Product Summary
Before the COVID pandemic, Signant Health was a leader in using connected devices to gather objective patient data in conjunction with their TrialMax eCOA application. To address urgent needs in vaccine clinical trials, ongoing investments in these integrations slowed and existing solutions languished.
When I officially joined the product management team at Signant after the VirTrial acquisition, I assumed responsibility for our sensors and wearables initiative. I developed a short-term, tactical strategy to revive or retire existing integrations and a multi-year plan to expand the use of connected devices with eCOA and other applications in the product portfolio, such as those in Advisory and Telemedicine.
Rather than researching specific devices to integrate, we focused on identifying the clinical measurements that would benefit the data-gathering needs of most clinical trials.
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Vital signs, e.g., pulse rate, body temperature, respiration rate, blood pressure, and blood oxygen saturation
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Actigraphy, e.g., sleep, activity, and movement
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Blood glucose monitoring
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Spirometry
Product Accomplishments
We prioritized vital signs as the most critical measurement domain to support in the near term. While existing integrations covered some of these measurements, we still needed a key measurement to assess and monitor overall patient health: blood oxygen saturation or pulse oximetry.
After researching various devices, we selected the Masimo MightySat Pulse Oximeter. It offered clinical-sensors sensors, a range of additional measurements not supported by other devices, and immediate support in existing studies from some of our largest customers. We brought support for this device to market in seven months and solidified trust from a critical customer in our ability to execute.
My role in the initiative:
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Interfaced directly with the Masimo commercial team and engineers to obtain access to technical documentation and test devices, then coordinated a plan to procure the device.
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Developed overview and planning documentation, including requirements, user and data flows, assumptions, and customer timelines, to guide engineering and establish consensus on the plan with our commercial team.
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Evaluated feature trade-offs during implementation to maintain aggressive customer timelines.
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Provided design guidance during regular in-sprint reviews, including: copy reviews, potential experience challenges for patients, interface graphics including illustrations from Pablo Stanley's Humaaans library, in-session animations from Lottie Files, icon suggestions, and detailed diagrams of the UX flow.
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Prepared the new feature for operational readiness with our existing eCOA product: pricing, device logistics, user support, marketing, compliance, and commercial training.
Cristina Rhoads, a report on my team, was the product manager working on all aspects of sensors and wearables. She supported efforts in each phase of this implementation. Read a blog post she wrote and published shortly after we announced support for pulse oximetry in July 2022: With Sensors and Wearables, It's Not All About the Hardware.
