MEDEI launches global support programme for MedTech start-ups

MedTech software vendor, MEDEI, has announced a global support programme 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 the SMART-TRIAL website 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, randomisation functionality, safety data reporting, IoT data integration, and more. The discount is dependent on a number of organisational parameters such as size and age.

”MedTech start-ups are revolutionising the medical device industry in numerous small and not-so-small ways,” said Pall Johannesson, MEDEI’s chief executive.

“However, the costs of bringing new device technology to market are now proving prohibitive to most MedTech start-ups.

“This SMART-TRIAL support programme will help them overcome the hurdles in providing clinical evidence to the regulators at less cost.”

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 and more clinical evidence is now required to be collected and managed.

“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,” said Johannesson.

“This will also prove invaluable in further product development, funding, market access and marketing.”