CERSI Collaborators: Leslie Wilson, PhD (UCSF)

FDA Collaborators: Heather Benz, PhD, Eugene Civillico, PhD, Martin Ho, MSc, Telba Irony, PhD, Xuefeng Li, PhD, Anindita Saha

Project Start Date: May 2016

Regulatory Science Challenge

Implantable, active prostheses that replace missing upper limbs have the potential to greatly improve the quality of life of disabled individuals, including service members and veterans. Emerging technologies such as implantable electrodes, surgical techniques for device integration, and electrical stimulation for sensory feedback are promising solutions to some of the challenges faced by amputees. However, these technologies pose new risks, such as the possibility of poor surgical outcomes, implanted device malfunction, or infection. Understanding the views of amputees on urgency for potential benefits and concerns about risks will help FDA regulators better perform benefit-risk assessments and make informed decisions about these new products and procedures.

Project Description & Goals

Patient views of the benefits and risks of novel upper limb prosthetic devices will be assessed using several different preference approaches, including face-to-face and telephone interviews, focus groups, and surveys. This work will contribute to developing the science of patient input by helping to identify the advantages and challenges associated with each preference-eliciting approach. In addition, knowledge of patient views on these devices will help inform regulatory decision-making and the scientists and engineers involved in prosthetic development.