Medtech is interesting because it's one of the few sectors where AM has really succeeded at scale in production. It's forced to be rigorous: validation, traceability, change control, standardized documentation. That is harder than mastering AM technology itself.
Lessons From Medtech: Deciding When Additive Manufacturing Works and How to Scale It
Expert Interview with Radhika Dhuru, Market Manager for Medtech at | Materialise
Tell us about yourself and your role.
I am the Market Manager for Medtech, at Materialise, working with manufacturers across the full lifecycle, from concept through to scaled production. My focus is on helping teams figure out where additive manufacturing actually solves a real manufacturing problem: complexity, customization, supply chain risk, or iteration speed. A lot of what I do is also talking companies out of ideas that won't work at scale and helping them invest where AM genuinely delivers.
What's the bigger picture on AM in serial manufacturing right now?
AM is now a legitimate production technology for end-use, production-grade parts at scale across many industries, including aerospace, automotive, Medtech, and consumer goods. Regulated industries are leading this shift. Aerospace has proven it works at scale; at Materialise only, we have produced over 650,000 parts. Medtech has proven it through customization at speed. These industries had no choice but to be rigorous as their standards force discipline throughout the entire process. Companies gaining a competitive advantage are those combining AM with process control, software, and regulatory expertise, meaning it is not just about knowing how to print a part. This is a big shift in our industry.
The technology hype is over, and to succeed in series production, you must go through the same process you have with any other manufacturing decision: Does this production technology solve a real problem? Does it outperform alternatives? Can we make it repeatable and compliant?
Medtech is interesting because it's one of the few sectors where AM has really succeeded at scale in production. It's forced to be rigorous: validation, traceability, change control, standardized documentation. That is harder than mastering AM technology itself. Other industries can learn a lot from watching how Medtech has done it.
What's changed in Medtech AM in the last 2–3 years?
The shift is from "Can we print it?" to "Can we repeat it reliably and affordably?" Three years ago, we proved feasibility. Now it's about documentation rigor, automation, traceability, and total cost of ownership, not just cost-per-part. Regulators expect higher standards: formal validation, audit trails, and change control. And there's sharp scrutiny on whether AM truly beats alternatives when you factor in post-processing, inspection, supply chain risk, and lead time. It's more mature, more realistic, but also more interesting.
What's the most common misconception manufacturers have about AM in Medtech?
Everyone focuses on personalized implants, patient-matched hips, surgeon-specific instruments. Those are important applications, but the overlooked value of AM is often in standard, repeatable parts such as enclosures, housings, holders, and connectors, where it can improve manufacturability, reduce assembly, or enable faster design changes without retooling.
Take our work with Ossila’s USB spectrometer as an example. AM enabled component consolidation, halving the number of individual parts, maintaining high accuracy, and enabling assembly three to four times faster. Sartorius eliminated expensive retooling for customized bioreactors. These cases have generated proven economic advantage. The misconception is that personalization is the only driver, when supply chain flexibility, design complexity, and iteration speed matter just as much and represent strong business cases.
What signals that AM is right or wrong for an application?
AM is the right choice when you have:
- Geometry complexity: Internal channels or multi-component consolidation that traditional manufacturing can't do. Look a this MMI's surgical instruments showing this.
- Customization or frequent design changes: Variants that would trigger expensive retooling.
- Low-to-mid volumes (10s to a few thousand annually): where tooling costs are prohibitive. (Mindsailors EEG headset and LMT incubators prove this.)
- Speed to market: When iteration matters more than per-unit cost.
- Supply chain constraints: Long tooling lead times or single-source suppliers.
AM is the wrong choice when you have:
- High, stable volumes (10,000+ units annually): Traditional tooling wins on cost.
- Extreme cost-per-part targets: If throughput dominates margin, AM can't compete.
- Material limits: Performance requirements exceed what AM processes can deliver.
- Post-processing bottleneck: Finishing costs erase the manufacturing advantage.
- Design lock-in: Geometry can't change without an expensive redesign.
How should you think about unit economics in AM?
