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.
On a wearable controller for a neural implant the specification that matters is jitter, not latency. The implant is unserviceable, so every changeable function belongs
On a wearable stimulator the disposable electrode is the product and the electronics are its support system. The pad sets the load the output stage
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
