Archetype, a medtech innovation management consultancy, has launched, with a commitment to guide innovators through the complex process of market approval for their medical innovations.
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At present, around three quarters of medtech innovations fail to make it to market. Archetype's mission is to ensure that potentially life-changing medical devices reach patients as quickly and efficiently as possible, by offering a comprehensive suite of services that embeds the end goal of market approval into every aspect of the complex product design innovation process.
Led by principal consultant Dr Stuart Grant, PhD, Archetype brings together a global network of experts who have achieved success in a range of medtech sectors.
This collective expertise spans every facet of medtech product development and market approval, encompassing concept development, product design, quality assurance, regulatory documentation, and project management.
With a 25-year career, that includes initiatives at Johnson & Johnson MedTech and DePuy Synthes, Grant is the named inventor on numerous patents for medical devices, with a particular focus on orthopaedic medical devices.
He has extensive experience in the areas of customer needs and insights, front-end innovation and product innovation management, including risk management (ISO 14971) and design control, and technical file submission.
Grant said: “The medtech product approval process is multifaceted, constantly evolving, and often arduous. There is no single path to success, so failure to launch is a very real risk."
“It’s a serious challenge for medtech companies – most of which are SMEs – to keep market approval top of mind while managing everything from initial concept and design development to regulatory oversight and the submission of the relevant technical documentation.”
“I believe Archetype is unique in offering specialised market approval knowledge at every stage of the product development process. This allows us to collaborate with innovators’ in-house teams or their consultants to embed a market approval mindset into every stage of the process, maximising the likelihood of successfully launching their product.”