Welcome to the OVA Solutions knowledge hub. Here we share what we have learned building medical devices: prototyping and design transfer, what development actually costs and how long it takes, and the regulatory path through the FDA, ANVISA and COFEPRIS. Real numbers from real projects, not generalities.
A remote patient monitoring bracelet that measures blood pressure, ECG, oxygenation, pulse, and skin temperature looks on a requirements document like five independent subsystems sharing
A transport ventilator has to do everything an ICU machine does while weighing what a laptop bag weighs. Hamilton Medical lists the T1 at 6.5
Table of Contents Why Transferred Devices Are Opportunity-Rich (and Risk-Loaded) 3 Innovation Lab Strategies for Upgrading Transferred Devices What Happens When You Skip the Lab
Table of Contents Why Independent Manufacturing Requires a System — Not a Vendor 5 Essential Steps to Set Up Independent Manufacturing Successfully The Hidden Costs
Table of Contents Why Fast Redesign Starts With Brutal Clarity The 12-Week Redesign Framework That Works Why Chinese Hardware Needs Redesign — Not Just Adaptation
Table of Contents Why Reverse Engineering Isn’t a Shortcut — It’s a Parallel Process 4 Hard Lessons from Reverse Engineering Chinese Devices The Hidden Risks
