MSCA Postdoctoral Fellowships (PF) on "Delineation and validation of a harmonized methodology for the design, prototyping and testing of context-based open source medical devices"

Recent trends, including open innovation, collaborative engineering, and the “makers” movement, are reshaping traditional engineering design, resulting in new horizons opening in many areas of industry. By leveraging user-oriented designs and creativity promotion through collaboration, they can be of enormous value as drivers of change and harbingers of unprecedented breakthroughs. Medical technology could also benefit from these changes, but special attention must be paid to safety, efficacy, and usability of medical devices, given that they are often in intimate contact with the human body and that their ultimate goal is to safeguard human health. Regulatory compliance, for example to the European Medical Device Regulation (MDR) is also a crucial aspect to consider, as are sustainability and accessibility, both key for ensuring equitable healthcare. The main question to be addressed in the research study is “how can an MDR compliant open source medical device be developed, validated, marketed and traced”?

As such, the project’s main goal is to implement a methodology for delineating pathways towards the mainstreaming and harmonization of open source medical devices through design, prototyping and testing of technological solutions in the area of healthcare. Attention to safety and compliance to the EU MDR will underpin the entire process, which will be based on collaborative methods, frugal innovation, sustainability, and accountability. It will centre on developing and validating a number of medical devices and following them through the regulatory pipeline in preparation for testing and marketing. The study will be carried out using the UBORA platform (http://ubora-biomedical.org) and will be supported by academic and industrial experts.

The successful candidate will be hosted at the Research Center “E. Piaggio” of the University of Pisa. The Center is dedicated to interdisciplinary research in the areas of bioengineering and robotics and possesses state of the art machining and fabrication facilities as well as competencies in biomedical device regulation, design, and testing. He/she will be supervised by Profs. De Maria and Ahluwalia both of whom have extensive experience in capacity building and open source biomedical device design. A background in engineering, science or informatics with an interest in global issues and sustainability are desirable.

Eligibility criteria

• Applicants must have a PhD degree at the time of the deadline for applications (11^th September 2024).
• Applicants who have successfully defended their doctoral thesis but who have not yet formally been awarded the doctoral degree will also be considered eligible to apply.
• At the call deadline, the applicant must have a maximum of 8 years experience in research, from the date of the award of their PhD degree. Years of experience outside research and career breaks will not count towards the above maximum, nor will years of experience in research in third countries, for nationals or long-term residents of EU Member States or Horizon Europe Associated Countries who wish to reintegrate to Europe.

Mobility Rule: The applicant may be of any nationality but must not have resided or carried out their main activity (work, studies, etc.) in Italy (for European Fellowships) or the host organisation for the outgoing phase (in case of Global Fellowship) for more than 12 months in the 3 years immediately before 11^th September 2024.

Application procedure

Expressions of interest must be sent by email to Carmelo De Maria or Arti Ahluwalia (carmelo.demaria@unipi.it;arti.ahlwalia@unipi.it no later than 25^th May 2024  and must consist of two pdf files:

1. Complete and updated CV, clearly demonstrating all 3 eligibility requirements.
2. Motivation letter, maximum one page.

Please include names and contacts of at least two referees.