Inzentiz® Medical Software is developing a software platform that meets all CE and FDA demands in the highest risk-class (class IIB). The platform can even be used in high-risk applications like sensor-medicine pump closed loops or treatments with radioactive sources.
Hans Meijs, co-founder of Inzentiz: “We saw that a lot of mHealth and eHealth companies were struggling with CE certification: The certification was a bottleneck for the entrepreneurs since they were too busy to handle all the paperwork needed to meet the Medical Device Directive. But doctors will not, for liability reasons, use uncertified products and the reimbursement for eHealth Apps is therefore far away. This is a worldwide problem, both in the USA and in Europe.”
To be used widely and to be scalable, the platform covers the general functionality which covers about 80% of the code needed by all applications. Domain specific functionality (20%) must then be developed by the manufacturers on top of the platform. The platform can be compared with an Operating System (OS): All nowadays applications are built on top of the OS and don’t need to code the OS anymore.
Steps to take
Inzentiz started the preparations for the platform 2 years ago: there are a lot of aspects to be considered. The Inzentiz team started the implementation in April: A recent 200K€ EFRO grant of OP OOST gave the kick-start. But another 700K€ is needed to create the platform.
Meijs: “The next big step is to find investors. When we find 700K€, we can realize the platform and enter the market actively… a senior marketer is on board. The second challenge we face is to find a way to the US market: US mHealth companies are 3 years ahead of EU companies and they also avoided certification so far. More than 1,000 USA mHealth manufacturers are waiting for our platform that will make certification 3x faster and 3x less expensive.”
CE and FDA certification focus on patient safety but security and privacy are also very important: The medical and patient-data will be stored in the Inzentiz® cloud and patients must be 100% sure that their data are secure in our cloud. ISAE3000 is worldwide recognized as (one of) the toughest industry standards in defining controls mitigating security- and privacy risks. Deloitte certifies our security and privacy framework using the ISAE3000 standard.
LS@W Value Centre
The Value Centre Voucher supported the decision for Inzentiz to start the ISAE3000 certification process relatively early. The first step was to recognize the security and privacy risks and define adequate controls. With this voucher Inzentiz could ask Deloitte to assess our risk-framework and risk-mitigations. This work is almost finished and once this is done, Inzentiz can inform the market that our ISAE3000 framework is approved by Deloitte.
Meijs: “In this way we tell the market that we take patient safety (CE and FDA, class IIB) very seriously but we are also very serious about patient security and privacy (ISAE3000).”
- About Inzentiz: visit the website.