Development of a smart sensor kit for monitoring of scoliosis treatment braces
Each year about 2% of European teenagers must be treated with braces (spinal orthosis) to counteract the evolution of scoliotic curve by applying a mechanical stress against the body and favouring the correct posture of rachis. Despite the need of recording the exerted pressure expressed by orthopaedic specialists, there is currently no device available, in the market, able to quantitatively measure acting forces inside the braces and to monitor the wearing time. Market analysis outlines big potential in the scoliosis management market, stressing increasing year to year demand still not satisfied by products on the market. It also identifies among main drivers the advancement of technology with tracking devices that can monitor the patient health evolution.
Protolab aims at: i) developing an innovative plug & play wearable sensor kit for monitoring the pressure inside scoliosis braces, ii) improving the compliance with medical prescriptions and iii) boosting the patient active participation in order to reach satisfying results from the care treatment. Digitization will boost the development of automated analysis to frequently check treatment progresses, while the availability of gathered data will allow the use of predictive algorithms to favour rapid intervention in case of wrong trends, thus favouring the active participation of the patient to the care treatment.
Thanks to FED4SAE project that leverages the collaboration with STM, CEA-Leti and IRT Nanoelec, Protolab will first develop a prototype system based on a novel STM32 microcontroller referred as STM32WB that integrates all the hardware means to support Bluetooth™ 5.0 and IEEE 802.15.4 wireless standards such as ZigBee 3.0 and Openthread. The STM32WB will be used to collect data from sensors, to process them and then transferred via BLE to a dedicated smartphone app for representation and further analysis.
Then tests of the new prototype data communication in realistic conditions will be performed in the Products & Technologies Living-Lab (PTL) of IRT Nanoelec at CEA-Leti in Grenoble. The evaluation of regulatory constraints related to patient’s data management will be assessed as well, including evaluation of the cybersecurity and privacy risk analysis. Then the miniaturized and integrated solution will be developed and tested in the same realistic environment.
Innovation management & business expertise provided by Blumorpho will support Protolab in the identification of the strategy and the statutory constraints in order to secure the go-to-market strategy.
Protolab targets to enter the market by end of 2020, its customers being the braces manufacturers, fragmented in 1 or 2 major players geographically distributed in every region. The overall EU market is estimated at 100 000 braces per year, e.g. more than 60 M€/year. The niche market represents a great opportunity for Protolab where two strategies can be addressed with two different growth perspectives: 1) in-house growth, 2) direct investment from a top player in the market of Orthopaedics.