spring Luncheon Committee in 2010, 2011, and 2012 and the EAC Golf Committee in 2011.  Finishing her term on the Board of Directors of the Executive Women’s Golf Association, Long Island, NY Chapter as the Sponsorship Chair and former Communications Chair; Palker is now co-site director for LPGA Girls Golf in Long Island.Leading the way in an annual fundraiser for the American Cancer Society, she chaired the Island Hills Golf Club Babe Zaharias Tournament in 2008 and 2009 and served on the Executive Committee in 2011. Previous to that she served on the Board of the Foundation Fighting Blindness and worked with the Long Island Foundation for Hospice Care and Research where she lobbied in both Albany and Washington D.C. to help build awareness and support for hospice as an alternative to traditional cancer treatment in the late 1980s. Palker continues to offer seminars and webinars on profitable trade show exhibiting and smart selling. She is a regular columnist in Golfing Magazine, Networking Magazine, and hosted the FIOS1 My LI Show “Golfing on Long Island in 2011.  Laura Palker and her husband Marc P. Palker reside in South Huntington, NY.Laura PalkerContact:Website: www.tssolutioncenter.com E-mail: Laura@tssolutioncenter.com
In this episode of SPOT radio, Charlie Webb speaks with Ryan Erickson Vice President of Packaging Compliance labs about the value of outsourcing medical device packaging validation, engineering, and testing lab services. As we develop more complicated medical devices with embedded drugs, packaging systems will continue to become more complex.  SME's can provide a valuable link to conform to the heightened expectations of the new regulatory girth of the ISO-11607-2019. Guest Description:Ryan Erickson is a co-founder and Vice President of Packaging Compliance labs; he serves as the technical expert on the team, guides trainings, and runs lean events. Erickson formed PCL with partner Matthew Lapham with the mission to help medical device and pharma clients speed their products to market by breaking down the barriers that relate to packaging. Ryan has 12 years’ experience in medical device packaging engineering, beginning as a Packaging Engineer at Cardinal Health in Chicago. At Cardinal Health, Ryan served as a packaging engineer as he developed his skills in packaging validation and testing. Upon returning to his hometown of Grand Rapids, Erickson became the Packaging Engineering Manager for Vention Medical, a large contract manufacturer.Ryan EricksonContact:Website: https://pkgcompliance.come-mail: rerickson@pkgcompliance.com
In this episode of SPOT radio, Charlie Webb speaks with Lisa Wassberg general manager of Van der Stahl Scientific about the importance of proper machine care. Siloed quality departments often seem unaware of maintenance issues that could risk their sterile packaging program. Listen in and hear the perspective of a medical device packaging machine provider regarding the proper care of the critical equipment. Guest Description:Lisa Wassberg is the General manager of Van der Stahl Scientific, she has worked as the general manager of an industrial caster company overseeing the process from development to distribution. She worked as a marketing manager from one of the nation's oldest custom metal fabrication companies developing key national accounts in a highly competitive industry. Lisa is certified as a Kaizen facilitator and co-manages Van der Stahl Scientific's busy ISO-17025 calibration and testing Laboratory.   Lisa WassbergLinkedin:https://www.linkedin.com/in/lisa-wassberg-webb-07769bb/
In this episode of SPOT radio we ask the question, how are medical device manufacturing and packaging engineers managing with the new connection tools such as videoconferencing during this pandemic event? The COVID event continues to make collaboration difficult as packaging validation requires many hands-on steps and connections. In this episode we speak with medical device packaging engineer Swandand Kuuawar from Abbott to learn about his workflow during the challenging COVID event.Guest Description:Swanand Kullarwar is a packaging engineer at Abbott and was previously a packaging engineer at Zimmer Biomet. Sawnand holds a master's in packaging science degree from RIT and a bachelors degree in printing engineering from India. Swanand is currently working on his CPP (certified packaging professional) certification. Swanand KullarwarLinkedin:https://www.linkedin.com/in/swanand-kullarwar-45540716/?msgControlName=reply_to_sender&msgConversationId=6636453303867756544&msgOverlay=true
