EU approves LumipenPro under Medical Device Regulation (MDR) due to its defined type.
In a strategic move to expand its reach in the European market, LumipenPro, a medical illumination device designed for aesthetic surgical procedures with restricted visibility, has appointed innovation management consultancy Archetype to drive its EU MDR approval process.
Archetype, headed by Dr Stuart Grant, an innovation management and MedTech specialist, brings a unique skillset and experience to the table. Recognised for its expertise in obtaining market approval for medical devices, particularly in navigating the EU MDR process, Archetype is expected to help LumipenPro achieve sales similar to those in the US.
The decision to partner with Archetype comes as LumipenPro, which has significantly enhanced aesthetic surgical procedures such as deep-pocket dissection in breast augmentation and secondary breast surgery in the US, seeks to tap more deeply into the established cautery pen market, estimated to reach a global value of $541 million by 2029.
Securing EU MDR approval is crucial for LumipenPro's global expansion strategy, according to Dr Warnock, the inventor and founder of LumipenPro. Dr Warnock, who is working alongside Archetype, VP of Business Development David Hawkes, and Dr Grant, recognises Archetype's expertise in obtaining market approval for medical devices.
David Hawkes, VP of Business Development at LumipenPro, states that achieving EU MDR approval would be a significant step forward in the company's global expansion plans. Dr Grant's objective is to ensure LumipenPro's cost-efficient medical illumination device reaches new markets.
LumipenPro offers smoke evacuation, illumination, and suction capabilities in a single, easy-to-use device, making it an attractive option for surgeons in the European market. The UK market access from a regulatory perspective is not mentioned in the current paragraph, but it is clear that LumipenPro's ambitions extend beyond the US.
Dr Grant, who has been featured in the "Being An Engineer" podcast discussing his career path and challenges, aims to provide strategic insights, support, and guidance to MedTech entrepreneurs like Dr Warnock. With Archetype on board, LumipenPro is poised to make a significant impact in the European medical device market.
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