SPOT Radio

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-OutThis 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: info@thepackout.comWebsite: https://thepackout.comLinkedin: 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: Charlie@vanderstahl.comWebsite: www.vanderstal.comPTT-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: info@sterilestate.comWebsite: www.sterilestate.comPhone: (906) 295-5250

On this episode of SPOT Radio Podcast Charlie Webb CPPL speaks with Jeff Meleville from Mini Mover about how conveyance systems can increase packaging workflows and improve worker ergonomics. In this episode, Charlie speaks with Jeff about utilizing companies that deeply understand the clients needs. Guest bio:Jeff Melville is the National Sales Director for Mini-Mover Conveyors. Mini-Mover Conveyors specializes in creating personalized conveying solutions in industrial automation applications.  Jeff credits the success of Mini-Mover Conveyor to the dedicated team behind the scenes whom he says are “focused on the same goal and achieves this by an unwavering commitment to a team mentality”.  Jeff uses an optimistic attitude and positive energy to encourage others to work hard and succeed. He is inspired daily by his wife and three children. In his free time, he likes to be outdoors, hunting, fishing, and playing sports with his kids.E-mail: jmelville@mini-mover.comWebsite: https://mini-mover.com/ Phone: 800-586-4585LinkedIn profile:  https://www.linkedin.com/in/jeff-melville-57171732/Movement efficiency kaizen dishwasher unloading and loading: https://youtu.be/E6rRHqb5MV0

Listen in as Charlie Webb CPPL speaks with Malinda Elammari Clinical Education Specialist at Healthmark Industries. Today's discussion speaks to the different packaging workflows of medical device manufacturers versus hospitals and clinics. During this discussion, Charlie and Malinda cover the topic of the critical importance of preventative and predictive maintenance.Guest  Description:Malinda Elammari, CST, CSPM, CSPDT, CFER, CSIS, CRCST, CIS, CHL, CER, CLSSGBMalinda Elammari is a Clinical Education Specialist for Healthmark Industries. She began her career in the medical field as a Certified Surgical Technologist specializing in Open-Heart surgery. Throughout her career, Malinda has served in a variety of positions within SPD, such as Interim Director of Education and Quality, Sterile Processing Educator and Quality Control Manager, Clinical Operations Manager, OR Liaison, and an Endoscopic Service Rep. In addition, Malinda was the lead instructor for the Central Sterile program at Durham Technical Community College. She holds several certifications in sterile processing through CBSPD and HSPA. Malinda is a TeamSTEPPS Master trainer and is certified as a Lean Six Sigma Green Belt. She is an active member of AAMI and sits on multiple national standard writing committees. Malinda sits on the Editorial Board for AAMI Publications and is a project manager for KiiP’s Aseptic Presentation subgroup. She is a graduate of Duke’s Innovation & Entrepreneurship program and Duke’s Technical Excellence Program. She currently serves as president for the North Carolina HSPA chapter.Contact: melammari@hmark.com

