Archetype
Archetype, a MedTech innovation management consultancy, has launched, with a commitment to guide innovators through the complex process of securing market approval for their medical innovations.
At present, around three quarters of MedTech innovations fail to make it to market, according to the National Library of Medicine. 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 cutting-edge 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 says the company.
With a 25-year career, that includes leading groundbreaking initiatives at Johnson & Johnson MedTech and DePuy Synthes, Grant is the named inventor on numerous patents for market-leading 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 states: “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.”
Archetype’s services include:
- Strategically reviewing product innovation practices to mitigate risk and optimise processes.
- Assessing the targeted market to provide a realistic prognosis for gaining regulatory approval.
- Delivering a customised suite of innovation procedures to ensure documents filed with the EU notified bodies and other global regulatory bodies are robust.
- Providing training to in-house teams to enhance expertise, maximise productivity, and improve the chances of gaining approval for an innovative medical device.
Grant adds: “Archetype’s comprehensive, approval-focused support will benefit innovators and, most importantly, the patients whose lives could be transformed by the latest medical products on the market.”
