Case Study - Medical manufacturer finally meets regulatory compliance

The client was under pressure to find a molder capable of producing a bolus plug that met industry and regulatory requirements. Initially attempting to mold the part in-house, they faced setbacks when the FDA required a change in the material formulation, which compromised the product's performance. Complicating matters, the bolus plug had to be manufactured using a specific compound that ensured visibility during X-rays. Maintaining the precise molecular weight and chemical composition of this specialized material proved to be a unique challenge.

Thunderbird Molding submitted a competitive bid to manufacture the bolus plug and focused on addressing the material and regulatory challenges head-on. To achieve the necessary precision, we purchased a very specific injection-molding machine, designed to handle complex molding requirements. Three other molders were competing for the contract, but only Thunderbird Molding had the experience and equipment to meet the manufacturer's needs. We successfully molded sample parts that maintained the necessary molecular weight while also passing FDA-required testing by a third-party lab.