It is not surprising that additive manufacturing (AM) has made quite the splash in the medical sector. Additive manufacturing makes intuitive sense for the medical industry as it opens up new avenues for both prescriptive and proactive methods.

Whether it is implemented into clinical environments or for improving medical devices, AM has been embraced by surgeons and clinicians in need of patient-specific applications. Now we are seeing surges in use among medical device manufacturers.

With more AM technologies, AM research, and manufacturers, we can expect to see more modalities in the orthopedics field and more aging bodies living longer!

What is 3D Printing for Orthopedics?

A type of additive manufacturing, 3D printing is a process where a machine produces a three-dimensional object. It does so by repeatedly building layers of raw material on top of each other. Each new layer is added to the next to create a complete object.

In order to produce this object, it first needs to be produced in a 3D digital format. Usually, this file type is created in a program like CAD (or computer-aided design) or MRI (magnetic resonance image).

3D provides a lot of flexibility in both how a product is designed and the materials with which it can be created. It even allows for bioprinting, or the use of printing on organic materials, to better assimilate the body and increase the chance that the body will accept the part.

Finally, it is possible to create devices that match a patient’s anatomy (patient-specific) and devices with complex internal structures. Medical devices produced by 3D printing include orthopedic and cranial implants, surgical instruments, dental restorations such as crowns, and external prosthetics.

Now, 3D for medical devices is funded by the U.S. FDA for its three primary medical applications:

  • Medical devices
  • Biologics
  • Drugs regulated

Orthopedics Industry: The Perfect Market for AM

This behemoth industry has no doubt benefitted from additive manufacturing. According to SmarTech Publishing(opens in a new tab), “The global orthopedics market, inclusive of a wide array of products, treatments, and medical practice areas, is massive. Most estimates for market sizing in orthopedics take into account devices, implants, procedures, and equipment used in surgical environments. These all-encompassing market sizing estimates show a global market projected to be worth close to $100 billion over the next eight to ten years.”

Requiring medical implants, orthopedic implants, and more, additive manufacturing has the potential to transform this industry(opens in a new tab). And it already has!

Implantable orthopedic medical devices are, reasonably so, subject to necessary regulations. These regulations improve and control the quality and safety of the device.

Many 3D printed implants are jumping through very similar hoops that non-3D printed medical devices go through. While these regulations are necessary for the health of our patients, it also means that medical device manufacturers are placed under tight restrictions themselves, which inevitably delays the time that updated technologies get in the orthopedic surgeon’s hands and on the patient.

By increasing the precision of device printing through AM and 3D, medical devices are able to get to patients and clinicians faster.

Improved Research for 3D Medical Devices

Research into the best and most cost-effective orthopedic implants has improved the market viability of 3D printing, contributing notably to these developments.

Increasingly, due to demand and funding, medical device manufacturers are able to get more creative in what 3D medical devices can be offered. 3D printing allows surgeons and doctors on-demand solutions for a wide spectrum of needs. Especially in hard times, 3D has been pulled through as one of the technologies able to rapidly produce personal protection equipment (PPE)(opens in a new tab) and other medical devices for isolation wards. This versatile technology is suited to address supply–demand imbalances caused by socio-economic trends and disruptions in supply chains.

Fueled by new research, these manufacturers are able to offer specialized medical devices, which improve upon standard orthopedic implants and move away from only using metal powder bed fusion (laser and electron beam powered) to using mesh structures. This is more affordable with reduced lead-times compared to conventional techniques.

Naturally, 3D printing has helped medical device manufacturers to mimic bone structure almost to a T. The bone structure, surface texture, and porosity can be achieved more accurately, produces high-friction, and improves bone ingrowth around the implant.

Issues with AM in the Medical Market

Unfortunately, getting to market as an additive manufacturer is intense. This sector is a highly regulated process, reasonably, for minute accuracy and the risk of contamination and even death. So even if the hardware is viable, the product needs to pass a quality assurance based on the material, the build process, and the post-build process (like sterilization of the product).

However, and with many manufacturers within the medical industry, this is all par for the course. Companies can (and will) make it through these regulations because the market demands it. For example, hip replacements were quite quickly switched to 3D acetabular systems; knee and spinal implants are also quickly being approved as these implants are becoming more and more critical, and prevalent, as our society ages.

As of 2018, the orthopedic medical device industry is dominated by a few multi-billion conglomerate organizations: Stryker, DePuy Synthes, Zimmer Biomet, and Smith & Nephew. Companies such as 4WEB Medical, Additive Orthopedics, Emerging Implant Technologies, SI-BONE, and OSSDsign are also building a reputation around AM driven-business. Oxford Performance Materials is another contributor, as well as OPM’s OsteoFab process, which combines selective laser sintering(opens in a new tab) with its proprietary material for patient-specific cranial, spinal, and facial implants.

When working directly with manufacturers, companies are able to seek solutions faster than before. Undoubtedly, this is changing how the medical device manufacturing market functions! With specific demands, each company needs to be able to meet anatomical needs. Therefore, we are seeing medical device manufacturers, businesses, researchers, and production crews all working together for quicker product development and approval.

Integrating Additive Manufacturing into Medical Models

The orthopedic industry is clearly embracing additive manufacturing as a viable solution for patient needs. Increased volume in medical device production and in promoting this approach bodes well for this not-so-emerging technology.

Companies with both software and service backgrounds within additive manufacturing will succeed in this regard. Materialise(opens in a new tab) has long been an advocate for this model, and they bring in medical device companies and medical professionals for collaborative product development with patient needs and patient-specific devices as its focal point.

By covering the entire medical spectrum, such as all medical models, surgical tools, and medical guides, integrated with implants and across the disciplines (of virtual planning via autoCAD, device design, 3D printing, and the surgical teams) we can more accurately move towards progress in integrating additive manufacturing into the orthopedic models, and medical models globally!