For most of the last 15 years in orthopedic design and manufacturing, the question I’ve heard again and again about metal additive components was whether the part could be built. That question is much more straightforward today. Any qualified shop can print the part - and while that question is still valid today, the customer expectation bar has been raised and now the focus is on whether the supplier can provide evidence that the part is the same every time and how that documentation is owned and managed.
From my work on one of the first additively manufactured orthopedic device concepts in 2009 to the current time in 2026, the foundational question has changed from “can you print it” to “can you prove it.”
- John Kapitan, CEO Kapstone Medical & Kapstone Manufacturing
That shift is not theoretical and not unique to our experience. Jay Dinsmore of ADDMAN put it plainly in BONEZONE: "Printing is the easy part." What customers now want to know, as Claire Brown, Director of Quality at Precera Medical, has described, is not just "can you print it," but "can you prove it, every time." When the people who make the parts tell you the proof is the product, it is worth paying attention.
Back in 2009, Kapstone Medical teamed up with the Morris Technologies team on what was one of the industry’s first turnkey DMLS services. We paired their leadership in metal additive manufacturing with our engineering, quality, and regulatory work so a customer could realize an additively manufactured part and the evidence to stand behind it all from a single source. The processes and materials have really come a long way since those early days; however, the proof has always driven the value of the part.
FDA’s 2017 guidance on additively manufactured devices is specific about scope: process validation has to hold for all devices and components built in a single build cycle, between build cycles, and between machines.
That is a real list, and most of it lives in the supplier’s files, not yours.
The responsibility for the proof is still yours. The sponsor organization retains ultimate responsibility for product quality, regulatory compliance, and patient safety. Purchasing controls consistently ranks among the top 10 most frequently cited observations in the medical device industry, and change control is where many oversight systems fail.
Since February 2, 2026, FDA inspects outsourcing and purchasing under ISO 13485 clause 7.4 rather than the old 820.50, and lists outsourcing and purchasing among its inspection areas. While the standard has changed, the responsibility hasn’t shifted. Make sure you understand one arrangement in particular: a supplier that holds its qualification data in an FDA Master File and grants you a right of reference has answered a reviewer’s question, but it has not put the data in your hands, let you audit it, or let it travel with you to a second source.
Every item in that package is fine until something changes, and this year a great deal changed. In May, Tecomet and Orchid Orthopedic Solutions closed a merger combining two of the largest orthopedic contract manufacturers across 24 sites. Each merger, site move, or ownership change sits behind somebody’s cleared part. If your equivalence baseline is in your file, each one is a comparison. If it is in the supplier’s, each one is a requalification you may have to fund.
The enforcement version is simpler. FDA cited an orthopedic manufacturer that did not audit an outside supplier of powder to confirm it met product specifications. That powder was polyethylene, not titanium. The finding was about purchasing controls, regardless of what the powder is made of.
On June 18, FDA cleared the 3D MAC Titanium Cranial Plate System for manufacture at Walter Reed — described in trade press as the first implant cleared for a point-of-care institution. In its own release, 3D Systems said it contributed process controls, device design optimization, additive manufacturing workflows, and regulatory strategy, and helped establish a quality management system. The release names no printer. This tells you again where the value sits.
Put the evidence list in the quality agreement before the first production purchase order. Name the delivery format. Name who on your side owns the file. Put an annual audit right in writing, covering the additive facility, the post-processing suppliers, and the quality system. Ask for the package with a due date.
Kapstone Manufacturing will scope and deliver this evidence package for the components we build, and can review the package behind components you source elsewhere and tell you what is missing.
Here is a helpful checklist to reference as you get started:
Ask for the evidence that shows the part is the same every time: machine qualification with equivalence data across every approved machine, a build-position and orientation study, powder specifications with incoming inspection and a validated reuse study, residual-powder removal validation, heat treatment or HIP records tied to lot, surface-finishing and cleaning validation, witness-coupon and CT data, and full traceability from powder lot to release — plus the audit history behind all of it. Most of this lives in the supplier's files, so it should be defined as a deliverable, not assumed.
You are. Even when production is outsourced, the manufacturer of record retains ultimate responsibility for product quality, regulatory compliance, and patient safety. Purchasing controls are consistently among the FDA's most-cited inspection observations — the supplier makes the part, but you remain accountable for proving it meets specification.
What changed for supplier oversight under the FDA's QMSR in 2026?
Since February 2, 2026, the Quality Management System Regulation (QMSR) has governed device quality by incorporating ISO 13485 by reference, so outsourcing and purchasing are now inspected under ISO 13485 clause 7.4 rather than the former 21 CFR 820.50. FDA's inspection program lists outsourcing and purchasing among its inspection areas, which puts supplier qualification and audit records within inspection scope. The standard changed; the manufacturer's responsibility did not.
What should be in place before the first production purchase order?
Put the evidence package in the quality agreement before the first PO: list the required documentation, name the delivery format, and name who on your side owns the file. Include a written annual audit right covering the additive facility, the post-processing suppliers, and the quality system. In short, request the proof along with the parts — with a due date.