How Additive Manufacturing Is Changing the Orthopedics Industry—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief
 
The orthopedic device industry (and really, medtech at large) is going through a rapid revolution where the influx of numerous technologies are leading to incredible advancements. From artificial intelligence to automation to digital healthcare, both the face of manufacturing as well as the offerings to physicians and patients is changing quickly.
 
Included in this wave of innovation is additive manufacturing (AM). In comparison, 3D printing and additive manufacturing are already a more mature technology than some of the aforementioned advancements, but it’s still relatively young in the potential for it being realized. As such, companies need to consider how it can be used and the factors they need to consider before implementing it.
 
To address questions around this topic, Alkaios Bournias Varotsis, product marketing manager for nTopology, took time to respond to questions about the use of additive manufacturing and its impact on the orthopedic device industry. He tackles topics such as the use of AM for custom implants and also how the fabrication technique compares to other, more traditional technologies.
 
Sean Fenske: How is additive manufacturing being used in the orthopedic device industry today?
 
Alkaios Bournias Varotsis: There are two primary areas where additive manufacturing is being used within the orthopedics industry. It can be used to develop implants with structures to promote bone growth and better follow the individual patient’s anatomy. It can also be utilized to create custom surgical cutting guides that improve surgical precision and reduce operation times.
 
Fenske: When compared to more traditional fabrication technologies, such as machining, what advantages does additive manufacturing offer?
 
Varotsis: AM brings a host of advantages to the table that are fairly unique to the process. It enables porous structures to be created that promote bone growth (aka cementless implants). These 3D-printed structures greatly outperform the conventional metal spray coatings. Also, AM allows for the fabrication of implants that mimic the mechanical properties of bone, bypassing complications (i.e., stress shielding effect). In addition, the process allows for the personalization of an implant (i.e., patient-specific implants) for a rather inexpensive cost. Patient-specific implants can be delivered within days, which is not possible with other technologies.
 
Fenske: What limitations are there with additive manufacturing in the development and fabrication of orthopedic devices and implants?
 
Varotsis: While orthopedic AM implants have been around for a decade already, they are still considered a new technology. This means collecting the body of clinical evidence and establishing the quality control procedures required to receive approval from regulatory bodies can be a significant barrier. Yet, the number of companies offering AM implants has been increasing rapidly over the past few years, demonstrating a clear path to market exists.
 
Another practical barrier has to do with design. To get the most out of the technology, you need software tools to accompany your hardware systems that will optimize the print.
 
Fenske: What materials can be used with additive manufacturing when fabricating for orthopedic devices and implants?
 
Varotsis: The primary materials used for orthopedics would include biocompatible metals (mainly titanium), polymers (PEEK, etc.), and ceramics.
 
Fenske: How do additive manufacturing costs compare to other fabrication methods for orthopedic technologies?
 
Varotsis: AM implants can be approximately 10% to 30% more expensive than traditional implants. However, this is the wrong number upon which to focus. If you consider the total cost of care, there are multiple clinical studies that have shown AM implants reduce the total cost.
 
In nine out of ten cases, using a patient-specific hip implant is more cost effective than using a standard implant.¹ Only 5% to 25% of the total cost of orthopedic surgery is attributed to the implant. The majority comes from hospital services and length of stay.² In addition, the average time saved in the operating room when using patient-specific surgical guides is estimated at 23 minutes, which equates to approximately $1,500 saved per case.³ The fact that AM implants can result in shorter procedures and reduced total cost of care¹ should demonstrate the advantages of using this fabrication method.
 
Fenske: What types of benefits are being realized when using additive manufacturing in conjunction with other manufacturing technologies, such as machining (i.e., a hybrid approach)?
 
Varotsis: AM is never used as a standalone process for implants. There is always post-processing involved, as is typical for any critical AM. First, the implants still need to be sterilized. Also, critical surfaces are CNC machined to ensure good-fit of those mating surfaces. There may also be a need for thermal treatment to relieve stresses.
 
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
 
Varotsis: Just a few comments. AM implants are becoming mainstream. The next step is personalized (or patient-specific) devices. These can be built by leveraging the mass customization capabilities of the AM technology. Early clinical studies have shown very positive results.
 
Finally, remember that customization with AM is inexpensive, but the engineers capable of effectively using the technology are not. Selecting a design software that offers design process automation capabilities will unlock this opportunity for your organization.
 
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References
¹ https://pubmed.ncbi.nlm.nih.gov/32409268/
² https://www.mckinsey.com/industries/life-sciences/our-insights/solutions-and-services-in-medical-devices-white-space-or-white-elephants
³ https://www.sciencedirect.com/science/article/abs/pii/S1076633219304180