Medtech company Vectorious created the first direct heart pressure monitor, which is implanted in the heart's left atrium and allows physicians to receive the earliest indications of any changes to heart pressure - which could signal the onset of a congestive heart failure exacerbation.
The groundbreaking V-LAP system is a wireless, battery-free micro computer that provides ongoing data on left atrium pressure levels. Power is provided through a wearable belt worn by the patient which transmits data to the cloud. A physician interface uses AI-based analytics to identify trends and recommend preventive actions.
Having developed their combination implantable/wearable system, Vectorious needed to extend their innovation into a full-fledged connected care solution.
With large amounts of patient data being generated by the implant, Vectorious required a medical-grade cloud that was able to accommodate a large volume of raw data with maximum cyber security and privacy measures. The ever-changing nature of medical device regulation means that Vectorious needs to adhere to all existing regulations across a number of different regulatory bodies and be ready to adapt to any changes in regulation.
To add to the challenge, Vectorious was under pressure to begin its first human clinical trial as soon as possible. In order to accelerate the project, Vectorious decided to find a ready-made platform enabling quick and easy implementation of the entire digital part of the connected care solution so that the Vectorious team could concentrate on developing their core intellectual property - namely the implant and the raw data processing algorithm.
The ideal platform needed to be:
“We knew we needed to find a way to overcome gaps in technology and ensure compliance with HIPAA and GDPR regulations,” says Keren Raiten, Head of Marketing. “We wanted to achieve a fully functioning solution that could be implanted in patients as soon as possible.”
Vectorious overcame all of its challenges and reduced time-to-market by partnering with BioT, which uses Amazon Web Services as part of its unique solution.
BioT is a self-service platform for building cloud-based medical devices that execute a major part of their functionality on the cloud. Choosing the distributed medical device architecture enabled Vectorious to have minimal hardware BOM footprint and cost, faster evolution of its raw data processing algorithm, as well as improved protection of privacy.
Another major breakthrough BioT introduced to the regulated medical device space is a unique ‘no-code’ approach, enabling the manufacturer to teach the BioT platform about its device and ecosystem data model in less than a day without writing a single line of code. This enables building connected care medical device solutions in a fraction of the time it would otherwise take. In-house development efforts and associated costs are significantly reduced, as well as the ongoing costs of maintaining a medical-grade system in an ever-changing cyber threatened environment.
BioT enhances security for Vectorious through built-in HIPAA and GDPR regulatory compliance capabilities, which are easily adaptable to any use case through a NoCode interface. “These capabilities help us reduce our cybersecurity risk and avoid penalties or even device recalls from failure to comply,” says Raiten. BioT maintains a team of regulatory specialists ensuring that its services meet HIPAA, GDPR, and other regulatory compliance requirements at all times.
BioT supports the storage of large quantities of patient data, qualifying for AWS’s strict Foundational Technology Review (FTR). V-LAP sensor data, in the form of pressure waveforms flows to the External V-LAP device and then to the BioT platform using the Amazon Elastic Load Balancing and Amazon Elastic Container Service (ECS).
After a signal-processing algorithm is executed, the V-LAP data is stored in Amazon databases. “By using AWS, we can enable compliance as well as many security services such as AWS Key Management Service and AWS Web Application Firewall (AWS WAF) for the customers who use our platform,” says Guy Vinograd, CTO of BioT.
BioT has enabled Vectorious to create a custom user experience with clinician dashboards that link to the central data repository. In addition, Vectorious’ proprietary AI algorithms plug into the BioT platform to allow clinician alerts and predictive analytics to be shared on the dashboard.
Partnering with BioT enabled Vectorious to considerably accelerate its development time to start human trials. With all necessary regulatory requirements relating to connectivity handled by the BioT team, Vectorious was able to pass their Declaration of Helsinki ethics committee on its first attempt. (For class III devices, this can be challenging and frequently poses a barrier to beginning clinical trials.)
“We currently have V-LAP implanted in nine patients, with more scheduled,” says Raiten. “We are moving down the path to full regulatory approval in Europe and deployment to many more heart failure patients.”
When the clinical trials reach a successful conclusion, Vectorious expects V-LAP to improve the lives of congestive heart failure patients worldwide. “We believe V-LAP can slow down the deterioration of heart failure and reduce hospitalizations,” says Raiten. “V-LAP will be a game-changer, helping millions of people living with heart failure to take control and manage their disease. We are delighted that our partnership with BioT has enabled us to move towards that future faster than ever before.”