Duncan Keeble Email & Phone Number

Abingdon, England, Gb

OxDevice provide a wide range of services to assist in the development of medical devices, low-volume manufacturing and associated testing. Founded by myself and Praveen Sagar, each with 20+ years of experience working in small, start-up and multinational companies, OxDevice can help take your product to the next level.The company's facilities include laboratory space and a class-7 cleanroom. Engineers and technicians are available to help with concept development, detailed design, risk analysis, verification and validation testing, process development, medical electronics consulting and more.Accelerate your product development with OxDevice, your UK medical device partner.Some of the services and expertise that we can offer are listed below:• Medical Device Development• Endovascular and neurovascular device experts• Medical sensor development• Clean-room manufacturing• Medical electronics• Start-up and university spin-out specialists• Testing services• Medical device coating services

Started Stockcross Consulting Ltd in 2014 to provide expertise to organisations primarily in the areas of medical device design, design control, and quality systems. Examples of projects undertaken so far are:•A project, working with a UK-based manufacturer of medical devices to improve their design control and risk management procedures. Initially, the company’s systems for design control and risk management were reviewed against the requirements of international standards and regulations. Once the review was completed, a revised design control procedure was written, compliant with the requirements of ISO 13485, EU Medical Devices Directive (93/42/EEC) and US FDA quality system regulation, 21 CFR 820.•Working with a UK-based manufacturer of specialist textile solutions for the medical devices industry, the aim of the project was to work with their US partner to improve the product release and testing criteria for textile products for the US market. Test methods were developed for batch release to ensure that products for export to the US continue to meet the product requirements. •With the same company, help was also provided to prepare for their first FDA audit, including participation in the entire 4 day inspection. No non-conformities were identified by the investigator•Working with an EU manufacturer of tissue adhesive. Initially, risk management procedures and activities were reviewed. New procedures were written suited to the needs of the organisation. Failure mode and effect analyses (FMEAs) were then facilitated for the organisation after implementation of these procedures.•A contract to provide assistance to the Design Assurance department of a multinational contract manufacturing organisation. Working on a project for a high volume injection-moulded drug delivery product assisting with design and process FMEAs, design verification reviews, process validation (including Validation Master Plan – VMP) and quality planning.

Oxford, Gb

Oxford Endovascular Limited is a spin out from The University of Oxford. The Company is developing metallic mesh tube devices invented by engineers and clinicians at the university to treat patients suffering from brain aneurysms. OE has raised significant capital from investment company Oxford Sciences Innovation PLC, the University of Oxford Innovation Fund and private investors from China.My role is to take the fascinating invention and, with the help of an excellent team internally and externally, develop the product into a safe, reliable, cost-effective medical device.

Didcot, Oxfordshire, Gb

Joined this highly innovative start-up company in 1999 to lead the development of their flagship product, Aorfix™, an endovascular graft and delivery system. Subsequently delivered three generations of the device through regulatory approval and commercialisation. Implemented comprehensive design control systems creating a design history file suitable for gaining approval from regulatory authorities in EU, US and Japan. A fourth generation product, developed in conjunction with a large external manufacturing partner, is now entering the design verification and validation stage.Director of Product Development (Feb 2010 – Dec 2013)Responsible for all product development and design control. Selected and managed a large multinational partner for product design and manufacturing in conjunction with internal team leading to >$1M tooling investment. Re-validated Aorfix product for FDA submission and achieved PMA approval in Feb 2013.• Managed external manufacturing partner to develop fourth generation Aorfix delivery system• Assembled and managed internal and external cross-functional product development team• Fully implemented Good Laboratory Practice for verification and validation testing• Upgraded design control documentation for full compliance with US FDA requirements• Participated in FDA inspection with no 483s and positive commendations for design control systems and design history file• Successfully gained US FDA PMA approval for the Aorfix product

Didcot, Oxfordshire, Gb

Selected to take on responsibility for Quality during a period of downsizing and restructuring to reduce notified-body non-conformities to zero.• Lead the restructure of the quality management system to comply with US FDA regulations • Management Representative to both the European notified body and US FDA• Managed elements of modular Pre-Market Approval (PMA) application process for complex class 3 productMedical Devices, Quality Systems, ISO 13485, 21CFR820, Product Design & Development, Cardiovascular, Endovascular, Abdominal Aortic Aneurysm (AAA)

Developed revolutionary endovascular stapling device, subsequently licensed by blue chip organisations, working with external European manufacturing partner.• Managed intellectual property portfolio to maximise value• Managed rigorous product integration process with blue chip partner.• Set-up International Clinical Advisory Board and developed strong relationships with clinicians.• Led first-in-man trials, providing training and gaining feedback direct from users• Maintained strong cross-functional links throughout the company and with external partners.Medical Devices, Product Design & Development, Cardiovascular, Endovascular, Abdominal Aortic Aneurysm (AAA)

Didcot, Oxfordshire, Gb

Joined as fifth employee in this very early stage start-up business. Designed and implemented design control and risk management processes. Experienced rapid growth after early funding; recruiting and building a product development team. Achieved CE mark of first generation stent-graft product in 2001 in less than 2 years and for two more generations by 2006.• Formed and led the team (13 people) which developed three generations of endovascular AAA stent-graft system from concept to CE mark and US IDE.• Implemented robust design control systems to encourage cross-functional working and minimise regulatory delays.• Adapted methods of working to embrace the challenges involved with changing from a five- person startup to a 100-person manufacturing and sales organisation.• Developed strong relationship with EU notified body reviewers to expedite European device approvals.• Organised and participated in GLP pre-clinical trials in US labs.

Responsible for all new product development work including development of spinal implants and instruments. Developed new project documentation system for CE marking requirements.Orthopaedics, spinal implants, knee implants, ligament repair, obstetrics

Development of new spinal implant system including all testing and design transfer of the new device.Selected and introduced new 3D solid modelling CAD system.

Re-design of high volume injection moulded product resulting in 100% increase in sales and 50% cost saving.Designed new range of surgical instruments and implants for arthroscopic knee surgery.Increased productivity of high volume assembly line by 15%

Project managed large numbers of critical design changes to control system of Sizewell B Power Station and designed & implemented a database system for control of engineering changes.

Managed small pipeline projects for the oil & gas industry and performed materials testing including tensile, corrosion, hardness & impact tests. I also learned important customer-facing skills working in the sales department and worked hands-on in the Operations department.