Sam Brusco, Associate Editor11.15.22
According to Fortune Business Insights, the size of the global hip replacement market was $6.91 billion in 2021. Growth was slowed fairly dramatically due to COVID-19’s negative effect on the market, which according to the firm declined 12.1% in 2020. However, the market is expected to balloon to $9.91 billion in 2028 at a CAGR of 5.3%, according to the market research firm.
One key trend to hip replacement market growth is incorporation of web-based tools and online resources to gather information for specific diseases. Joint replacement in general is an area where online tools have proliferated, helping patients communicate with their orthopedic surgeons. Robotic-assisted and navigation technologies continue to refine hip replacement and make it more repeatable, as well. The rapid adoption of customized hip implants has also been a critical factor driving the market.
This article will further examine the hip replacement market by way of two large manufacturers with many legacy implants, one smaller company offering personalized options, and a conversation with manufacturing partners.
“Hip replacement patients have high expectations,” said Keith Palmer, worldwide president of hip reconstruction at DePuy Synthes. “Today's patients trend toward the active, middle-aged adult with different demands for post-surgery mobility than those of decades past. They expect to continue to bike, hike, mountain climb, or participate in longer activities on foot without being held back by limited hip mobility and pain.
They want to do so as soon as possible following surgery and may want to engage with their surgeon before surgery and define some surgical goals. They may also be interested in outpatient surgery that could mitigate loss of time at work and enable getting back on their feet sooner.”
“Our solutions are designed to improve accuracy of implant placement and achieve reproducible outcomes,” continued Palmer. “Surgeons need this. We invest the time to understand the surgeon's perspective to gain valuable insights about how and what must be done to achieve repeatable clinical results.”
DePuy Synthes’ Anterior Advantage hip replacement replaces the traditional approach where muscles are cut, allowing the surgeon to keep them intact. By doing this, the technique can allow for shorter recovery, less pain, a shorter stint in the hospital, and fewer post-op restrictions.
“Our technology empowers surgeons to plan for and conduct surgery in ways unique to each patient,” Palmer said. “This begins with the preoperative planning, from sizing of implants to component positioning. One innovation is the Anterior Advantage or Anterior Approach, a suite of solutions including clinically proven implants, surgical instruments, and digital technologies. Surgeons, their OR staffs, and patients benefit from the efficiencies and reproducibility this comprehensive portfolio and approach provides.”
The company also makes a slew of enabling technologies for hip procedures. Its VELYS Digital Surgery platform, which already has FDA clearance for robotic-assisted total knee surgery, also features hip navigation for precise analysis of implant selection and positioning via non-invasive navigation, pre-op digital templating, and case planning.
DePuy Synthes acquired Cuptimize hip-spine analysis this past March. The tool is used to understand and address abnormal spine-pelvis motion in hip replacement patients.
“VELYS Hip Navigation provides non-invasive navigation for component positioning and implant selection, which is designed to increase accuracy and precision to support better patient outcomes and improved surgical experience,” said Palmer. “More recently, we're very excited about the launch of CUPTIMIZE, which automates hip-spine analysis. It's the latest in surgical planning and a feature in VELYS Hip Navigation—a simple, X-ray based, digital tool that uses patient-specific data to help surgeons assess dislocation risk and identify patients with abnormal pelvic tilt who may require unique cup placement.”
“We believe that we're revolutionizing hip reconstruction,” he continued. “It's our job to address unmet surgical needs and meet patient expectations while mitigating the cost challenges arising from today's economic environment. As we continue to design new technologies, we must also prepare for adequate accompanying training materials for surgeons and their OR staffs to quickly adapt these new tools to their clinics and reduce stress in the uptake process, as well as offer ongoing professional education to help to maintain a well-educated staff. Additionally, by co-creating hip solutions alongside surgeons, we can continue to empower them and their healthcare teams with state-of-the-art implants, enabling technology, and surgical techniques that advance and revolutionize the standard of care and hip reconstruction.”
It seems that the focus for companies already well-established in the hip market is on technologies like robotic assistance, navigation, case planning, and post-op guidance to further refine the procedure and bring about improved outcomes.
