On this episode of the SPOT Radio podcast, Charlie Webb CPPL speaks with Jeff Devich BSME, MBA about the Sterile Start™ program, together they break down why so many medical device manufacturers struggle with the complexity of the ISO 11607 framework and how gaps in understanding can lead to costly delays, failed validations, and audit findings. They share real world insights, practical strategies, and clear explanations that help teams strengthen their sterile packaging programs and avoid common pitfalls.
About Jeff Devich BSME, MBA
Jeff’s background includes serving as Director of Operations for a combination of device contract manufacturers. He has extensive experience in equipment and process validation within the MedTech industry. Jeff applies his mathematic and engineering expertise to for the Sterile Start™ program creating Design of Experiments and characterization reports for Van der Stähl Scientific sealers, helping customers understand how process parameters affect their specific products.
Email me: jeffrey.devich@gmail.com
LinkedIn: https://www.linkedin.com/in/jeffrey-devich-1b6b2788
