A video podcast for people who work in medical devices and life sciences. Two practitioners talk through sterilization, biocompatibility, industry standards, quality management, and regulatory work, grey areas included, over a Scotch and a bourbon.
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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 and Jason brings a bourbon. Each gets a sample of the other's bottle ahead of time, so we both taste both on camera.
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 case.
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.
We both do this work for a living: R&D, biocompatibility, sterilization engineering, quality, and process validation.
Brings the ScotchPhiladelphia, PA
R&D, biocompatibility, sterilization
Michael leads R&D, biocompatibility, and sterilization work in medical devices and life sciences. He has also worked in product development, quality assurance, process validation, supplier audits, root cause analysis, and risk management.
Brings the bourbonPhoenix, AZ
Sterilization engineering
Jason is a senior sterilization engineer who works hands-on with the processes and validations that take product from built to sterile and releasable.
Every episode is filed under one of these, and plenty cross into a second. More on each one.
EO, radiation, steam, and newer methods, plus the validation and routine control that keep a sterility claim defensible.
In the glassPeat smoke sticks best to damp malt. EO cares about moisture too: humidity is a cycle parameter like gas, heat, and time.
More on sterilization
Biological evaluation of the finished device, chemical characterization, extractables and leachables, and toxicological risk assessment.
In the glassMuch of an aged whiskey's flavor came out of the oak. A barrel is a leachables study that runs for years, and you drink the results.
More on biocompatibility
How ISO and AAMI standards get written, recognized, and revised, and how to work with one that changes under you.
In the glassScotch is defined by law. Device standards are voluntary, written by practitioners in committee, then recognized by regulators.
More on industry standards
Process validation, CAPA, risk management, supplier controls, and day-to-day life under the QMSR.
In the glassA master blender makes this year's bottling taste like last year's. A quality system does the same job, with more paperwork.
More on quality management
US and EU pathways, change control, post-market obligations, and the judgment calls in between.
In the glassBourbon has a legal standard of identity. So do devices: every classification regulation opens with "Identification."
More on regulatory workFull video on YouTube and audio wherever you get podcasts.
The channels open when Episode 1 comes out. Until then, email is how to hear about it.
Episode alertsOne email per episode
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