A global support programme to help medtech start-ups bring new devices to market faster has been announced by software vender MEDEI.
Partnership
The programme has been launched in response to the rising cost of providing data from clinical trials to bring new medical devices to market. Through the programme, medtech start-ups will be able to cut the costs of clinical trials, helping them develop their product in compliance with the European Union’s Medical Device Regulation (MDR).
MEDEI's Smart-Trial gives medtech start-ups and small medtech organisations discounts on license services for 12 months. These services include access to the Smart-Trial data management platform, randomisation functionality, safety data reporting, IoT data integration, and more.
Pall Johannesson, MEDEI’s CEO, said: “Med-tech start-ups are revolutionising the medical device industry in numerous small and not-so-small ways. However, the costs of bringing new device technology to market are now proving prohibitive to most medtech start-ups. This Smart-trial support program will help them overcome the hurdles in providing clinical evidence to the Regulators at less cost.”
Whilst FDA regulations are lowering requirements for some medical market approval, the EU is heightening its regulations. This means that it is more difficult to access the EU, with processes becoming time consuming and costly.
“With higher quality data management, start-ups will be more likely to succeed in today’s market because they will have data that can prove device efficacy, safety and usability. This will also prove invaluable in further product development, funding, market access and marketing,” adds Johannesson.