PMD34 RAPID Medtech Innovation Briefings for COVID-19

Objective: MedTech innovation briefings (MIBs) are advice produced by the National Institute for Health and Care Excellence (NICE) During the COVID-19 pandemic, NHS England requested advice on devices that were relevant to COVID-19 NICE adapted the MIB process to produce advice for NHS England more quickly This study reviews how the MIB process was adapted to produce rapid MIBs for COVID-19 related medical devices Methods: Retrospective analysis of the time taken to publish rapid MIBs compared to the standard timeline and process for MIB development Results: Rapid MIBs took 4 to 13 days to complete, standard MIB development takes approximately 78 days The first rapid MIB draft took 2 to 3 days to write compared with 19 days for standard MIBs Five topic experts were recruited to comment on rapid MIB drafts, exceeding the minimum of 3 required for a standard MIB Experts and companies have 8 days to review the standard MIB;the experts and companies involved in the rapid MIB had between 1 and 3 days Two of the three rapid MIBs were only reviewed once by the experts and companies, standard MIB process includes two separate review periods Two of the rapid MIBs did not have evidence searches conducted by NICE’s information services team and were not reviewed by the MHRA as the information was already available to NICE Conclusion: Two of the devices had previously been reviewed by NICE during the digital guidance pilot, this is likely to have impacted the findings and may limit the generalisability of the comparison with the standard MIB timeline Key challenges identified included the limited amount of published evidence and short review periods for experts and companies Despite the limitations, NICE’s development of rapid MIBs demonstrates how NICE can adapt their processes to meet the needs of the NHS