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

Area of Science:

• Medical Devices
• Surgical Innovation
• Biomedical Engineering

Background:

• The Stanford Biodesign process is a needs-driven innovation methodology originating in clinical settings.
• Practicing clinicians and surgeons champion this approach to identify and address unmet medical needs.
• Applying this process in head and neck surgery aims to foster targeted innovation.

Purpose of the Study:

• To apply the Stanford Biodesign process through clinical immersion in head and neck surgery.
• To identify unmet clinical needs within the specialty.
• To brainstorm, prototype, and develop a commercialized medical device addressing a key unmet need.

Main Methods:

• The study followed the three phases of the Biodesign process: identify, invent, and implement.
• Clinical immersion involved shadowing head and neck surgeons for one month.
• Identified needs were filtered, and a top need was selected for concept development and prototyping.

Main Results:

• A total of 111 unmet needs were identified during the immersion period.
• The process led to the design of an in vivo surgical lighting concept.
• This concept evolved into the KLARO™ in vivo surgical lighting device, developed with a commercial partner.

Conclusions:

• The Stanford Biodesign process offers a structured framework for translating clinical needs into viable solutions.
• The development of the KLARO™ device demonstrates the process's effectiveness in advancing head and neck surgery.
• This innovation has the potential to significantly improve patient outcomes in the field.