“It is absolutely a strategic focus—we already have an innovative portfolio of DePuy Synthes implants and will continue to innovate and partner with our surgeons. We do see more focus on the enabling technology—arguably the hip procedure is already a successful and efficient procedure, and we want to continue to enhance the procedure and ensure our surgeons and their patients’ goals are optimized and reproducible with enabling technologies that we continue to bring to the market,” said Palmer.
“Zimmer Biomet continues to adopt new thinking and best practices to stay nimble and predict, innovate, and adapt to shifting market forces,” said Jim Lancaster, president of Zimmer Biomet’s global reconstruction business. “Despite macro-pressures created by the ongoing pandemic, we continue to have a positive outlook on the future and are prepared to meet the demands of an aging population, increasing patient demand for satisfaction, and surgeon desire for technology that aids in efficiency and assists in accurate implant positioning.”
The company earned FDA clearance for ROSA Hip robotically-assisted direct anterior total hip replacement in August 2021. The technology assists direct anterior surgeons with preparation, positioning, and component impaction, while intra-operatively quantifying cup orientation, leg length, and offset.
“ROSA Hip, an application in our ROSA Robotics platform, is our latest innovation in the hip space, an area we are continually investing in,” said Liane Teplitsky, Zimmer Biomet’s president of global robotics and tech & data solutions. “ROSA Hip provides real-time data to the surgeon, which assists in determining accurate implant position based on the patient’s unique anatomy. ROSA Hip specifically accommodates the minimally invasive anterior supine hip approach, which uses a 3-to-6 inch incision on the front of the patient’s leg, compared to an 8-to-12 inch incision on the side with a conventional hip replacement procedure.
This enables the surgeon to have an optimized view of the hip joint during surgery, to preserve the tissue that keeps the joint tight, reducing the risk of dislocation, and to accelerate patient recovery time.”
Surgical Planning Associates (SPA) released HipInsight in February 2021. HipInsight is the first FDA-cleared surgical guidance platform contained entirely within a head-mounted device, the Microsoft HoloLens 2. The platform combines cloud-based pre-operative planning and virtual interoperative guidance, allowing more precision in the most critical operational aspects.
Zimmer Biomet began a deal with SPA in September to commercialize the solution.
"We partnered with SPA on an exclusive agreement to co-market the HipInsight System, the first FDA-cleared mixed reality navigation system for hip replacement," Teplitsky stated. "The HipInsight System is an intuitive, intraoperative guidance system leveraging the Microsoft HoloLens 2 providing 3D holograms of patient-specific anatomy, instrumentation and implants, to help visualize component placement and alignment in real-time. The HipInsight System joins the OptiVu Mixed Reality suite of applications merging real and virtual worlds to provide innovative solutions that enable surgeons and care teams to educate, collaborate and visualize in ways they never have before to create richer understandings.”
“ROSA Hip and HipInsight System Application further enhance ZBEdge, offering customers advanced hip technology solutions to support their preferred philosophies, delivering meaningful connections to unlock insights elevating the standard of care,” said Teplitsky.
The ZB Edge Connected Intelligence suite combines the company’s advanced planning software, the mymobility care management platform, OptiVu Mixed Reality, ROSA Robotics, and smart implants to generate objective data on surgeries and optimize outcomes. Once again, for the hip market denizens, the focus for now is on enabling technologies.
“Our future hip strategy centers around our mission to alleviate pain and improve the quality of life for people around the world,” said Lancaster. “Through focused management and thoughtful investment, we will continue to streamline our business, close portfolio gaps, and drive portfolio leadership through clinically proven implant systems, and integrated digital and robotic technologies ensuring long-term sustainable growth. We continue to invest in solutions that benefit the surgeon and care team and streamline surgical workflow to provide greater efficiencies.”
“Due to demographic and activity level changes, total hip replacement patients are increasingly younger, driving an industry focus on longer lasting implants,” said James Paiva, Conformis’ VP of marketing. “While hip surgery in general has a very high success rate, proper sizing and positioning is more important when it comes to the longevity of any implant. As a result, both enabling technologies and software planning techniques that provide more accurate sizing and placement opportunities contribute to longer implant durability. Implants with aligning features are in high demand, with surgeons adapting to these newer approaches and technologies.”
