The Next Generation of 3D Printed Surgical Instruments

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The Next Generation of 3D Printed Surgical Instruments

restor3d is on a mission to empower healthcare providers who repair and reconstruct the human body. It has pursued an approach driven by additive manufacturing due to the design freedom and affordability of 3D printing, which offers a path to disrupt traditional medical markets. The restor3d team drives innovation in precision surgery by changing the way both implants and surgical instruments are developed and delivered.The company was co-founded in 2017 by distinguished entrepreneur, orthopedic surgery professor, and highly-cited materials scientist and engineer Ken Gall.

restor3d leverages 3D printing capabilities to drastically improve surgical care delivery by printing procedure-specific polymer instrumentation that is tailored to cervical spine implants. With over 132,000 anterior cervical discectomy and fusion (ACDF) procedures performed per year in the United States1, this massive market traditionally uses stainless steel instruments. These traditional instrumentation systems are slow to evolve, have significant upfront costs, and often present complications in the surgical workflow.

With a fleet of over 25 Formlabs 3D printers in its production line, restor3D is already printing the next generation of surgical tools. This procedure-specific, single packed sterile instrumentation system result in:

  • Replacement of large, expensive surgical trays.
  • Ability to iterate designs and quickly introduce new tools or features based on surgeon preferences.
  • Dramatic reduction of supply chain and sterilization costs for hospitals.

We spoke with Cambre Kelly, VP of Research and Technology at restor3d, to understand how the team tackled this ambitious endeavor, why they invested in Formlabs 3D printers, and understand what is next for restor3d.

A New Frontier of Surgical Instrumentation

restor3d is comprised of a team of highly skilled biomedical engineers and material scientists who initially focused on 3D printed implants for cervical spine surgeries. But in developing these new implants, the team kept running up against a recurring issue: traditionally manufactured stainless steel instrument systems.

A traditional surgical tray. Source and © : Zimmer Biomet

 

Kelly explained the situation, saying, “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.”

Kelly continued, “we are uniquely capable of delivering true just-in-time products because of our in-house manufacturing and the ability to quickly tune design and geometry based on feedback from the field. Traditional instrument trays are typically machined from stainless steel, and cost upwards of $50,000 per tray. 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. On the other hand, because of what we're doing with directly printing single-use instruments, we're able to iterate and revise our designs pretty nimbly.”

Creating single-use, procedure-specific, surgeon-matched tools required a truly agile development process, closing the gap between surgeon feedback and product development to an extent not previously attempted. restor3D knew surgeons might be hesitant to change their tools; not every surgeon was trained the same way, changing habits is hard, and experienced surgeons may have their own techniques honed over decades of work.

Because of these concerns, restor3D works closely with orthopedic spine surgeons to quickly turn around new tools based on their feedback. By deploying a truly agile and integrated development process, powered by the same in-house 3D printing technology for R&D and manufacturing, the team is able to deliver nimble and precise instrumentation, freeing surgeons from traditional trays that are typically updated every few years at best.

To get a clinical perspective, Formlabs spoke with Dr. Erik Westerlund, a fellowship-trained orthopedic surgeon who specializes in spine. Dr. Westerlund has been highly impressed with the first generation ACDF system created by the restor3d team, saying “the current development process has been the same for the last 20 years. A company has a new implant and/or instrument system. The company shows up, does some prototyping, and a few days or weeks later there is something to look at. Several weeks later a beta instrument shows up. But now, restor3D isn’t turning out a prototype in a few weeks, they’re turning out the real instrument in a few days. To me, that completely changes what is possible.”

He continued, “it’s not just the implants that are important, but the implants and the implant technique. That’s what makes a successful procedure. 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.”

Dr. Westerlund sees an opportunity to not only replace old instrument systems, but also to create new ones that exceed what was possible before. Working with the restor3D team, his input has been critical in designing and developing the new instruments. What’s exciting for him is not just the use of 3D printing in manufacturing, but the capable team restor3D has assembled around the technology, saying, “I feel like someone just took the handcuffs off of us. Most companies are still approaching this as rapid prototyping, not rapid instrument manufacturing – that mindset is completely disruptive, and you need an engineering team built around it to make it happen. This is very disruptive, from an instrument standpoint, because you can start thinking how this completely changes traditional approaches to implant and instrument systems.”

