Mike Newton

Experience

• 

  Mars Electronics

  Apr 1986 - Dec 1992

  Principal Engineer

  Design engineer working on development of Cashflow range of coin acceptors. Led development of coin handling system for London Underground.

• 

  Strix Ltd

  Jan 1993 - Sept 1994

  Project Manager

  Led the development of novel stainless steel kettle element, including de-bugging of existing manufacturing line.

• 

  Cambridge Consultants

  Sept 1994 - Feb 2002

  Consultant

  Worked on various in-house and client projects including active dry powder inhaler technology, initial concepts for the NEXThaler®, 120 dose pre-metered dry powder inhaler, arthroscopic electro-surgical instrument, network connector, dialysis monitor.

• 

  Vectura Group plc.

  Feb 2002 - Oct 2016

  Responsible for oversight of dry powder inhaler development projects (Lever-Operated inhaler, GyroHaler®, Aspirair, single unit dose inhaler), including device design, verification, development of powder filling processes and establishment of pilot-scale manufacturing facilities.Achieved ISO13485 and Medical Devices Directive compliance for the design policy. Supported major US licensee (with no previous device experience) in establishing multi-million unit DPI manufacturing capability (component manufacture through to finished device). Show less

  • Director- Device Industrialisation

    May 2014 - Oct 2016

  • Director - Device Engineering

    Feb 2002 - May 2014
• 

  Principia Technica Ltd

  Oct 2016 - now

  Director

  I offer consulting support for medical and pharmaceutical device development and industrialisation. I have 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 have first-hand experience in successful Notified Body audits and FDA Pre-Approval Inspections of Medical Devices and Combination Products. I have successfully transferred both low and high volume products to production.Recent projects:Cambridge-based design company: supported an inhaler development to establish design robustness and carry out design transfer.West Country-based design consultancy: carried out extensive design controls update.Cambridge-based parenteral drug delivery device company: carried out technical review of developing prototype concept; carried out review of and recommendations to improve design controls system.I offer support in three main areas:Design controls: Regulatory-compliant design policies Effective specification development Procedures for- -Design planning -Risk management -Design reviews -Design transfer -Design history fileDevelopment project support: Independent expert in design reviews Risk management Identification and control of critical features and quality attributes (CQA) Quality by Design (QbD) techniques Control of CQAs into manufacture Documentation preparationIndustrialisation: Manufacturing strategy development Manufacturing partner selection and set-up Tooling and assembly line project management pilot scale and high volume Tool and moulding process validation techniques Show less