Regulatory Science for Engineering Intuitive, Engaging, Safe and Effective Human-Device Interaction
(Contreras-Vidal, UH BMI Lab, Kimberly Kontson, FDA)
Background: Sensor-based digital health technologies (DHTs) offer the potential to derive digital endpoints from objective data collected more frequently than traditional clinic visits, capturing insights from the real-world environments where individuals live and work. These endpoints can reflect patient priorities while meeting FDA's benefit and effectiveness requirements. While endpoints applicable to any clinical population with upper limb impairment are desired, this project will initially focus on upper limb prosthesis users to demonstrate clinical validity. The main objectives are to gather feedback from prosthetic device users and clinicians on sensor-based DHTs and use it to develop a patient-centric digitally derived endpoint. The specific aims to accomplish these objectives are:
- Collect Perspectives: Conduct interviews and focus groups with upper limb prosthesis users and clinicians to identify key outcomes for home and community settings
- Develop Measures: Conduct lab-based studies to determine feasibility of using sensor-based DHTs to capture these outcomes
- Implement Take-Home Study: Design and conduct a longitudinal study to validate the digital measures in real-world environments, comparing sensor-based data with traditional outcome measures
Research Plan: The role of the REU student(s) will be to characterize wearable sensors for upper limb activity assessment and collect in-lab data to inform algorithm development. Activities may include experimental design, experimental setup, data acquisition, writing MATLAB or Python scripts for data analysis, and mastering the use of relevant lab instrumentation. The learning objectives of this research project are to (1) learn about upper limb loss/difference rehabilitation and emerging technologies, (2) learn how to acquire and analyze data from various wearable sensor modalities, (3) develop skills related to human subject research protocol development and implementation, and (4) develop communication, organizational, and other critical skills necessary for successful execution of a clinical study.
Prerequisites: Experience in human subject research and knowledge of MATLAB or Python is desirable.
Dr. Kimberly Kontson is a biomedical engineer with the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, Office of Science and Engineering Laboratories (OSEL). She also serves as a subject matter expert in sensor-based digital health technology verification and validation and human factors/usability engineering to the Office of Product Evaluation and Quality. As a member of the OSEL Interoperability Research Program, Dr. Kontson's current research interests include development of regulatory science tools to support evaluation of wearable technologies and clinical outcome assessment development for advanced prosthetic devices.