PhysIQ is a company dedicated to enabling proactive care delivery models through its proprietary, FDA-cleared Personalized Physiology Analytics technology. PhysIQ is a proven, first-of-its-kind data analytics platform designed to process multiple vital signs from wearable sensors to create a personalized dynamic baseline for each individual. By mapping vital sign relationships this way, physIQ’s analytics detect subtle deviations that may be a precursor to disease exacerbation or change in health.

physIQ system overview

Challenge

PhysIQ faced two challenges common to companies who develop connected care systems that fall under FDA regulations:

  • The complexity of parallel development of wearable hardware, bluetooth connectivity, mobile applications and cloud services.
  • The need to do so within a quality management system that would allow them to meet FDA requirements while keeping up to the rapid pace of mobile and cloud development.

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Approach

Orthogonal worked with PhysIQ to develop a testing framework that helped accelerate parallel development of hardware, mobile and cloud elements of the system by dramatically shortening the bug injection to bug fix cycle.

We also worked with PhysIQ and provided guidance on best practices for implementing an FDA-compliant quality management system that embraces agile development methodologies.

Outcome

PhysIQ was able to accelerate development and achieve FDA clearance for their Personalized Physiology Analytics technology.

“Orthogonal brought us the expertise we needed to ensure our technology platform met the high standards of the FDA. Through their involvement we absolutely accelerated our pace through the regulatory process.”

– Gary Conkright, CEO of PhysIQ