A combination of radiology, computer-aided design (CAD), and additive manufacturing technologies have made it possible to create patient-specific models, implants, or tools to aid in surgeries worldwide. Spinal implants, cutting guides, and replicas of patients’ hearts are just a few of the ways in which digital manufacturing processes have improved the medical industry today.
As the techniques for implementing additive manufacturing technology for medicine are refined, there looms a crucial problem, which is a problem of access. While the FDA is slowly approving some uses of additive manufacturing, most of them are still in a holding pattern, and as such are not eligible for insurance reimbursement.
If we can demonstrate that this process is intrinsically sterile, we would hypothetically be able to create patient-specific parts at an incredibly low cost.
This problem is compounded by the tremendous cost of industrial additive manufacturing technologies so far the only kind of technologies that can print in autoclavable materials. These machines generally have tremendous footprints, and expensive proprietary material. The significantly more affordable hobbyist machines, while alleviating the issues of cost and size, are not able to print in autoclavable materials.
What if we could prove that 3D printing—in the form of fused deposition modeling (FDM)—provides sterile printing? If we can demonstrate that this process is intrinsically sterile, we would hypothetically be able to create patient-specific parts at an incredibly low cost, thereby increasing access and quality of life for our patients.
A 2010 survey estimated that roughly one-third of people living in low-income countries have almost zero access to surgical tools due to the lack of facilities or basic equipment. However, research at the University of Arizona demonstrated that this can be solved by 3D printing sterilized Army-Navy surgical retractors.
Normally, these instruments cost approximately $47 USD, yet with the sterilized 3D printing methods utilized by university researchers, the cost was reduced to a mere $2.77 USD per unit. The instruments in these cases were sterilized with glutaraldehyde, an FDA-approved sterilant. However, glutaraldehyde is also toxic, and its use is thus limited.
With the sterilized 3D printing methods utilized by university researchers, the cost was reduced to a mere $2.77 USD per unit.
Luckily, a collaborative study between the University of California Davis Genome Center, University of Michigan, Michigan State University, University of Washington, and Pivot Bio, Inc. demonstrated that the process of FDM 3D printing is, from a methodological perspective, intrinsically sterile. The high heat and pressure from the extruders end sterilizes the plastic as it passes through. The result is an inexpensive, sterile unit, which will remain as such as long as it is handled properly. This technology would be perfect for implementation in any scenario where resources are finite, which tends to be the majority of cases.
3D printing has revolutionized many different industries, allowing for the printing of custom parts at low costs. If the process of FDM printing can be proven to produce sterile unit, and a method can be devised to maintain their sterility, it would allow the medical field at large to take advantage of the unique properties of 3D printers as well, opening the doors to many possibilities for many more people.
Specifically, in healthcare, a reduced cost option poses a value based outcome poised to accelerate wider adoption of 3D printed patient anatomies and pre-surgical guides by mitigating the need to seek insurance reimbursement which are currently posing barriers.
Dima Elissa is CEO and founder of VisMed-3D, a biomedical design and consulting firm that has emerged as one of the leaders for 3D biomedical visualization and printing in personalized medicine.