Prototyping, Design, & Engineering

Hart provides engineering-driven device design and prototyping for specialty needles, cannulas, and multi-component medical devices. We help you define how your device should perform, how each part interacts, and how to scale production without compromising quality. Our cross-functional approach reduces development risk by aligning engineering decisions with manufacturing realities early—delivering a device that’s optimized for usability, consistency, and cost-effective production.

Prototype-Ready Engineering Without Production Minimums

Hart supports early-stage development without requiring large orders. Whether you need a handful of units for evaluation or multiple prototype rounds, we provide agile manufacturing to help refine materials, bonding, coatings, and components.

End-to-End Design for Multi-Component Devices

We engineer every interface with purpose, ensuring that each component—from tubes and hubs to lumens and coatings—works seamlessly together. By integrating assembly strategy into the design phase, Hart ensures your device transitions from prototype to production smoothly.

Precision Development That Moves From Concept to Build

Hart blends engineering insight with practical manufacturing experience to create devices that are both innovative and buildable. We determine the right combination of sharpness, material, joining method, flexibility, and flow to ensure your product delivers repeatable results.

Need Rapid Iteration or a Device Designed From the Ground Up? Hart Can Help.

From urgent development cycles to long-term device planning, Hart’s engineering team brings clarity and speed to the product design process. We identify risks early, refine device function through targeted prototypes, and select the right materials and processes to improve stability during assembly and high-volume production. You gain a design that satisfies product requirements without introducing unseen manufacturing challenges later.
100% Engineered and Manufactured in the US
Founder-owned and operated since 1976
FDA Registered & ISO 13485 Certified

Our Core Custom Capabilities

Hart’s vertically integrated capabilities allow us to manage every engineering decision through prototyping, testing, and production scale. With in-house tooling, grinding, coating, cleaning, packaging, and sterilization support, we control quality at every step and enhance speed to market.

Rapid Prototyping for Needles, Cannulas, and Plastic Assemblies

Hart provides fast-turn prototype builds using production-grade tooling and processes. This enables early testing of performance-critical features like penetration, flow, and bonding strength, helping teams validate assumptions before investing in full manufacturing.

Integrated Device Design That Supports Efficient Production

We design for scalability from the beginning. By aligning engineering choices with high-volume manufacturing constraints—like tolerances, material performance, and assembly throughput—we reduce cost, variability, and regulatory risk when your product reaches commercialization.

A Development Partner That Accelerates Your Path to Market

Hart engineers bring decades of experience across specialty needles, single-use devices, multi-lumen assemblies, and advanced biocompatible finishes. We understand the regulatory path, manufacturing constraints, and risk-mitigation strategies needed to support device partners from early ideation through commercialization.

Case Studies

Explore how Hart’s engineering expertise has helped medical device manufacturers overcome unique design and manufacturing challenges. Each case study highlights our problem-solving approach and the measurable impact for our partners.

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

For complex medical devices, there are frequently multiple opportunities for improvement. Materials, assembly methods, packaging, and production flow all contribute to the ultimate success or failure of a complex device. When one thing goes wrong, it affects everything else down the line.
Read Case Study

Optimization and Partnership for Reliable Endoscopic Needles

Hart partners with OEMs to design and build complete medical components and assemblies. Our integrated process combines engineering insight with full-scale production efficiency.
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Scalable, Flexible Approaches to Custom Ophthalmic Surgical Devices

We design and manufacture precision needles for specialized medical applications. Hart engineers to meet exact performance needs through collaboration, quality, and decades of expertise.
Read Case Study

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.

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