Should You Outsource Your 3D Printing?

3D printing can be a boon for spine specialists, but both cost and investment in time to learn the technology and print to exacting standards can be prohibitive. Here’s how spine specialists can outsource their 3D printing needs.

Intrigued by 3D printing but not sure if that’s an expense your practice can bear? Are you asking yourself, “Is this something I really need?” If you want to the benefits of 3D printing but don’t want to incur the costs—not only monetary, but in terms of time spent learning to use the technology and actually performing the necessary printing tasks—you still have an option: Consider outsourcing.

3d printing spine outsourcingSpine specialists can benefit from 3D printing even if they don't have in-house capabilities. “In the past five years, not only the entire orthopedic arena, but specifically the spinal field, has really gravitated toward trying to integrate 3D printing into their companies. In part it's a new technology and has a bit of glitter and glam to it. But the bigger thing is specific to the fact that when you use 3D printing for spinal implants you can actually create a trabecular structure, a structure you couldn’t generate using conventional machining.”

This, says Randy Theken, is one of the foremost benefits of 3D printing for spinal practices, and a driving factor continuing to popularize the method today. Theken is the founder of numerous medical device companies over the past thirty years, most focused on the spinal industry, including Slice Mfg., , dedicated to full-process metal 3D printing for the spine.

When it comes to actually determining how 3D printing can and will benefit your practice, whether to outsource your printing, and how to choose a printing operation, there’s a lot to consider.

How 3D Printing Can Benefit Spine Specialists

Among the primary uses that 3D printing currently sees in the spinal field are the creation of:

●      Anatomical models for complex surgeries

●      Educational models and teaching tools

●      Custom-made surgical implants (intervertebral discs, biotissues, lateral lumbar interbody fusions)

●      Patient-specific jigs or guides to optimize instrumentation placement

The two most common of these are pre-surgical anatomical models and surgical implants, according to Laura Gilmour, Senior Healthcare Development Manager for EOS. However, she notes that there are often key differences in the types of 3D printing operations creating these two different types of equipment, as models are generally printed with polymers and implants use metal, most often titanium, requiring different printers and processes entirely.

As to the overall benefits of 3D printing, Gilmour notes, “Most spinal organizations are looking at 3D printing because of its ability to make unique shapes. They’re often looking at the titanium cages that [can be] created with additive technology [of which 3D printing is a subset].”

She adds, “If you look at the overall medical device space for implants, spine represents 32% of all additively-manufactured implants that are created, [according to] data from late 2019.” Having a large portion of the market means more uses are constantly being developed and the technologies are always improving.

Ultimately, “Studies have shown that with pre-planned surgery specifications and streamlined 3D printing solutions, patients benefit through reduced operating time, reduced exposure to radiation during operation and, most importantly, significantly reduced complication rates and re-operation rates,” according to EOS.

Benefits to Outsourcing 3D Printing

In most cases it would appear that the benefits of outsourcing your 3D printing needs, whether anatomical models or especially implants, outweigh the drawbacks. Says Theken, “The value in outsourcing 3D printing to a company that knows what they’re doing is huge. Most think you can go buy a 3D printer, bring it back, and start 3D printing, but that’s furthest from the truth, especially in the medical implant market, where you have certain ASTM standards to hit.”

“In other words, if you’re in metal 3D printing for medical implants or aerospace, you have to hit standards that are equivalent to what you would have [created] from a raw piece of material using conventional machining. You can make the same part using 3D printing, but it has to meet all of the mechanical testing standards that your old part would have hit [via] conventional machining.”

On top of the extreme quality standards that need to be met, there are also rigorous steps involved in 3D printing medical implants, making it extremely difficult to do properly in-house in a medical environment. According to Theken this involves bringing “the finished product to a test lab, [doing] elemental analysis on the part, [and testing] the powder before ever [building] something, using very expensive chemical-testing equipment.”

When you’re outsourcing, that’s all handled by your printing partner.

However, it is true that larger surgery centers have a higher likelihood of doing smaller printing projects like these on-site. A Mayo Clinic article even specifies that they opt for in-house printing, noting, “based on spatial information, Mayo Clinic can program the printer to create patient-specific models, such as anatomically precise vertebrae.”

Drawbacks to 3D Printing Outsourcing

The biggest reason to avoid outsourcing, says Theken, is that, “if you keep something in house, one typically can control their outcome better.” You can supervise every step of the process. However, to do it right and hit ASTM standards requires extensive equipment, labs, and machines that traditional practices and hospitals usually can’t have on-site, both because of cost and space constraints.

Theken says 3D printing needs in the past were a different story. “Five years ago as a spine company you maybe didn’t have anywhere to go and had to try to do it in-house. Today, there are more options to do it. And one of those, of course, is Slice Manufacturing.”

How to Choose a 3D Printing Outsourcing Partnership that Lasts

When it comes down to actually selecting a 3D printing operation to outsource your practice’s needs to, whether anatomical models, surgical implants, or other equipment, Theken recommends a few key steps to selecting the right partnership:

  1. Dive deep into the details of 3D printing, and specifically how it relates to the equipment you’ll be looking to print. Know the terminology, the materials you want to use, the ins and outs of the printers, so that you’re able to ask the tough questions and make sure the operation knows what they’re doing and can handle your practice’s needs.
  2. Make calls to various facilities and hold brief phone interviews, narrowing the field to any that will be able to fulfill the equipment you need, with the right materials, timing, and pricing.
  3. Confirm that they’re able to hit the necessary ASTM standards, including the most important, ASTM F-3001.
  4. Visit the facility, especially if you plan to be printing anything that will be surgically implanted into patients. Walk through their entire process on-site.

“You want to find a facility that has everything under one roof. Somewhere they can do everything from the 3D printing itself to the subtractive machining (...because nothing comes out of a 3D printer completed; you always have secondary machining) to the inspection and sterile cleaning and laser marking and packing,” says Theken.

Gilmour advises, that you want to know “whether the facility has a couple different certifications. One, the general quality certification, is ISO 13485. The other thing, especially for the implant side of things, is if the organization is registered with the FDA as a manufacturer.”

You can even get into more intensive questions like whether the facility has a proper powder recycling program and documentation, and how they inspect incoming and outgoing materials. Theken says, once you can “see [firsthand] how they handle the powder, how they do their inspections, and even confirm if they have in-house mechanical testing to validate the 3D printing they do” it’s time to move forward and commit to a partnership. 

Updated on: 01/12/21
Continue Reading
3D Printing Advances Spine Surgery Planning and Training

Get new patient cases delivered to your inbox

Sign up for our healthcare professional eNewsletter, SpineMonitor.
Sign Up!