3D printed anatomy models for teaching and display

Printed anatomy models are a teaching tool. Stratasys Direct, a printing service, describes them as giving "hands-on experiences" for medical student training and "visual aids that demystify complex procedures" [1]. In a 2020 survey of 21 hospital 3D printing facilities in North America, every facility that answered reported at least one educational use, such as student or resident teaching, simulation or patient education [2].

What makers here print

• Skulls, with or without a removable top, and individual bones.
• Skeleton sections and spine models.
• Hearts, kidneys, lungs and other organ models, often split in half to show the inside.
• Enlarged models of small structures, such as the inner ear or a tooth.
• Class sets: the same model several times for a group.

Where the files come from

Makers print from generic anatomy or open educational files. Some public libraries publish anatomy files: Stratasys Direct describes heart models printed from the University of Minnesota Visible Heart Lab library [1]. Every library has its own licence, so check that it allows printing and, if you sell or hand out the models, that use too.

Never send a patient's CT or MRI scan. In the US, patient-specific models used to plan surgery are discussed by the FDA as point-of-care device manufacturing [5], and Stratasys, a printer maker, summarises FDA's position that models marketed for diagnostic use must be made with FDA-cleared software [6]. Scans are also health data.

Steps

1. Decide what the model is for. A class demonstration, student handling, a display case or an event stand. Write that in your post.
2. Choose the file. Pick a generic or open educational file and note its licence and source link.
3. Set the size and parts. Life-size or enlarged, and which parts come apart.
4. Pick colours and labels. Colour-coded structures and numbered labels with a key card make a model easier to teach with.
5. Add the label line. Ask for "Education and display model. Not a medical device. Not for diagnosis, treatment planning or use in the body." on the base or a tag.
6. Post the job and compare makers' quotes, past work and the material they plan to use.

Why the purpose matters

Whether something is a medical device depends on what it is made and sold for: the US definition covers articles intended for diagnosis or treatment [3], and the EU regulation defines the intended purpose by what the label, instructions and sales material say [4]. Our reading is that a model made and sold only for teaching and display, with no medical purpose claimed, is not sold as a medical device. Keep the brief, the label and any listing to that purpose.