Home » Future of Healthcare » Streamlining medtech clinical trial development with end-to-end support

Professor Fidelma Dunne

Director of the Institute for Clinical Trials, University of Galway

John Kilmartin

Medtech Regulatory Consultant, Adjunct Professor at University of Galway

Ireland excels in medical innovation, hosting top medtech and pharma firms. However, innovators face hurdles hindering full potential realisation.

According to Professor Fidelma Dunne, smaller companies may not have the experience or know where to obtain the support and expertise to get a great idea to the clinical trial stage.

The Institute of Clinical Trials was established at the University of Galway to ensure that Irish innovation in the medtech and pharma sector remains a world leader.

Comprehensive clinical trial support

Dunne, the Institute’s director, says the Institute offers end-to-end support in conducting clinical trials in processes such as addressing regulatory hurdles, appropriate trial design and protocol development, supplementary development of supporting systematic reviews, core outcome sets and use of patient-reported outcomes, health economic analysis and communicating findings to ensure patient impacts.

“The Institute is poised to take people along a continuum of clinical research from the very beginning when thinking about a trial and putting a trial design together, through to delivering the final report to stakeholders,” she adds. “We also pledge to ensure that clinical trial results have a meaningful output to health services and patients.”

Ireland has the highest per capita
employment of medtech professionals
in Europe, so we punch above our weight.

Mr John Kilmartin

Five pillars of clinical trial design

Institute activities are designed around five pillars: developing partnerships with stakeholders, creating an Accelerator Hub with experts to make the delivery of the clinical trial process simpler; looking at trial designs and additional activities researchers may not have thought about; education and training; translating results into policy guidelines and impact to healthcare.

“Having people to help with writing as well as navigating through the documentation will relieve pressure for those inexperienced in such areas but who nonetheless might have a great device or idea,” adds Dunne.

She says it is crucial to capture good ideas and avoid them being developed elsewhere, as failure to do so would mean: “Irish patients, the Irish economy and the Irish health system are losing out.”

Success for Ireland’s medtech sector

Independent medtech regulatory expert Mr John Kilmartin, Adjunct Professor at the University, says Ireland’s medtech sector is a fantastic success story with a mix of multinationals, SMEs and innovators.

“With about 450 companies,” he continues, “Ireland has the highest per capita employment of medtech professionals in Europe, so we punch above our weight. “However, there is still an opportunity for more clinical research to be conducted. At the Institute, we have all the ingredients — clinicians, SMEs multinationals, academic infrastructure — and can provide a fantastic coordination role.”

Kilmartin says the Institute can also play a strategic role in dealing with regulators, ethics committees and sponsors, as well as in tactical execution and implementation of trials.

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