Artificial intelligence is reshaping what medical technology companies can do, from streamlining regulatory work to improving access to information and running more efficient operations. But at the Veeva MedTech Summit in Amsterdam, the question that dominated presentations, panels and interviews was not how fast organisations can adopt AI, but whether they have the foundations to use it effectively.
The message repeated across sessions was consistent: successful digital transformation depends on getting the fundamentals right first, bringing together reliable data, consistent processes, appropriate governance and the people accountable for them.
Medtronic spent four years preparing
The clearest illustration came from Becki Brasher of Medtronic, who described a four-year effort to become ready to implement AI. Rather than starting with the technology, the company concentrated on the organisational groundwork: harmonising processes, improving data consistency, consolidating systems and establishing governance structures.
"We didn't start with AI. We had to earn AI," Brasher said during her session — a formulation that captured why introducing the technology into fragmented or inconsistent environments can create more problems than it solves. Without reliable information and standardised processes, organisations risk outputs that are difficult to trust, validate or scale. Brasher also stressed preparing employees for the change: technology alone cannot deliver transformation, and staff need the knowledge, confidence and oversight to fold new tools into their daily work.
Governance built in, not bolted on
Balancing innovation with regulatory compliance was the focus of the closing keynote from Erik Orzechowski and Benjamin Rochette. As adoption accelerates, they argued, MedTech companies must move quickly without compromising the quality, safety and regulatory standards the industry is held to. Their central point was that governance should be embedded in technology development from the outset rather than treated as a final compliance exercise.
That requires closer collaboration between IT, Quality and Regulatory teams. IT understands the technology and how it is implemented, while Quality and Regulatory professionals assess risk and define the evidence needed to demonstrate compliance. The speakers also called for proportionate governance: an application supporting low-risk administrative work does not need the same controls as one influencing patient safety or regulatory decisions. Clear responsibilities, early risk assessments and appropriate controls allow a more flexible approach that supports innovation without overlooking obligations.
Human judgement still the backstop
The summit also underlined the value of retaining human expertise. Brasher said she expects human judgement to remain in place as it is today until organisations build trust that what AI agents deliver is accurate, and that AI should assist human reviewers rather than replace them.
Her point was echoed in the closing keynote's comparison between relying on AI without understanding its subject matter and using a calculator without knowing the mathematics behind it. The concern is practical: if employees lean on AI before developing underlying knowledge, organisations could end up with fewer people able to challenge inaccurate or inappropriate recommendations. The consensus was not to avoid AI but to treat it as a complement to expertise, with accountable individuals retaining responsibility for important decisions.
Measuring value, starting small
With applications proliferating, organisations were urged to resist pursuing every opportunity at once and instead target areas where technology addresses existing operational problems. The keynote listed time savings, shorter process cycle times, less rework, improved quality and employee adoption as ways to gauge value, and recommended controlled pilots that build confidence before successful applications are scaled.
Because the technology and regulatory expectations will keep changing, governance structures need to adapt alongside new capabilities. Success, the summit suggested, will depend less on the number of initiatives launched than on the ability to turn promising applications into reliable, scalable capabilities — and on recognising that technology, compliance, data management and culture cannot be tackled separately.
The mood was optimistic but pragmatic. As Orzechowski put it, organisations sometimes need to "slow down to speed up" — getting the foundations right now to be positioned for what comes next.