The first episode is set. The other seven are still open, and we're taking suggestions.
Each episode opens with the two bottles and why we picked them for the topic. We taste them, then spend most of the episode on the technical side.
Michael brings a Scotch, Jason brings a bourbon, and each has a sample of the other's bottle before we record.
Why we picked these bottles for this topic. Some connections are tighter than others, and we'll say which.
Most of the episode: what the standard requires, what the data supports, and how we'd build the validation strategy.
Where the standard doesn't settle it: the judgment calls, how we'd defend them to an auditor, and stories from the field with identifying details removed.
Recorded between Philadelphia and Phoenix, two hours apart in winter and three in summer, because Arizona doesn't do daylight saving.
Leads R&D, biocompatibility, and sterilization work in medical devices and life sciences. Along the way he's also worked in product development, quality assurance, process validation, supplier audits, root cause analysis, and risk management.
Senior sterilization engineer who works hands-on with the processes and validations that take product from built to sterile and releasable.
Most episodes sit in one of these, and plenty will cross into two. More on each one.
01
Sterilization
EO, radiation, steam, and newer methods, plus the validation and routine control that keep a sterility claim defensible.
02
Industry Standards
How ISO and AAMI standards get written, recognized, and revised, and how to work with one that changes under you.
03
Biocompatibility
Biological evaluation of the finished device, chemical characterization, extractables and leachables, and toxicological risk assessment.
04
Quality
Process validation, CAPA, risk management, supplier controls, and day-to-day life under the QMSR.
05
Regulatory
US and EU pathways, change control, post-market obligations, and the judgment calls in between.
Full video on YouTube, and audio wherever you get podcasts, starting with the first episode.
The channels open when Episode 1 comes out. Get an email when it does.
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