Enabling a Department of Defense Contract Through U.S.-Based Manufacturing

Product Type

Pneumothorax Decompression Needle

Client

U.S. Defense Contractor Supplying the Department of Defense

When soldiers are injured in combat, a collapsed lung (pneumothorax) can be fatal within minutes. A decompression needle relieves the pressure, allowing the lung to re-expand and the soldier to breathe again. It’s a small device, but it makes the difference between survival and tragedy.

Every U.S. service member deployed to the battlefield carries these devices in their kits. They are also increasingly found in ambulances and civilian emergency packs across the country. For a product this critical, reliability and compliance are mandatory—especially when supplying the U.S. Department of Defense.

The Challenge | Overseas Production Couldn’t Deliver Compliance

The client, a U.S.-based defense contractor, had previously sourced these needles from a Chinese manufacturer. But problems quickly surfaced:

  • Lack of control: They didn’t own the drawings or specifications.
  • Sterilization concerns: Documentation was only in Chinese, with no clear validation.
  • Government requirements: To secure a Department of Defense contract, they needed a U.S.-made device.

Without a domestic partner, the client risked losing the opportunity to supply this life-saving device to the U.S. military.

Hart’s Solution: Reverse Engineering and Domestic Production

Hart Enterprises stepped in and provided a pathway forward. The client shipped a sample device, and Hart got to work:

  • Reverse engineering the part to create drawings, specifications, and material standards.
  • Validating materials to ensure compatibility with sterilization processes.
  • Prototyping and refining until the device met performance and reliability needs.
  • Supporting sterilization validation to align with FDA and DoD requirements.

With Hart as a U.S.-based partner, the client could now present a fully compliant, domestically manufactured product—unlocking their contract with the Department of Defense.

With Hart as a U.S.-based partner, the client could now present a fully compliant, domestically manufactured product—unlocking their contract with the Department of Defense.

The Outcome: Securing the DoD Contract and Expanding Use

By shifting production to Hart Enterprises, the client gained more than a reliable manufacturing partner—they gained access to new markets. The device became eligible for Department of Defense contracts, ensuring U.S. soldiers carried dependable equipment made on U.S. soil.

The partnership didn’t stop there. With the foundation in place, Hart helped the client expand to multiple sizes and iterations of the product. What began as a single part has now grown into a family of devices, all manufactured domestically with consistent quality.

Today, these needles save lives not only in combat zones but also in ambulances and emergency response kits across the country. Every unit is a testament to how U.S.-based manufacturing enables compliance, trust, and readiness at the highest levels.

Talk to Our Engineers

Our engineers are ready to collaborate with you on your next product. Whether you’re refining an existing design or developing a new device, Hart’s deep manufacturing experience ensures faster timelines, lower costs, and uncompromising quality.

"*" indicates required fields

This field is for validation purposes and should be left unchanged.

More Case Studies

How One Medical Device Program Became a Long-Term Manufacturing Partnership

Read Case Study

Optimization and Partnership for Reliable Endoscopic Needles

Read Case Study