Miniature Medical Gears

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Medical Gears
Medical Gears
Miniature Gears
Miniature Gears

At American Precision Gear Co., Inc., our reputation as a provider of precision manufacturing services comes from an understanding of the real world circumstances that many of our customers face. This insight drives the flexibility of our process capabilities, allowing us to provide a level of responsiveness unavailable from other manufacturers.

We were recently contacted by the procurement manager of a major medical device OEM, who was having serious quality issues with high precision gear they were using in a critical FDA-regulated medical device. The gear was exhibiting a high level of failures in use, precipitating a recall of the device and the loss of FDA certification. To enable recertification, the FDA required verification of the root cause and adherence to an FDA authorized corrective action. The corrective action was to replace the current vendor with another qualified ISO certified vendor. It goes without saying that they were under severe time constraints and needed prototypes and production to ramp up as quickly as possible.

To save time on the initial 30 prototypes that would be required for qualification, we decided to use conventional machining methods, as they would eliminate the lag caused by developing the special tooling required for CNC machining. Luckily, our facility is equipped with a large number of both conventional and CNC machining systems, as well as a team of skilled machinists to operate them.

Another advantage that we offered this customer is our skilled and experienced engineering staff. These gears are very small--only .8750" in diameter and .33" in length, with 15 teeth, 20 DP, a 20° pressure angle, and a 63 RMS finish. They are composed of A303 stainless steel and require tolerances of .8500"/.8495" on the diameter and ±.0005" on concentricity. This combination of challenging dimensions, specialized gear profiling, FDA requirements, and accelerated lead times would be a challenge for most manufacturers.

However, we were able to provide this customer with 30 qualified prototype gears within 4 weeks; we also passed the required FDA shop inspection that was required for recertification. We are now this customer's sole provider of this part, supplying 3,600 gears annually.

For more information, see the table below or contact us directly.

Medical Gear Details

Project/Product Name
Large Volume Miniature Medical Gear
Project/Product Description
Medical Device Manufacture had gear failures, required fast turnaround of replacement Contract Manufacturer
Capabilities Applied/Processes
CNC Swiss Turning (Lathe), Threading
Gear Cutting - Hobbing, Conventional
Ultrasonic Cleaning
Laser Etching
Equipment Used to Manufacture Part
Star CNC Swill Machine
Mikron A21/1 Fine Pitch High production gear Hobbers
Monnier Zahner CNC hob machine w/ auto loading
Crest Untrasonics OCJ parts cleaner
Micro Vu Excel visual comparator
Profile Engineering Gear Analyzer 4FPRL w/ PC Software
Overall Part Dimensions
Gear: 15Teeth, 20 DP, 20° Pressure Angle
Length: .33"
Diameter : Ø .8750"
Tightest Tolerances
Ø 0.8500 / .8495 with .0005 Concentricity
Material Used
A303 SST (Stainless Steel)
Material Finish
63 RMS
In process testing/inspection performed
Dimensional Inspection, Gage Inspection
AGMA Quality Testing
Certificate of Conformance Reports
First Article Inspection Report
Industry for Use
Medical Device
Prototype: 30
Production: 3,600 per year
Delivery/Turnaround Time
4 Week prototype including First Article Inspection, and FDA site Inspection.
First production shipment 4 weeks after First Article Approval (by Customer and FDA)
Delivery Location
Ohio, USA
Standards Met
Customer Specifications, 3D CAD Drawing
AGMA Q11 (Quality Level), ISO Certification for procedures.

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