Martin Cooke

Responsible for ANGLE operations including manufacturing, supply chain, logistics and engineering product development of the Parsortix® cell separation products. Responsible for the implementation of ANGLE’s quality systems and the engagement with global medical device regulators and other regulatory agencies and notified bodies. Led the team that secured the first ever US FDA product clearance (De Novo Class II classification DEN200062) of the Parsortix® PC1 Clinical Device to harvest cancer cells from metastatic breast cancer patient blood samples for downstream analysis. The work included two formal pre-submissions with FDA, the submission of over 400 technical reports and regulatory documents, performance study design leading the processing of over 16,000 analytical and clinical samples, together with extensive dialogue with FDA reviewers. Creation of a Technical File and CE-IVDD marking of the Parsortix system for use in UK/Europe and the development of an IVDR Transition Plan. Set up ANGLE’s ISO13485 Quality Management System (MD616151) in 2014 and held overall responsibility through to 2024, including transition to ISO13485:2016 and alignment with 21CFR820. Management Representative ensuring QMS remains aligned with business objectives. Established product engineering function and supply chains required to produce and support ANGLE’s equipment and consumables and deliver them to international markets. Development of long-standing relationships with key suppliers including contract medical device manufacturers. Managed internal and external product design resources. Subject Matter Expert for New Product Development. Led product safety certification activities and acceptance of test reports. Set up ANGLE’s Regulatory team managing technical files, international product registrations, post market surveillance and marketing reviews. Devised product regulatory strategies. Acted as PRRC (IVDR 2017/746, Article 15) for the Company.

Responsible for ANGLE's UK management services and consulting operations. This included marketing and business development (c£10M won contract values), client acquisition, project/programme delivery and income and key client relationship management. Specialised in the strategic development, design and implementation of innovation and knowledge transfer centred business support programmes with emphasis on high growth, technology based enterprises and academic engagements and collaborations.

Product Manager responsibility for revenue stream of a core, global product line executed via the management of existing product marketing and customer support projects combined with new product strategy, market entry and technical development projects. As Project Manager, full technical development life cycle experience acquired managing a number of complex hi-tech product development projects (c$3M budget) using globally based multidisciplinary teams (up to 50 people), covering systems hardware and software, mechanical engineering and manufacturing processes. As Senior Design Engineer, responsible for the conceptualisation, design and delivery of electronic systems in support of new products, including transition to manufacturing phase. Provided technical leadership and managed teams of engineers to deliver objectives.

Responsible (hands-on) for the timely delivery of high accuracy electronic designs for new instrumentation products. Involved from initial product concept through to stable manufacture. Design authority for intrinsically safe instrumentation products.

In-depth technical contribution to engineering projects as part of post design support activities for a highly resilient data network product supplied to the Royal Navy.