SPOT Radio

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=4833

LinkedIn page: https://www.linkedin.com/company/iopp-mdptc

 e-mail: [email protected] 

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 Barnum

Carol 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.com

e-mail: [email protected]

Phone: 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 Barnum

Carol 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.com

e-mail: [email protected]

Phone: 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.com

E-mail: [email protected] 

Phone: 800-550-3854

On this episode of SPOT radio, Charlie Webb speaks with Jeff Barrett President and CEO of J-Pac Medical. Jeff gives keen insight from the point of view of a contract provider of assembly, packaging, and sterilization. Because contract packagers see a variety of packaging configurations, materials, and sterile delivery requirements, their global vista often can provide fast solutions for a host of healthcare packaging challenges.

About: Jeff Barrett

Jeff Barrett is the President and CEO of J-Pac Medical. Jeff has more than 25 years of experience building high-growth medical product-based companies. He leads the advancement of J-Pac’s growth strategy, pursuing opportunities to further drive adoption of the company’s offerings and optimizing capabilities to better serve customers.

Prior to joining J-Pac Medical, Barrett held CEO positions at GI Supply and Optim LLC and Vice President of Operations roles at Haemonetics and Aspect Medical Systems. He is also a successful entrepreneur. By applying his operational and engineering aptitude, Barrett founded Eggrock Modular Solutions, which became a disruptive business in the building technology industry. Barrett has proven expertise building and managing high-performance management teams, developing and implementing optimized operating infrastructure and manufacturing processes, and both improving existing product pipelines and growing new ones.

Barrett holds an MBA from Boston University’s Graduate School of Management, a B.S. in industrial engineering, and a B.A. in economics from Rutgers University.

Websites: https://www.J-pacmedical.com

E-mail: [email protected]

Phone: 603-692-9955

On this episode of SPOT radio, Charlie Webb has an edifying conversation with Jeremy Stackawitz from Senzo about the future of at-home diagnostics systems. As this new market grows in healthcare it is a great time to ponder how medical device packaging will support this new end-point.  This new paradigm will surely launch new growth for medical device and diagnostic packaging machines and material providers. 

About Jeremy Stackawitz:

Jeremy holds a science degree from Dartmouth and earned his MBA in Healthcare management from Wharton. He has 25+ years in healthcare with 15 of those years in diagnostics. At present Jeremy is CEO of Senzo, he resides in Pennsylvania with his wife and 3 kids and loves bringing innovative products to market.  

About Senzo:

Senzo, is a leading in vitro diagnostics company, that recently announced the successful development, and completion of a new 7-minute Covid-19 lateral flow rapid antigen Self-Test with the same accuracy as professional laboratory PCR tests, the industry’s gold standard. In an operator-blind study of 59 positive and 101 negative Covid-19 test samples, across all major variants, the Senzo Amplified Lateral Flow (ALF) test achieved 98.3% positive percent agreement (PPA) and 99.0% negative percent agreement (NPA) with PCR results, and 100.0% positive percent agreement (PPA) for samples with a Ct value between 33 - 38, representing very low levels of target nucleic acid in the sample. 

LinkedIn:
https://www.linkedin.com/in/jeremystackawitz/

Websites:
http://www.senzo.com

https://www.emdevicelab.com

E-mail:

[email protected] 

On this episode of SPOT radio, Charlie Webb speaks with founding members of the Pack-Out conference that will be held in Austin Texas, May 10-12. The Pack-Out promises to bring an exciting new attendee experience designed to facilitate peer connection and foster industry learning. Listen in and learn more about this exciting new medical device packaging professional conference.

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, there are limited options available for our specialized profession, the content and accommodations of legacy events have not kept pace with expectations, which leaves 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:

Rod Patch: https://www.linkedin.com/in/rod-patch-756227a/

Sarah Rosenblum: https://www.linkedin.com/in/sarahrosenblum/

Jenn Goff : https://www.linkedin.com/in/jenn-goff-8714785/

Karen Polkinghorne: https://www.linkedin.com/in/karen-polkinghorne/

Kiley Djupstrom: https://www.linkedin.com/in/kileydjupstrom/


Websites: https://www.thepackout.com

E-mail: [email protected]

On this episode of SPOT radio, Charlie Webb continues his conversation with Pat Kothe a medical device innovator and host of the mastering medical device Podcast. On this two-part podcast, they cover a gambit of issues surrounding medical device and packaging development including sustainability, innovation hierarchies, and balancing the voice of the customer with product development.

About SPOT Radio guest Pat Kothe

Pat Kothe has spent his entire career in the Medical Device industry and is currently the CEO of EM Device Lab, Inc., an early-stage company that provides a breakthrough product for treating abscesses. During his career, he and his teams have successfully launched over 50 implantable and external hardware and software devices, including brain health assessment devices, ECG algorithms, heart valves, and interventional and diagnostic cardiology products. He was founding CEO at NeuroChaos Solutions and contributed to Marketing and Sales leadership roles at Monebo Technologies, Sulzer CarboMedics, Mallinckrodt Medical, and American Hospital Supply Corporation. Pat earned a B.S. in Business Administration from Carroll University.

LinkedIn:

www.linkedin.com/in/patrick-kothe 

Websites:

https://www.masteringmedicaldevice.com 

https://www.emdevicelab.com 

E-mail

[email protected]