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August 19, 2020

SEMI | SMART MedTech | NBMC | AFRL

SMART MedTech Virtual Workshop #3

Human Wearables Enabling Rapid Decision Making in the Integrated Care Continuum
 

WORKSHOP SERIES OVERVIEW

Time

10:00 am - 12:00 pm

Location

Online, Pacific Time,
United States

SEMI | SMART MedTech | NBMC | AFRL

Agenda

Wednesday, August 19, 2020

10:00 am - 10:05 am
Jeremy W. Ward, PhD, United States Air Force Research Laboratory
Jeremy Ward, PhD
Soft Matter Advanced Development Team Lead, Air Force Research Laboratory, Materials and Manufacturing Directorate

Moderator

10:05 am - 10:30 am
Christopher Scully, PhD, U.S. Food and Drug Administration
Christopher Scully, PhD
Research Biomedical Engineer, U.S. Food and Drug Administration

Regulatory Science for Evaluating Wearable Patient Monitoring Systems

Biography

Wearable sensors can enable continuous collection of physiologic signals to measure physiologic parameters or identify signatures of disease. The combination of wearable sensors and artificial intelligence to continuously analyze data provides new approaches to patient monitoring at all levels of care. This talk will outline some of the factors that can affect the safety and performance of wearable patient monitoring systems from sensors to data-driven applications and discuss regulatory science approaches we are taking to address the challenges in their evaluation.

10:30 am - 10:55 am
Ashleigh Coker
Program Lead for Cyber-physical Exploitation for Disaster and Emergency Response (CEDER), Air Force Research Laboratory, Sensors Directorate

Cyber Physical Sensing and Medical Internet of Things

Biography

Studying the cyber kinetic effects of medical IoT devices for intelligence purposes and warfighter situational awareness.

10:55 am - 11:20 am
Ted Hammer, Air Force Research Laboratory, Airman Systems Directorate
Ted Harmer
Electronics Engineer, Air Force Research Laboratory, Airman Systems Directorate

Establishing Transmission and Collection Protocols and Architectures to Better Enable Data Collection and Integration

Biography

In recent years, human wearable technologies have grown to include smart watches, fitness trackers, smart shirts, smart shoes, and more. While there seems to be overwhelming agreement that the data available from these devices [are useful], may radically improve healthcare decision making, and could pave the way toward a true, integrated care continuum, there is little acknowledgement of the complexity and cost of collecting, compiling, and presenting those data to allow healthcare providers and researchers to draw meaningful conclusions.

Despite a focus on personalized learning and readiness within the Air Force, the Performance-Enabled Operational Training Environments (PEOTE) work may emerge as an adaptable [system architecture] model for healthcare information technology and informatics systems to overcome these data proliferation challenges.

PEOTE, in development at Air Force Research Laboratory, is an approach to architecting information networks, by leveraging existing operational communications and data infrastructure and applying these pathways to training. The technologies and the methods in development enable the most flexible data collection and analysis capabilities by creating and leveraging standards-based data architectures, infrastructure capabilities, and data structures. When applied to a training scenario, this framework enables the use of biodata, not as human performance indicators, but as mission performance indicators.

This talk covers the networked training environment, how our team is developing performance measures, and some of the use cases we are exploring, including using the Survival Health Awareness Responder Kit (SHARK) data within Air Force Combat Search and Rescue mission training and large-force exercises.

11:20 am - 11:45 am
Oxana Pantchenko, PhD, NextFlex
Oxana Pantchenko, PhD
Program Manager for Medical Devices, NextFlex

State-of-the-Art in Wearable EEG, EOG and EMG Medical Devices

In this presentation, a review of wearable EEG, EOG, and EMG state-of the-art medical devices with clearance for US marketing will be discussed. A team comprising of researchers from NextFlex evaluated 510(k) cleared, de Novo granted, and PMA approved wearable medical devices by searching through various US FDA databases. Additionally, the team also examined adverse events reported through the Manufacturer and User Facility Device Experience database that houses medical device reports submitted to the FDA. Wearable EEG, EOG, and EMG medical device profiles will be presented discussed on usability for detecting decrement in human performance due to cognitive stress and/or cognitive fatigue.

11:45 am - 12:00 pm

Q&A

Registration

Registration Includes:

  • Live access to four (4) webinars
  • Post-webinar access to recordings and presentations
     

Member Price: $199

Non-Member Price: $399

Non-Member Price for Government, Military, and Academia: $249 
(Contact Michelle Fabiano at mfabiano@semi.org for discount code. Must have a valid .gov, .mil or .edu email address)