On this episode of the SPOT™ Radio Podcast Charlie Webb CPPL speaks with Chris Danek CEO of Bessel about human-centered design and agile teamwork. Chris speaks on using advanced technology like artificial intelligence, additive manufacturing, and digital engineering and their support to medical device manufacturers.Guest bioChris Danek, CEO of Bessel, is an entrepreneur and life sciences industry veteran. Chris believes in empowering technical teams. Trained in business and engineering, he has worked with dozens of teams in industry and at universities across the US. He helps them speed time-to-market with agile teamwork and human-centered design while using advanced technology like artificial intelligence, additive manufacturing, and digital engineering. Bessel clients and Powered by Bessel startups are located nationwide.Chris is a visiting professor at the University of Texas at El Paso. This leading Hispanic-serving research university has adopted the Bessel Origin program in its Department of Aerospace and Mechanical Engineering. Chris is also a visiting professor at the W.M. Keck Center for 3D Innovation at UTEP.Chris was co-founder and CEO of AtheroMed (now Philips AtheroMed), and before that was V.P. R&D of Asthmatx (Boston Scientific). Chris is an advisor to the Santa Clara University Healthcare Innovation and Design Lab. He has a Ph.D. in mechanical engineering from Stanford University and an M.B.A. with a concentration in finance from the Wharton School - University of Pennsylvania. He is an inventor of over 85 U.S. patents.  About BesselBessel's roots are in product lifecycle support for medical device and diagnostic products. With a foundation of more than 20 years of experience designing and developing medical devices, Chris Danek and Bessel have provided full-service support for over 5 years to diverse organizations ranging from startup companies to Fortune 50. We bring innovation throughout the product lifecycle -- from a clean sheet of paper through commercial release.We combine human-centered design and agile teamwork (scrum) in our approach to work, with a dual focus on results and on improving the capabilities of our clients' teams.Mentoring startup teams reminded me of my love of teaching. It was natural to step from putting the patient first as a medical device developer to putting the student first as a teacher. The core of the Bessel Origin program stems from my work helping students transform into excellent team members ready for the workforce.My co-founder, Carolyn Danek, inspired the start of Bessel. Trained as an architect, Carolyn is professionally versed in human-centered design. Her deep-rooted empathy sparked the creation of Bessel. I'm fortunate to be her co-founder. ​We saw the broad applicability of the Bessel Origin program and its mindsets, methods, and discipline to train the next generation of innovative thinkers and high-performance team members. Now we deliver corporate critical innovation projects and our Bessel Origin program.Website: www.bessel.co 

On this episode of the SPOT Radio® Podcast Charlie Webb CPPL speaks with Elon Goldbaum about the value of medical device packaging inspection and testing in order to monitor process value. Guest bioElon Goldbaum is Vice President, Packaging Engineering & Client Solutions, Lon has over 20 years of experience in the MedTech and Pharmaceutical industries, specializing in packaging, labeling, quality, CAPA systems, and sterilization. Lon is focused on business development for growing the Network Partners packaging engineering organization and commercial sales.Prior to joining Network Partners, Lon held various roles with Beckman Coulter, 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.E-mail: elon.goldbaum@networkpartners.comWebsite: http://www.networkpartners.com/Linkedin: https://www.linkedin.com/company/network-packaging-partners/

On this episode of the SPOT™ Radio Podcast Charlie Webb CPPL speaks with Roy Morgan about new ways medical device manufacturers can streamline the process of sterilization and medical device packaging through Eagle Medical's PATH (packaging accelerated timeline help) program.Guest bioRoy Morgan is best known for his work in electrochemistry; the inventor of the world's first orthopedic device to upregulate genetic progenitor compounds in the healing process of osteoarthritis of the joints. His skills in R&D team building and fast-paced project execution, requiring FDA product acceptance are well known in the med-device community. Mr. Morgan possesses expert know-how in regulatory submission drafting, platform strategy, intellectual property, and project management.Mr. Morgan is currently expanding Eagle's growth strategy; requiring new business methods for improving volume, speed-to-market and customer service. These are adjunct areas to which Mr. Morgan has consistently excelled having launched many medical devices with companies such as: Abbott Laboratories, Meditrina, and Stryker. Using his "advantage maker" leadership approach, he has brought to market episodic blood glucose meters; wireless continuous glucose monitoring systems; drug infusion pumps; and several electrosurgical systems.His product design skills are highly sought after as are his engineering skills in both electromechanical-engineering and injection molding. Educated at Brown University, Providence, Rhode Island, Mr. Morgan gained a BSc. in Mechanical Engineering and a BA in Semiotics. At the University of California at Berkeley he became a Registered Professional Engineer and was awarded a Certificate in Project management. In 2000 Mr. Morgan was also awarded Project Management Professional designation from the Project Management Institute. At Eagle Medical, he leads with efficient and FDA compliant manufacturing, sterilization, packaging & packaging design service options for the medical device industry.E-mail: info@eaglemed.comWebsite: www.eaglemed.comPhone: 1 (805) 238-7401

