Word is the biggest threat to your Mom getting life-saving treatment
Clinical trials run on some of the most consequential decisions in medicine — most of those decisions are being made in Microsoft Word.
If you think MS Office is keeping you in the Stone Age, this week’s post — and this week’s episode of Life Sciences Today — is for you.
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Intro
Life saving decisions in clinical research are being made with a word processing tool launched 43 years ago.
That’s the hook, but it’s also the reality.
In my latest conversation on Life Sciences Today, I sat down with Scott Chetham, Co-founder and CEO of Faro Health, to talk about one of the least glamorous and most important bottlenecks in drug development: protocol design.
Scott has spent more than 20 years inside clinical development, working nearly every angle of the system — hospital coordinator, principal investigator, pharma, biotech — before starting Faro.
What he built comes from lived frustration, not abstract theory.
His core point is simple: the industry still lacks real-time feedback at the moment when trial design decisions are being made. That means teams tend to over-collect data, overburden sites and patients, and drive up both costs and timelines.
In other words, by the time many companies realize a protocol is bloated or unclear, the damage is already baked in.
Faro’s approach is to move protocol review upstream and make it actionable.
Scott described a system that uses AI to perform clinical, therapeutic, regulatory, and operations review in about an hour — work that he says previously took five people working for three weeks. He pointed to a published study with Merck showing -
$130 million in cost avoidance across six programs by identifying data points that were never going to be used anyway.
That alone is compelling.
But the sharpest insight from the conversation came when I asked Scott about the biggest anti-pattern in the industry.
The biggest anti-pattern in the industry
His answer: teams don’t talk to each other.
That sounds obvious until you realize how much clinical operations depend on cross-functional precision.
Protocol design touches clinical operations, feasibility, data management, safety, regulatory, analysis, and eventually reimbursement strategy.
A single detail buried in one section of a protocol can ripple all the way through EDC build, SDTM shells, statistical analysis, and the clinical study report.
And yet, companies still operate in silos.
Scott made the point that when R&D leaders bring in a new platform without including clinical ops and feasibility teams early, success becomes much harder.
Not everyone needs a vote, he said — but everyone needs visibility.
That’s the kind of insight you only get from someone who has actually done the work.
A lot of AI CEOs can talk about transformation.
Far fewer can tell you where the process actually breaks, why it breaks, and what happens downstream when one team misreads what another team meant.
In clinops, the weeds are the strategy. And Scott clearly knows the terrain.
Visit Faro Health here
Watch the Life Sciences Today show with Scott here
OpenCRO
This conversation also touches a theme I think about a great deal in my own work: commercialization is not something to “add later” after you do a clinical protocol.
Revenue assurance has to be designed into the company’s value proposition.
That is the premise behind OpenCRO, my latest company. We help medtech teams build development and commercialization programs in which the revenue logic is legible early — before companies discover, too late, that regulatory progress and commercial readiness are not the same thing.
One of the most common mistakes I see is treating the product label as a regulatory output rather than a commercial input. By the time payers ask, “How do you measure benefit?”, the pivotal trial is often already enrolled and the protocol can no longer be changed. At that point, commercial failure is no longer hypothetical. It is simply delayed.
I have seen variations of this problem across more than 40 medtech commercialization programs in the US.
If that sounds familiar, I’m offering a free 30-minute stress test of where your next deal is most likely to break: FDA review, hospital IT, procurement — or all three.
I’d love to talk to you - grab a time here. No strings.