Medtech companies weighing artificial intelligence need to fix their data, processes and governance before they try to scale the technology, according to discussions at this year’s Veeva MedTech Summit in Amsterdam.
The event highlighted uses ranging from streamlining regulatory work to improving access to information and supporting more efficient operations. But speakers repeatedly returned to a less glamorous question: whether organisations have the foundations needed to use AI reliably.
Medtronic’s groundwork
Becki Brasher of Medtronic described a four-year effort to prepare the company for AI implementation. Rather than starting with the technology, Medtronic focused on harmonising processes, improving data consistency, consolidating systems and putting governance structures in place.
Brasher’s message was that the company had to earn the right to use AI. The implication was clear: introducing AI into fragmented or inconsistent operations can create more problems than it solves. Without reliable information and standardised processes, outputs can be hard to trust, validate or scale.
She also stressed that technology alone cannot deliver transformation. Employees need the knowledge, confidence and oversight to incorporate new tools into their daily work.
Governance from the start
In the closing keynote, Erik Orzechowski and Benjamin Rochette argued that governance should be built into technology development from the beginning rather than treated as a final compliance step. They said closer collaboration between IT, quality and regulatory teams would be necessary, with IT understanding implementation while quality and regulatory specialists assess risk and define the evidence needed for compliance.
The speakers also called for proportionate governance. An AI application supporting low-risk administrative work may not need the same controls as one that influences patient safety or regulatory decisions. Clear responsibilities, early risk assessments and appropriate controls can give organisations a more flexible approach without weakening their obligations.
Human judgement remains central
Despite advances in AI, the summit did not portray human expertise as expendable. Brasher said AI should assist human reviewers rather than replace them, and argued that human judgement would remain essential until organisations build trust that agents are delivering accurate results.
AI can analyse large volumes of information, draft documentation and make recommendations, but its output still needs scrutiny. In a regulated industry, a convincing answer is not necessarily a correct one. Closing keynote speakers compared relying on AI without understanding the subject matter to using a calculator without knowing the mathematics behind it.
That analogy raises a question for workforce development. If employees rely on AI before developing underlying knowledge, companies may have fewer people able to challenge inaccurate or inappropriate recommendations. The consensus was that AI should complement human expertise, not replace it, and that accountable individuals must remain responsible for important decisions.
Pilots and measurable value
With many possible applications available, organisations should resist trying to pursue every opportunity at once. Instead, they should target existing operational challenges and set clear measures of success. The keynote cited potential value indicators including time savings, shorter process cycle times, less rework, improved quality and employee adoption.
Controlled pilot projects can show where AI is most effective, preserve human oversight and build confidence before wider deployment. This matters because AI capabilities and regulatory expectations will keep changing, requiring governance structures that can adapt.
The broader message was pragmatic rather than promotional. Success will depend less on the number of AI initiatives launched than on the ability to turn promising applications into reliable, scalable business capabilities. As Orzechowski put it, organisations may sometimes need to “slow down to speed up.”