By Sean Fenske, Editor-in-Chief
While the orthopedic industry can sometimes seem to advance at a snail’s pace, there has been much to be excited about in terms of new innovations breaking into the sector. From the influx of digital technologies, robotic surgical systems, and efficient manufacturing methods, the industry has seen better results for surgeons and their patients.
While not as new as some of the other aforementioned technologies, additive manufacturing (AM) has been one that has rapidly made a positive impact and provided new capabilities to device makers. Questions still abound, however, with regard to how this fabrication technique compares to more established options and the advantages gained from its use.
To help clarify the value proposition for orthopedic device and implant manufacturers considering additive manufacturing, Alkaios Bournias Varotsis, product marketing manager for nTopology, addressed a number of questions. He offers insights about the use of AM for orthopedic devices, considerations to keep in mind, and benefits.
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.
Click here to learn more about nTopology >>>>>
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
While the orthopedic industry can sometimes seem to advance at a snail’s pace, there has been much to be excited about in terms of new innovations breaking into the sector. From the influx of digital technologies, robotic surgical systems, and efficient manufacturing methods, the industry has seen better results for surgeons and their patients.
While not as new as some of the other aforementioned technologies, additive manufacturing (AM) has been one that has rapidly made a positive impact and provided new capabilities to device makers. Questions still abound, however, with regard to how this fabrication technique compares to more established options and the advantages gained from its use.
To help clarify the value proposition for orthopedic device and implant manufacturers considering additive manufacturing, Alkaios Bournias Varotsis, product marketing manager for nTopology, addressed a number of questions. He offers insights about the use of AM for orthopedic devices, considerations to keep in mind, and benefits.
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.
Click here to learn more about nTopology >>>>>
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
