Maternal Need and Early Concept
Identifying the everyday challenges breastfeeding mothers face and translating those experiences into the earliest Waiū product concept.
Our Development
Moving forward with purpose, documentation, and care.
Bringing a maternal health device from concept to market requires careful development, testing, documentation, regulatory preparation, and review. Waiū by VHM is building this pathway step by step, with the safety and experiences of mothers at the center of the work.
Product and Manufacturer Documentation
Collecting and organizing device specifications, component information, manufacturing records, labeling materials, and technical documentation.
Design Review and Product Requirements
Reviewing the device concept and translating maternal care priorities into clear product, usability, and performance requirements.
Regulatory Strategy
Determining the appropriate FDA pathway, identifying relevant requirements, and coordinating the documentation needed for regulatory review.
Testing and Evidence Development
Planning and completing applicable performance, electrical, biocompatibility, usability, labeling, and other testing required for the device and its submission pathway.
FDA Submission Preparation
Compiling technical evidence, administrative documents, testing results, labeling, and required forms into a complete submission.
FDA Review
Responding to FDA questions and providing additional information when requested during the review process.
Clearance and Responsible Commercialization
Following FDA clearance, preparing for responsible manufacturing, quality oversight, distribution, healthcare partnerships, and customer support.
Current Status
Waiū remains in development.
Our team is organizing the regulatory, product development, manufacturing, research, grant, and testing work required to prepare for FDA review. We will update this page as verified milestones are reached.
References to the FDA describe our intended regulatory pathway and ongoing preparation. They do not indicate that Waiū has been reviewed, authorized, approved, or cleared by the FDA.
