Mike Newton - Engineering Consultant
Mike has more than twenty years’ experience of designing, developing, and industrialising medical and pharmaceutical devices, specialising in dry powder inhalers but also with expertise in smart nebulisers and electrosurgical tools.
He has extensive experience in setting up and operating design, development and documentation practices that conform to the requirements of ISO 13485 and 21.CFR.820.30, and has first-hand experience in successful Notified Body audits and FDA Pre-Approval Inspections of Medical Devices and Combination Products.
Before working with Coalesce, Mike spent 14 years at Vectura, helping to develop the device team in Cambridge from the starting five to the 20+ team it is today. During that time, he contributed to the designs of the GyroHaler® and Lever-Operated inhaler and was deeply involved in the development of the blister strip manufacturing systems. He was responsible for establishing device manufacturing systems at both pilot-scale and, in partnership with a licensee, multi-million unit industrial scale. This experience covers assembly systems for both mechanical and electro-mechanical devices.
Prior to joining Vectura, Mike worked at Cambridge Consultants, working on diverse projects such as active dry powder inhalers, dialysis monitors, RJ45 connectors, and the feasibility of hand-powered needle-free injectors. Before that, Mike worked at Strix developing kettle elements and controls, Mars Electronics developing coin acceptors and IBM designing colour monitors.
Mike has a B.Sc. in Mechanical Engineering from Imperial College, London and is a Fellow of the Institute of Mechanical Engineers.
Mike enjoys cycling, running and dinghy sailing.