ABHI Leadership Further Strengthened with Boost to Diagnostics Expertise
ABHI is pleased to welcome Steve Lee to its leadership team. In the newly created role of Director, Diagnostics Regulation, Steve will lead ABHI's engagements on diagnostics regulations.
Recognised nationally, and internationally, as an authority on in-vitro diagnostics (IVD) regulations, Steve brings over 20 years of government experience from the MHRA, most recently in the role of Senior Regulatory Policy Advisor - IVDR.
His appointment is a significant boost to ABHI's diagnostics capabilities and reflects the decision by ABHI's Board to build and strengthen its diagnostics work and community. Two years ago, ABHI began using HealthTech as the descriptor for its industry, noting the blurring between medical technologies, digital devices and diagnostics. In the time since the Association has done much to establish its leadership of the sector.
A key lesson of the COVID-19 pandemic is that the health system must place diagnosis at its core. Government and the NHS recognise and understand this. ABHI's report on the role of diagnostics in modern healthcare delivery led to the creation of the Diagnostics Alliance, and the Health Technology Partnership, led jointly by Ministers and ABHI, has been tasked to consider a strategy to invest in “resilient, scalable and holistic” diagnostics capability for our country.
Steve will work closely with Nishan Sunthares, ABHI's Chief Operating Officer, and Eleanor Charsley, ABHI's Associate Director, External Affairs, to deliver leadership on this agenda, and build a community of members with specialism in diagnosis as part of the wider HealthTech sector. IVD regulation is at a critical juncture, and Steve will provide expert support and guidance to the Association’s long-standing and newly joined diagnostics companies.
A biomedical scientist by background, Steve worked within both the NHS and industry prior to joining MHRA in 1996. Commenting on his appointment, Steve said: "I am delighted to be joining the ABHI team at what is an important, but also incredibly exciting time for the diagnostics sector. The pandemic has demonstrated the MHRA's effective use of regulatory flexibility to enable access to diagnostics, and there is much we can take from this experience as we look at future regulatory frameworks within the UK. I look forward to working with ABHI members to ensure their voice is heard and represented."