Archetype appointed to secure EU Market approval for LumipenPro

Medtech innovation management consultancy Archetype has been appointed to drive the EU MDR (European Medical Device Regulation) approval process for LumipenPro, a groundbreaking medical illumination device designed to enhance precision and efficiency during aesthetic surgical procedures where visibility is restricted. 

Archetype, headed by innovation management and medtech specialist Dr. Stuart Grant, will leverage its deep market approval expertise to navigate the complexities of the EU MDR and facilitate LumipenPro's expansion into the European market. This strategic partnership will ensure that LumipenPro meets the stringent requirements of the EU MDR, paving the way for its widespread adoption in Europe.

LumipenPro is a unique, cost-efficient illumination device that snaps onto electrocautery pens widely used in aesthetic surgery. It provides highly targeted surgical illumination in enclosed spaces with limited visibility, offering smoke evacuation, illumination, and suction capabilities in a single, easy-to-use device.

Archetype will work alongside LumipenPro Inventor and Founder Dr. Steven Warnock, a plastic and reconstructive surgeon of 20 years’ standing, and VP of Business Development David Hawkes.

LumipenPro was developed by Warnock to deliver targeted surgical illumination in enclosed spaces with limited visibility. It is unique in being the only LED light to offer smoke evacuation in addition to illumination and suction.

In the US, LumipenPro has significantly enhanced aesthetic surgical procedures such as deep-pocket dissection in breast augmentation and secondary breast surgery. The easy-to-use clip-on illumination device means surgeons do not require expensive lighted retractors and headlights, making it cost-efficient for aesthetics practices, as well as eliminating the physical strain and discomfort associated with wearing headlights.

Warnock and Hawkes recognized in Archetype an innovation management consultancy with unparalleled expertise in obtaining market approval for medical devices.

Warnock says: "Securing EU MDR approval is paramount to our global expansion strategy, Archetype's proven track record in navigating the EU MDR process, coupled with Dr. Grant's extensive experience in medical device development and market approval, makes them the ideal partner to guide us through this critical phase.

“Sales in the US market have fed our ambition for achieving significant growth over the next five years and we’re confident that following EU MDR approval we will have similar success in Europe.”

Grant says: “Our objective is simple – to empower medtech entrepreneurs like Dr. Warnock with the strategic insights, support and guidance they needed to achieve market approval for their cutting-edge medical devices.

“We’re excited to work with the LumipenPro team to ensure their cost-efficient medical illumination device reaches new markets and improves aesthetics procedures to the benefit of surgeons and patients alike.”

Hawkes, says achieving EU MDR approval would mark a significant step forward in the global expansion plans for LumipenPro, enabling the company to tap more deeply into the established cautery pen market, which is estimated to achieve a global value of $541 million by 2029.

He adds: “Securing EU MDR approval is a crucial springboard into the European market and Archetype has the singular skillset and experience to help us navigate towards that aim and achieve sales such as we have already seen in the US.”