About Hart Enteprises, Inc

Founded in 1976 on a challenge other manufacturers deemed impossible, Hart Enterprises has built its reputation on solving the toughest engineering and manufacturing problems in the medical device industry. What began as a single project has grown into a vertically integrated operation serving leading OEMs worldwide.

From our headquarters in Sparta, Michigan, we design and manufacture custom precision needles and medical devices that set the standard for quality, reliability, and innovation. For five decades, we’ve remained committed to one goal… helping our customers and partners deliver better care through better engineering.

100% Engineered and Manufactured in the US
Founder-owned and operated since 1976
FDA Registered & ISO 13485 Certified

History of Hart

Jump to end
1976

Hart Enterprises Founded After Doing “The Impossible”

Our beginning started with the impossible: a project that had been considered impractical for manufacturing for several years. We’ve been doing “the impossible” ever since.

1976

1981

Grand Rapids Relocation

In 1981, the company relocated to the southwest side of Grand Rapids, Michigan to Wyoming, Michigan.

1981
1998

Growth Continues in Sparta, MI

In 1998 we outgrew our facilities and broke ground on our current facility in Sparta, Michigan.

Our growth is the result of dedication to our customers, your customers, and the patients whose fundamental concern is receiving the best care with the least amount of discomfort. You wont find better quality than Hart’s at any price, and we won’t sell directly to end users – not hospitals or doctors.

1998

Today

Leading OEM Supplier of Special Application Needles & Custom Medical Devices

Superior performance produces value and loyalty. Hart’s commitment to zero-critical defects saves time and money.

User-friendly design, exceptional sharpness, and tight tolerances make Hart needles precision instruments with uncommon control and reliability during their intended procedure. Unlike many of our competitors, supporting your business is our full-time job.

Today

Our Commitment to Quality and Innovation

Every component we produce reflects our commitment to process control, repeatability, and precision. Hart’s vertically integrated manufacturing and ISO 13485–certified quality systems ensure that performance and reliability are never left to chance.

Engineering That Solves Real Problems

Our engineers make what’s never been done before practical for manufacturing. From concept to production, Hart’s integrated approach ensures every design decision supports performance in the field and efficiency in production.

Precision, Performance, and Partnership

Every project is engineered to meet strict FDA and ISO 13485 standards, ensuring quality that goes beyond compliance. We invest in advanced technologies and process control to deliver consistent, repeatable results, whether we’re producing one prototype or thousands of assemblies.

Built on Experience, Driven by Purpose

Nearly five decades later, Hart remains a family-owned company grounded in integrity. Our legacy is defined not only by the products we make, but the trust we’ve built with our partners in healthcare and medical technology.

HOW IT ALL BEGAN…

The Dummy Story

Long, long ago, just before Congress created the Medical Device Act in the land of Lilliput, the Kendall Company identified an opportunity to manufacture and market a device conceived at Northwestern University for the early detection of cervical cancer. Due to the small size of the device and the inherent presence of tissue contamination, a disposable device was called for.

After two years of repeated and unsuccessful attempts to have the device manufactured by every known needle and device manufacturer in the country, they referred the project back to one of Kendall’s three engineering facilities. The object was to simplify and modify the design, eliminating those features which were believed to be too difficult for current manufacturing technology, then to find or develop a source to manufacture the device.

The project was assigned to a design engineer with a reputation for solving the most difficult problems in innovative ways. In addition, he had many years of manufacturing experience prior to working at Kendall.

After interviewing the inventing physician and studying the device’s application, he eliminated the separate tip, which had been falling off inside the body (not good!) and replaced the standard metal luer hub with a plastic luer hub, which included a sail or single wing, for identifying the position of the device’s curved tip while it was concealed in the body cavity.

These changes added to the device’s safety and utility, however, these changes made the device even more difficult to manufacture (again, not good!) and moved things in the wrong direction when it came to finding a manufacturer, since both changes required even more specialized and sophisticated manufacturing techniques.

Well, this engineer just didn’t see it that way. After studying the device in a manufacturing context, he concluded that “any dummy should be able to make it…and I know just the dummy!!!”

That engineer was my dad. Can you guess who the dummy was? My dad gave me invaluable help with what became Hart Enterprises, Inc.’s first project. Thanks, Dad!

Alan Taylor, President

Have a complex challenge or a new project? Reach out to Hart’s engineers. We’d love to connect.