Etteplan has extensive experience in design engineering of medical devices as well as in related regulatory issues and technical documentation. Etteplan has designed point-of-care monitoring devices, diagnostics, rehabilitation aids, dental equipment, electromedical & imaging equipment, transplantation equipment, respiratory devices and surgical instruments, to name a few.
Royal Philips Electronics of the Netherlands is a diversified Health and Well-being company, focused on improving people’s lives through timely innovations. As a world leader in Healthcare, Lifestyle and Lighting, Philips integrates technologies and design into people-centric solutions, based on fundamental customer insights and the brand promise of “innovation and you”.
The development of an IVD (in vitro diagnostic) device provides many challenges. An IVD device does not only have to comply with regulatory requirements and pass all certifications but also often contains complicated measurement technology and precision mechanics.
It all began with a problem – and a brilliant idea. Professor Hans Wiksell, founder of the medical technology company NeoDynamics, recognized that breast cancer biopsies involve certain problems and risks. He discovered a method that provides better, safer and less invasive sampling.
When the company set out to find a product development partner, its objective was clear: it wanted to improve the usability of a tonometer (internal eye pressure measurement device) which was on the market. It was also important to ensure the accuracy of the results of measurement made at home.