Clinical Research Development Ireland (CRDI) is a funded partner in CÚRAM, SFI Research Centre for Medical Devices. CÚRAM’s researchers focus on designing and manufacturing ‘smart’ medical devices to improve health outcomes and quality of life for those with chronic illness.
The CRDI / CÚRAM partnership drives the project ‘Developing Key Structures and Resources to Support Medical Device Clinical Research in Ireland’.
Objectives and approach
The project focuses on the development of methods and media to support excellence in medical device research in Ireland to include raising awareness of the potential of regulation to impact the successful translation of medical device research. Work focuses on capturing clinical medical device development experience and the provision of CRDI medical device based e-Learning education and training resources for CÚRAM researchers with a view to promoting the incorporation of ‘principles of best practice’ from the earliest stages of the medical device research development process. It also comprises the development and maintenance of a knowledge portal (MedTechTranslate) to provide regulatory information and clinical expertise resources to support medical device innovation and translation at all stages of the device development process. This approach will significantly contribute to the rapid progression of clinical research to market.
Dr Mark Watson (Head of Education and Development, CRDI) leads the project working closely with Dr Anne-Marie Miller (Project Manager, CRDI) and in collaboration 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).
CRDI medical device e-Learning assets are integrated into the CÚRAM Education and Training programme by the CÚRAM Education and Training Steering Committee comprising representation from CRDI as well as medical device researchers from academia and industry, clinician scientists, teaching and learning leads, and clinical trials methodology experts.
The core objectives of the CRDI / CÚRAM partnership project as well as the development and delivery of its initiatives are strongly underpinned by the support and input from industry, regulatory and clinical trials experts: Aerogen Ltd, the National Standards Authority of Ireland, the Health Products Regulatory Authority and HRB Clinical Research Coordination Ireland in particular.
Medical Device Regulation
Regulation functions to provide stability in the market place by ensuring delivery of safe, high quality devices for clinical use across the EU. By increasing sector awareness of the EU regulatory framework and by promoting its incorporation from the earliest stages of R&D through to manufacture and post-market processes we can drive innovation and enable sector expansion by means of more rapid transfer of safe, high performing and effective medical devices from concept to clinic.
The new Medical Device and In Vitro Diagnostic Device Regulations (here and here) were introduced in 2017 to ensure harmonised application and heightened control of medical device regulatory legislation throughout the EU. The new regulatory framework aims to ensure that medical devices are safe and effective whilst allowing for best practice-based innovation and competitiveness in the medical device sector.
Click images below to download documents
The Regulations involve; a broadening of the scope and definitions to include non-medical device products with a similar risk profile to medical devices; a clarification of the roles and responsibilities of economic operators in the supply and distribution chain of medical devices; a definition of equivalence is also introduced and clinical data requirements are to become more stringent impacting on clinical evaluations, clinical investigations, post market surveillance and vigilance processes; furthermore the Regulations also outline new criteria for the designation and oversight of notified bodies and importantly, will enhance transparency and traceability in the sector by strengthening reporting requirements throughout the medical device life cycle and through the introduction of the Unique Device Identification (UDI) system.
Potential for impact
The Regulations mean greater accountability on the part of device innovators and have the potential to significantly impact on levels of medical device clinical research and commercialisation activity. The CRDI / CÚRAM partnership aims to heighten sector awareness of these legislative provisions and support the optimal delivery of education, training and information in this area.
Project Priority Area 1: Education and Training
A core objective of the CRDI / CÚRAM partnership project is the development of key information and training tools to support excellence in medical device research in Ireland. The development of project deliverables is informed and supported by medical device researchers from academia and industry, clinician scientists, regulatory specialists, teaching and learning leads, and clinical trials methodology experts. (Hover over below images for furter info)
Introduces the EU Medical Devices Regulatory Framework, describes CE marking and conformance assessment processes, their requirements and the obligations placed on the manufacturer in this regard. This knowledge is designed to support device design and development, and facilitate further study or training in the area of EU medical device regulation.
Introduces the learner to the fundamentals of medical device design, delivering key concepts such as biocompatibility and processes involving biomaterials and biomechanics. It also discusses the multi- and inter-disciplinary nature of the field and describes the medical device industry in Ireland.
Fundamentals in Medical Device Design and Regulation (FMDDR) is an increasingly popular bespoke online course which utilises a multimedia approach to content delivery using filmed presenters, dynamic graphics, case studies, interviews, downloadable resources and quizzes. FMDDR blends elements of ‘Principles in Medical Device Design’ and ‘EU Regulation of Medical Devices’ modules and content development and delivery is supported through workshops by industry and regulatory experts. FMDDR is ECTS accredited for post-graduate students through NUIG and is also designed to support CPD.
2017 – 23 EOIs
2018 -23 EOIs
FMDDR 100% Good - Excellent - Satisfaction Rating 2017 - 2018
FMDDR 90% respondents agree it contributed to their knowledge and understanding of the topic
FMDDR Workshop – Class of 2018. Mr. Colm O’Rourke (standing), Business Development Officer, Medical Devices Division, NSAI delivering important regulatory concepts from the perspective of the Notified Body
Project Priority Area 2: MedTech Research Translation Support
‘Enabling translation of Innovative MedTech Research’
MedTechTranslate is an online resource which will serve to centralise expertise to support medical device research translation. In particular it will provide guidance and information to its members on key concepts, including the regulatory, quality and clinical data requirements, associated with bringing a medical device to market.
Download the MedTechTranslate flyer by clicking the image on the right
Translation Navigation and Guidance
Clinical Expertise Support
MedTech research translation support will be facilitated via an online portal which will provide information on pathways to EU regulatory approval for medical devices and map EU regulatory requirements to key stages of a medical device product’s life cycle. The portal will also sign-post device innovators towards relevant practice and expertise information and will serve as a conduit to increased linkage between device-based industry representatives, academics, clinicians and clinician-researchers.
MedTechTranslate resources can be accessed in two formats. The first allows users to bring together content thematically or by topic, with the second allowing for content to be phase, or stage-tailored, to reflect the developers journey from project initiation through to launch.
MedTechTranslate is also designed to support access to a clinical expertise registry where members can request clinical input, advice or support from MedTechTranslate members with a medical background and expressed interest in, or experience of, supporting medical device development from concept to clinic.
Stakeholder Review Committee
A MedTechTranslate stakeholder review committee comprising many of the project’s major contributors has been established to assess the functionality of; validate the content and message of; and identify areas for expansion and development within the MedTechTranslate portal. It is the intention that this iterative review process will serve to bring together the clinical, regulatory, academic and industry perspectives central to MedTechTranslate’s primary purpose and enhance the impact and message of this important resource.