Custom Needles and Custom Medical Device Manufacturer
For 50 years, Hart Enterprises, Inc. has manufactured custom needles and medical devices for a wide range of customer needs. Hart partners closely with each customer to understand the project, whether it begins as an early concept without a print or is ready for the next stage of development with specifications already in place. Hart is an FDA-registered and ISO 13485-certified custom needle and medical device manufacturer.
Prototyping, Design and Engineering
Many of Hart’s production parts begin with simple prototypes. With no minimum quantities and cost-effective prototyping, the project can get to the next stage as soon as possible. If design help or engineering services are required, Hart can assist with that aspect of the project as well. Engineering the prototypes with production quantities in mind means a more cost-efficient part in the future.
Metal Fabrication
Hart fabricates custom medical device components from stainless steel as well as Nitinol, Inconel and even Titanium. While precise geometric grinding may be the key to many projects, others may require precision slots, holes, bending and even welding metal parts together. Standard or custom depth markings may also be added to the needle. Fabricating metal to tight-tolerance dimensions is at the forefront of Hart’s capabilities. Precise manufacturing techniques coupled with process controls and 100% inspection ensure a quality part.
Plastic Fabrication and Assembly
With nearly 30 dedicated custom molding machines, Hart helps customers save time and reduce costs by producing both the needle and overmolding in-house rather than relying on multiple vendors and creating additional scrap. Hart can overmold needles with standard hubs or custom hubs designed to meet each customer’s specifications. After overmolding, Hart can also assemble inner and outer needles into a complete device.
Custom Catheter Fabrication
Custom catheter manufacturing is growing segment of Hart’s business. Catheter fabrication includes tipping, marking, overmolding and assembly over the needle. Hart’s ability to not only manufacture the needle but also mold, tip and assemble the catheter creates a one stop shop for any catheter over a needle project. Hart eliminates the need for multiple vendors to ensure a precise fit between the catheter and needle.
Standard Products
In addition to custom needles and devices, Hart has several standard one and two-piece molded products for use in kits. Standard arterial introducer needles include single wall Flashback and Seldinger needles as well as two-piece assembled Cournand and Seldinger needles. Biopsy needles include a range of Chiba needle and Franseen sizes. Two neonatal Spinal needles complete the standard needles provided by Hart.
50 Years of Manufacturing Excellence
Founder owner and operated since 1976, Hart established itself by tackling the difficult solutions in the very first part manufactured at Hart. A design the customer said could not be made but Hart manufactured it, nonetheless. After 50 years, Hart continues to manufacture challenging and even not so challenging projects. Details to quality and tight tolerances make Hart Enterprises a great starting point if you are unsure of your needs or already have specifications in place. If you have an idea or a problem and need a solution…TAKE IT TO HART.
Contact us
- https://www.hartneedles.com
- engineering@hartneedles.com
- 616-887-0400
-
400 Apple Jack Ct
Sparta
MI 49345
United States







