Case studies of Zamak in FDA-approved medical housings?

Case Studies of Zamak in FDA-Approved Medical Housings

Overview: Why Zamak Is Used in FDA-Regulated Medical Devices

Zamak alloys—particularly Zamak 3 and Zamak 2—are commonly used in medical device housings for diagnostic, monitoring, and therapeutic equipment. These alloys offer precise castability, high surface quality, and mechanical strength suitable for protective enclosures and actuator structures. When paired with FDA-compliant coatings and validated manufacturing processes, Zamak components can be successfully integrated into FDA-approved medical devices.

Case Study 1: Zamak Housing for Diagnostic Blood Analyzer

Application: Enclosure for a handheld point-of-care (POC) blood analysis device

Zamak Alloy Used: Zamak 3

Challenges:

• Required to withstand repeated handling in clinical environments

• Must support nickel-free plating for skin contact compliance

• Needed EMI shielding to protect onboard sensors

Solution: Neway provided a multi-cavity zinc die casting mold to mass-produce the housing with integrated grounding bosses and EMI shielding ribs. The part was electroplated with trivalent chrome and coated with a medical-grade clear lacquer.

Result:

• Passed biocompatibility testing (ISO 10993-5)

• Withstood chemical disinfectants and light EtO sterilization

• Approved as part of an FDA-cleared Class II device

Case Study 2: Locking Housing for Powered Surgical Tool

Application: Internal frame and locking shell for a battery-operated orthopedic surgical tool

Zamak Alloy Used: Zamak 2

Challenges:

• Needed high strength and tight tolerances for mechanical interfaces

• Required precision fit with polycarbonate outer shells

• Must be validated for fatigue durability and thermal exposure

Solution: Neway produced CNC-machined Zamak 2 components post-casting for critical flatness and pin alignment. The component was finished with epoxy powder coating for enhanced wear resistance.

Result:

• Successfully integrated into an FDA-cleared Class I surgical device

• Validated for >100,000 cycle durability under load

• Passed drop, vibration, and chemical resistance testing

Case Study 3: Zamak-Encased Control Panel for Patient Monitoring System

Application: Button housing and rear casing for an ICU-grade monitoring console

Zamak Alloy Used: Zamak 5

Challenges:

• Required a consistent cosmetic finish with minimal secondary processing

• Needed to support painting in multiple OEM color schemes

• Tight deadlines due to hospital system rollout schedule

Solution: Neway delivered production-ready castings within 4 weeks using high-speed tool and die development and fast-turn plating and painting. Surface finishing was validated for adhesion and color stability under disinfectant exposure.

Result:

• Approved as part of a system listed in the FDA 510(k) database

• Maintained coating integrity after 1,000+ cycles of surface disinfection

• Delivered on time for a nationwide clinical equipment upgrade

Neway’s FDA-Oriented Production Capabilities

Neway supports medical OEMs with:

• ISO-aligned zinc die casting for regulatory-compliant components

• Post-processing compatible with FDA-grade finishes

• Material traceability and batch-level inspection

• Full-service assembly and packaging for Class I and II devices