3D-Printed implants for surgery: The ultimate guide

Imagine a world where your medical solutions are as unique as you are. 

That's the promise of 3D-printed implants – a medical marvel set to revolutionize healthcare. Tailored perfectly to individual needs, these implants are not just replacements; they're custom-crafted keys to a more personalized future in medicine, designed for better health.

This innovative approach is more than just a concept; the global 3D printing medical implants market is on an upward trajectory. The global 3D printing medical implants market is projected to reach USD 8.92 billion by 2032, growing at a CAGR of 18.80% from 2023 to 2032 (Global Markets Insights Report).

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What are 3D-printed implants?

3D-printed implants are medical devices designed and manufactured to fit each patient’s unique anatomy. 

They are also known as patient-specific implants, personalized implants, custom implants, customized implants, or even custom-fit implants. These implants are designed to replace or augment damaged or missing tissues, bones, and organs. 

These 3D-printed implants are tailor-made to match each patient’s anatomy based on X-ray, CT, MRI, or other medical imaging scans.  

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What are the benefits of 3D-printed implants?

Personalization

3D printing's capability to recreate intricate anatomical structures provides unprecedented precision and customization that surpasses what conventional implant manufacturing methods could achieve.

Ability to create complex anatomical structures

With the introduction of 3D-printed implants, designers can now replicate complex anatomical structures, including complex medical conditions, congenital deformities, injuries, wear, and fractures.

For instance, consider the intricacy of the human spine and the challenges it poses in spinal surgery. 3D-printed Titanium alloy spinal cages have demonstrated the capacity to alleviate stress on the spine and increase the range of motion at the joint for patients after surgery.

Similarly, let's examine the ankle joint, which has a small surface area but endures substantial forces during activities like walking or running. The bones in this region are small and irregular in shape, rendering it extremely difficult for conventional implant manufacturers to provide a range of sizes and designs. 

3D printing allows medical device manufacturers to tailor their implants to match each patient’s unique needs and bone size, greatly improving fit.

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Enhanced efficiency

3D-printed orthopedic implants streamline surgery by providing surgeons with precise 3D anatomical models for planning. 

By visualizing a patient’s anatomy, diseased areas, and bone structures more accurately before stepping into the OR, surgeons can prepare better for surgery and optimize incisions and surgical techniques, ultimately saving time in the operating room (OR). 

Additionally, with custom-fit implants, surgeons and OR teams can spend less time searching for the right-sized instrument and finding the best-fit implant in each surgery. 

With personalized implants, there are fewer implant and instrument trays in the OR, so preparing the OR for an upcoming surgery takes less time. 

Shorter R&D time

3D-printed implants make it easier to create quick and cost-effective prototypes of implant designs through rapid prototyping. This way, engineers can design, test, and iterate concepts much faster, which can help medical device companies launch innovations faster. 

The medical device industry is also subject to stringent quality requirements, including rigorous testing of implant designs before manufacturing. With 3D printed implants, anatomically accurate models of varying sizes can be created and tested much faster, which can help shorten the time to market. 

Accelerated manufacturing time

Once the implant design, required materials, and the chosen manufacturing method are determined, the production process is swift.

Reduced inventory and warehousing costs

Customized implants offer the potential for reductions in inventory and resource requirements. This is particularly true in the field of orthopedics. 

Typically, orthopedic surgeons depend on 2D patient X-rays to estimate the required size and type of implants before surgery. However, X-rays do not offer a 3D perspective of the affected bone. 

To account for this uncertainty, medical device companies resorted to stockpiling a massive number of trays containing implants of various sizes and their associated instruments for each surgery, incurring substantial expenses. 

Planning for surgeries involved moving a lot of implant and instrument trays between cases and from warehouses—a formidable logistical challenge.

As patient-specific implants become more of a norm, there is a huge potential to lower these costs.

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How are 3D-printed implants made? 

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‍The production of 3D-printed implants involves several key steps:

Step 1: Uploading patient images

The process begins with medical imaging, such as CT scans or MRIs, to create a detailed digital model of the patient's affected area or anatomical structure.

Step 2: 3D modeling

Using specialized 3D planning software, the digital medical imaging data is converted into a 3D design model that reflects the patient's unique anatomy. 

Benefits of the latest advancements in 3D modeling platforms include:

• Cloud-based 3D visualization of anatomic models eliminates the need to download, install, and manage bulky software. 
• Direct conversion of 2D X-ray, CT, or MRI images into a 3D representation of a patient’s anatomy.
• Teams of all sizes in different locations can access the platform easily from their laptops or iPads. This makes it incredibly efficient to create, review, and approve 3D implant designs.
• Flexible workflows with role-based permissions for greater security and data privacy.
• Artificial intelligence (AI) powers more streamlined 3D anatomic modeling and implants.  

