Medical Devices

Human-Device Interaction

Contact

Kimberly Kontson, Ph.D.

Summary

The human-device interaction group advances regulatory science through the study of human interaction with existing and emerging medical device technologies. Our overarching goal is to improve therapeutic, diagnostic, and rehabilitative outcomes for patients. In addition to applications to neurology, physical medicine, orthopedics, and surgery, the lab is equipped to address cognitive and other human factors that influence device usability across therapeutic areas.

Available instrumentation includes an extensive array of leading edge equipment for monitoring and modeling medical devices and human users, including 3D-printing capabilities, motion and ground force capture technologies, computational modeling and simulation tools, and muscle monitoring (electromyogram), brain monitoring (electroencephalogram), and eye-tracking systems.

Equipment for studying human performance and cognition

Optical markers are used to track and quantify movements in space.

Equipment for studying human performance and cognition

A virtual environment for studying prosthetic function.


Equipment for studying human performance and cognition

A hand function test based on activities of daily living.

Current project areas include:

  • Test method development for next-generation upper limb prosthetics
  • Sex-specific modeling and analysis of ACL injury susceptibility
  • Assessment of patient views on risks and benefits of innovative prosthetic technologies
  • Human factors evaluation of 3D-printed patient-matched surgical instrumentation
  • Real-world data collection for larger, smarter, distributed clinical trials
  • Population variability of EEG biomarkers with potential diagnostic utility

We are continually seeking collaborations with other medical device stakeholders, including clinicians, academic researchers, technology developers, and our colleagues at the FDA and the National Institutes of Health.

For Center and Agency programs and initiatives related to work in this group, please see the following resources:

Current funding sources

FDA Critical Path Initiative

Personnel

FDA Staff:
Kimberly Kontson, Ph.D.
LT James Coburn
David Soltysik, Ph.D.

Research Fellows:
Mahsa Alborz
Janell Joyner
David Nahmias
Sophie Wang

Visiting Scientist:
Eugene Civillico, Ph.D.

FDA collaborators

Heather Benz, Ph.D.
Ian Marcus

External collaborators

Advanced Arm Dynamicsdisclaimer icon
Defense Advanced Research Projects Agency (DARPA)
Temple University Electrical & Computer Engineeringdisclaimer icon
Medical Device Innovation Consortiumdisclaimer icon (MDIC)
University of Maryland Mechanical Engineeringdisclaimer icon
University of Albertadisclaimer icon 
University of Houston Electrical & Computer Engineeringdisclaimer icon
University of Maryland Neuroscience and Cognitive Science
Veterans Administration
disclaimer icon
Walter Reed National Military Medical Center
 

Resource facilities

Hardware

  • Gait and force measurement
    • 2 Kistler force measurement platforms integrated into a portable walkway
    • Vicon Bonita 3D motion capture system
    • ATI Industrial Automation Mini-45 6-degree of freedom force transducer systems
  • EMG
    • Delsys tethered 8-channel EMG system
    • Trigno 16-channel wireless EMG/accelerometer system
  • Eye tracking
    • Mobile Eye-XG
  • EEG
    • 64 channel BE Plus LTM mobile system
    • 64-channel EGI system
    • NetStation software
    • “button box” for registering subject input and choices
  • Empatica E4 Wristband for EDR, temperature, PPG, and acceleration monitoring

Software

  • ANSYS
  • LabView
  • MATLAB
  • ePrime
  • Solidworks

Relevant Standards & Guidances

 

Page Last Updated: 06/07/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English