Ketryx and Accenture Team Up for Medtech Transformation

On why Accenture chose Ketryx, and what it actually takes to deploy AI across regulated product development at scale.

We are living through a very special time of technological change in history. It is so profound that every single medtech executive today is asking how their company moves faster and how it can incorporate AI. Companies that would have spent two years deliberating an infrastructure decision are making it in a quarter, sometimes without a pilot. They are asking for full-scale, enterprise-wide adoption as fast as they can get it.

For years, we’ve been in the trenches with some of the largest life sciences companies in the world, proving that compliance doesn’t have to be the thing that slows great products down. We’ve helped teams move from validation cycles measured in quarters to release cadences measured in days. We’ve seen engineers get back the majority of the time they used to lose to documentation. And through all of it, one lesson kept surfacing: the technology isn’t the hard part, “the system” is.

Changing that system means changing how an entire organization works. It’s unwinding processes that have been in place for decades, defended by muscle memory and audit history, and the very reasonable fear that changing anything in a regulated environment invites risk. It’s getting engineering, quality, and regulatory teams, who often don’t share tools, incentives, or vocabulary, to trust a new way of operating. You can build the best platform in the world, and if the people who are supposed to use it don’t change how they work, nothing changes at all.

Early on, our wins were single products and single teams. An AI group inside a larger company would adopt Ketryx, get dramatic results, and become believers. That’s a wonderful thing. But it’s also where a lot of good technology quietly stops because the moment you try to go from one team to the whole enterprise, the problem changes shape.

At enterprise scale, you’re no longer selling a better way to do a task. You’re asking a global organization to rethink how it manages quality, risk, and evidence across every product line, every business unit, and every regulatory regime it operates in. That is no longer a software rollout, but instead an organizational change. And organizational change, at that scale, is a different discipline entirely.

This is the wall that most AI transformation efforts hit. Not because the technology fails, but because no one owns the human side of the transformation. New tools get layered on top of old behavior, and the old behavior wins.

And that is what concerns me about the speed. When AI is writing code, generating tests, drafting documentation, and proposing design changes across every product line at once, the volume of change inside a regulated company rises by an order of magnitude, while the number of people available to review, approve, and attest to that change stays exactly the same.

That is not a tooling problem and it is not a staffing problem. You cannot hire your way out of it, and no document management system makes it go away. Deploying AI at that scale requires a fundamentally different model for how evidence gets produced. It requires partners who have done this work inside organizations of this size and know what it actually takes.

A platform alone won’t transform a Fortune 500 medtech organization, no matter how good it is. And services alone, transformation programs built on top of legacy, document-centric systems, won’t scale either, because they’re trying to change behavior without giving people a fundamentally better system. You need both world-class change management and a platform that makes the new behavior genuinely easier than the old one.

That combination is what this next chapter is about.

So, I’m proud to share that Accenture has selected Ketryx as the continuous compliance platform behind their medtech transformation work.

Accenture has one of the largest life sciences transformation practices in the world, with more than 15,000 professionals across 50-plus countries, serving many of the world’s leading medical device and pharmaceutical companies. They have spent decades helping regulated organizations change how they operate. That is the muscle most technology companies simply don’t have, but it’s the muscle this problem needs.

In our partnership, Accenture will do what they do best: strategy, process redesign, and the deeply human work of helping thousands of people adopt a new way of working. Ketryx will provide the technology foundation beneath it: an AI-native, continuously validated compliance platform that overlays the tools teams already use, automatically maintains traceability and documentation, enables trusted agentic workflows, and keeps evidence audit-ready as the product evolves.

So, as Jens Lauber, Accenture’s Global Lead for Quality and Regulatory in Life Sciences, told me when we began working together:

“Our clients are moving quickly to bring AI into product development, and their quality and regulatory operating model isn’t ready. Their processes and tools are no longer sufficient to produce evidence at even close to the pace of change. We need a new, AI-based model of thinking and operating.”

The shift underway isn’t from old tools to new tools. It’s from compliance as something people produce to compliance as something a system maintains autonomously and continuously. When one of the most credible names in the industry decides to build its transformation practice on that model, it’s a signal that the transition has started.

And the stakes here are bigger than efficiency. Inside every one of these organizations, there is a product that already works, already finished, waiting on evidence to catch up. Every month it spends in that queue is a month it isn’t with the patient who needs it. That cost never appears on anyone’s balance sheet, but it is the largest one we pay as a society.

The organizations that fix this won’t just ship faster. They will build the things they don’t attempt today. No longer will products quietly die in a planning meeting because the cost of proving them safe outweighed the will to try. That is the future worth building, and with Accenture we have the reach to build it at scale.

So here is the question I would leave with you: if compliance stopped being your constraint, what would your organization attempt that it isn’t attempting today?