“There’s also been a shift toward minimally invasive surgical techniques and performing orthopedic procedures at Ambulatory Surgery Centers (ASCs),” Paiva continued. “Outpatient sites of care appeal to the younger generation of patients undergoing total hip arthroplasty, as they provide an earlier return home post-operatively and reduce infection risk.”
The Actera hip hit the market in September, featuring a tri-taper femoral stem design. It added another personalized alternative to cementless hip stems on the market, utilizing the company’s advanced surgical planning and “surgery in a box” delivery model.
“Our recently FDA-approved ACTERA implant utilizes an advanced tri-taper femoral stem design that facilitates minimally invasive total hip arthroplasties, such as the direct anterior approach,” said Paiva. “It provides our surgeon customers with a stem option designed to fit well with their patients’ anatomies and/or preferred surgical techniques.”
“Our Personalized Hip System is the only primary total hip replacement system on the market designed with 3D imaging technology,” he continued. “This system provides a stem (Cordera) with a dual taper femoral geometry, and an acetabular cup size that matches each patient’s specific anatomy. In comparison, generic, off-the-shelf implants can only provide a limited number of femoral neck options, which can inhibit the surgeon’s ability to provide patients with the measurements needed to return them to their anatomical leg lengths and offsets. Studies have shown leg lengths are commonly shorter post-operatively, or the patient’s gate is affected due to widening or shrinking of their hip width (offset). Our implants are designed to provide the patient with the surgeon approved leg length and offset, as well as accurate implant sizing. Because the patients’ sizing needs are determined pre-operatively, our product offerings enable lower inventory of both implants and instruments at medical centers. This model has the potential for cost and resource savings for surgical processing departments and warehousing, which is especially appealing to ASCs.”
For a newer firm like Conformis, breaking into an established market full of legacy products like hip replacements means addressing a clinical need that has been left unfulfilled. The strategy for Conformis in all of its markets has been personalization, which has thus far propelled the company into quite substantial growth.
“Conformis focuses on delivering best-in-class personalization options,” said Paiva. “We are a data-driven company that leverages our novel clinical database and automated surgical planning software to maximize surgeon and patient choice by using this developing a full breadth of solutions—from standard implants to fully personalized solutions through our Image-to-Implant technologies. We will continue to be a pioneer in the personalization space while keeping an eye on developing technology and trends aligned to our mission.”
In order to gather insights on hip implant and instrument manufacturing, ODT spoke with the following experts over the past few weeks:
Sam Brusco: What are the most significant market forces at play for hip implant manufacturing at present?
Ryan Aleshevich: The raw material supply chain, which is likely a universal answer today. Lead times have gone up due also to capacity constraints, and there are price increases due to recent and ongoing inflation. There is demand fluctuation due to COVID’s impact, where most items today are needed due to lack of inventory, thanks to reduced demand and so many unknowns from COVID.
Serdar Omur Goren: MDR is a game-changer not only in hip, but in all OEM manufacturing. MDR restricts the change of validated or ongoing manufacturing processes with a history of safety from the market, without any further validation/clinical proof of safety on the change. Therefore, it’s nearly impossible to change even the machining shop, as addressing change of manufacturing requires new validations for biocompatibility and cleaning tests. Most of the market thinks of MDR as the end of innovation and new processes for European manufacturers or companies interested to sell in Europe.
Seann Nichols: The biggest market forces we see today are skilled labor availability, supply chain disruptions, and predictable demand. The level of quality for an implant drives very tight requirements, which historically has demanded highly skilled machinists and talented finishers to achieve the end results. The pandemic has made it harder to recruit and retain this level of labor across the industry. We’re not the only ones, referring to supply chain disruptions, our suppliers are facing many of the same labor challenges, which has driven longer lead times and disruptions in availability of raw materials and consumables.
