Widespread change in the healthcare industry breeds opportunity for innovative companies to disrupt the norm and make significant improvements to patient care. The focus in healthcare today is value-based care, rewarding providers that markedly reduce readmissions and lower the cost for an episode of care.
This content is sponsored by ChoiceSpine.
As an innovator on the forefront of technology trends with the potential to truly improve outcomes and the surgeon experience, ChoiceSpineTM sees great opportunity with an expanded portfolio that includes PEEK, titanium and 3D-printed technology.
ChoiceSpine has been making an impact in the marketplace since it was founded in 2006 and over the past three years has exploded to experience over 20 percent growth annually. While looking to develop new, innovative and dynamic solutions, ChoiceSpine is dedicated to improving patient lives with a team comprised of more than 100 years of experience, including Co-Founders Rick Henson and Marty Altshuler, newly hired Vice President of Marketing KC Gilbert, Vice President of Biologics Christy Coyner and Vice President of Sales Kurt Kessler.
Even through the recent period of changes in the regulatory process, ChoiceSpine as a dynamic company has earned significant clearances for highly innovative technologies and techniques. It is imperative to stay updated on new guidelines and regulations while working with government bodies to ensure patients are given superior quality. ChoiceSpine understands achieving successful market growth and expansion throughout the years requires constant attention to all details surrounding devices, including regulation.
ChoiceSpine was granted FDA clearance for Tiger SharkTM, a titanium alloy interbody spinal stabilization system, in January and worked swiftly to launch the 3D-printed interbody device. The device was developed using ChoiceSpine's BioBondTM porous structure to promote bony ingrowth while offering a large graft window. Since launching in May, Tiger Shark has capitalized on the 3D printing technology process to yield large graft volume and a hydrophilic nanosurface.
"Being successful in the industry requires improving all lives from patients and surgeons to distributors and even regulatory bodies," said ChoiceSpine's Executive Vice President of Strategy and Technology Stephen Ainsworth, PhD. "For surgeons, this could mean improving instrumentation so the implant works more effectively. For regulatory bodies, this means providing all the appropriate information for them to make the best decision. It's all about improving everyone's lives throughout the process."
Titanium vs. PEEK
The interbody fusion cage market is anticipated to reach $2.31 billion by 2023, as predicted by Research Beam, creating an exciting opportunity for cutting-edge companies to develop new technologies. High costs associated with spinal fusions will remain a challenge. The right technology can help lower the overall cost of care due to fewer complications, reduce readmissions and return patients home quickly.
Implant material can affect the quality and cost of a procedure. Typically, implants are produced with either titanium or PEEK. Titanium implants provide a rougher surface and less breakage, promoting better fusion; however, costs to manufacture the implant are high. On the other hand, PEEK implants are radiolucent and can cost less to manufacture.
ChoiceSpineTM first saw success with its SharkTM Spinal Stabilization System. The PEEK-Optima-based implant is designed to provide stabilization in lumbar interbody spinal fusions. Its self-distracting nose for ease of insertion and large graft window are key features to give surgeons success. The company wanted to build off of this product while creating more titanium-based implants and in turn Tiger SharkTM was born. Today, ChoiceSpine's spinal interbody portfolio includes nine PEEK implants, two titanium implants and two titanium sprayed PEEK implants.
"A large-scale process change is being made in the spine fusion space to titanium and more specifically 3D-printed titanium," said ChoiceSpine's Director of Product Development David Hannah. "Titanium has always been a fixture in the spinal market. Now with the addition of manufacturing, we can be creative and even eliminate any previous challenges."
Tiger Shark, however, is not ChoiceSpine's first 3D-printed titanium device. The company has always strived to advance and be innovative with both PEEK and titanium surfaces. In October 2017, ChoiceSpine received FDA clearance for Hawkeye TiTM, a 3D-printed titanium vertebral body replacement device. Similar to the development of Tiger Shark, Hawkeye Ti offers the same complete implant portfolio as the original PEEK Hawkeye device with the added advantage of a 3D-printed, open titanium structure for bone in-growth.
There is room for innovation in both titanium and PEEK implants. "The ability to create a titanium implant through 3D-printed technology brings on a new design ability, such as creating a porous structure rather than relying on subtractive manufacturing techniques," Dr. Ainsworth said. ChoiceSpine recognizes the desire for both titanium and PEEK implants and includes both in their portfolio. Its Tiger Shark launch complements ChoiceSpine's SharkTM Spinal Stabilization System, an interbody made from a PEEK-Optima polymer. Looking into the future, advancements in technology will address the cost issues and manufacturing challenges with titanium implants.
3D-Printed Technology Brings New Possibilities to Life
3D-printing technology is a new concept for orthopedic and spine device companies that could be disruptive to traditional implant manufacturing; it allows surgeons to request patient-specific implants but remains a luxury in most cases.
"3D-printing techniques create intricate three-dimensional implants, layer by layer, allowing a freedom of design and surface characteristics unattainable through conventional machining," said Dr. Ainsworth. "It revolutionizes our approach to design."
However, 3D-printed technology is still emerging in the orthopedic space, leaving room for significant innovation. "It's too early to predict how the introduction of 3D-printing technology has affected ChoiceSpineTM since the market is moving, but it is moving at a slower pace compared to the spine industry as a whole," said Mr. Altshuler. "The desire to cut down on inventory by utilizing better lead times and smaller orders, where sometimes the uncommon sizes can accumulate, is boosting the use of 3D-printed technology."
Additionally, the pressure to develop patient-specific implants follows the demand to keep infection and readmission rates down. The chance of deformity from fusion procedures decreases with patient-specific technology, reducing the number of revision surgeries. Hospitals then report lower overall costs while capturing more of the reimbursement under value-based contracts such as bundled payments.
The 3D-printed technology can also be a win for surgeons. It interacts well with titanium as well as promotes implant customization based on the patient's anatomy. In a customer-focused healthcare system, ChoiceSpine's new technology can fulfill the demand to provide patients with the most efficient and high-quality care.
New Partnerships, New Possibilities
Device manufacturers are able to produce and deliver implants quicker by using 3D-printed technology. In the past, surgeons were delivered a mass supply of various implants; however, in some cases the implants still didn't fit the patient. As a result, patients either received unfit implants or waited longer times for an implant to be manufactured.
While 3D printing is not accessible for all spine device companies, there are ways to acquire the technology, and ChoiceSpine has made significant investment into this opportunity. The company initially partnered with other players in the industry that excel in 3D-printed technology. As a result of their strategic partnerships and subsequent technology acquisition, the company is able to make impactful improvements and advancements to distinguish itself in the market.
The key partnerships formed to develop and distribute 3D-printed technology pave the way for customizable surgery. Device companies can no longer stand alone in the market with implants only working with specific surgical systems. It is imperative to remain innovative and to challenge the technology thriving in the market. Mr. Altshuler advises companies to broaden their scopes to acquire new technology most valuable to them.
Most recently ChoiceSpine acquired Exactech's spine business in February 2017. Beyond securing its place in the spine industry, the purchase allowed ChoiceSpine to expand their reach internationally. In addition to the company's acquisitions,ChoiceSpine created new possibilities for future development through its addition of a 3D-printed titanium interbody cage product to its portfolio, complementing the existing products while remaining on the forefront of innovation in the spine field.