The Therapies Scientific Committee (TSC), the Interdisciplinary Scientific Committee (ISC) and the University of Twente, the Netherlands, are jointly establishing a Working Group to explore the role and value of medical devices in rare diseases. The Working Group will primarily focus on devices used for either the treatment of rare diseases, such as implants, and devices used to support physical activities of patients, such as exoskeletons.
The development of “orphan” devices faces scientific and technological challenges, next to the need for an improved clarity regarding the requirements for specific technical and functional needs for each device (development, clinical trial, regulatory aspects). As such, the Working Group aims to create a better understanding and enhanced awareness of device developer’s needs, the standardized outcomes to define user needs for devices, and to offer a groundwork for developing solutions to improve the (regulatory) landscape of MedTech use for rare disease patients.
IRDiRC is looking for members to populate this Working Group with the below expertise in one or more of the following areas:
- Patient (representatives), who have previously been involved in medical technology development.
- Health care professionals with experience in the use/development of medical devices, including running clinical trials
- Medical device design experience (academic and industrial)
- Experts in technical file preparation
- Regulatory experience for medical devices, from different geographies
- Funders with experience on funding medical technology
The usual time commitment includes quarterly 1-hour teleconferences, one face-to-face workshop (1-2 days), and regular email correspondence.
If you are interested in taking part in this activity: Please send a CV, biosketch and letter of motivation (one paragraph each) to the Scientific Secretariat (scisec-irdirc [at] ejprarediseases.org) before December 14th, 2021.
Importantly, do not forget to add in the subject of your email the reference of the project (Ref: WG-IRDIRC-MedTech).
Only selected candidates will be contacted. Other applications will be kept for potential future use.