On this episode of SPOT radio, we discuss protecting our brands and products from counterfeiters with our guest Robert Sherwood from Veritrace. Worldwide sales of counterfeit medications could top $75 billion this year. This is a 90% rise in five years according to an estimate published by the Center for Medicine in the Public Interest of the United States of America. This influx of counterfeit medicines into the marketplace poses huge risks to consumers. Robert speaks to solutions that Veritrace has created to combat this threat.Guest Description:Robert Sherwood, CPP, is a security print and software technology specialist with 25 years of Brand protection experience.  He designs security solutions to protect IP, products, revenue, customers, and to reduce liability.  He applies a total approach to brand protection solutions by analyzing counterfeiting, diversion, supply chain security, packaging, and stakeholder concerns.His packaging and labeling expertise includes security design, anti-counterfeit print technologies, substrates, adhesives, specialty converting, and authentication/track & trace software systems. Robert holds certification as an ASIS Certified Protection Professional. He is a past chairman and current board member of NASPO International and contributed to the writing and publishing of the 2015 ANSI/NASPO International Security Management Standard.VeriTrace Inc.Robert Sherwood513.673.1576rsherwood@veritrace.comWebsitewww.veritrace.com
On this episode of SPOT radio, we discuss automated handwashing systems with our guest Paul Barnhill from Meritech. Mr. Barnhill speaks on best practices in hand hygiene and how automated technologies can greatly improve Hand Washing outcomes. Medical device manufacturing will benefit from these automated technologies as they can now better control bioburden in the cleanroom.Guest Description:Paul Barnhill is Chief Technology Officer and Head Engineer at Meritech, the leader in automated employee hygiene. He has over 28 years of experience working with professionals in food manufacturing, healthcare, and food service to understand the challenges they face when creating hygiene programs and how to overcome these obstacles through education and automated technologies. Mr. Barnhill often speaks on best practices in hand hygiene, footwear sanitation, and the science behind pathogen removal. Helping food processing and packaging facilities produce safe and healthy products through hygiene excellence is a passion for him. Prior to joining Meritech, Mr. Barnhill worked at Medtronic, Inc. a leader in cardiovascular equipment and implantable devices, in their Hemostasis division as a Mechanical Designer within the R&D department.Mr. Barnhill earned his accreditation degree from the A.I.D.D. (American Institute for Design & Drafting). When he's not inventing a new method for guaranteeing effective hygiene, you can find Mr. Barnhill spending time with his loving wife Ann of 26 years, son Josh, daughter-in-law-to-be Emily, and dog Beau at his home in Aurora, Colorado.Website:https://www.meritech.com/Phone:+1 800-932-7707
On this episode of SPOT radio, we speak once again with medical device packaging influencers Rod Patch and Jennifer Benolken about the progress of the "Kilmer innovations in packaging" group. This group hopes to imagine best practices in sterile packaging and will pose questions to colleagues that will spark innovations that will shape the future of medical device sterility and delivery. 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. 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 Master 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.Kilmer Innovation in Packaginghttps://www.linkedin.com/groups/12301596/?msgConversationId=6592084813891596289&msgOverlay=trueRod Patchhttps://www.linkedin.com/in/rod-patch-756227a/?msgConversationId=6592084813891596289&msgOverlay=trueJennifer Benolken, CPPLhttps://www.linkedin.com/in/jbenolken/?msgConversationId=
This episode our host Charlie Webb speaks with Larry Nichols From Next Thermal on the process of Integrating heating and temperature sensing systems to medical devices.Guest  Description:Larry Nichols is a Technical Manager with Next Thermal, he is an MBA and with 24 years of industrial sales experience. Larry shares his skills with his students as an adjunct professor at Baker College.(269) 964-0271www.nexthermal.com 
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.877-297-7763https://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.comhttps://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 Packaginghttps://www.linkedin.com/groups/12301596/?msgConversationId=6592084813891596289&msgOverlay=trueRod Patch
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