On this short episode of the Spot Radio Podcast Charlie Webb CPPL speaks about his visit to the HSPA (healthcare sterile processing association) conference in Nashville Tennessee.  Charlie also looks ahead to upcoming discussions on spot radio...Host bio:Charlie A. Webb CPPL | Founder & CEO of Van der Stähl ScientificCharlie 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 Podcast for his Podcast "Antidote to Despair" Charlie earned his BS degree in Management at 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, he is a co-PM in 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 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.E-mail:Charlie@vanderstahl.comWebsite:www.vanderstahl.comwww.spotradiopodcast.com 

On this episode of SPOT radio Charlie Webb speaks with members of the Pack-Out conference that will be held in Austin Texas, May 9-11. This is the 2nd year of the Pack-Out and this healthcare packaging conference promises to bring exciting new additions to the attendee. Built into the architecture of this conference will be experiences designed to facilitate peer connection and foster industry learning. Listen in and learn more about the exciting plans for this year's healthcare packaging conference, the Pack-Out.About: The Pack-Out conference:To advance the industry and continue building a strong community, we need a new, single-industry event that meets the needs of both packaging engineers and suppliers – we’re ready for [out]standing!The problem is that there are limited options available for our specialized profession. The content and accommodations of legacy events have not kept pace with expectations, leaving the healthcare packaging community without an acceptable forum to come together and share ideas that advance the industry and build strong networks. We came together and created the[PACK]out because we believe the future of healthcare packaging shouldn’t be left in the hands of event planners. As industry packaging professionals and suppliers, we understand how frustrating it can be to spend precious marketing dollars at conferences that don’t produce the results you’d hoped for and lack consistent technical content, which is why a team of industry professionals came together to change the model. (description from the Pack-Out website)LinkedIn connections for today's guests:Sarah Rosenblum: https://www.linkedin.com/in/sarahrosenblum/Karen Polkinghorne: https://www.linkedin.com/in/karen-polkinghorne/Kiley Djupstrom: https://www.linkedin.com/in/kileydjupstrom/Cassandra Ladd: https://www.linkedin.com/in/cassandra-ladd-7b138241/Websites: https://www.thepackout.comE-mail: info@thepackout.com

On this episode of the SPOT radio Podcast, Charlie Webb CPPL speaks with Sarah Deputy CKF from Van der Stähl Scientific about preventive maintenance of critical medical device packaging equipment. Learn how PMs can help save a medical device company from a potential packaging recall.Guest bio: Sarah DeputySarah is a skilled Service technician in Van der Stahl Scientific's ISO 17025 calibration and service center. She performs laboratory studies for medical device pouch seal strength and integrity for validating the sterile barrier system. Sarah is also a skilled calibration technician and calibrates force, time, and thermal environments under Van der Stahl Scientific's ISO 17025 scope of accreditation.  Sarah is Kaizen and Six Sigma Green & Black Belt certified, and is currently working towards a CPP certification through the IOPP.About Van der Stähl ScientificVan der Stähl Scientific has helped thousands of medical device manufacturers deliver their devices safe and sterile to the point of care. We provide advanced microprocessor-controlled medical device pouch-sealing machinery to deliver seal-to-seal consistency. With a host of medical device validation support options, you can choose from a selected area of support or a complete end-to-end validationE-mail: Sarah@vanderstahl.comWebsite: www.vanderstahl.com 

