PhD Position Decision-making Under Uncertainty Emerging Orphan and Breakthrough Medical Devices

What uncertainty in clinical evidence is acceptable for regulatory actors and patients to allow orphan or breakthrough devices on the market, while also ensuring these devices are sufficiently safe?

Innovative medical devices can offer important benefits to patients, especially when existing diagnostic or treatment options are limited. At the same time, the available clinical evidence may be limited or contain uncertainties when a device is assessed for market access. Regulators and notified bodies therefore need to decide when evidence is sufficient, what uncertainties can be considered acceptable, and under what conditions additional evidence should be collected after a device enters the market.

In this PhD project, which is part of the European COMPASS4MD project, you will study how these decisions are currently made in practice, and how uncertainty could be managed in the future. You will explore how uncertainty in clinical evidence is described and assessed, which factors make uncertainty more or less acceptable, and how unmet medical needs, small patient populations and expected patient benefits influence regulatory decisions.

Building on these insights, you will examine how future regulatory approaches could support more responsible decision-making under uncertainty.

The research combines several methods. You will review regulatory documents and publicly available regulatory opinions from accross Europe (and possibly other jurisdictions). You will also interview professionals involved in the assessment of medical devices, such as notified-body assessors, regulators, and Expert Panel members. Based on these findings, you will develop realistic case scenarios that present different types and levels of uncertainty.

These scenarios will be discussed with patients, clinicians, manufacturers, regulators, notified bodies, and health technology assessment bodies to explore where their views overlap and where they differ.

The final part of the project focuses on how regulation can deal with uncertainty in a responsible way. A particular area of interest is the use of regulatory sandboxes: controlled environments in which regulators, developers, and other stakeholders can explore regulatory questions and test approaches to evidence generation while a technology is still developing. You will also consider related approaches, including conditional market access and post‑market evidence generation.

The aim is to develop practical recommendations that support access to promising medical technologies while continuing to protect patients.

This PhD project is part of the European COMPASS4MD consortium and will involve close collaboration with research institutes, regulators, clinical experts, patient representatives, and other partners across Europe. You will contribute to joint project activities, exchange findings with partners from different countries and disciplines, and help organise interviews and stakeholder workshops. The position therefore suits someone who communicates easily, enjoys working with people from different countries and disciplines, and is willing to take an active role in an international consortium.

You should be comfortable working independently on your own research while also contributing to shared activities, meetings, workshops, and deliverables with European project partners. Some travel within Europe may be part of the position.

English proficiency is required. Proficiency in Dutch is considered an advantage, but is not a requirement. Experience with medical-device regulation, clinical research, benefit–risk assessment, stakeholder workshops, survey experiments, or…