ID266 Deliver Medical Device Clinical Investigations

The Idea

Keele University should invest in enabling ourselves to sponsor Medical Device Clinical Investigations alongside our existing clinical trial activity. More companies and researchers are developing medical devices and Software as a Medical Device (SaMD), creating opportunities for Keele to support testing of their effectiveness and approval. By sponsoring these types of investigations, the University could attract more research funding, industry partnerships and innovative healthcare projects. 
The Health and Social Care Research (HSCR) Quality Management System (QMS) and Keele Clinical Trials Unit (CTU) already possess strong foundations in trial management, quality assurance, and regulatory compliance. By adapting and expanding existing processes to meet the requirements of medical device research the University, supported by Keele CTU, could establish a sustainable and nationally competitive capability in this growing area. 

This development would involve including the additional requirements of the Medical Device regulations to our QMSs, developing device-specific procedures and templates, training staff, and building expertise in device investigation management and regulatory compliance. 

The proposal aligns with Keele's ambitions for research excellence, innovation and real-world impact. It would enable the University to diversify its research portfolio, generate new income streams, strengthen partnerships with the health technology sector and support the evaluation of technologies that improve patient care and healthcare delivery.

Why This Idea Should Be Considered

Medical technologies are becoming increasingly important in addressing healthcare challenges, creating growing demand for organisations that can support high-quality clinical investigations. Keele has a well-established, UK CTU Network registered CTU, with expertise in quality management and trial delivery. Building capability in medical device investigations would leverage these strengths while creating opportunities for growth, commercial partnerships and external funding. Over the past few months, the CTU has received 7 collaboration requests for the delivery of device trials. These have come from a mixture of industry, NHS and academic partners. If these studies could be adopted, this would broaden the University's research offering, enhance its reputation for innovation and translational research, and position Keele as a partner of choice for NHS organisations, academic investigators and medical technology companies. 

How We Would Implement This Idea

Implementation could begin with a gap analysis of the University’s current capability to deliver medical device clinical investigations. This would identify changes needed to policies, standard operating procedures, templates and oversight processes. The CTU could then develop specific QMS processes with associated documentation, provide targeted staff training and establish expertise in device regulations and investigation management. Existing quality and governance structures could be adapted rather than rebuilt, making this a cost-effective and achievable enhancement to current CTU operations.

What Success Would Look Like

Success would see Keele University and Keele's CTU recognised as a trusted provider of support for both medicinal product trials and medical device clinical investigations. The University would have a fully implemented and operational QMS supporting device studies, a trained workforce, and a portfolio of device investigations. This will enable the attraction of new research funding and commercial collaborations, increase our contribution to healthcare innovation and strengthen our national reputation for clinical research excellence. Ultimately, success would be demonstrated through sustainable growth in activity, income generation and measurable impact on patient care and healthcare outcomes.