Despite the elective nature of hip implants, we actually saw an increase in demand during the pandemic, which I don’t think any of us could have predicted off-hand—including our customers. This puts further strain on the supply chain and unlike in some industries, there is a patient in need of our support at the end of that supply chain. We partnered with one of our customers to transfer a significant portion of their internal manufacturing of a hip implant and integrate it seamlessly into our production. They were facing similar labor challenges and constraints, and needed help addressing this without having to invest significant capital on internal improvements. Utilizing us as a partner gave them a runway to address those labor challenges.
Scott Reese: Our customers constantly look for ways to improve surgical outcomes. In hips, we support a number of OEMs offering more refined implant designs that aid in surgical efficiency and accuracy. This is a major driver for rapid adoption of “fit and fill” or Anterior First tapers hip stems. These designs help maximize the benefit of cementless fixation while reducing the potential for stress shielding. These designs accomplish this by very closely matching the implant shape to that of the broaches used to prepare the IM canal. This close match requires a high degree of manufacturing precision that hasn’t been typical of legacy hip stems. The industry has also been learning how and where to locate ingrowth surfaces to maximize near and long term fixation and limit the potential for stress shielding. The added design features resulted in more complex designs that require many different manufacturing technologies. Because these hips differ significantly from their predecessors, we must look at the process under new lenses. We have to consider the effects of downstream operations and how they can be tailored to improve process capability, repeatability, and cost.
Brusco: What recent technological/operational advancements have most benefitted your hip implant manufacturing business?
Aleshevich: Bio-absorbable implant materials have been the most impactful.
Mark Allen: In the past 10 years our developments in direct compression molded processing capabilities of UHMWPE yielded a composite structure that can reduce potential failure via implant loosening. In addition, this new evolution can promote bio-integration and bone ingrowth, shortening procedure and recovery time. We invest in research and development programs with an eye toward a 10-year vision. By constantly assessing material and implant failure modes, we utilize data and our team’s expertise to drive programs and spur innovation.
Goren: 3D printing, I should say—but 3D printing should already be a validated manufacturing process for that particular implant or instrument. On the other hand, Sayan started to receive more orders from our existing customers in a wider range of products, as we’re already in their approved supplier list complying with MDR.
Guillaume Henry: As many in this industry know, recalls often stem from quality, such as labeling or mix-up issues. We’ve developed a process to avoid product mix up: When it reaches laser marking, we have an automated recognition system that compares the real profile with the DHR number and the part drawing to ensure we’re laser marking the right part. When we begin actually marking the parts, we mark a 2D barcode that serves as a unique identification number for this part. At the last stage of production, just before packaging, we perform a free-weight check to ensure we’re packaging the right product with the right label. By cross-checking the 2D barcode, the DHR, and the patient label, there is no mix-up or mislabeling.
We’ve also worked with customers to reduce the number of labels we need to include. More labels provide greater risk for error or mix-up, so it was important to run this initiative in tandem with our inspection process to reduce that risk. With a key customer we were able to reduce the amount of labels on the finished product by four times the original amount.
Reese: We have been manufacturing hip stems for over 20 years. Today’s hips are intended to serve a younger and more active (high demand) patient. Our operations had previously worked as individual sites working under the Orchid umbrella. This worked well for less complicated products but was not ideal for new devices. We have since realized dedicated value streams allow for greater collaboration across our broad manufacturing modalities. These conversations now consider the entire process, which makes for a better product and more predictable project timelines.
We are also tasked to develop new technology that enhances our customers’ designs. One such example is HA coating—over the years our customers defined a need for an HA coating that delivers HA’s benefits but is not so thick it reduces the implant’s initial stability. They also wanted a strong coating that can survive impaction and stay on the device though the patients recovery.
Our HA coating does this without clogging up the pores of the ingrowth surface. Our thin HA coating was designed specifically for use over a Ti ingrowth surface and has very strong adhesion to the implant surfaces—much higher adhesion strength than the standards developed many years ago, long before these new hip stem designs were even a consideration. This advanced technology is now being used by many of the leading hip brands and we expect to see greater adoption across industry as awareness grows around the importance of adhesion strength of coatings in these new high-demand situations.