"Most companies are still approaching this as rapid prototyping, not rapid instrument manufacturing – that mindset is completely disruptive, and you need an engineering team built around it to make it happen. This is very disruptive, from an instrument standpoint, because you can start thinking how this completely changes traditional approaches to implant and instrument systems.”

- Dr. Erik Westerlund, Orthopedic Surgeon

 

Addressing Operational & Sterilization Costs

A major line item for hospitals is sterile processing costs. Each time a surgeon opens a surgical tray, even for a single tool, the entire tray has to be processed and re-sterilized. With hundreds of thousands of surgeries per year, these tools generate significant costs for health systems. This also becomes an issue when tools are accidently dropped in the operating room. Someone will have to run out of the O.R., down to central sterile, while the patient is under anesthesia, to find an entirely new tray to replace the dropped tool.

This is where the new restor3D tooling system has another major advantage: they are pre-sterilized, one time use tools, completely eliminating the sterile processing costs for hospitals and surgery centers.

Cambre Kelly

“the timeline between Gen One and Gen Two for a typical medical device manufacturer could be on the order of years. We expect that our iterative loop will be on the order of weeks to months.”

Dr. Westerlund said, “there have been attempts at hospitals to implement lean processes to reduce costs. One hospital was able to save $600,000 per month after using a lean program to reduce their sterile processing costs. That money can buy a lot of implants! So if all these tools became nothing more than a lean process to reduce costs, the hospitals would not complain. Operational costs matter to the patient, to the surgeon who may own the practice, and to the hospital system.”

Along with the sterilization costs, polymer tools offer further long-term cost savings since they can be easily replaced and upgraded. Under traditional manufacturing methods, surgeons could give feedback and not get access or approval for new tools for years. Kelly expects to see this change, saying “the timeline between Gen One and Gen Two for a typical medical device manufacturer could be on the order of years. We expect that our iterative loop will be on the order of weeks to months.”

One reason for the long upgrade cycle for legacy tooling is costs. Instead of waiting for huge upgrades and the associated injection molds, supply chains, and product launches, additive manufacturing enables constant evolution and the capital expenditure reduction of replacing traditional trays. According to Dr. Westerlund, “the whole idea of a product launch goes out the window. If you have a product that continually evolves without the confetti, at any given time you’re getting the best instruments and the best implant out there. The tools are always evolving. That’s huge.”

In-House Additive Manufacturing For Healthcare

Cambre Kelly

“We’re not delivering the bare minimum, but all the ‘nice to haves’ that surgeons are asking for.”

There have been two major developments in recent years that has enabled restor3D to fundamentally change how spine surgeons operate: clinical interest in additive manufacturing solutions, and expanding 3D printing capabilities. Kelly told us, “I think the overall appetite for education from our surgeon users is growing, and they're excited about this technology. I think that they're starting to see the opportunities and the ability to apply this technology in what they're working on to solve some of the clinical problems.”

Growing clinical interest has allowed restor3D to design in parallel or in collaboration with surgeons. Getting input directly from key opinion leaders (KOLs) like Dr. Westerlund is always a benefit in any development process, but it can be vital in healthcare where patient outcomes are on the line. “As the benefits of additive manufacturing have become clear, the old engineer-driven processes are going to become obsolete.” Kelly said that her team “really likes to collaborate directly with our KOLs, get their input, and develop products and instruments that are meeting their clinical needs. We’re not looking to deliver the bare minimum, but all the nice to haves, as well.”

The second advancement is evolving 3D printing capabilities. In recent years, in-house 3D printers have become reliable workhorses for medical device firms, with growing material libraries, quality systems, and ability to scale to production level output.

The continuing development of biocompatible materials for 3D printing exemplifies this progress, and they were an important consideration for restor3D. Its surgical tools are a combination of metal and polymer parts, created to replace the fully stainless steel instruments many surgeons have used for their entire careers. restor3D engineers needed to assess a range of materials, but most importantly one that could handle threading and that would stand up to use during the surgical procedure after either gamma or steam sterilization. Kelly said, “a high toughness 3D printing material was important. The inserters in particular are something that see a lot of impaction force when they're malleting the implant into this space. We needed a material that was not brittle, and would not crack off if it's being malleted, something that could closely replicate what surgeons are used to.” Further, implant trials and sometimes inserters have to be visible under intraoperative fluoroscopy to facilitate sizing testing and implant placement.

