About

Hyivy Health is a Canadian medical device and digital health company developing an integrated therapeutic and diagnostic system for chronic pelvic pain. Its Floora system combines an electromechanical intravaginal device, a patient mobile application, and a clinician-facing software platform to deliver therapy, collect physiological data, and support remote monitoring. The company addresses women’s health, urogynecology, pelvic floor physical therapy, chronic pain management, and remote therapeutic monitoring markets. Hyivy’s device has been used in clinical environments and is moving through late-stage regulatory and commercialization readiness activities.

Project

This project will complete a manufacturing review and optimization program to prepare the Floora pelvic rehabilitation device for larger-scale production and a U.S. beta launch. Working with McMaster University, Hyivy will analyze materials, assess the manufacturing process, identify opportunities for automation, move from paper-based to software-based tooling, conduct design-for-manufacturing work, and create tools to support verification and validation activities. The project will focus on reducing assembly complexity, improving silicone and plastic components, increasing repeatability, and strengthening documentation so the company can scale production efficiently while meeting medical device quality and regulatory requirements.

Impact

The project will help Hyivy reduce product and material costs, streamline assembly, improve manufacturing documentation, and prepare for more efficient commercial production. By optimizing the device for scale and adding automation-ready processes, the company can better support clinical and commercial demand while maintaining quality and regulatory discipline. The project strengthens Ontario’s medical device manufacturing ecosystem, supports commercialization of a women’s health innovation, and contributes to improved access to quantitative, remote-enabled care for chronic pelvic pain patients.