Scaling a Specialty Catheter for a Global Medtech Leader
The Project
A venture-backed startup developed an innovative peripheral PTA balloon catheter featuring a shape-set nitinol structure mounted directly on the balloon. The developer engaged Forj Medical to supply portions of the device, and after Forj helped improve the challenging manufacturing processes, they moved the entire product to Forj. When a top 30 global medical device company acquired the product, Forj evolved from component supplier to finished-device manufacturer, shipping packaged, rebranded product straight to sterilization and on to the OEM’s distribution center.
The Challenge
- Mounting a shape-set nitinol structure onto the balloon
- Packaging & sterilization had to fit the OEM’s newly validated sterile cycle
- Cost pressure as every component was purchased from outside vendors
- Post-acquisition transfer from component supply to finished device without burdening the OEM’s quality system
- Rapid volume growth as the OEM expanded beyond the U.S. and Europe
The Solution
- Proprietary mounting process developed by engineers who saw the failures firsthand
- In-house nitinol shape setting, forming, balloon bonding & catheter testing
- Fast-turn qualification into the OEM’s validated sterile cycle
- Second sourced & qualified outer shaft, inner member & hub in parallel with sterile validation
- Mature, high-yield offshore production in Singapore under a QMS built for multinational OEMs; Forj manages all suppliers
