In the GENEESS project the focus was on the implementation of nano-electronics in several medical devices for solutions in healthcare. The GENEESS project was a project of DSP Valley and imec.
There are many different application domains in the medical context where smart solutions are desirable: pacemakers, hearing devices, vision and sight implants, brain electrodes, heart rate monitors, miniature insulin pumps, small diagnostics with biochips, etc. Worldwide there is a growing demand for such smart applications given the awareness of aging issues, the increase of chronic diseases and the rising costs in healthcare.
In Flanders several companies are involved in electronics but they still lack sufficient activities in the medical field. During the GENEESS project we aimed to identify, approach and bring together players involved in the medical field. In this way cooperation in an atmosphere of open innovation leads to successful creation of new and smart products. This to increase the competitiveness of Flemish companies and strengthen the technology-driven transformation of the industry.
In the GENEESS project we developed tools for the companies of the target group. A guideline on Best Practices for Electronics in Medical Devices was written as well as a toolkit on active medical devices aiming at SMEs and starters.
The guideline covers the basics about the 2 major regulatory systems. The Medical Device Directives with CE marking in Europe, and the FDA regulatory system (Center for Devices and Radiological Health) in the USA.
Items you can find in the guideline are:
- Basic elements of regulatory requirements for medical devices.
- The realization of medical devices containing electronics.
- Basic elements of project management for active medical devices.
- Basic elements of Design-for-X: Design-for-Test, Design-for-Reliability, Design-for-RoHS, etc.
- Basic overview of biocompatibility, bio stability and sterility for medical devices.
- Design & testing of active medical devices.
A first version of the guideline was written by Maaike Op de Beeck, Filip Ponsaerts and Frederik Horemans in 2015.
The second version was published in May 2016 with updates on the ISO 13485:2016 revision and the upcoming conversion from Medical Device Directives to Medical Device Regulation in the EU.
Toolkit for SMEs and starters
The toolkit is a web based tool designed for SMEs and starters who want to design active medical devices with nano-electronics for the EU market. An active medical device is defined as incorporating some kind of power source. The toolkit does not cover In Vitro Diagnostic Devices (IVD) and implantable devices.
This tool will help starters in assessing the medical device by classifying it in the MDD system from class I to class III based on the intended use. This does reflect the level of risk to the patient and care provider, the level of invasiveness and the duration of direct contact with the patient. The device classification does impact the possible routes towards CE marking and the required quality management system.
With the tool SMEs and starters can get a first fast evaluation of the impact of intended use (and variations of it) on the device classification, the CE marking and thus the required level of quality management system.
The guideline and toolkit are available through DSP Valley and the center for Electronics Design & Manufacturing (cEDM / imec).