FAQ
Frequently asked questions
Straight answers on pricing, lead times, materials, and what it's like to work with us.
About us
What is a contract manufacturer?
OEMs, the companies that design medical devices and other products, need a manufacturing partner they can trust. We build designs handed to us by other companies, from first prototype to full production.
How old is your facility?
Our facility finished construction in 2023, built from the ground up around a streamlined additive workflow.
Are you FDA registered?
Yes.
What certifications do you hold?
We're ISO 13485 certified and FDA registered. Our quality system is all digital, built from the ground up for the demands of additive manufacturing.
Are you ISO 13485 certified?
Yes.
Can you help us get through the FDA?
We aren't FDA consultants, but we've been through the approval process many times ourselves. We have validations ready to share, which simplifies the process on your end.
Do you have a master file?
Yes. That makes it easier to approach the FDA using our process. You'll still likely need information from us to prepare your submission.
Do you manufacture products that are already on the market?
Yes. We print parts for customers that are actively used in the body today.
Printing
Do you print, or make printers?
We're a 3D printing service, not a printer manufacturer. Send us your files and we'll get printing.
What is reduced-support printing?
Our AddUp FormUp 350 printers use roller technology to compact the powder bed, which lets us push past what a traditional blade-based recoater can do. Paired with smart geometry and support strategies, we can cut supports and cost.
How does 3D printing give you an advantage over machining?
Speed, complexity, and accessibility. Parts that are too difficult, too costly, or too low volume to machine efficiently with traditional methods are often a great fit for 3D printing.
How do your printers compare to others?
Each of our three AddUp FormUp 350 printers runs roller recoating, a low oxygen chamber, a large build volume, advanced build prep software, and in depth build monitoring. Paired with our in-house parameter set, the results hold up.
What in-house services do you offer?
Printing, five axis machining, wire EDM, heat treatment, and a full inspection suite, all under one roof. See the full lineup on our machines page.
Materials & design
Why titanium?
An excellent strength to weight ratio and high corrosion resistance make titanium a strong choice across applications. Biocompatibility makes it a natural fit for medical devices.
Which material should I choose, titanium or stainless steel?
Grade 23 titanium (Ti-6Al-4V) is light, strong, and biocompatible, the go to for implants and weight sensitive parts. 17-4 PH stainless steel is harder and handles heat well, a good fit for suppressors, tooling, and rugged hardware. Not sure which fits your part? Send it over, or compare them yourself on our materials page.
Can you make lattice designs?
Yes. We design lattices in nTop, powerful lattice design software. Work with our team to build a lattice that meets your needs, or read more about our design process.
What is DfAM?
Design for additive manufacturing. Avoid features smaller than 0.2 mm, avoid islands, and avoid overhangs steeper than 30 degrees. Teardrop shaped holes print cleaner than round ones.
Working with us
What affects pricing?
Cost comes down to material used and time on the machine. To cut cost, reduce material and orient the part for a low Z height.
What is your average lead time?
About 3 weeks for in-house work. Rush options are available on request.
Do you do prototypes or small orders?
Of course. Get in touch and we'll get started.
What files do you need to get started?
We support most major CAD file types and most mesh formats, though .3mf is preferred. We work natively with SolidWorks.
How does quantity affect pricing?
Price drops fast as we fill the print bed (350 mm x 350 mm). The quantity needed to fill it varies by part, but printing 10 or more at a time is usually the most economical place to start.