After exiting J&J MedTech, I founded Archetype. An innovation management consultancy with unparalleled expertise in obtaining market approval for medical devices. Combining an end-to-end view of the MedTech innovation process with the hard skills needed to understand problems and communicate solutions in a clear, actionable way.I have spent my career on the front lines of a revolutionary shift in healthcare innovation and weathered massive regulatory shake-ups as the notified bodies try to keep pace. I recognise the challenge MedTech entrepreneurs, innovators and visionaries are facing, and I embrace the magnitude of the risk. I created Archetype with the core focus of market approval because I believe that is the only way to innovate cutting-edge MedTech products in an industry where there is no blueprint for success. As Principal Consultant, I lead a global network of battle-hardened and trouble-tested consultants who have surmounted every obstacle the MedTech world could dream up. Above all else, we consider it our duty to ask the tough questions about how each decision in the design innovation process will impact our client’s chances of market approval. All of our consultants are pioneers and seasoned experts in their specialist area. We can point to success in the most innovative and ground-breaking sectors of MedTech. Most importantly, we find it profoundly meaningful to us to deploy our collective knowledge in the service of MedTech innovation because we are fully aware of the benefits a well-designed product can offer the world once it reaches the market.

The new EU Medical Device Regulation created a state of upheaval in the sector, with all of the estimated 500,000 MedTech products currently on the market in Europe needing to be reapproved by May 2028. With the deadline distant but looming, DePuy Joint Reconstruction launched a significant and complex programme of work.I was recruited to lead the Joint Reconstruction MDR programme, managing a sizable staff and budget. With 20-years experience in MedTech product development, I had a reputation for quickly getting to the heart of even the thorniest problems, then organising and motivating a team to find a solution. My expansive network of industry specialists was also an invaluable asset. With every MedTech company in the world fighting for the same talent to manage their own MDR process, the inability to rapidly hire, onboard, and train the right staff was the single biggest risk to the DePuy programme’s success.My only measure of success was delivering market approval by the deadline. I was tasked with winning market reapproval for the most commercially critical devices in the portfolio. Budget adherence and potential loss of revenue were of course factors to consider, but the focus was always on the end goal: market approval must be achieved.The outcome? The Joint Reconstruction MDR Programme received MDR certification from BSI in 2021. Furthermore, MDR is now the new normal and fully embedded within the organisation. The scramble to recertify all legacy devices is over, but the legacy of my work can be seen in every NPD project. They are now MDR-ready from conception to ensure a smooth EU market approval process.With reapproval achieved, J&J MedTech can continue providing their ground-breaking medical devices to improve the lives of patients within the EU while retaining worldwide sales that fund ongoing cutting-edge NPD efforts.

Senior leadership at Johnson & Johnson MedTech needed to conduct a detailed assessment of their entire new product development (NPD) portfolio to ensure strategies and budgets were appropriate and aligned across business units.When they started the assessment, they discovered that the unique NPD processes in use at each business unit (as a natural consequence of multiple mergers, acquisitions, and organic growth) made it nearly impossible to get a clear, franchise-level view of what was happening. A deadline was set to harmonise NPD processes across 7 business units within 12 months. With extensive experience and knowledge of NPD processes and product innovation theories, I was recruited to lead the initiative. I was tasked with writing new, universal processes, getting buy-in from business-unit leaders, and implementing the new processes and training stakeholders within each business unit. A daunting project with the potential for immense benefits, including streamlined portfolio management and consistent, efficient working practices.The results were excellent. The new NPD and stage-gate processes I designed helped senior leadership efficiently evaluate the risks and benefits of each innovative MedTech product in development and ensured that the necessary resources were available for the products that most aligned with the company’s overall strategy.

The ASPAC Innovation Centre was set up by Johnson & Johnson MedTech with a mission to design and develop medical devices tailored to the Asian market. Having supported the ASPAC team as a Staff Engineer for 6-months prior, I was the obvious choice to put boots on the ground and establish the Joint Reconstruction unit within the centre. The task was to establish a viable R&D centre in China for Joint Reconstruction within 5 years. With an audit by BSI scheduled and a requirement to demonstrate to them that we had a well-equipped R&D facility, trained personnel, and established procedures, the clock was ticking. Within 6-months I had taken all steps to secure our certification for designing and developing Class I, II, and III medical devices. Recruitment proved to be the most significant challenge. MedTech was a nascent industry in Mainland China and direct experience was impossible to find. I had to think out-of-the-box and expand the search to industries with complementary skills, recruiting from companies such as Stanley, Black and Decker, Sulzer and Ryobi. As an expert in design control, the fun started with creating a complete QMS design control system for the facility. But my passion was let loose with the task of training the team on the product innovation process. I decided to get creative with the training and develop an actual product. This approach meant I had to teach the team to fly as they built the plane. Together we designed, developed and manufactured a pioneering knee replacement instrument kit uniquely for the China market.This success was closely watched by other business units within Johnson & Johnson MedTech, and further teams joined the centre including Trauma and Sports Medicine. Within 3 years I had established a team of around 60 skilled personnel in China and created a legacy in the form of a fully functioning innovation centre with the facilities and resources needed to design cutting edge MedTech products for the Asian market.