On this episode of SPOT radio Charlie Webb CPPL speaks with Karen Goelst CEO of KleenEdge about their technology that helps manage patient curtain exchange cycles with the aim of preventing patient infections. Guest bio's:Karen Goelst | Founder & CEO of KleenEdge With a 20-year background in architectural specialties and textiles, Karen Goelst became passionate about solving the issues surrounding privacy curtains following her 15-year-old son’s hospital stay with MRSA.Staying at his bedside she noticed everybody touched the fabric privacy curtain, but the label showed that it hadn’t been exchanged for 14 months. Thankfully her son recovered, but this realization started her journey in trying to understand why curtains weren’t getting exchanged when other touchpoints in the room were thoroughly disinfected.  Karen founded KleenEdge to ensure this infection risk did not impact other families.   About KleenEdgeLaunched in 2018, the company received early accolades for its innovative Protocol Compliance Software, receiving AHE’s Product Innovation Award, as well as getting patents for the QuickLoad and TeleTrack “no ladder” curtain exchange cubicle track solutions. KleenEdge’s solutions have helped many healthcare facilities dramatically reduce operational costs while having peace of mind knowing that their curtain exchanges are compliant and deliver the highest standard of care for their patient’s safety.KleenEdge builds its privacy curtain solutions on 4 pillars:·      Protocol software that monitors curtain exchange compliance·      Sustainable cost-saving recyclable curtains·      No-ladder solutions to promote lean workflows and safety·      Patient and staff safetyE-mail: kgoelst@KleenEdge.comWebsite: www.kleenedge.com 

On this episode of SPOT radio, Charlie Webb CPPL speaks with Jennifer Benolken, Sarah Rosenblum, Dannette Casper, Cassandra Ladd, and Arthur Castronovo from the Medical Device Packaging Technical Committee (MDPTC) about the success of the inaugural "Fundamentals of Medical Device Packaging" course. Listen in and learn about this valuable course as well as the big news that the course will also be available at the MD&M West meeting in Anaheim California in February.Jennifer Benolken CPPL, is a Medical Device and Regulatory Package Engineering Specialist with DuPont Tyvek® Medical Packaging. Jennifer works with DuPont Tyvek®’s medical and pharmaceutical downstream customers. For the past 30 years, Jennifer has played an active role in the medical device packaging community through industry organizations, speaking engagements, and by holding a variety of different roles in the value chain, including packaging, labeling, and sterilization. Currently, Co-Chair and DuPont’s Primary Member for AAMI’s ST/WG7, Packaging Working Group, the US’s mirror group to ISO TC198/WG7, Jen also represents the U.S. as a delegate to the ISO Packaging Working Group. Additionally, Jen is the Sub-Committee Chairperson for ASTM F02.50, Package Design, and Development. Jen has been a long-term member of the Institute of Packaging Professionals, currently serving on the National Board of Directors. She also is Chairperson for IoPP’s Medical Device Packaging Technical Committee.Arthur Castronovo CPPL is a Packaging Engineering professional who has over 32 years of experience working in R&D, Operations, and Supply Chain organizations. In addition to Medical Devices, he has also worked in the Consumer Products and Personal Care Industries. Art's specialties include strategically developing, resourcing, and leading Packaging Engineering and Global labeling departments. His strengths include technical problem-solving, change management, cross-functional collaboration, packaging development, labeling systems, validation, and operations management.Sarah Rosenblum is the Senior Director of Sales & Marketing at Packaging Compliance Labs (PCL). Currently, she is co-leading initiatives for Kilmer Innovations (KiiP) in Aseptic Presentation and serving as a board member for the Medical Device Packaging Technical Committee (MDPTC) of the Institute of Packaging Professionals (IoPP). After starting her career at an advertising agency in Chicago, she had the desire to make a difference with her work. Following her father being diagnosis of Parkinson’s, she decided to take her talents to PCL in 2016 with the initiative to help advance the medical and pharmaceutical industries through packaging. Sarah is a continuous student in the field of packaging engineering and always looks for new opportunities to learn from her mentors, peers, and colleagues.Cassie Ladd is the Sr. Marketing Manager at Packaging Compliance Labs (PCL). Cassie’s primary roles at PCL are managing and building the public reputation of PCL through marketing and assisting the sales team by creating funnels to generate qualified leads. Cassie is one of the founding members of thePACKout and assists with graphic design and marketing efforts for the Medical Device Packaging Technical Committee (MDPTC) of the Institute of Packaging Professionals (IoPP). After starting her career at a marketing agency and working freelance as a graphic designer in Grand Rapids, she realized clients weren’t fulfilling her desire to help others. She listed the qualities that she wanted her next job to have which quickly led her to PCL. Working at PCL and in the sterile medical device packaging industry feeds her desire to do work that matters and help others by keeping patients safe.  Registration Link: https://lnkd.in/gt2JRkyPLinkedIn page: https://www.linkedin.com/company/iopp-mdptc