One key trend to hip replacement market growth is incorporation of web-based tools and online resources to gather information for specific diseases. Joint replacement in general is an area where online tools have proliferated, helping patients communicate with their orthopedic surgeons. Robotic-assisted and navigation technologies continue to refine hip replacement and make it more repeatable, as well. The rapid adoption of customized hip implants has also been a critical factor driving the market.
This article will further examine the hip replacement market by way of two large manufacturers with many legacy implants, one smaller company offering personalized options, and a conversation with manufacturing partners.
DePuy Synthes
Johnson & Johnson MedTech’s orthopedic business DePuy Synthes has a rich portfolio of hip replacement implants. Options within the business include ACTIS (total), BI-MENTUM (dual mobility) CORAIL (total, revision), GRIPTION (acetabular revision, PINNACLE (total and revision acetabular cup, dual mobility liner), RECLAIM (modular revision), and SUMMIT (tapered).“Hip replacement patients have high expectations,” said Keith Palmer, worldwide president of hip reconstruction at DePuy Synthes. “Today's patients trend toward the active, middle-aged adult with different demands for post-surgery mobility than those of decades past. They expect to continue to bike, hike, mountain climb, or participate in longer activities on foot without being held back by limited hip mobility and pain.
They want to do so as soon as possible following surgery and may want to engage with their surgeon before surgery and define some surgical goals. They may also be interested in outpatient surgery that could mitigate loss of time at work and enable getting back on their feet sooner.”
“Our solutions are designed to improve accuracy of implant placement and achieve reproducible outcomes,” continued Palmer. “Surgeons need this. We invest the time to understand the surgeon's perspective to gain valuable insights about how and what must be done to achieve repeatable clinical results.”
DePuy Synthes’ Anterior Advantage hip replacement replaces the traditional approach where muscles are cut, allowing the surgeon to keep them intact. By doing this, the technique can allow for shorter recovery, less pain, a shorter stint in the hospital, and fewer post-op restrictions.
“Our technology empowers surgeons to plan for and conduct surgery in ways unique to each patient,” Palmer said. “This begins with the preoperative planning, from sizing of implants to component positioning. One innovation is the Anterior Advantage or Anterior Approach, a suite of solutions including clinically proven implants, surgical instruments, and digital technologies. Surgeons, their OR staffs, and patients benefit from the efficiencies and reproducibility this comprehensive portfolio and approach provides.”
The company also makes a slew of enabling technologies for hip procedures. Its VELYS Digital Surgery platform, which already has FDA clearance for robotic-assisted total knee surgery, also features hip navigation for precise analysis of implant selection and positioning via non-invasive navigation, pre-op digital templating, and case planning.
DePuy Synthes acquired Cuptimize hip-spine analysis this past March. The tool is used to understand and address abnormal spine-pelvis motion in hip replacement patients.
“VELYS Hip Navigation provides non-invasive navigation for component positioning and implant selection, which is designed to increase accuracy and precision to support better patient outcomes and improved surgical experience,” said Palmer. “More recently, we're very excited about the launch of CUPTIMIZE, which automates hip-spine analysis. It's the latest in surgical planning and a feature in VELYS Hip Navigation—a simple, X-ray based, digital tool that uses patient-specific data to help surgeons assess dislocation risk and identify patients with abnormal pelvic tilt who may require unique cup placement.”
“We believe that we're revolutionizing hip reconstruction,” he continued. “It's our job to address unmet surgical needs and meet patient expectations while mitigating the cost challenges arising from today's economic environment. As we continue to design new technologies, we must also prepare for adequate accompanying training materials for surgeons and their OR staffs to quickly adapt these new tools to their clinics and reduce stress in the uptake process, as well as offer ongoing professional education to help to maintain a well-educated staff. Additionally, by co-creating hip solutions alongside surgeons, we can continue to empower them and their healthcare teams with state-of-the-art implants, enabling technology, and surgical techniques that advance and revolutionize the standard of care and hip reconstruction.”
It seems that the focus for companies already well-established in the hip market is on technologies like robotic assistance, navigation, case planning, and post-op guidance to further refine the procedure and bring about improved outcomes.
