top of page
Search

Future Needs at IEEE ISSE 2025: Presenting a Vee-Model Framework for Trustworthy Connected Medical Devices


We are excited to share that the paper “Co-Designing Trustworthy Connected Medical Devices: A Vee-Model Framework for Usability and Regulatory Alignment”, authored by Anna Palaiologk and Thanos Arvanitidis from Future Needs, has been accepted for presentation at the 2025 IEEE International Symposium on Systems Engineering (ISSE) in Paris. Thanos Arvanitidis represented AI4LUNGS and present this work at ENSTA, France, from 28–30 October 2025, with the presentation scheduled for October 30th!


The paper introduces a refined Vee-Model systems engineering framework, adapted to meet the specific needs of the project and soon to be piloted in AI4LUNGS. The model integrates targeted co-creation points and legal–ethical assessment checkpoints, ensuring stronger trustworthiness, regulatory alignment, and user acceptance in the development of Connected Medical Devices. The framework was developed by the result of a robust mixed-method study that combined multiple sources of expertise and stakeholder perspectives:

  • Literature and regulatory analysis

  • Input from 52 internal professionals and 120 external users

  • Two expert workshops with 15 specialists across legal, ethics, systems engineering, and cybersecurity

  • 15 co-creation sessions with developers and clinicians

This extensive process ensured that the model reflects not only technical requirements, but also ethical, legal, and societal expectations.


This anticipatory co-design framework helps bridge the gap between technical development and real-world trustworthiness requirements. By embedding co-creation and regulatory considerations early in the development lifecycle, the approach supports more responsible, transparent, and user-aligned innovation in Connected Medical Devices.



Stay updated on the AI4LUNGS research development and progress by following the project on BlueSky, X and LinkedIn, and subscribing to our newsletter for the latest insights and advancements.

 
 
bottom of page