Additive manufacturing (AM) has transformed how orthopedic and medical device companies approach innovation. It enables faster iteration, personalized designs, and hands-on collaboration with clinicians. Whether prototyping a new implant geometry or printing patient-specific anatomical models, AM has become nearly universal in the development process.

But for all its success in R&D, 3D printing still rarely makes the leap to full-scale production. And even when it does, many teams struggle to scale consistently or compliantly.

So, what’s holding us back?

The answer lies not only in the printing process itself, but in how we design, plan, and validate new products from the start.

The Prototype Comfort Zone

In the early stages, 3D printing is truly an innovation enabler: Engineers can skip tooling delays. Surgeons can hold a patient’s anatomy in their hands. Design teams can co-develop in real time.

But that speed often leads to a stall once we enter the post-R&D phase. Designs aren’t optimized for production. Materials aren’t biocompatible. There are multiple build file versions. Regulatory documentation is patchy at best, nonexistent in most cases. 

This is the prototype plateau…where great ideas sit, stuck in a cycle of rework or endlessly awaiting the production phase. 

What “Production-Ready” Really Means

Whether your end process is additively manufactured, machined, molded, or cast, getting a device or part into production means meeting a new level of scrutiny. Key considerations include:

• Design for manufacturability: The chosen production method must shape design constraints from day one, not as an afterthought.
• Validated materials and workflows: Prototypes often use materials that enable fast builds. Production requires traceable, often regulated materials with proven post-processing and quality steps.
• Repeatability and compliance: Every print or part must meet the same specs, again and again. That means controlled parameters, inspection protocols, and quality records.
• Cross-functional alignment: The handoff from R&D to manufacturing often fails if manufacturing, regulatory, and quality weren’t involved from the beginning.
• Digital backbone: From segmentation to post-op analysis, a clear digital thread is the foundation of scalable and compliant production. 

When Additive Becomes the Production Method

Fortunately, AM has matured, and companies across sectors are now using it not just to prototype, but for the end game. For certain orthopedic applications, additive even is the ideal production technology. restor3d, for instance, manufactures FDA-cleared, patient-specific implants and devices for complex orthopedic procedures. 

Carlsmed takes a similar personalized-first approach. Its aprevo device is the first FDA-cleared implant specifically designed for anterior spine correction in adult deformity patients.

Both restor3d and Carlsmed rely on AM to actually produce implants, not just prototype them. And they’ve built scalable quality systems to support it.

Beyond startups and scaleups, established players are getting in the game too:

• Stryker has long been a leader in AM-enabled implants, with its Tritanium porous structures used across spine and joint replacement.
• Zimmer Biomet and DePuy Synthes (Johnson & Johnson MedTech) have launched 3D-printed implants in orthopedics and CMF, using additive manufacturing to enable complex geometries and bone ingrowth.

We are also seeing a growing number of hospitals producing regulatory-cleared, patient-specific guides, models, and implants. 

Planning as the Bridge from Design to Production

One of the most overlooked keys to success in scaling production is 3D planning. When planning is treated as part of the production workflow, and not just as a design tool, it creates the foundation for repeatability, automation, and compliance.

There are several reasons why planning matters.

• It anchors designs to surgical intent. Planning ensures what gets manufactured aligns with clinical objectives.
• It standardizes personalization. Structured planning platforms help scale custom products without sacrificing repeatability.
• It enables traceability. Planning data supports regulatory filings, design history, and post-market surveillance.
• It reduces risk. Simulated outcomes allow earlier validation of implant fit, guide orientation, or surgical strategy, before anything physical is built.

In other words, great planning makes production possible at scale.

Carlsmed’s device isn’t just a 3D-printed spinal implant; it’s the result of a personalized planning platform. The plan itself generates both the surgical strategy and the manufacturing-ready implant design.

The Takeaway

Additive manufacturing has evolved. It’s no longer just a tool for engineers to visualize ideas; it’s a legitimate production method for those who treat it as such. But whether you scale with 3D printing or transfer designs to other manufacturing methods, success hinges on the same fundamentals: structured planning, validated processes, and early cross-functional alignment.

3D planning doesn’t replace production, it powers it. And as more orthopedic innovators bridge this gap, the industry moves closer to a future where personalization and production can truly coexist.

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Nora Toure is a recognized leader in the additive manufacturing (AM) industry. She currently serves as the director of medical software sales for North America at Materialise, where she empowers healthcare providers and businesses to harness the potential of 3D planning and printing in medical applications. She is also the founder of Women in 3D Printing, a global organization committed to advancing diversity and inclusion within the 3D printing community.