Nigel McLean

Background

About Nigel McLean

A highly experienced hands-on and results driven enabler with a successful track record of product/project/program/portfolio and innovation management, business development, technology transfer, and contract negotiation in UK, EU & USA. Adopting a customer centric approach, I lead teams to develop and bring award winning products to market that are positioned to meet user demands, and regulatory requirements, in order to maximize market penetration and profit- PRODUCT MANAGEMENT: developed product strategy, go-to-market plan and promotional material for an in vitro diagnostic for bladder bladder cancer, plus two medical devices; coordinated production of a kit containing reagents and biomarkers for use in clinical pathology laboratories for an IVD; implemented a TeleMedicine service with the Technology Integration team at Kaiser Permanente- PROJECT / PROGRAM MANAGEMENT; coordinated manufacture (UK & EU suppliers) and service provision for an in vitro diagnostic product; coordinated CE marking of four IVD tests and launch of one- BUSINESS DEVELOPMENT; developed business cases and implement commercialisation strategies through forming mutually beneficial collaborations, licensing, grants, and company formation, in the fields of diagnostics, software, biotech and medtech products; negotiated collaborations with biotech, medtech and pharma- CLINICAL TRIAL MANAGEMENT: Principle Investigator for the USA Center for Medicaid and Medicare Services sponsored clinical trial within Kaiser Permanente; initiated a health economic, clinical evaluation and clinical utility strategy for an IVD in EU and USA; configured cloud based eCRF for NHS sponsored clinical trial. Previous experience: • Board Member of Kaiser Permanente MidAtlantic Medical Group Innovation Institute; improving healthcare efficiency, best practice and quality through innovation • Reviewer for Maryland Biotechnology Centre - Commercialization and Translational Research Awards • Certified in Epic Care Ambulatory Electronic Medicine Records - responsible for coordinating with clinical leads throughout Kaiser Permanente the management of consultations and referrals. • Observer on Board of Directors of an orthopaedic spin-out • Member of The Alternative Board • Genesis Innovation Technology Award 2011 winner. • Winner of the Scottish Enterprise Life-Science Award for best innovation emanating from NHS Scotland in 2010 and 2012.