SPOT Radio

On this 2 part Podcast, we speak with Joe Campbell of Universal Robots about how collaborative Robots can make a more efficient workflow on the packaging line in the cleanroom. As throughput demand for medical devices continues to surge medical device packaging engineers will look at smaller, easy to integrate Robots as a scalable cost-effective solution.   

Guest  Description:

Joe Campbell is the head of strategic marketing and applications development for Universal Robots North America, where he is leveraging his 35+ years’ experience in the robotics and factory automation industry.  Prior to joining Universal, Joe was vice president sales & marketing for Swiss-based gantry robot and track manufacturer Gudel.  Previous assignments include executive roles in sales, marketing, operations and customer service with industry leaders including ABB, KUKA, AMT, and Adept.  Joe has also consulted to the industry on strategy, marketing, M&A and product development.

Joe is a graduate of the University of Cincinnati. He is a regular speaker and lecturer at trade shows, industry events, and manufacturing symposiums, presenting the technology and economic benefits of robots and factory automation.  Joe and his family live in Birmingham, MI.

https://www.universal-robots.com

On this 2 part Podcast, we speak with Joe Campbell of Universal Robots about how collaborative Robots can make a more efficient workflow on the packaging line in the cleanroom. As throughput demand for medical devices continues to surge medical device packaging engineers will look at smaller, easy to integrate Robots as a scalable cost-effective solution.   

Guest  Description:

Joe Campbell is the head of strategic marketing and applications development for Universal Robots North America, where he is leveraging his 35+ years’ experience in the robotics and factory automation industry.  Prior to joining Universal, Joe was vice president sales & marketing for Swiss-based gantry robot and track manufacturer Gudel.  Previous assignments include executive roles in sales, marketing, operations and customer service with industry leaders including ABB, KUKA, AMT, and Adept.  Joe has also consulted to the industry on strategy, marketing, M&A and product development.

Joe is a graduate of the University of Cincinnati. He is a regular speaker and lecturer at trade shows, industry events, and manufacturing symposiums, presenting the technology and economic benefits of robots and factory automation.  Joe and his family live in Birmingham, MI.

https://www.universal-robots.com

Accurate regulatory-compliant packaging machine calibrations are the headwater to a rounded medical device packaging program. Many medical device makers are falling short with their calibration, is your company at risk. On this episode of SPOT radio our guess Cord Burnham CKF speaks to the 5 common mistakes in packaging machine calibrations.

Guest  Description:
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.  

www.vanderstahl.com 

Jan Gates provides valuable insight on how to conform to the latest iteration of the ISO-11607-2019. This lively discussion speaks to potential shortcomings of some device makers in terms of packaging their medical devices. If you are an ISO 13485 medical device manufacturing you will surely benefit from this important discussion.

Guest  Description:

Jan Gates has 35+ experience in package engineering for foods, pharmaceuticals, detergent, and medical devices with a BS in Food Science and MS in Packaging from Michigan State University. Her work includes individual contributions and leading teams for packaging material and systems design and development. The packaging design and development have been completed to meet regulatory, product protection, and customer use requirements; also, included are production optimization, validation, and minimal packaging for sustainability. 

She has previously worked for Bristol Myers Squib, Conagra, Lever Brothers, Dade Behring, and Abbott Vascular. She currently works as an independent consultant in her company, PackWise Consulting, and with Adept Packaging as their VP of Client Solutions and Principal Packaging Engineer.

Jan works with ASTM D10 and F02 committees for rigid/flexible packaging and environmental package testing. 

She is also working as a US representative on various ISO TC 122 committees for packaging tests, vocabulary, labeling, and product shipment. She was a task group lead with AMMI on a US guidance document for compliance with ISO 11607-1/-2 (packaging for terminally sterilized medical devices); the guidance document was converted to ISO/TS 16775. She is on the IoPP (Institute of Packaging Professionals) HealthPack Advisory board, IoPP Medical Device Packaging Technical Committee and is the Southern California IoPP Co-president. 

Contact: Jan Gates 

ph-650.743.5780

packwiseconsulting.com or Adeptpackaging.com

Jan Gates provides valuable insight on how to conform to the latest iteration of the ISO-11607-2019. This lively discussion speaks to potential shortcomings of some device makers in terms of packaging their medical devices. If you are an ISO 13485 medical device manufacturing you will surely benefit from this important discussion.

Guest  Description:

Jan Gates has 35+ experience in package engineering for foods, pharmaceuticals, detergent, and medical devices with a BS in Food Science and MS in Packaging from Michigan State University. Her work includes individual contributions and leading teams for packaging material and systems design and development. The packaging design and development have been completed to meet regulatory, product protection, and customer use requirements; also, included are production optimization, validation, and minimal packaging for sustainability. 

