Wohlers Associates helps organizations take advantage of technologies and strategies that enhance the rapid product development and manufacturing process.
By Clare Scott
Additive manufacturing (AM) has been making a significant impact on healthcare for several years. While some of that impact comes in the form of research advances, AM also offers many benefits directly at the point of care (PoC).
One well-known use for 3D printing in healthcare is the creation of anatomical models. Using increasingly detailed patient scans, physicians can print precise replicas of tumors or areas that will require surgery. This allows surgeons to plan an exact course of treatment, or even to simulate surgery before the actual procedure. Anatomical models can also be used to illustrate treatment plans to patients or to educate medical students.
With the increasing availability of biocompatible materials for AM, medical professionals choose the material that best fits the use case for the device. With the increased adoption of AM at the point of care, they can print patient-specific implants or surgical guides. The ability to create an implant, such as, for example, a cranial plate or a joint replacement, that precisely fits the patient means better chances of successful implantation and fewer complications.
The same is true for 3D-printed prosthetics, which also tend to be much more affordable than their traditional counterparts. Overall, 3D printing at the point of care can lower treatment costs, as well as increasing efficiency. If a hospital can print a patient-specific surgical guide in-house, it can not only improve accuracy but reduce the time required for the treatment process.
AM is also a solution to the supply chain issues that are currently so prevalent around the world. The technology has great value when it comes to being able to print supplies on demand. Healthcare professionals can print tools such as forceps, clamps, and scalpel handles as needed, rather than having to keep an excessive amount of supplies in inventory.
An increasing number of healthcare facilities are adding dedicated 3D printing centers in house. As point-of-care 3D printing becomes more common, the potential benefits are boundless. But are there any drawbacks? There are certainly concerns when it comes to the regulation of 3D-printed medical devices, or the lack thereof.
The FDA’s Center for Devices and Radiological Health regulates medical devices, including 3D-printed ones. All 3D-printed devices are still regulated in the same way as that of the conventional medical devices. However, because 3D-printed devices are produced in such a different way than traditional devices, things can get a bit murky. The FDA has drafted some regulatory framework around 3D printing at the point of care, but more details are needed. The agency has also stated that its guidance is subject to change due to the evolving nature of AM.
Many testimonials about point-of-care 3D printing have made the news. A risky surgery that went smoothly thanks to a 3D-printed anatomical model; a patient who is now free from pain due to a patient-specific implant. More regulation could reduce risk and improve safety and efficacy, especially when it comes to devices that will actually be in a patient’s body, such as implants. With the continued drive for point-of-care 3D printing regulation and standardization, the future of the adoption of AM at point of care looks positive
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