Biomedical engineers and material scientists at restor3D are on a mission to revolutionize human reconstructive surgery. They use additive manufacturing to create procedure- and patient-specific metal implants, polymer surgical instrumentation, and preoperative models. With more than 25 Formlabs Form 3B+ printers, they dramatically reduce costs and improve surgical workflows.
The restor3D team initially focused on 3D-printed implants for cervical spine surgeries and encountered a recurring bottleneck: traditionally manufactured stainless steel instrument systems. Such systems are slow to evolve, have significant upfront costs, and often present complications during surgery.
“We were developing an innovative implant that has features that are only achievable with 3D printing, but expecting surgeons to use a very traditional instrument system to deliver the implant. So we realized pretty quickly that evolving the instrument offering alongside the implant innovation was going to be an important differentiator for us,” said Cambre Kelly, CTO of restor3D.
However, the high cost of traditional instrumentation trays disincentivizes hospitals to customize their workflow, evolve their approach, or try new tactics.
“Traditional instrument trays are typically machined from stainless steel and cost upwards of $50,000 per tray,” said Kelly. “As a medical device manufacturer, if you’re going to make the investment into buying 10 instrument trays at $50,000 each, you’re going to be locked into using those for a really long time. You’re really not going to be willing to iterate the design, throw away a tray, and start from scratch or change some seemingly small features.”
restor3d now uses in-house additive manufacturing and offers instruments and accompanying trays at an accessible price so that hospitals can be agile and customize treatments cost-effectively. Creating single-use, procedure-specific tools required a truly agile development process, closing the gap between surgeon feedback and product development to an extent not previously attempted.
“Surgeons are most comfortable with what they trained with. And if they trained 20 or 30 years ago, this technology might not have been available,” said Nathan Evans, senior vice president of product development at restor3D. “We see adoption really start to pivot when surgeons see case reports from some of their peers and see the outcomes that are able to be achieved with technology that they have not yet tried and how it’s unlocking new value, new outcomes, new approaches or clinical workflows.”
Dr. Erik Westerlund, a fellowship-trained orthopedic surgeon who specializes in the spine, is highly impressed with the first-generation anterior cervical discectomy with fusion (ACDF) system created by restor3d.
“It’s not just the implants that are important, but the implants and the implant technique. That’s what makes a successful procedure,” he said. “This new approach by restor3d is a systems approach. Using additive manufacturing, there is integrated parity between the implant and the instrument — the ability to change both to create the best outcome for the patient.”
restor3d’s surgical tools combine metal and polymer parts, created to replace the fully stainless steel instruments many surgeons have used for their entire careers. Their engineering team assesses the range of materials in order to find a polymer that could handle threading and would stand up to use during the surgical procedure after either gamma or steam sterilization.
“The reason that we like Formlabs resin materials is their inter-operative characteristics. Primarily, they’re tough. They allow us to print what we want without too much concern about material thinning or breaking,” said Ben Wesorick, vice president of Patient Specific Engineering at restor3D. “We’ve actually seen these be pretty resistant for things like impactors and cutting tools and drilling guides. So they really provide surgeons with pretty good tactile feedback. I would say the other thing that these materials do for us really well is that they’re flexible from a design perspective.”
Formlabs offers multiple biocompatible SLA and SLS medical-grade materials called BioMed Resins. These materials are developed and manufactured in an ISO 13485-certified facility and are compatible with common disinfection and sterilization methods.
restor3D has an impressive lineup of metal 3D printers, creating tooling and implants in cobalt, chrome, and titanium alloys. Alongside room-sized metal printers, the company hosts a print production facility of Form 3B+’s and other polymer machines. The restor3d team relies on their fleet of Formlabs printers for both single-use instruments as well as patient-specific customized devices.
With this fleet, restor3D can scale on their own terms, adding additional printers over time. The plug-and-play nature of the Form 3B+ allows the team to grow their manufacturing capabilities with demand, instead of investing a massive amount of capital upfront with a long ROI. Plus, the flexibility that comes with using the same machine and material during the development process allows the team to move machines into production when needed.
The company recently moved into a massive, brand-new office complex to help them scale the company and their production to the next level. The new office will support growth in their current product lines and allow additional specialties to be developed.
Watch this video from Formlabs to learn more: