Whether in Europe or beyond, a growing number of hospitals that once relied on external providers for patient-specific models are bringing production in-house, cutting costs and reducing turnaround times. While it is easy to enthuse about this adoption of AM, we must also recognize the complexity that comes with it.
The in-house argument is well-evidenced. At Mayo Clinic, for example, the Anatomical Modelling Unit has built a 24/7 manufacturing service that takes surgeon orders straight from the Electronic Medical Record and turns them into patient-specific tools and sterilizable devices for the operating room. In France, CHU de Brest has gone further by expanding its in-house 3D printing program across multiple departments and developing a vision to produce models for other hospitals.
The arguments behind CHU de Brest’s initiative would be to justify costs and expand the adoption of 3D printing beyond applications meant for the operating theatre. These arguments underline a key consideration of AM integration within the hospital: cost.
Building a compliant, sustainable 3D printing lab inside a hospital requires capital investment, multidisciplinary staffing, appropriate quality management systems and compliance with applicable rules, including EU MDR requirements where relevant, and ongoing maintenance costs that many institutions cannot absorb (yet).
As Materialise noted in its 2025 point-of-care trend report, institutions moving in-house are discovering that scaling requires streamlined workflows, automation, and software integration that most hospital environments are not yet equipped to provide.
In Europe, the regulatory landscape adds another layer of difficulty. As we explored in our analysis of public policies around 3D-printed implants, the EU MDR’s health institution exception allows hospitals to produce and use devices in-house under an exemption from many MDR requirements, including CE marking, under strict conditions.
When devices are manufactured by a separate legal entity, even co-located on the same campus, the in-house exemption cannot be assumed to apply. Reimbursement frameworks, as seen in the healthcare edition of 3D ADEPT Mag, are another argument where countries are not aligned.
What about a hybrid model?
At AZORG Hospitals in Belgium, PrintPlace, once an external manufacturing partner, has been embedded directly on the hospital campus. The proximity enables the clinical intimacy of in-house manufacturing, while the regulatory and operational complexity sits with a specialist partner. Dr. Geert De Naeyer, a urologist at AZORG, is co-developing a patient-specific guidance tool for prostate punctures within this model.
Is this the ideal model?
At first glance, we could legitimately say each model solves a different problem and creates different ones. The in-house model maximizes clinical integration but demands infrastructure that most hospitals don’t have. The outsourced model reduces operational burden but introduces turnaround times, dependency on third parties, and regulatory boundaries that limit what can be produced. The hybrid model is promising but legally and operationally remains full of grey areas.
On July 1st, Additive Talks brings together three practitioners who have each chosen a different path. Dr. Luca Borro runs one of Europe’s most complex pediatric hospital 3D labs at Bambino Gesù. Dr. Geert De Naeyer is navigating the hybrid model at AZORG. Rajan Patel has built a commercial, distributed manufacturing model around an FDA-cleared patient-specific oncology device.
Together, they will discuss where clinical-scale AM in healthcare actually stands and what it will take to move it forward.
The conversation is open to all. Register here.
Source: European Commission, MDCG 2023-1, sections 3.2–3.5.
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