Additive manufacturing (AM), often referred to as 3D printing, is frequently used for product research and development in many industries and for commercial production in some, including medical device manufacturing. And it is expected to grow — fast.
In 2019, the global 3D printing market size was valued at more than $11 billion, and it is expected to expand at a compound annual rate exceeding 14% from 2020 to 2027, driven in large part by the healthcare industry. At least 97% of AM professionals expect an increase in medical AM/3D printing applications, according to SME. Between 2010 and 2016, there was a 3,200% increase in the number of hospitals in the United States with a centralized 3D printing facility.
AM describes a group of technologies used to produce three-dimensional objects by adding raw material and building successive layers of it, rather than by removing material through milling, machining or other traditional means of manufacturing. Objects are produced using a digital 3D file, such as a computer-aided design (CAD) drawing or a magnetic resonance image (MRI).
A type of additive manufacturing is 3D printing. The process of printing any 3D-printed device can vary, with different AM technologies and combinations of processing steps, but all require some kind of additive manufacturing software, such as design software, inspection software, printer software and scanning software. The use of a computer, 3D modeling software, 3D printer and layering material are common across AM technologies.
AM offers significant value in the production of customized, fast-to-market devices.
Additive Manufacturing Customization
One of the major benefits of AM is the ability to affordably customize products. AM allows the creation of light, complex designs that are often too difficult or costly to build using traditional machines and methods, so users can design and produce highly complex parts and components and, ultimately, create patient-specific devices or devices with very complex internal structures. For medical devices, AM enables the creation of patient-matched devices by using a patient’s own medical imaging.
Additive Manufacturing Time-to-Market
Another key benefit of AM for medical devices is shorter lead time. AM enables designers and engineers the tools to quickly create and iterate designs and produce parts. Due to its flexibility, 3D printing lets designers make changes easily without having to set up additional equipment or tools, meaning any design iterations of a 3D printed-device can often be done in a matter of hours, accelerating time-to-market for the new device.
Technological advancements and greater availability of AM fabrication equipment are spurring increased AM investment and adoption by the medical device industry and dentistry, where the technology can be used to produce final parts that conform to unique patient profiles.
“In the healthcare sector, additive manufacturing helps the development of artificial tissues and muscles, which replicate the natural human tissues and can be used in replacement surgeries. These capabilities are expected to help in driving the adoption of 3DP across the healthcare vertical and contribute significantly towards the growth of the industrial segment, “ according to a forecast of the 3D printing market between 2020 and 2027. “The dental vertical dominated in 2019, and it is expected to continue dominating the segment over the forecast period.”
Much of the medical industry is already recognizing AM’s value for a variety of applications, including surgical instruments, orthopedic and cranial implants, dental restorations (e.g., crowns), personalized prosthetics and hearing aids, and patient-specific replicas of bones, organs and blood vessels.
Due to its versatility, 3D printing has medical applications in:
The FDA’s Technical Considerations for Additive Manufactured Devices guidance describes the agency’s thinking on technical considerations specific to devices using additive manufacturing.
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