Drove end-to-end product, regulatory, reimbursement, and data strategy for the Ascend robotic knee orthosis — from FDA filing and CMS reimbursement to companion app design and cloud data architecture.
Regulatory & Quality (QARACA) — Led FDA regulatory filing for the Ascend powered knee orthosis. Designed and coordinated clinical testing protocols with the San Francisco VA and UPMC. Vetted, selected, and implemented Enzyme as the Quality Management System (QMS).
Reimbursement Strategy — Analyzed the durable medical equipment reimbursement landscape and built the business case for Medicare coverage. Prepared and presented a successful HCPCS code application to CMS/PDAC, securing a dedicated code for Ascend.
Product Management & Design — Designed the full user interface for the Ascend companion mobile app and the on-device controller UI. Collaborated with hardware engineers on the single-hand, magnetic quick-attach mechanism for the Ascend powerpack.
Data Architecture & Cloud — Partnered with backend and data architecture teams to build the end-to-end communication pipeline between the Ascend orthosis, the companion app, and the Roam cloud analytics platform.
Clinical Partnerships — Worked closely with VA and DoD partners on clinical pilot programs for veteran mobility solutions.
Photos
Bluetooth pairing flow for the Ascend powerpackDevice settings and motor tuning controlsDaily activity journal and session notesActivity tracking and usage analytics