Commercial Medical Devices

Veeva MedTech Summit: AI readiness starts with data, governance and human oversight

Dalia IvanovaNovember 8, 20265 min read0 views

At a glance

  • Industry speakers in Amsterdam said MedTech firms must fix processes, data and governance before scaling artificial intelligence.
  • At the Veeva MedTech Summit in Amsterdam, Medtronic and other speakers argued that AI adoption in MedTech depends less on speed than on reliable data, consistent processes, proportionate governance and retained human judgement. They also urged controlled pilots and clear value measures.
Concept illustration of a compact medical device resting on interlocking glass-and-metal foundation layers in a clean clinical engineering setting.

At the Veeva MedTech Summit in Amsterdam, the central message was that MedTech organisations should not treat artificial intelligence as a standalone technology project. Speakers and panellists argued that effective adoption depends on foundations that are often less visible: reliable data, consistent processes, suitable governance and clear human accountability.

Becki Brasher of Medtronic described a four-year effort to prepare the company for AI. Rather than starting with algorithms or applications, Medtronic harmonised processes, improved data consistency, consolidated systems and set up governance structures. Brasher summarised the approach as not beginning with AI but earning the capability first. The implication was that introducing AI into fragmented or inconsistent operations can create more problems than it solves, because outputs become difficult to trust, validate or scale.

Preparing employees was part of the same effort. The summit discussion made clear that technology alone cannot deliver transformation; staff need knowledge, confidence and appropriate oversight to use new tools in daily work.

Governance from the start

Balancing innovation with regulatory compliance was another theme, particularly in the closing keynote by Erik Orzechowski and Benjamin Rochette. They argued that governance should be embedded in technology development from the outset rather than treated as a final compliance step. Closer collaboration between IT, Quality and Regulatory teams was presented as necessary: IT understands implementation, while Quality and Regulatory specialists assess risks and define the evidence needed to show 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. Early risk assessment, clear responsibilities and suitable controls could allow a more flexible approach without ignoring obligations. Compliance and innovation, in this view, need not be opposing priorities.

Human judgement remains central

Despite advances in AI, the summit stressed the continued role of human expertise. Brasher said AI should assist human reviewers rather than replace them. She also said human judgement would remain essential until organisations build trust that what agents deliver is accurate.

AI can review large information sets, produce drafts and offer recommendations, but its output still requires scrutiny. A persuasive response may still be incorrect, especially in a highly regulated environment. The closing keynote used the analogy of relying on a calculator without understanding the mathematics behind it. The concern is that if employees depend on AI before developing underlying knowledge, organisations may have fewer people able to challenge inaccurate or inappropriate recommendations.

Pilots and measurable value

The discussion did not reject AI. Instead, speakers described it as a complement to human expertise, with accountable individuals retaining responsibility for important decisions. Organisations were urged to resist pursuing every possible application at once and to focus on operational problems where AI can deliver measurable value. Suggested measures included time savings, shorter process cycle times, less rework, improved quality and employee adoption.

Controlled pilot projects were presented as a way to learn where AI works best, maintain human oversight and build confidence before scaling. Because the technology and regulatory expectations will keep changing, governance structures also need to adapt. Success, the summit suggested, will depend less on the number of AI initiatives launched than on the ability to turn promising applications into reliable, scalable capabilities.

The broader conclusion was that digital transformation is a collective challenge. Technology, regulatory compliance, data management and organisational culture cannot be addressed in isolation. Orzechowski’s phrase “slow down to speed up” captured the argument: getting the foundations right now is intended to position the industry to take up future opportunities with greater confidence.

Reported by Dalia Ivanova, Infection Control, Quality and Procurement Editor.