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Optimization of process, quality and cost as well as clinical tests of the wearable miniaturized fall detection system for the elderly

Periodic Report Summary 1 - FALLWATCH DEMO (Optimization of process, quality and cost as well as clinical tests of the wearable miniaturized fall detection system for the elderly)

Project Context and Objectives:
Project summary

The general objective of FallWatch DEMO Programme is the Optimization of process, quality and cost as well as clinical tests of the wearable miniaturized fall detection system for the elderly developed through FP7-SME-2008-1 FallWatch Programme. Commercialized since the end of 2012 under the brand Vigi’Fall™, the solution consists in a miniaturized radiocommunicating embedded biosensor patched to the person enabling, in connection with peripheral sensors, the emission of an alert in case of a fall followed by an inability to summon help. It has to date no equivalent around the world in the area of health parameters monitoring of subjects with a health status demanding a permanent survey.

During the previous FP7-SME–2008–1-FallWatch Research programme, the miniaturized fall detection device, Vigi´Fall™, has been developed, achieving the following characteristics and performances:

- Ergonomics: Vigi´Fall™ has been miniaturized to a scale 50% smaller than current devices. Additional
biocompatible materials for the casing and the adhesive patch make it comfortable and easy to stick to the user’s skin;
- Reliability: to tackle the high rate of false alarms that hinder the market, the FallWatch Consortium has developed an enhanced data fusion algorithm that cross-checks accelerometers and heartbeat frequency meter monitored by the wearable device and infrared environmental information from the user’s home.

The Vigi’Fall™ solution is an automatic “context aware” system in opposition to past actively activated systems. It consists in:

- The biosensor embedded on the holder to continuously measure the kinematics (postures, intensity of movements) from accelerometers and heartbeat frequency meter, and classify the situation on a 3 degree scale (low activity, medium, high).
- The in-home control box continuously monitors the ambient activity from motion detectors (door contacts and infrared detectors) and classifies the situation on a 3 degree scale (inactivity, average, exceptional).

The present FallWatch DEMO Programme represents the next step, i.e. the progression from research developments and lab-prototype to industrialization and commercial products. It will aim at:

- Adapting the technology to the US standards, enhancing the performances of the device, optimizing the
components selection, process and overall cost;
- Organizing a clinical trial to demonstrate and validate the high performances of the Vigi´Fall™ solution;
- Obtaining CE marking and FDA clearance to launch Vigi´Fall™ on the EU and US markets;
- Develop the best business strategy and commercialization routes.

FallWatch DEMO will offer to the market a new generation of practical, easy to use and install, reliable fall
detector, which thanks to a strong supply chain of SMEs (Vigilio, BSE, PMBL & Plastod) and a large company (AEMtec) will enable an enhanced quality of life to millions of European citizens, saving more than 500,000 hospitalizations and above 40,0001 premature deaths caused by falls in Europe every year.

1. European Network for Safety Among Elderly (EUNESE) 2012

Project Results:
During the 1st period, the FallWatch DEMO programme has gone through technical as well as management and financial work. From a technical point of view, the work is progressing according to planning. The first part of the project has dealt with generating the new technological knowledge needed for the successful completion of the project.

The engineering and optimization has involved three subjects complex enough to be thought as separated technological routes. These subjects are the adaptation of the transmitter RF to US standards, the optimization of the heart rate module and the optimization of the rechargeable battery.

The optimization of components/assembly process/quality/cost has been considered a specific topic to be dealt with from an industrial and commercial point of view.

Concerning the RF adaptation to the US standard, Vigilio has adapted the hardware of the RF electronic board of the biosensor and developed a dedicated router enabling the transmission of RF information.

The optimization of the Heart rate module relies on a miniaturized microphone and the corresponding signal conditioning (amplification, noise filtering, level adjust, etc) proving an appropriate signal to one of the A/D converter inputs of the microcontroller.

As regards to the optimization of the rechargeable battery, a study of the different available options has driven to recommend the use of a LIR 2032 Lithium-ion rechargeable technology.

The process-quality-cost optimization of the different components for industrialization enabled a price decrease of 38% in comparison to the FallWatch biosensor price.

Currently, the work is focused on the integration and prototyping in order to prepare the clinical trial operations in good conditions.

The integration and prototyping of the whole solution: heart rate module, US standard RF transmitter, rechargeable battery, patch and supervision software for clinically validation and US/EU certification of the Vigi’Fall v2.0 solution will be performed on the second period, but it has already started with the preparation of a new design for the biosensor bringing forward the start date for industrial activities, US market study and dissemination activities in the coming months in compatibility with the time schedule.

The exploitation and dissemination activities are running according to expectations presenting the project results regularly to commercial partners, health professionals, distributors and the project existence to the large public. Also management, coordination and technical steering activities, are running according to planning and will remain open until the end of the project.

Potential Impact:
The FallWatch DEMO Programme expects final results are the following: optimized heart rate module, rechargeable battery and RF transmitter compatible with US standards, within an industrially process-quality-cost optimized fall detection solution. Second Project Result: a clinical trial to be set both in France and the USA in order to validate the Vigi’FallTM performances and accuracy. Third Project Result: the EU & US Certifications (Technical tests & Documentation, UL/UN battery certification). Fourth Project Result: Market research & Business Plan enabling a huge commercial dissemination of the novel Vigi’FallTM v2.0 version through the US and international markets.

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