SPOT Radio Charlie Webb

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: carolbarnum@uxfirm.com
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: Cord@vanderstahl.com 
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: JBarrett@j-pacmedical.com
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:
Jeremy@senzo.com 

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: info@thepackout.com