top of page

Implementing the Biodesign Process for Medical Device Innovation in Head and Neck Surgery

Updated: Nov 15, 2021

KLARO was conceptualized and co-developed as a result and identification of the top unmet clinical need in the field of Head and Neck Surgery, during the Stanford Biodesign Process. This process is a 3-phase model of clinical needs identification, invention through brainstorming and prototyping and finally, implementation of the final concept developed.

A multidisciplinary team consisting of 2 clinical engineers and a clinician embarked on a clinical immersion in the Head and Neck Surgery Department, under the mentorship of experts in Medical Device Innovation.

Due to the complex nature of the head and neck anatomy, extreme precision in the surgical technique is a challenge faced in training competent head and neck surgeons. Healthcare innovation may be crucial in bridging this gap and improving surgical techniques in head and neck surgeries. Overall, the aim would be to reduce complications and the morbidity of the surgery to improve patient outcomes and their quality of life.

During the project team’s clinical immersion in the Head and Neck Surgery Department, a total of 111 unmet clinical needs were obtained and analyzed.

“A way to provide consistent and focusable light on the operating area for procedures done in deep cavities of the body” was chosen as the top need to focus on during the invention phase.

Such a need was especially evident during transoral surgery whereby the intraoral cavity was often too deep for adequate and proper illumination. Overhead lighting was prone to blockage by the surgeons’ and assistants’ heads, resulting in poor visualization of the surgical cavity. Alternative lighting solutions such as surgical headlights and flexible optical fiber lighting were subject to a multitude of issues including high cost, poor ergonomics, high power consumption as well as low portability. The resulting lack of visualization was dangerous especially during instances of hemorrhagic complications. Moreover, ease of operation was compromised when maneuvers such as stitching had to be performed intraorally. Hence was born the need for a a cost-effective solution that provides consistent and focusable light on the operating area for procedures done in deep cavities of the body. Through multiple iterations a prototype with a bendable light source and minimal heat generation was developed and tested cadaveric study to document the effectiveness of trans illuminating the intraoral cavity and in other deep

spaces like the pelvis.

After many rounds of prototyping and testing in collaboration with the industrial development partners, our company (Vivo Surgical Private Limited) and Panasonic Lighting Europe GmbH, the final prototype was developed, which was the precursor to the commercial KLARO device currently being commercialized by our company.

KLARO is a fully flexible 4.6-mm diameter LED light strip that is freely bendable to be safely placed into deep cavities during open head and neck surgeries. It is an entirely disposable product and meant for one-time use. The product had its commercial pilot launch in 2019 and is now Food and Drug Administration, United States (Class II) registered, Health Sciences Authority, Singapore approved, and Conformite Europeenne Mark approved.

Since its commercial launch in November 2019, KLARO has generated good reviews from key opinion leaders. The device is currently under clinical across several international territories.


bottom of page