Putting FDA regulatory strategy at the heart of medical device development

A voice-controlled surgical loupe headset, sPEEK, designed by Sagentia Innovation’s multidisciplinary team has been awarded a coveted Red Dot: Best of the Best award for the highest design quality. 

Developed in response to surgeons’ issues with existing loupes, the headset eliminates manual adjustment of magnification and illumination which can otherwise interrupt surgical flow. 

Across all industries, there has been growing demand for voice control to be a ubiquitous part of a user interface as it can bring many benefits, one of which for sPEEK is that the advanced voice control features are built on edge processing which ensures the headset functions reliably in the operating room. The local nature of edge processing also avoids the transmission of potentially sensitive data over hospital networks or to the cloud.

Surgeons can use voice commands to activate the headset’s light and toggle between brightness settings as well as increasing or decreasing magnification by 3x, 4x and 5x. Wake words can be customised and the physical design is optimised for maximum comfort and balance.

Unlike existing powered surgical loupes, the sPEEK headset concept contains a battery-powered microcontroller. Microphones are also embedded. This eradicates the need for cables and belt/body mounting that can present user issues due to the need for surgical gowns and other PPE.

Carl Hewett, Design and Innovation Manager at Sagentia Innovation says the concept satisfies the three core areas of ‘design thinking’: user-centricity, commercial viability and technical feasibility.

“Our interviews with practicing surgeons revealed multiple issues associated with existing surgical loupes,” Carl explains. “The lack of intuitive optic control accelerated eyestrain and stooped posture which can contribute to fatigue in surgical staff. In developing sPEEK, we drew on the expertise of our electro-mechanical engineers and software specialists to overcome these problems. The hands-free control of illumination and magnification empowers clinicians to deliver seamless quality of care during surgical procedures.”

This year, Red Dot received 4,110 entries for its Design Concept category, with just 61 entrants receiving the Best of the Best award. Sagentia Innovation’s sPEEK is one of 5 finalists now being considered for the Red Dot: Luminary award, the highest level of Red Dot recognition.

Rob Morgan, VP, Medical says “We are delighted to receive this award. Innovation projects like sPEEK are key for us; innovation that addresses the needs of healthcare providers to improve their efficiency and workflow. Due to client confidentiality, we often can’t talk about the exciting developments we work on so it’s great to be able to show what our team are capable of achieving through this exciting project. I’d like to thank and congratulate our designers, usability experts, mechanical and electronics engineers, and software developers who work tirelessly on technologies that really do make a difference in the healthcare industry”.

A case study of the entry is available here.

More information about the international Red Dot awards is available here.