On this episode of SPOT radio, Charlie Webb CPPL and Pieter Van Gool speak with Eddy van den Berg of Pharmafilter B.V.  about their company's amazing technology that provides a much deeper solution for hospital waste stream management. The centralization of the waste stream holds incredible promise for reducing the expanding burden of hospital waste.Guest bio's: Pieter Van GoolStrong product development professional with demonstrated capabilities in leadership, strategy, innovation management, product development and industrial design, and significant experience in the medical device packaging industry. Focused on including patient safety till the point of care and improving patient outcomes. Formerly worked at Nelipak Healthcare Packaging with multiple international leadership roles in packaging design, development, and innovation management. Active member in Kilmer innovations in Packaging; Co-Chair Education committee, Sustainability Program member, Marketing and Communication and Branding committee member. Active member of the Sterile Barrier Association; Co-Chair Education Committee.About SÜDPACK MEDICAServed the global medical device, pharmaceutical and diagnostics industries for over 30 years. Our company’s mission and passion are to help to improve people's lives with safe and reliable sterile packaging at the point of use. SÜDPACK Medica is a specialist in co-extrusion of plastic films, and we convert sterile barrier systems in cleanrooms, such as pouches, bags, die-cut lidding, to name a few.  Environmental, economic, and social responsibility are deeply rooted in our DNA, combined with product protection and patient safety as top priority. With a plant for biopolymers and compounding, SÜDPACK Medica is a competent partner for forward-looking, sustainable packaging concepts.E-mail: Pieter.vanGool@suedpack-medica.comWebsite: www.suedpack-medica.comEddy van den BergEduardo previously held senior management posts at the Hilton GroupBenelux. In 2001 he founded EcoVase International a company focused ondeveloping single use disposal environmental products for use inhospitals. He successfully introduced his first product a disposable flowervase into hospitals in the Benelux and Germany.The idea for Pharmafilter originated in 2005 as result of his observationsand daily consultation with hospital staff. He applied his findings andcombined with his previous years experience in hotel management to thedevelopment of Pharmafilter. Pharmafilter today is being introduced tohospital across Europe and this is as a result of his passion, vision,creativity, skill and entrepreneurial drive.Website: www.pharmafilter.nl E-mail: info@pharmafilter.nl

On this episode of SPOT radio, Charlie Webb CPPL speaks with Don Alip and Randall Troutman from the SPMC (sterilization packaging manufacturers council) on this episode of SPOT radio you will learn the history as well as future plans for sterile packaging days events. Guest bio's:Don Alip is the Director of Product Excellence, Healthcare with 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. He can be reached at https://www.sterilizationpackaging.org/members/amcor. Randall Troutman is a Senior Executive business leader with a history of building and empowering high-performance teams in the packaging industry. 20 plus years of advancing technical, commercial, and business leadership roles driving market expansion, revenue growth, profit enhancement and overall enterprise value creation strategies.Excelled in roles accountable for Strategic Planning, International Expansions, M&A Assessment/ Integrations, and P&L responsibility. Worked in various business ownership structures under Public, Private Family Owned, and Private Equity funded enterprises.Expertly skilled in Business Development, Sales/ Marketing Leadership, Research and Development, U.S. Food and Drug Administration (FDA)/ EU MDR Regulations, Antitrust related matters (DOJ), Third Party (external consultant) Operational Improvement Programs, and Value Creation Strategic Plan Execution.Website: https://www.sterilizationpackaging.org/

