SPOT Radio

Human error is known to be the primary cause of quality and production losses in many industries including medical device manufacturing and medical packaging. In this episode of Sterile Packaging on Track (SPOT) radio host Charlie Webb speaks with Dr. Ginette Collazo a leading Industrial-Organizational Psychologist about how human errors develop and what can be done to manage the human failure ris...

Professor Michael Cima chats with host Charlie Webb about his Drug and Medical device development course offered through the xPRO program at MIT. The course goals are to help participants gain a “big picture” perspective of the entire drug and medical device development process, from day one strategic planning through product commercialization. Also, students will understand the critical interplay...

We visit with Greg Jones from SGS North America and gain insight into the ISO 13485 certification process from a seasoned auditor. Start-ups or established medical device manufacturers can benefit from this discussion as we speak about potential pitfalls that could jeopardize accreditation.  Guest  Description: Greg Jones is the Technical Director at SGS in North America. In that capacity, Greg is...

Listen in as we speak with the founder and president of AWS Bio-Pharma Technologies. Bruce speaks on how the process of a modular cleanroom is specked out and delivered. Bruce has great insight into the process of controlled environments from his 40 years of experience in facilities and process engineering, and management. Guest  Description: Bruce Anthenat earned his BS degree from the College of...

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...

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...

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...

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 enginee...

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 enginee...

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 ma...

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...

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 uncertai...

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 yea...

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-valida...

In this episode, Nick Webb the nations leading technology futurist and best selling author speaks about innovation pitfalls in medical device development. Nick Webb has been awarded over 40 patents by the U.S. Patent and Trademark Office for breakthrough technologies in a wide range of industries including consumer products, as well as one of the world’s smallest medical device implants.  Nicholas...

Charlie discusses the "lifecycle approach" to medical device packaging. Some medical device manufacturers do not continue to watch the arc of their sterile packaging validation plan and failures, therefore, happen as a result. Validation is a living process that needs constant monitoring at all levels to thwart potential packaging failures that could result in a sterility loss of the dev...

This episode we speak with Andy D'Esposito a technical account executive for Merrill’s Packaging. He is a CPP (certified packaging professional) he is certified through the Institute of packaging professionals where he is an active member of his local chapter. Andy provides a look into the process of developing a packaging program with thermoformed trays. Andy discusses the human factors in t...

Charlie Webb and Cord Burnham talks about the critical value of medical device packaging machine service and maintenance. Medical device package failures have been traced back to poorly maintained packaging machines. Listen in on this important conversation centered around the essential steps on staying on track with your maintenance plan. 

Charlie Webb explains what will be covered on the Sterile packaging on track podcasting on upcoming episodes.  Subscribe and receive notifications on our latest episodes.