Medical Device Documentation: 4 Critical Failures When Working with Chinese Manufacturers

The overlooked crisis in medical device documentation? It doesn’t happen at the FDA audit. It doesn’t happen during CE submission. It happens silently — during early engineering handoffs and uncontrolled revisions with Chinese manufacturers. We’ve seen it too many times: a MedTech startup rushes to outsource to save time. A few months later, they realize […]

7 Critical Pitfalls in Medical Device Development When Transferring Out of China

The harsh truth about medical device development? Most teams think the transfer is about manufacturing. It’s not. It’s about rebuilding your development process under new constraints — and most companies have no idea how many traps they’re walking into. If you’re planning to shift your medical device development from China to another region, you’re not […]

IP Recovery After Working With Chinese Suppliers: Real-World Case and Step-by-Step Guide

When developing a medical or wellness device, working with Chinese suppliers often feels like a cost-effective shortcut. But many founders discover—too late—that they’ve lost control of their most valuable asset: intellectual property (IP). From unauthorized replicas to suppliers holding molds hostage, IP recovery after working with Chinese suppliers is a challenge we see often at […]

Outsourced RnD for Hardware Migration: 1 Reason When and Why It’s the Only Real Option

In the rapidly evolving world of medical and wellness technology, hardware migration is no longer optional—it’s inevitable. Devices age. Components become obsolete. Compliance standards tighten. And users expect more from every interaction. When your in-house team hits a wall—technically or resource-wise—outsourced RnD for hardware migration isn’t just an alternative. It’s often the only real option […]