Medical Devices using 3D Printing
Before kick start projects for 3D printing medical devices, looking for biocompatible material is the key objective we are looking at, but how much do we understand about biocompatible materials? Biocompatible materials are materials that are natural or synthetic which are harmless to humans that should not be toxic or injurious and should not cause immunological response.
More and more topics on 3D printing for healthcare had been discussed over the years, but 3D printing may not replace traditional manufacturing of producing medical devices, it offers alternate solution for manufacturers to create medical devices or products with complex geometries or low volume quantity production or prototypes where only 3D CAD file is needed without fabricating the tooling.
Some examples with potential uses of 3D printing:
- Personalized medical products
- Customized prosthetics
- Orthopaedic implants
- Anatomical models
- Surgical Instruments
- Human organs and tissue
Under Food and Drug Administration (FDA), medical devices are defined as follow:
- Instrument, apparatus, implement, machine, contrivance, in vitro reagent, implant or other similar or related article including part or accessory of a component which are recognized in the official National Formulary, or the United States Pharmacopoeia or any supplement to them.
- Intention for use in the diagnosis of disease or other conditions, or in the cure, treatment, mitigation or prevention of disease, in man or other animals.
- Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
Learn more about FDA’s medical devices for 3D printing.
FDA also categorized them into three classification:
Class I: Lowest risk devices such as toothbrushes, very simple diagnostic test, standard wheelchairs, etc.
Class II: Riskier devices with more potential for harm such as complicated test, implantable devices, electronics, etc.
Class III: Lifesaving but high-risk devices such as heart valves, heart pumps, intraocular lenses, etc.
Before any material certified as biocompatible, it needs to go through Biocompatibility Tests like Cytotoxicity, Irritation, Sensitization, Hemocompatibility, Genotoxicity, Long-term toxicity and many more.
Carbon offers best-in-class 3D printing materials for prototyping and functional parts. Their materials combine excellent mechanical characteristics, high resolution and exceptional surface quality into isotropic parts ready for real-world.
MPU 100 is Carbon’s first medical-grade material that offers a unique combination of biocompatibility, sterilizability and durability in addition to engineering-grade mechanical properties. MPU 100 is designed to help medical product manufacturers to accelerate their product development cycles and product quality.
The industry is trying to leverage the power of additive software and hardware to reduce the number of processing steps and components in a device to reduce the overall manufacturing cost.
Part Count Challenge:
Using the two parts shown below, can you think of the “After Design” and “Before Design”?
How would the “After Design” for additive printing look like?
How would the “Before Design” using convention method look like?
The Ginkgo Barista manages Ginkgo3D publications.