A seed-stage digital health startup partnered with iO Lifescience to build the first working prototype of a handheld, connected multi-sensor device for rapid vital-sign capture. The vision: a noninvasive “checkup in 60 seconds” for remote monitoring of cardiopulmonary and chronic-disease patients, usable both at home and in ambulatory care.
iO led systems architecture, sensor selection, PCB/firmware, airflow path design, industrial design, rapid builds, usability testing, and regulatory risk planning.
Challenges
The team faced several hurdles:
- Sensor integration: Combine respiratory, SpO₂/HR, temperature, and cardiac signals into a compact, patient-friendly device.
- Signal reliability: Deliver stable, repeatable data across diverse users and environments.
- Ease of use & hygiene: Ensure intuitive operation, biocompatible materials, and cleanable interfaces.
- Connectivity & data: Enable BLE app connection, secure storage, and clinician-ready exports.
- Manufacturability: Rapidly prototype a design that could scale to assembly-ready architecture with credible COGS for investors.
Outcomes
- Delivered alpha to beta prototype with integrated sensors, closed-loop algorithms, and BLE telemetry for live demos.
- Produced engineering accuracy data vs. reference equipment, supporting IRB and clinical-pilot planning.
- Cut concept-to-demo timeline to 12–20 weeks, enabling faster investor engagement.
- Developed regulatory starter package with risk files and FDA pre-submission framing.
- Provided DFM and COGS insights with vetted suppliers for pilot manufacturing.
