Utah Surgeon's LumipenPro Enlists Archetype to Pursue EU MDR Approval
Medtech innovation management consultancy Archetype has been appointed to drive the European Medical Device Regulation (EU MDR) approval process for LumipenPro™, a 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 Stuart Grant, PhD, will leverage its deep market approval expertise to navigate the complexities of the EU MDR and facilitate LumipenPro's expansion into the European market, the company said in a press release.
“This strategic partnership will ensure that LumipenPro meets the stringent requirements of the EU MDR, paving the way for its widespread adoption in Europe,” the company said.
LumipenPro is a 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.
Archetype will work alongside LumipenPro inventor and founder Steven Warnock, MD, FACS, a Utah-based plastic and reconstructive surgeon of 20 years, and VP of Business Development David Hawkes.
In the US, LumipenPro has enhanced aesthetic surgical procedures such as deep-pocket dissection in breast augmentation and secondary breast surgery. The 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.
"Securing EU MDR approval is paramount to our global expansion strategy,” Dr. Warnock said in the press release. “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.”
Hawkes added that 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.
“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,” Hawkes said.