I attended a small SVB-sponsored seminar today with the chair of the Medical Technologies Advisory Committee (“MTAC”) of NICE. I think I was the only VC invited (or that bothered to show up) and there was a captive audience of small device companies. The slides are available here and below.
Any device with a new procedure MUST go through the Interventional Procedures committee before a NICE technology appraisal can occur. An IP review can take 6 months. Devices should be CE marked at time of review. New procedures can be submitted by hospitals, clinicians, or manufacturers. Seldom are procedures denied (only about 2 in 350 cases), but often times procedures without strong evidence will be given special arrangements. Such arrangements take the form of governance (telling the hospital), consent (telling the patient), or research (reviewing the outcomes). Evidence considered by the Interventional Procedures committee includes published studies, questionnaires completed by medical advisors, questionnaires completed by patient commentators, committee members’ knowledge, and public consultation.
Technology appraisals by MTAC occur after the procedure has cleared the Interventional Procedures committee. These are confidential reviews of the evidence and economic models presented by the manufacturer. MTAC carefully studies patient outcomes or experience, use of resources (facilities, staff, tests), cost, and sustainability. Manufacturers can continue to market product during this period. If a resolution is put in place, the device is not “mandatory” in the UK, but it is economically advantaged. If a technology is not accepted, then the manufacturer will receive a letter with reasons why and advice. The goal of MTAC is to boost adoption of novel and useful technologies.
I was most surprised to learn that the UK Trade and Investment office is available to offer FREE assistance with navigating all of these processes. While these processes seem complicated, difficult to manage, and highly ambiguous, there is actually outstanding support available, even for US-based medtech companies.