CRDI/CÚRAM Partnership

CRDI's partnership with CURAM, the SFI Centre for Research in Medical Devices

Cinical research development Ireland is a funded partner in CÚRAM, the SFI Centre for Research in Medical Devices (http://www.curamdevices.ie). Dr Mark Watson (Head of Education and Development, CRDI) leads the project entitled ‘Developing Key Structures and Resources to Support Medical Device Clinical Research in Ireland’, working closely with Professor Matthew Griffin (Professor of Transplant Biology, NUI Galway) and Professor Martin O’Donnell (Professor of Translational Medicine at NUI Galway & Director of the HRB Clinical Research Facility Galway).

The project includes analyses of current regulatory pathways and forthcoming revisions of legislation for complex medical device clinical investigations/trials in Ireland and in selected comparator countries. A portal and database will be developed and maintained with information on clinicians/clinical researchers working in areas of interest to the medical devices sector.

There is also a role for CRDI in coordinating education and training for the centre postgraduates, working with CÚRAM Scientific Director Professor Abhay Pandit and his team. This will include provision of existing CRDI E-learning modules (see https://www.crdi.ie/resources/elearning/), identification of training resources available across the CÚRAM partners, and new E-learning development.

An important aspect of the project is the engagement with industry, regulators, academic researchers, clinicians and the clinical research infrastructure. This speaks to the strengths of CRDI in cross-institutional coordination, and the centralised competence will form a key resource for CÚRAM and Ireland’s medical device sector.

Dr Mark Watson commented, “This exciting collaboration with CÚRAM is multi-faceted and provides significant opportunities to advance medical device clinical research. There is great potential in synergies of the SFI Centre with HRB Clinical Research Coordination Ireland, incorporating Enterprise Ireland’s long-standing medical device industry liaison support function in CRDI, and our track record in education and training.”



Photo credit :
Biofunctional nanotube scaffold, courtesy of Dr Manus Biggs' laboratory

Visit the CÚRAM website at www.curamdevices.ie

e-Learning Initiative

The CRDI / CÚRAM Partnership developed a new e-Learning course ‘Fundamentals in Medical Device Design and Regulation’, designed to be highly interactive. It supports the acquisition of state of the art biomedical, regulatory and clinical research knowledge with much of its content produced in collaboration with national and international experts.

The course benefits from the input of national agencies including the Health Products Regulatory Authority and the National Standards Authority of Ireland as well as the involvement of key industry partners including pharmaceutical and medical device companies.

Fundamentals in Medical Device Design and Regulation comprises two modules, Principles of Medical Device Design and EU Regulation of Medical Devices. It has been developed to impart important industry, research and regulatory concepts relevant to the entire life cycle of medical device development.

The two video trailers below introduce the two modules.

Principles of Medical Device Design

EU Regulation of Medical Devices

The course is designed so that on completion participants appreciate the multi- and inter-disciplinary nature of the field, have good insight of the medical device industry in Ireland, and understand key concepts such as biocompatibility, as well as processes involving biomaterials and biomechanics in medical device design.

In addition, participants learn about the existing legislative framework for medical device regulation in the EU and how this applies to medical device research and development. Recent revisions to the EU medical device regulatory framework are covered along with a brief review as to how the key changes will affect medical device research and development going forward.