KardiaMobile/AliveCor
Scaling research operations to improve remote EKG devices
UX Research Lead, 2020
Context:
AliveCor is a $64 million medical device and AI company producing EKG hardware and software for a consumer smartphone-connected ECG recorder known as KardiaMobile - cleared by the FDA in 2012 for detecting atrial fibrillation and normal sinus rhythm. A professional product known as KardiaPro provides medical professionals with the ability to monitor their patients using Kardia devices.
The challenge:
To establish and lead all product research operations, standards, protocols, and procedures.
Solution:
Developed internal teams of six part-time researchers and one full-time contract researcher to drive enterprise level results at a lower cost with actionable results; maintain compliance with HIPAA, FDA, legal, and ethical research.
Results:
Authored 40+ reports and studies on formative and summative research with qualitative and quantitative methodologies regarding product research, FDA regulatory testing, usability, and accessibility.
Key stakeholder in the FDA clearance process, helping the Regulatory and Quality Assurance teams in devising and driving user tests to support new filings.
Delivering insights on product design, development, and iteration while scaling Alivecor from $24 million to $64 million in funding.
