Medical algorithms transform data into clinical insights.
The challenge is proving those insights are trustworthy.
MIOTIFY offers a platform for algorithm integrity.
Introducing MIOTIFY –
a web-based platform specifically designed to enable the use of algorithms in medical software using a standardised and scalable ‘Compliant Component’ approach. Based on medical device standards.
MIOTIFY’s web-based platform guides product teams through a standardised design control framework for configuring algorithms into a Compliant Component format for release, monitoring and reuse.
A Compliant Component consists of a package of externally deployable code with a corresponding evidence package to aid regulatory compliance and demonstrate quality assurance to enable the algorithm’s use in software intended to inform or drive a clinical decision.
Medical algorithms are used to transform input data into clinically actionable insights and play a key role in enabling data driven clinical decisions. Before introducing an algorithm into a software product to inform clinical decision making, product teams and regulators need evidence that demonstrates the integrity of the outputs generated by that algorithm. Documenting control over the design and risks of an algorithm adds cost and complexity but is essential to ensure any outputs generated are fit for purpose, especially when these are intended to inform a clinical decision.
Three key needs must be addressed to enable medical algorithms to be implemented at scale:
1) Need for standardisation of the controls to make it easier to review the design process and algorithm performance.
2) Need for validated tools to make it easier for proactive monitoring of the ongoing performance and risks for deployed algorithms.
3) Need for algorithm reusability to eliminate duplication of effort, decrease testing and cost of redevelopment.
AstraZeneca collaborates with MIOTIFY to test MIOTIFY’s ‘Compliant Component’ approach for deploying algorithms into digital patient solutions
“AZ undertake >100 clinical trials annually to support development of novel therapeutics and intends to use validated digital platforms both to accelerate the development of these novel products, and also to deliver digital therapeutic solutions to improve outcomes for our patients. Delivering these objectives requires AZ to develop and validate medical device grade software solutions and a component based approach enabled by MIOTIFY’s platform has the potential to standardise the approach to deploying algorithms ranging from standard algorithms used to transform data from devices/sensors for remote monitoring in clinical trials to supporting the deployment and ongoing monitoring of more complex algorithms to be used in digital therapeutics leading to enhanced outcomes for patients.”
-Matt Bonam, Head, BioPharmaceuticals R&D Digital Patient Health, AstraZeneca (AZ)
“MIOTIFY is committed to working with both innovators and regulatory stakeholders to empower the advancement of healthcare by fostering responsible and high-quality digital health innovation with a platform for providing efficient and least burdensome oversight, while meeting the regulatory standards for safe and effective products”
-Sheena Macpherson, Founder and CEO, MIOTIFY LTD.
Want to build your own Compliant Components?
For product teams interested in using algorithms to transform input data into clinically actionable insights for use in SaMD development or Clinical research then please enter your details in the form provided to be invited to participate in our Early Access Programme.
Interested in joining our ecosystem?
If you’re a manufacturer of a connected device, sensor or wearable and would like to discuss partnering and integration opportunities then please enter your details in the form provided.
If you’re an algorithm creator and would like to explore collaboration opportunities then please enter your details in the form provided.