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Step 3: Implant design

Engineers and surgical teams work together to design the implant to match a patient's specific needs and anatomy. 

This step may involve adjusting the shape, size, and features of the implant for optimal fit and function. Surgeons may also recommend moving the location of the implant or the angle of implantation based on their experience and preference.

Surgeon review and approval are mandatory before an implant can be manufactured and implanted in surgery. 

Step 4: Material selection

The appropriate biocompatible material for the implant is chosen based on the patient's medical condition and the implant's intended purpose. Common materials include metals (e.g., titanium or cobalt-chrome alloys), polymers (e.g., PEEK), and ceramics (e.g., hydroxyapatite). 

Typically, the decision to select a suitable material involves a collaboration between design engineers and manufacturers. 

Step 5: 3D printing

The digital file of the implant design is transferred to a 3D printer capable of handling the selected material. 

Layer by layer, the 3D printer adds material to create the physical implant (which is why 3D printing is also known as additive manufacturing). 

There are various methods of 3D printing technology, like selective laser sintering (SLS) or fused deposition modeling (FDM). The right process for 3D printing is selected based on the design requirements.

• SLS: The SLS 3D printing process involves stacking heated powdered resin with a high-energy laser, scanning the design to melt and fuse metallic powders, and creating the final product.
• FDM: In FDM, 3D printing, a plastic wire is heated until it melts and then squirted out to build up an object layer by layer. It’s like drawing with a glue gun.

Step 6: Post-processing 3D implants

After 3D printing, the implant may undergo post-processing steps, such as heat treatment, polishing, or surface finishing, to improve its structural integrity, biocompatibility, and aesthetics.

Step 7: Quality control

Rigorous quality control and testing procedures are carried out to ensure that the 3D printed implant meets safety and performance standards. This includes assessing dimensional accuracy, material properties, and structural integrity.

Step 8: Sterilization

Implants are subjected to sterilization processes to eliminate any potential contaminants and ensure they are safe for implantation in the human body.

Step 9: Packaging and shipping

3D implants are packaged and shipped to the medical device manufacturing hub or the surgical center in time for surgery. 

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What are the challenges with 3D-printed implants?

Patient-specific implants can be a game-changer in the field of orthopedics, transplants, and other types of surgeries. However, they are still not the gold standard for surgery. 

This is because there are several stages in the process that need to be ironed out before they can be used for every single hip and knee replacement, spine and ankle surgery, and more.

Challenges with 3D printed implants include:

Collaboration between teams during the planning stage is complicated

Creating patient-specific implants involves complex coordination between various teams. Delays and misunderstandings can occur due to frequent communication exchanges, such as emails and calls, between surgical teams and medical device companies. 

Delays in verifying patient images

Additionally, verifying patient images can be time-consuming. Traditionally, medical device teams must confirm that accurate patient files have been uploaded for each case. This step is essential but can lead to delays. 

Time taken to create 3D patient anatomies manually

It could also take a week or more for each patient’s 3D anatomy to be recreated digitally. This could be because of busy or limited team resources needed for this manual process. 

Iterative surgeon review and approval process

After the patient's anatomy is generated, an implant is tailored and precisely fitted onto the patient's digitized anatomy. Another round of phone calls, emails, and text messages ensues to facilitate communication among the busy surgical teams for plan review and approval. 

This process may be time-consuming due to the surgeons' heavy workload and the need for them to evaluate the 3D surgical plans thoroughly.

After reviewing a surgical plan, surgeons may request adjustments or edits to the implant fit or positioning. This triggers another round of necessary but time-consuming communication between surgical teams and the medical device engineers.

3D printing, shipping, and distribution

Depending on the medical device company and its logistics teams, it can take time to print, ship, and ensure the right implant is delivered to the right surgical teams before the surgery date. 

The entire process can take a few weeks, a month, or more. Patients may not be willing to wait so long to schedule surgery, particularly for standard elective procedures like total knee replacement surgeries. 

Expensive user licenses for 3D planning surgeries limit designers

Medical device companies must ensure the highest quality of their 3D surgical software and implants while monitoring costs. 

However, many 3D surgical planning platforms charge exorbitant rates per user license, forcing companies to limit the number of engineers working on patient-specific implant cases. This constraint also slows growth, and business leaders may focus their efforts elsewhere. 

Enhatch offers unlimited user licenses, flexible workflows, and cloud-based 3D planning. So, you can plan and manage all your patient-specific cases on one platform from anywhere.