Intelligent data management software offer will enable MedTech start-ups to bring new devices to market faster in compliance with toughening EU medical regulations
Acknowledging the rising cost of providing data from clinical trials to bring new medical devices to market, MedTech software vendortoday announces a global support program for medical technology start-ups that will enable them to slash the cost of clinical trials and bring new devices to market faster in compliance with the European Union’s Medical Device Regulation (MDR).
With immediate effect, MedTech start-ups and small MedTech organisations can apply for a special start-up offer via thewebsite and receive a discount of up to 50% on all SMART-TRIAL license services for 12 months. These services include access to the SMART-TRIAL data management platform, randomization functionality, safety data reporting, IoT data integration, and more. The discount is dependent upon a number of organizational parameters such as size and age.
“MedTech start-ups are revolutionizing the medical device industry in numerous small and not-so-small ways,” says Pall Johannesson, MEDEI’s CEO. “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.”
Johannesson points out that while FDA regulations are lowering requirements for some medical market approvals, the EU is heightening its regulations. This means access to the EU for new medical technology products is proving more difficult, time consuming and costly. More clinical evidence is now required to be collected and managed by MedTech companies.
“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.