JRO expertise helps shape new national template for implantable device research

Staff from the UCLH/UCL Joint Research Office (JRO) have contributed to a high-profile publication that defines a new national approach to complex medical device research.

The JRO Clinical Operations team acted as the Sponsor’s operational and regulatory lead, coordinating the approvals, ethics and governance needed to deliver the UK’s first paediatric trial using adaptive deep brain stimulation technology. Their work reflects the JRO’s subject matter expertise in navigating complex regulatory frameworks and ensuring safe, ethical delivery of innovative research.

The paper, published in Nature Reviews Bioengineering, outlines a template for conducting research into class III active implantable medical devices in the UK. These are the highest-risk category of medical devices and include advanced technologies such as deep brain stimulators, cardiac devices and neurotechnology.

The publication draws on the Children’s Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET) - a UCL-sponsored, first-in-human study led at Great Ormond Street Hospital (GOSH). The CADET trial explores the use of adaptive deep brain stimulation to treat Lennox–Gastaut syndrome, a rare and treatment-resistant form of childhood epilepsy.

The collaboration brings together clinicians, engineers, industry partners, patients and parents alongside regulatory specialists from the Medicines and Healthcare products Regulatory Agency (MHRA). It demonstrates how multi-stakeholder partnerships can reduce barriers to innovation, improve regulatory understanding and accelerate access to safe and effective implantable technologies for patients.

Read the full publication: A template for class III active implantable device research in the UK