She has previously worked for Bristol Myers Squib, Conagra, Lever Brothers, Dade Behring, and Abbott Vascular. She currently works as an independent consultant in her company, PackWise Consulting, and with Adept Packaging as their VP of Client Solutions and Principal Packaging Engineer.

Jan works with ASTM D10 and F02 committees for rigid/flexible packaging and environmental package testing. 

She is also working as a US representative on various ISO TC 122 committees for packaging tests, vocabulary, labeling, and product shipment. She was a task group lead with AMMI on a US guidance document for compliance with ISO 11607-1/-2 (packaging for terminally sterilized medical devices); the guidance document was converted to ISO/TS 16775. She is on the IoPP (Institute of Packaging Professionals) HealthPack Advisory board, IoPP Medical Device Packaging Technical Committee and is the Southern California IoPP Co-president. 

Contact: Jan Gates 

ph-650.743.5780

packwiseconsulting.com or Adeptpackaging.com

David Cocke MBA, offers insight on delivering medical devices to the point of care from his 25 years of managing a contract packaging company. Charlie Webb and David speak to the challenges of medical device packaging from regulatory science, cost containment as well as managing cleanroom staff.

Guest  Description:

David Cocke David is an MBA and he has spent the past 27 years in medical device manufacturing at the executive level. Currently, David is the VP of Manufacturing at NuPak Medical an ISO 13485 certified contract manufacturer that specializes in thermoplastic injection molding, silicone molding and assembly and packaging in controlled environments.

We were interviewed on the Podcast "Beyond Clean" and spoke on the contrasting approach of medical device packaging OEM's and SPD groups. Also, Charlie gives a brief talk on the growth and challenges of the "Sterile Packaging on Track" Podcast.

Guest  Description:

Beyond Clean Podcast takes a creative look into the inner workings of the healthcare industry at the Hospital level, which is surrounded by challenges and disrupted by change. The team at Beyond Clean brings on the biggest names in surgical instrument reprocessing and provide commentary on the biggest issues facing sterile processing professionals, facilities, administrators, manufacturers, and vendors.

www.beyondclean.net

Our host Charlie Webb CPP interviews Richard Hogan of ISO budgets and learns about his 7 step approach to estimating measurement uncertainty.  Listen in on this informative conversation and gain a clearer view of this often challenging process.

Guest  Description:

Richard Hogan holds a bachelors and master’s degree in Engineering and his consultancy ISO budgets, specializes in measurement uncertainty analysis for ISO 17025 accredited laboratories. His process for estimating measurement uncertainty has helped more than 9,000 laboratories worldwide get accredited. He combines his cross-functional competencies in all phases of Metrology, including calibration, quality management, and research.    

www.isobudgets.com 

In this episode, Karen Greene CPP speaks on the verity of medical device pouch testing methods. Charlie Webb CPP gains clarity on the ASTM F-88 test method and learns how her company (life pack labs) approaches medical device package testing.


Guest  Description:

Karen Greene is a tenured packaging professional, A CPP certified through the institute of packaging professionals. with more than 20 years of experience in the medical device and pharmaceutical packaging industries.

The first seven years of her 30+ year career were in the food packaging industry where she held professional positions with Nabisco Brands and Thomas J. Lipton Company.

Her medical device and pharmaceutical packaging experience included leadership positions with IMED Corporation (now Cardinal Health), Edwards Lifesciences, and Allergan.

She has led teams of individuals responsible for medical device and pharmaceutical package development, validation, and production implementation. She has also led teams responsible for documentation, configuration management, and label development and control.

Karen has published several articles in her area of specialization, (the packaging of terminally sterilized medical devices) and she presents frequently at industry conferences such as Medical Design and Manufacturing conference.

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 that include package design, prototyping, as well as validation consulting by visiting her website.

www.lifepacklabs.com

Charlie A. Webb CPP asks. "Is it time to upgrade your medical device packaging machinery? Charlie points out: "My advice is don’t get duped with the pointless bells and whistles that are really at the end of the day just marketing pitches that may add no value in creating better/stronger seals on your pouches. On the flip side don’t hang onto outdated equipment because you fear re-validation, this is a recipe for disaster. Re-validation can feel like a herculean task however if new packaging machinery better manages potential "Infection risk to patients" than it is time to push into better equipment and refresh your validation plan…

Guest  Description:

Charlie Webb is the founder and President of Van der Stahl Scientific he manages the company’s new technology development through the company’s vendor partners. Charlie is a certified packaging professional “CPP” certified through the institute of packaging professionals as well as a “Six Sigma Master Black Belt”. Charlie has been in sterile device packaging for 25 years and has been involved in numerous FDA and ISO audits as a regulatory advisor. Charlie has multiple granted and pending patents on medical device packaging machinery and pouch testing systems. His current patent-pending technologies include a sterile containment system for the processing of human donor tissue as well as a 100% inspection system for medical device trays.