About the show

Proof, both kinds.

A video podcast about the evidence behind medical devices, recorded over a Scotch and a bourbon.

Why we started it

More time than a webinar allows.

Sterilization validation, biological evaluation, quality systems, standards, and regulatory strategy usually get discussed in conference rooms and webinars, with a hard stop at the top of the hour.

We wanted more time than that, so we set up two desks in two time zones and each poured a whiskey. The whiskey earns its place. Distilling and device manufacturing deal with the same problems: raw material control, process consistency, extraction from the container, and a legal definition of what you can call the finished product.

The name

Two words, two meanings.

Proof & Practice seal

Proof is the evidence: what you have to show a regulator, an auditor, or yourself before a device reaches a patient. It's also the strength of the pour; in the US, twice the alcohol by volume.

Practice is the rest of it: learning the job, getting better at it, and doing the work in a regulated environment, including the grey areas the standards don't settle for you.

How it works

Two pours each.

Michael picks a Scotch. Jason picks a bourbon. Before we record, each of us gets a sample of the other's bottle, so we're both tasting both pours on camera.

We explain why we picked them, taste through nose, palate, and finish, and then spend most of the episode on the technical side. Each episode page lists the bottles, tasting notes, chapters, and the standards we discuss.

Two seasons a year, eight episodes each. Season 1 opens with the 2026 revision of ISO 10993-7, ethylene oxide residuals, and how they tie into ISO 10993-17 and ISO 10993-18.

What we cover

Five subjects, in depth.

Every episode lands in one of these. Here's what each one spans, and how the glass connects to it.

A glass of smoky Scotch beside sealed sterile pouches 01

Sterilization

Getting product from its starting bioburden to a validated sterility assurance level, and keeping it there. EO, gamma, e-beam, X-ray, steam, VHP, and newer modalities, plus the validation, routine control, and change management that keep a sterility claim defensible for the life of the product.

What we get into

  • Choosing a modality
  • Cycle development & validation
  • Dose setting & audits
  • Product adoption & families
  • EO capacity & emissions rules
  • Sterile barrier & packaging
  • Moving between modalities

In the glassPeat phenols stick best to damp malt, so distillers burn the peat early, while the grain is still wet. EO cares about moisture too. Humidity sits alongside gas concentration, temperature, and time as a parameter the cycle has to control.

Suggest a sterilization episode
Analytical sample vials beside a tasting glass 02

Industry Standards

How consensus standards get written, and how to live with them once they're published. ISO and AAMI committees, FDA recognition and EU harmonization, and what to do when the standard you validated against changes under you.

What we get into

  • How consensus standards are made
  • Recognition & harmonization
  • Revisions & transition periods
  • Gap assessments
  • Reading a standard: shall vs. should
  • When guidance and standards disagree
  • Joining a working group

In the glassScotch is defined by law, in the Scotch Whisky Regulations 2009, written with heavy input from the distillers. Device standards work the other way: voluntary documents written by practitioners in committee, which regulators then decide whether to recognize.

Suggest an industry standards episode
A beaker of bourbon on a charred oak barrel stave 03

Biocompatibility

Showing that the finished device, made and sterilized the way you'll sell it, is safe for the way it contacts the patient. Biological evaluation plans, chemical characterization, extractables and leachables, toxicological risk assessment, and the shift from animal testing toward chemistry and risk-based arguments.

What we get into

  • Biological evaluation plans
  • Chemical characterization
  • E&L study design
  • Toxicological risk assessment
  • Material & supplier changes
  • Reducing animal testing
  • Reprocessing & reuse

In the glassA lot of what you taste in an aged whiskey came out of the oak: vanillin, lactones, tannins, and every bit of a bourbon's color. A barrel is a leachables study that runs for years, and you get to drink the results.

Suggest a biocompatibility episode
Rows of lot-numbered barrels in a rickhouse 04

Quality

The system that keeps lot 400 coming out of the same validated process as lot 1. QMS design, process validation, CAPA and root cause, risk management, supplier controls, audits, and life under the QMSR.

What we get into

  • Process validation (IQ/OQ/PQ)
  • CAPA & root cause
  • Risk management
  • Supplier controls
  • Audits & inspections
  • Life under the QMSR
  • Data integrity

In the glassA master blender's job is making this year's bottling taste like last year's, out of casks that are all a little different. Process validation is the same job with a tighter spec and more paperwork.

Suggest a quality episode
An open law book, a wax seal, and a glass of bourbon 05

Regulatory

Getting a device to market and keeping it there. US and EU pathways, building a submission a reviewer can say yes to, change control, post-market obligations, and the judgment calls that live between the regulations.

What we get into

  • 510(k), De Novo & PMA
  • EU MDR & notified bodies
  • Significant change decisions
  • Post-market surveillance
  • Labeling & claims
  • Global submissions
  • Talking to regulators

In the glassBourbon has a legal standard of identity: grain, barrel, proof, place. So do devices. Every classification regulation in 21 CFR 862–892 opens with a paragraph titled “Identification.”

Suggest a regulatory episode
Suggest a topic

What should we pour next?

Send us a standard you want picked apart, a grey area you're stuck in, or someone we should have on. Suggest a Scotch and a bourbon to go with it, too. It goes straight to both of us.

Please don't send anything confidential. If we use your question on air, we won't name you or your company.

The fine print

Independent, and not advice.

Proof & Practice is an independent show. Opinions are the hosts' own and don't represent their employers, clients, or any standards committee or regulator. Mentioning a standard, agency, or brand isn't an endorsement by or of it.

Nothing here is regulatory, legal, or medical advice. Check with your own regulatory, quality, and legal people before you act on anything you hear. We discuss standards; we don't reproduce them. Buy your copy from ISO, AAMI, or your national standards body.

The show is for audiences of legal drinking age where they live. Enjoy responsibly.