NIHR launches MedTech campaign in response to new regulations
NIHR has launched their MedTech campaign of Bringing innovation to the NHS – designed in response to the EU regulations for medical devices (MDR) and in vitro diagnostic devices (IVDR).
The new regulations – which started being phased in from May 2017 - require companies to generate and publish more clinical data demonstrating the safety and performance of their product. In addition, cost pressures within the NHS have led to an increased requirement for health economic (cost saving) data before a product will be recommended for implementation.
The new campaign will use case studies from MedTech companies describing how NIHR services have helped them to develop their products for the NHS. These case studies will be showcased through a programme of marketing activities aimed at MedTech companies in the UK, Europe, United States and Asia. Further case studies will be added throughout the duration of the campaign which will run until March 2019.
Case studies featured in the MedTech hub online include:
- Healum. This company accessed the NIHR’s Study Support Service to help conduct clinical research in the NHS and generate evidence to demonstrate the efficacy of a digital solution that enables healthcare professionals to empower, support and motivate their patients to make healthier choices to tackle type 2 diabetes.
- Mologic Ltd. This company received NIHR support to develop a urine-based test for an early indication of exacerbation of COPD, simple enough for patients to monitor their disease status at home, enabling care in the community reducing A&E visits and admissions.
- MIRA rehab Ltd. The NIHR is currently supporting the GAME trial which is investigating MIRA; a digital approach to physiotherapy that turns exercises into video games, and could improve patient adherence, reduce the number of trips to the clinic for patients and reduce overall costs for the NHS.
Matt Cooper, Business Development and Marketing Director for the NIHR Clinical Research Network, explained the purpose of the campaign: “Previously clinical research was not a specific requirement for MedTech companies seeking a CE marking. But since 26 May 2017, when the EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR) came into being, companies are now having to think longer and harder about their evidence strategy. Generating robust clinical and health economic data is an essential part of bringing a product to market in the UK’s health service. It’s a competitive playing field and cost pressures in the NHS mean that the requirement for health economic data, in particular, is increasing.