Custom Medical Device Design & Manufacturing

Hart collaborates with medical device teams to design and manufacture components that perform with accuracy, stability, and repeatable quality. We engineer each feature with purpose, from tip sharpness and lumen size to bonding, coating, and packaging. Whether you’re developing an innovative device or refining an existing one, our engineers bridge the gap between early concept and scalable production. With a focus on manufacturing feasibility, we design products that perform reliably in the field while meeting cost, timeline, and regulatory requirements.

Device-Level Engineering That Integrates Every Component

Our engineers approach each design as part of a complete system. We evaluate how every component interacts, how forces transfer through the device, and how materials impact performance over time.

Tolerances and Materials Tuned for Complete Device Performance

Hart applies strict tolerance control to ensure consistent penetration, flow, stability, and yield across production runs. We assess structural requirements, material compatibility, and bonding stability to define a balance of strength and flexibility that supports safe, predictable use.

Prototype-Ready Manufacturing, No Minimum Order Requirements

Whether you need a few prototypes or large-scale production, Hart designs with manufacturability in mind. Our no-minimum approach enables testing and validation early in the process, minimizing risk and accelerating market readiness.

A Collaborative Team That Brings Complex Devices From Ideation to Production

Precision devices demand more than individual parts—they require thoughtful engineering that considers the entire workflow of assembly, clinical use, sterilization, and storage. Hart works side by side with OEMs to create custom devices that meet performance specifications without compromising manufacturability. Through upfront collaboration, we reduce downstream risk, shorten timelines, and ensure your product is optimized for real-world use.
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 facility controls every aspect of production, enabling tight process control from design and prototyping through assembly and packaging.

Precision Components Engineered to Work Together

We engineer each feature to work cohesively within your full device. From wall thickness and lumen consistency to tip sharpness and flow rate, every design decision is driven by patient safety and field reliability. Our controlled manufacturing processes help ensure consistency across thousands, or millions, of units.

Complex Device Assemblies Built With Repeatable Accuracy

When multiple materials, bonding methods, or welded interfaces are required, Hart provides expertly engineered assembly processes that deliver consistent performance. Our joining methods maintain dimensional accuracy, prevent leaks or breaks, and protect structural integrity during use and sterilization.

Industry-Seasoned, Collaborative Team Members

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.
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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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