Speaking on the feel of the new polymer tools, Dr. Westerlund said “the transition has been completely seamless. The feel is a little different, but the technique is the same.”

3D printers for medical device production have become far more reliable, and industrial level quality is now available at affordable prices. Medical 3D printers are now multi-functional machines, often running 24/7, used across the development process. Kelly commented on this versatility, saying “our goal is to deliver iterative solutions very quickly. And without 3D printing that would not be possible. We’re able to prototype here on the benchtop on the same Formlabs systems that we are using in production.”

Scaling With Formlabs Printers

restor3d has organically expanded their Formlabs printing fleet over the past three years. Today, restor3D has a fleet of 25 Formlabs printers, with 20 of them qualified for use in production full time, and five available for R&D. Using the same machines and materials for R&D and production established a seamless creation process for the engineering team.

Formlabs printers meet the sweet spot for restor3D for a few reasons. One is the ability to scale on their own terms, adding additional printers to their 3D printing fleet over time. The plug and play nature of the Form 3B allows Restor3D to grow their manufacturing capabilities with demand, instead of having to invest a massive amount of capital upfront with a long return on investment. Second, 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 two reasons we have stuck with Formlabs are production flexibility and the ability to incrementally scale. The investment into one of your printers is significantly less than investing half a million dollars to buy one metal printer. So over time we can continue to tack on to our Formlabs fleet as we need to scale incrementally, and do so in a sustainable way that doesn't require a huge capital investment upfront.”

Cambre Kelly, VP of Research and Technology

Kelly put it succinctly, saying “the two reasons we have stuck with Formlabs are production flexibility and the ability to incrementally scale. The investment into one of your printers is significantly less than investing half a million dollars to buy one metal printer. So over time we can continue to tack on to our Formlabs fleet as we need to scale incrementally, and do so in a sustainable way that doesn't require a huge capital investment upfront.”

restor3D has customized one of Formlabs’ resins to achieve the perfect properties for their 3D prints. Formlabs customers can gain access to the Materials Settings Editor program to fine-tune the performance of different materials, or work with our Factory Solutions team to develop a new 3D printing resin or manufacturing facility from scratch. While Formlabs offers a growing library of 30+ materials, including multiple biocompatible materials for healthcare, companies such as restor3D will modify materials to meet specific requirements. 

restor3D: A Proven, Cutting-Edge Partner in Medical 3D Printing

restor3D has established itself as a leader using 3D printing to bring innovation to the surgical room. From algorithm-based operative planning, performance-focused implants, and now a groundbreaking polymer instrument kit. 

Kelly thinks the company is just getting started: “We’re going to continue to expand in the foot and ankle segment as well as the spine segment while developing our pipeline of products into additional orthopedic segments, including upper extremity, trauma, and probably sports medicine as well. Outside of the orthopedic space there's a lot of opportunity to use 3D printing technologies and evolving materials that we have available. We're really positioning ourselves to have the infrastructure and the foundational technology platforms to support addressing problems all across the body and with multiple segments of medicine. We know that there are rules for design for additive manufacturing and we like to push the bounds of those things and try things that might be fringe cases or may or may not work.”

The medical space has seen a major uptick in the adoption of 3D printing in just the past five years. As costs continue to fall, and material selection expands, additive manufacturing is going to fuel partnerships like those between restor3D and innovative surgeons like Dr. Westerlund. Ultimately, it’s going to be the surgeons and patients who benefit through more affordable, safer, and successful operations. “We don’t need to talk about the disruptive capacity of additive manufacturing, it’s happening now,” said Dr. Westerlund. 

To learn more about how 3D printing can be used for medical applications, email us at sales@puzzlebox3d.com.

This guest post was originally published on Formlabs blog site. The content in this guest blog is for informational and educational purposes only and may contain copyrighted material from Formlabs.
Source: Formlabs

 

 


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