Safe-by-Design Report for SIXTHSENSE wearable health monitor

SIXTHSENSE: Safe-by-Design Report

Project Deliverable by BNN
Project: SIXTHSENSE – Smart Integrated eXtreme environmenT Health monitor with Sensory feedback for ENhanced Situation awarEness (EU – Grant Agreement No 883315)
Date of publication: September 2023
Area: Design for Technology Development (DfTD)
BNN team involvement: Clemens Wolf

The SIXTHSENSE project developed a wearable health monitoring system with closed loop tactile biofeedback, so that first responders in hazardous situations can sense their current health status. It allows early detection of risk factors that could lead to rapid deterioration of health or operation capabilities of first responders, by leveraging predictive models based on multimodal biosensor data. As a team management tool, it enables real-time monitoring of all deployed operatives, helping increase team effectiveness and operational safety.

To accelerate the pace of technological advancements aimed at first responders, SIXTHSENSE established a novel research methodology for sustainable inclusion of first responders in a co-development process.

To ensure that safety-related issues were considered from the very beginning of the design phase, partner BNN implemented the Safe-by-Design (SbD) concept in SIXTHSENSE. This report explains the principles of SbD and its relation to a classic chemical risk assessment, as well as how BNN adopted it within the SIXTHSENSE project, with a special focus on nano-related safety issues and impacts for first responders.

Regarding the impact for first responders BNN performed extensive literature research of the to-be-measured biomarkers and their impact and relevance in high-demand situations, such as emergency deployment. On top, recommendations for improving (mental) health of first responders, based on the learnings from using SIXTHSENSE during deployment, on individual and institutional levels were formulated. By applying the SbD concept, all project-relevant materials, processes and (interim) products that may pose a risk for human health and/or the environment are identified and assessed, through timely and close interaction with the technical developers. Special focus is put on nano-safety issues, i.e., regarding the nanoparticles used in the screen-printed inks and the usage of microneedles. The SbD concept allowed SIXTHSENSE to design innovative materials as safely as possible and should prevent late development failures, as also gave recommendations for implementing the learnings in handling first responders (mental) health.

BNN was chosen to perform this task due to our expertise in SbD, which has by now expanded to Safe-and-Sustainable-by-Design (SSbD). Our Design for Technology Development (DfTD) team specializes in SbD and SSbD, drafting tailor-made concepts for international and national funded research projects. These projects span over different sectors, including also med tech, wearables, and other related fields, underlining BNNs suitability as project partner in SIXTHSENSE.