Evidence map›Paper›PMID 35106697›Full record

Review3D printing in medicine2022

Interpretation of regulatory factors for 3D printing at hospitals and medical centers, or at the point of care.

Brian G Beitler, Paul F Abraham, Alyssa R Glennon, Steven M Tommasini, Lisa L Lattanza, Jonathan M Morris, Daniel H Wiznia

Abstract readReview
In one paragraph

Review in 3D printing in medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Clinical applications of 3D printing in spine surgery: a systematic review.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2025
    Pooled it
  2. Review
  3. Three-Dimensional Printing in Pediatric Orthopaedics: Cost Analysis and Emerging Applications.Journal of the Pediatric Orthopaedic Society of North America · 2026
    Review
  4. Review
  5. Mixed reality improves agreement on surgical approach selection and patient positioning in tibial plateau fracture planning compared to CT, 3DCT and 3D printing.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2026
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Brian G BeitlerDepartment of Orthopaedics and Rehabilitation, Yale School of Medicine, 800 Howard Ave 1st Floor, CT, 06519, New Haven, USA. Brian.beitler@yale.edu.
Paul F AbrahamDepartment of Orthopaedic Surgery, Keck School of Medicine of USC, Los Angeles, CA, USA.
Alyssa R Glennon, Materialise, Plymouth, MI, USA.
Steven M TommasiniDepartment of Orthopaedics and Rehabilitation, Yale School of Medicine, 800 Howard Ave 1st Floor, CT, 06519, New Haven, USA.
Lisa L LattanzaDepartment of Orthopaedics and Rehabilitation, Yale School of Medicine, 800 Howard Ave 1st Floor, CT, 06519, New Haven, USA.
Jonathan M MorrisDepartment of Radiology, The Mayo Clinic, Rochester, MN, USA.
Daniel H WizniaDepartment of Orthopaedics and Rehabilitation, Yale School of Medicine, 800 Howard Ave 1st Floor, CT, 06519, New Haven, USA.

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NIA Short Term Research Training: Students in Health Professional SchoolsT35AG049685 · NIA · YALE UNIVERSITY · PI Sarwat I Chaudhry, Terri R. Fried · 2016 to 2026
$804k
NCATS NIH HHS UL1 TR001863NIA NIH HHS T35 AG049685
6 · The paper itself

Abstract

3D printing is revolutionizing the medical device landscape through its ability to rapidly create patient-specific anatomic models, surgical instruments, and implants. Recent advances in 3D printing technology have allowed for the creation of point-of-care (PoC) 3D printing centers. These PoC centers blur the line between healthcare provider, medical center, and device manufacturer, creating regulatory ambiguity. The United States Food & Drug Administration (FDA) currently regulates 3D printed devices through existing medical device regulations. However, the FDA is increasingly interested in developing guidelines and regulations specifically for PoC 3D printing due to its rapid adoption across the healthcare institutions. In this article, we review the regulatory framework that governs medical devices, discuss how PoC 3D printing falls within this framework, and describe a novel conceptual framework that the FDA has proposed. Finally, through analysis of the aforementioned regulations and discussions with industry medical 3D printing regulatory experts, we provide recommendations for PoC medical 3D printing best practices so that institutions are best positioned to utilize this revolutionary technology safely and effectively.

Indexed as

3D PrintingFDAMedical device designOrthopedicsPoint-of-care (PoC) 3D Printing

Identifiers

PMID35106697
PMCPMC8809025

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.