Manufacturing solutions from the simplest to the most complex needle and medical device manufacturing challenges
100% Engineered and Manufactured in the US
Founder-owned and operated since 1976
FDA Registered & ISO 13485 Certified
Solutions for the Most Complex Challenges
Looking for a solution that your current vendor or off the shelf needle can’t provide to your customer? Hart is your solution-oriented engineering partner.
Precision Quality for the Largest Range in the Industry
Hart’s manufacturing tolerance can make quality needles as small as 32 gauge, and as large as required. We’ll work with you to optimize tolerances for budget vs. where it matters most.
Custom Needles Engineered for Your Customer’s Needs
From unique dimensions to specialized materials and coatings, our engineers partner with you to design and manufacture solutions that perform reliably and repeatedly.
No Minimum Quantities Enables Engineering Experimentation
Unlike other manufacturing partners, we do not require a minimum for our factory runs. This allows us to partner with your team to experiment in small batches before full scale production.
Have a complex engineering or manufacturing problem?
Take it to Hart.
When off-the-shelf products won’t cut it, Hart provides engineering-driven solutions that bridge the gap between concept and production. Our team works side by side with you to solve unique challenges, from prototype development to full-scale manufacturing.
With over five decades of experience, we know how to balance precision, performance, and manufacturability. Whether you need tighter tolerances, specialty finishes, or scalable production runs, Hart repeatedly delivers solutions that give you and your customers confidence.
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.
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.
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.
Standard Products
Be the first to market and control development costs by utilizing Hart’s standard products. Hart has standard products which have 510k clearance as well as the ability to be customized.
Guidewire Introducers
Easy penetration, control and low trauma are common to all Hart needles. An internally tapered hub promotes smooth introduction of the guidewire. Ultra-Thin wall reduces the puncture size required for a given guidewire.
Product Details
Biopsy Needles
Hart combines its versatile cutting edge grinding capabilities with lightweight, ergonomically designed hubs to provide outstanding accuracy and control on a wide range of percutaneous biopsy procedures.
Product Details
Spinal Needles
Our differential bevels eliminate coring, light-weight, Sure Grip™ plastic hubs bring exceptional control for spinal procedures.
Product Details