On this episode of SPOT radio, Charlie Webb CPPL speaks with Brian Nissen, Jennifer Benolken, and Amy Stewart from the IOPP's Medical Device Packaging Technical Committee (MDPTC) about the upcoming "Fundamentals of Medical Device Packaging" course. Listen in and learn about this exciting new event. Guest bio's:Brian Nissen, CPP received his Bachelor of Science in Mechanical Engineering from the University of Minnesota. He has been with QTS for twelve years and currently holds the position of Project Engineering Manager. Brian has over twenty years of experience in the medical device industry and has previously held positions at Medtronic, St. Jude Medical, American Medical Systems, and Lifecore Biomedical.  Brian holds current certifications as a Certified Packaging Professional (CPP) and Six-Sigma Green Belt (CSSGB) Certified Lean Practitioner and has previously held certifications as a Certified Quality Engineer (ASQ-CQE) and Certified Quality Auditor (ASQ-CQA) Amy Stewart, Product Development Manager - Printpack Medical, has 25 years of experience in the flexible packaging industry in operations and technical roles for healthcare and various other markets including food, health and beauty and industrial.  Amy is committed to impacting patient safety through her work and with industry organizations in medical device packaging.  She serves as program leader for the IoPP Medical Device Packaging Technical Committee Fundamentals of Medical Device Packaging course and formerly served as Chairperson of MDPTC, named 2020 Technical Committee of the Year.  Also, Amy serves on the FPA Sterilization Packaging Manufacturers Council (SPMC), which established the annual Sterile Packaging Day and promotes patient safety awareness and celebrates the supply chain organizations dedicated to patient safety.  Additionally, Amy supports leadership programs as a mentor within her organization and specifically, women's leadership in the Greater Atlanta business community.Jen Benolken, CPPL, is a Medical Device and Regulatory Package Engineering Specialist with DuPont Tyvek® Medical Packaging. Jennifer works with DuPont Tyvek®’s medical and pharmaceutical downstream customers. For the past 30 years, Jennifer has played an active role in the medical device packaging community through industry organizations, speaking engagements and by holding a variety of different roles in the value chain, including packaging, labeling and sterilization. Currently Co-Chair and DuPont’s Primary Member for AAMI’s ST/WG7, Packaging Working Group, the US’s mirror group to ISO TC198/WG7, Jen also represents the U.S. as a delegate to the ISO Packaging Working Group. Additionally, Jen is the Sub-Committee Chairperson for ASTM F02.50, Package Design and Development. Jen has been a long-term member of the Institute of Packaging Professionals, currently serving on the National Board of Directors. She also is Chairperson for IoPP’s Medical Device Packaging Technical Committee.Registration Link: https://www.iopp.org/i4a/pages/index.cfm?pageid=4833LinkedIn page: https://www.linkedin.com/company/iopp-mdptc e-mail: jennifer.a.benolken@dupont.com 

In this two-part episode of SPOT radio, Charlie Webb CPPL speaks with Carol Barnum Ph.D. from the UX firm about the human connection piece for medical devices and medical device packaging to the clinician. Carole provides insight during this engaging conversation on how the UX Firm guides clients through comprehensive user research projects and single usability studies. UX Firm’s toolkit of usability services includes usability testing, human factors validation testing, and a wide variety of UX research tools to uncover user experience at every stage of development.About: Carol BarnumCarol Barnum brings her academic background and years of teaching and research to her work with clients to deliver the best research approaches that have proven to produce practical solutions. Carol’s many publications (6 books and more than 50 articles) have made a substantial contribution to the body of knowledge in the UX field. Her latest book Usability Testing Essentials: Ready, Set…Test! (2nd edition, 2021) is used by professionals and students around the world.Carol has received top honors, awards, and recognition for her work in many ways. The Society for Technical Communication has awarded her the designation of Fellow and the distinction of the Rainey Award for Research and the Gould Award for Excellence in Teaching.  IEEE Professional Communication Society has honored her with the 2013 Blicq Award for Distinction in Technical Communication Education. Also in 2013, Carol was named one of the Top 20 Women Professors in Georgia.Websites: www.uxfirm.come-mail: carolbarnum@uxfirm.comPhone: 404.881.8136 or 404.680.0329 (cell)

