development of a childhood obesity treatment application to an approved medical device
|Coordinator||Svensk Barnmat AB|
|Funding from Vinnova||SEK 135 000|
|Project duration||December 2016 - October 2018|
|Venture||Medtech4Health: Competence Enhancement in SME|
Purpose and goal
The aim is to provide a medical device certificate for a digital support system which we develop to individualize and optimize childhood obesity treatment. Outcome measures are collected at home, presented in the families’ smart phone applications and in the computers at the health care providers who directly can give feed back to the families. The project has been delayed but the pilot clinical trial required for the finalization of the application for CE mark is ready and the documentation required for the CE mark is now almost ready and under review.
Expected results and effects
When we get the medical device approval the product will be offered to health care authorities In Sweden and internationally. We are convinced that the system will make the childhood obesity treatment less time-consuming for both the families and the health care providers and thereby make the treatment more cost-effective. The delay is unfortunate but our product is needed.
Planned approach and implementation
The technical development has been ongoing in parallel with clinical pilot testing and in a randomized clinical pilot study. The experiences obtained has been continuously used for optimization of the technical product. Preliminary results from this study are positive with better obtained weight loss and lower number of late cancellations for the clinical visits and we are now convinced that we will have a good product ready for the market as an approved medical device during 2019.