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From Pilot to Practice
AI in MedTech product development

What to automate? What to keep human? And how to align regulatory, development and clinical in that world that is moving faster than ever.

How far can you push AI integration in the product lifecycle?

AI has already revolutionized software development.
Beyond that, advanced teams are now integrating AI deeper across the MedTech product lifecycle including design controls, regulatory approval, qualify management, claims management, etc.
The question is, how far can you reliably push AI integration with current capabilities?

– When to use generic vs specialized AI tools for the MedTech lifecycle
– What can be reliably achieved today vs what should be aimed for in 3 years?

How do you stay in control?

Speed has little value if outputs cannot be trusted or verified.
Effective AI integration requires reliable tools, secure data handling, traceable sources, defined review steps, and clear accountability. The speakers will discuss how they assess AI outputs, prevent unverified content from entering regulated documentation, and determine how to mitigate automation risks.

How do you align across teams to ensure success?

Regulatory, development, and clinical teams often work from different inputs, timelines and tools, even though their decisions shape the same submission. Effective AI adoption requires shared use cases, consistent inputs and clear responsibilities.
The panel will explore how to align these teams given the added capabilities and relentless speed unlocked by AI.

Henk Stapert

CTO –  smartQare | Fractional CTO – ShanX Medtech

  • Serial healthcare innovator and entrepreneur with 25+ years of experience building new healthcare businesses, including senior R&D roles at Philips. He has helped bring three diagnostic and image guidance devices to market.
  • Currently CTO at smartQare and fractional CTO at ShanX Medtech, he leads the ongoing development of an established wearable biosensor and the introduction of a novel in-vitro-diagnostics platform for bacterial infections.

Stef Rommes

CTO – MONA Health | Founder – Mediwear

  • AI expert with deep experience across the AI and regulatory lifecycle for medical device software, from problem definition and careful data handling to model development, deployment, and delivery to real users in compliance with applicable regulations.
  • CTO at MONA.health, leading technology and regulatory development of novel AI-based screening solutions for the leading causes of blindness. Founder of Mediware, providing consultancy for medical device software at the intersection of technology and regulation.

Charusheila Ramkumar

Chief Scientific Officer – Cntrl+ | Principal Consultant – CR Regulatory Advisory Inc

  • Scientist and regulatory affairs expert with more than 20 years experience across end-to-end medical device development, clinical evidence generation and regulatory affairs.
  • Currently CSO at Cntrl+ and Principal Consultant at CR Regulatory, she is driving the development and commercialization of novel solutions for pelvic floor disorders in women as well as consulting on regulatory strategy and submissions for novel medical devices, with a focus on Femtech and IVDs.