In this two-part episode of SPOT radio, Charlie Webb CPPL speaks with Carol Barnum Ph.D. from the UX firm about the human connection piece for medical devices and medical device packaging to the clinician. Carole provides insight during this engaging conversation on how the UX Firm guides clients through comprehensive user research projects and single usability studies. UX Firm’s toolkit of usability services includes usability testing, human factors validation testing, and a wide variety of UX research tools to uncover user experience at every stage of development.About: Carol BarnumCarol Barnum brings her academic background and years of teaching and research to her work with clients to deliver the best research approaches that have proven to produce practical solutions. Carol’s many publications (6 books and more than 50 articles) have made a substantial contribution to the body of knowledge in the UX field. Her latest book Usability Testing Essentials: Ready, Set…Test! (2nd edition, 2021) is used by professionals and students around the world.Carol has received top honors, awards, and recognition for her work in many ways. The Society for Technical Communication has awarded her the designation of Fellow and the distinction of the Rainey Award for Research and the Gould Award for Excellence in Teaching.  IEEE Professional Communication Society has honored her with the 2013 Blicq Award for Distinction in Technical Communication Education. Also in 2013, Carol was named one of the Top 20 Women Professors in Georgia.Websites: www.uxfirm.come-mail: carolbarnum@uxfirm.comPhone: 404.881.8136 or 404.680.0329 (cell)

On this episode of SPOT Radio Charlie Webb CPPL speaks with Karen Greene CPPL about the ASTM F-88 medical device pouch testing method. As laboratory owners Charlie Webb CPPL and Karen Greene CPPL provide a fresh optic to the discussion developed from their voice of the customer insight.Guest Description:Karen Greene is a tenured packaging professional, A CPPL certified through the institute of packaging professionals. with more than 20 years of experience in the medical device and pharmaceutical packaging industries.30+ years of professional experience in package engineering. 22 years in medical device and pharmaceutical package engineering and engineering services. Leadership experience, 20+ years.Specialties: Sterile barrier packaging, structural packaging, films, cushioning, and regulatory compliance for the medical device industry. ISO 11607, ASTM, and ISTA standards. IQ, OQ, and PQ for packaging designs and packaging equipment. DOE experience, test method development, accelerated aging, and pkg design qualifications. Package design and prototyping for sterile medical packaging(sterilization) and all types of structural packaging designs. Thermal package design, development, and validation.Karen is also the Co-President of the Southern CA Chapter of IoPP and she is the Chair of the Task Group Subcommittee of the IoPP Medical Device Packaging Technical Committee.You can learn more about her package engineering services which include package design, prototyping, as well as validation consulting by visiting her website.Contact: www.lifepacklabs.com

On this episode of SPOT radio, Charlie Webb speaks with Cord Burnham regarding needless regulatory and packaging process risks due to inaccurate calibrations and poorly maintained medical device packaging machinery. Cord Burnham highlights process failures from his experience as the service Director and calibration laboratory manager at Van der Stahl Scientific's ISO 17025 laboratories.About: Cord Burnham CKF Cord Burnham is the director of laboratory services for Van der Stahl Scientific's ISO-17025 accredited calibration laboratory. Cord has traveled throughout the country providing technical and calibration services to the largest and smallest medical device manufacturers. He is Six Sigma trained and a Kaizen trainer.  Websites: http://www.vanderstahl.comE-mail: Cord@vanderstahl.com Phone: 800-550-3854