SPOT Radio

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, CLSSGB

Malinda 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: [email protected]

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 bio

Chris 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 Bessel

Bessel'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 bio

Elon 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: [email protected]

Website: 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 bio

Roy 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: [email protected]
Website: www.eaglemed.com
Phone: 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 Scientific

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 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:
[email protected]

Website:
www.vanderstahl.com
www.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.com

E-mail: [email protected]

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 Deputy

Sarah 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 Scientific

Van 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 validation

E-mail: [email protected]
Website: 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 KleenEdge

Launched 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 safety

E-mail: [email protected]

Website: 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/gt2JRkyP
LinkedIn 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 Gool
Strong 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 MEDICA
Served 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: [email protected]

Website: www.suedpack-medica.com

Eddy van den Berg

Eduardo previously held senior management posts at the Hilton Group

Benelux. In 2001 he founded EcoVase International a company focused on

developing single use disposal environmental products for use in

hospitals. He successfully introduced his first product a disposable flower

vase into hospitals in the Benelux and Germany.

The idea for Pharmafilter originated in 2005 as result of his observations

and daily consultation with hospital staff. He applied his findings and

combined with his previous years experience in hotel management to the

development of Pharmafilter. Pharmafilter today is being introduced to

hospital across Europe and this is as a result of his passion, vision,

creativity, skill and entrepreneurial drive.

Website: www.pharmafilter.nl 

E-mail: [email protected]