Most manufacturers focus on cost-per-part alone. You need to think about the total landed cost, including raw materials, scrap, rework, inspection time, sterilization, packaging, and inventory carrying costs.
Then there's the cost of change. With conventional tooling, a design change means a new tool ($50K–$500K) and weeks of lead time. With AM, it's a CAD file update and a reprogram. That flexibility has real value: faster iterations, safer risk-taking, lower cost-of-ownership for customization.
Service level and lead time matter too. AM gives you faster delivery, on-demand production without MOQs, and the ability to absorb demand spikes without inventory buildup. This reduces working capital and improve customer satisfaction.
Finally, consider the supply chain risk cost. Single-source tooling, long lead times, and inventory concentration have hidden costs. AM's flexibility reduces that risk premium.
When you model all of that together, the economics often favor AM even when the per-unit cost looks higher.
What does "industrializing AM" mean in a regulated Medtech?
Industrialization means moving from "we can make this" to "we can make this consistently, traceable, and compliant." That requires process validation with IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification) frameworks tailored to AM. You're validating the printer, the material, the parameters, the post-processing, and the inspection protocols as a system.
Every part you produce needs genealogy: which build, which batch of material, which parameters, which operator, which QA checks. Regulators expect this traceability. All of that needs to be recorded, versioned, and auditable because that's where data integrity and audit trails come in. Formal processes must govern any change and everyone who touches the process needs to follow the same rules, same techniques, same documentation through training and standardized work.
It sounds bureaucratic, and it is! But it's also what separates a production process from a hobby.
Where do AM projects most often fail during scale-up?
I often see the same patterns. Teams optimize the part for printability but don't think through support strategy, post-processing capacity, or inspection complexity, so you end up spending more time finishing than printing. Support removal, cleaning, finishing, and metrology become bottlenecks. When a 2-hour print requires 8 hours of manual finishing, you haven't solved anything.
Lack of traceability. If your production data is disorganized, when something fails, you can't trace it back. And there's always a gap between prototype and production: what worked in R&D with small batches, artisanal post-processing, and manual inspection doesn't translate to production. The constraints are different, and not all AM manufacturers are ready for it.
What role does software play in scaling AM?
Software connects design intent to production reality. Standardized build prep rules ensure every design goes through the same logic: orientation, support placement, parameter selection. Inconsistency in prep equals inconsistency in parts. Manual decisions are the enemy of manufacturing: software that enforces rules, prevents outliers, and automates repetitive work is the difference between art and manufacturing.
Versioning and traceability are equally critical. Every build file, every parameter set, every inspection result needs to be tracked, versioned, and auditable. You need to know exactly what was made and how. And software that provides DFAM feedback helps designers understand constraints early—can't print unsupported overhangs, minimum wall thickness, surface finish expectations—before you commit to a design.
Without software-enabled workflow, you're still doing artisanal manufacturing. You'll never scale reliably.
What should manufacturing leaders watch in 2026 for Medtech AM?
Several things are moving. Workflow automation that gives you a good visualization of the full production process is becoming increasingly sophisticated and easier to use. That reduces bottlenecks and human error. As regulators see more AM in production, they're pushing for standardized validation frameworks. That's actually good as it reduces the ad-hoc approach that slowed early adoption.
The race is now on throughput and post-processing focus. People are realizing the printer is only half the problem. Whoever solves finishing, cleaning, and inspection capacity wins. And as manufacturing becomes more digital, cybersecurity and data integrity matter deeply. Regulators in Medtech care about protecting against unauthorized changes, audit trails, and data tamper-proofing. This is non-negotiable in regulated environments.
The content & opinions in this article are the author’s and do not necessarily represent the views of ManufacturingTomorrow
Materialise
Materialise incorporates more than three decades of 3D printing experience into a range of software solutions and 3D printing services that empower sustainable 3D printing applications. Our open, secure, and flexible end-to-end solutions enable industrial manufacturing and mass personalization in various industries — including healthcare, automotive, aerospace, eyewear, art and design, wearables, and consumer goods. Headquartered in Belgium and with branches worldwide, Materialise combines the largest group of software developers in the industry with one of the world's largest and most complete 3D printing facilities
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