Duncan Keeble

Biography

 Duncan has worked in the medical device industry for over 19 years, primarily leading the design and development of implantable medical devices. He is now an independent consultant, providing expertise to organisations mostly in the areas of medical device design, design control and quality systems. Working in start-up and small companies and in close partnership with multinational corporations, he has gained a deep understanding of medical devices quality system requirements, particularly with regard to design control and supply chain for the EU, US and Japanese markets. For Lombard Medical, Duncan led the development of three generations of their flagship Abdominal Aortic Stent graft, ultimately gaining full PMA approval for the product in 2012. During this time, he implemented robust design control and risk management systems compliant with EU and FDA requirements. In this role, Duncan also adapted methods of working to scale-up from a five-person start-up to 100+ person manufacturing and sales organisation. At Lombard Medical, Duncan was also responsible for all product development and design control throughout the company’s development of a revolutionary endovascular stapling device, and was responsible for the achievement of CE marks for three generations of an AAA stent-graft device over just 5 years. Duncan is also an inventor on 9 patent families in the areas of surgical implants, endovascular delivery systems and test machines.  

Research Interest

 Business and Management