Process
Path to production
Get your product to market. Whatever stage your part is at, there's a clear set of steps between here and a finished, validated production run.
Two tracks
New design or existing 510(k)
Starting from a blank sheet takes more steps than picking up an existing clearance. Here's what each path looks like.
New products
- 01
Design
It starts with a good design. Optimize your part for additive manufacturing, following DfAM principles, and work with our team to define critical dimensions and tolerances. Consider lattice work to cut weight and cost. Need a hand? You've come to the right place.
- 02
Build
We set the print orientation and support strategy together, then slice the part and fire up the printer.
- 03
Inspect
We inspect the resulting geometry and figure out whether it's acceptable.
- 04
Iterate
It can take a few tries to dial things in. We update drawings and callouts until everything is just the way it should be.
- 05
Validate
Make sure the part performs the way it needs to in use. Depending on your part, that might cover:
- Mechanical performance
- Chemical composition
- Cleaning
- Packaging
- Sterilization
- Transportation
And beyond. Work with your FDA consultant to understand what your unique product needs.
- 06
Iterate
Testing might turn up a few changes worth making. We go back to the drawing board and make them.
- 07
Submit
Our team puts together a design package ready for governing bodies to review as a supplement to your submission.
Existing products
Already have a 510(k)? Send us your designs. We'll get started right away.
- 01
Verify
We create first articles of inspection and make sure your parts are good for testing.
- 02
Validate
Show equivalency to your current offering. Consider which existing validations deserve a second look, like chemical composition and mechanical performance. Work with your FDA consultant to understand what equivalency requires.
- 03
Iterate
Sometimes it takes a few tries. We go back to the drawing board and try again.
- 04
Submit
Our team puts together a design package ready for governing bodies to review as a supplement to your submission.
Production
See it in action
A quick look at how a printed part moves through our facility, from build plate to finished, inspected hardware.
Want the details behind each step?
See how we prove every part meets spec, and how we approach design work before a single layer gets printed.