“It is absolutely a strategic focus—we already have an innovative portfolio of DePuy Synthes implants and will continue to innovate and partner with our surgeons. We do see more focus on the enabling technology—arguably the hip procedure is already a successful and efficient procedure, and we want to continue to enhance the procedure and ensure our surgeons and their patients’ goals are optimized and reproducible with enabling technologies that we continue to bring to the market,” said Palmer.
Zimmer Biomet
Orthopedic giant Zimmer Biomet’s hip replacement portfolio includes Avenir (femoral), Echo (femoral), Taperloc (femoral), G7 (acetabular), Trabecular Metal (acetabular), Arcos (revision), Wagner (revision), and the patient-match Triflange acetabular component.“Zimmer Biomet continues to adopt new thinking and best practices to stay nimble and predict, innovate, and adapt to shifting market forces,” said Jim Lancaster, president of Zimmer Biomet’s global reconstruction business. “Despite macro-pressures created by the ongoing pandemic, we continue to have a positive outlook on the future and are prepared to meet the demands of an aging population, increasing patient demand for satisfaction, and surgeon desire for technology that aids in efficiency and assists in accurate implant positioning.”
The company earned FDA clearance for ROSA Hip robotically-assisted direct anterior total hip replacement in August 2021. The technology assists direct anterior surgeons with preparation, positioning, and component impaction, while intra-operatively quantifying cup orientation, leg length, and offset.
“ROSA Hip, an application in our ROSA Robotics platform, is our latest innovation in the hip space, an area we are continually investing in,” said Liane Teplitsky, Zimmer Biomet’s president of global robotics and tech & data solutions. “ROSA Hip provides real-time data to the surgeon, which assists in determining accurate implant position based on the patient’s unique anatomy. ROSA Hip specifically accommodates the minimally invasive anterior supine hip approach, which uses a 3-to-6 inch incision on the front of the patient’s leg, compared to an 8-to-12 inch incision on the side with a conventional hip replacement procedure.
This enables the surgeon to have an optimized view of the hip joint during surgery, to preserve the tissue that keeps the joint tight, reducing the risk of dislocation, and to accelerate patient recovery time.”
Surgical Planning Associates (SPA) released HipInsight in February 2021. HipInsight is the first FDA-cleared surgical guidance platform contained entirely within a head-mounted device, the Microsoft HoloLens 2. The platform combines cloud-based pre-operative planning and virtual interoperative guidance, allowing more precision in the most critical operational aspects.
Zimmer Biomet began a deal with SPA in September to commercialize the solution.
"We partnered with SPA on an exclusive agreement to co-market the HipInsight System, the first FDA-cleared mixed reality navigation system for hip replacement," Teplitsky stated. "The HipInsight System is an intuitive, intraoperative guidance system leveraging the Microsoft HoloLens 2 providing 3D holograms of patient-specific anatomy, instrumentation and implants, to help visualize component placement and alignment in real-time. The HipInsight System joins the OptiVu Mixed Reality suite of applications merging real and virtual worlds to provide innovative solutions that enable surgeons and care teams to educate, collaborate and visualize in ways they never have before to create richer understandings.”
“ROSA Hip and HipInsight System Application further enhance ZBEdge, offering customers advanced hip technology solutions to support their preferred philosophies, delivering meaningful connections to unlock insights elevating the standard of care,” said Teplitsky.
The ZB Edge Connected Intelligence suite combines the company’s advanced planning software, the mymobility care management platform, OptiVu Mixed Reality, ROSA Robotics, and smart implants to generate objective data on surgeries and optimize outcomes. Once again, for the hip market denizens, the focus for now is on enabling technologies.
“Our future hip strategy centers around our mission to alleviate pain and improve the quality of life for people around the world,” said Lancaster. “Through focused management and thoughtful investment, we will continue to streamline our business, close portfolio gaps, and drive portfolio leadership through clinically proven implant systems, and integrated digital and robotic technologies ensuring long-term sustainable growth. We continue to invest in solutions that benefit the surgeon and care team and streamline surgical workflow to provide greater efficiencies.”
Conformis
Conformis is a much newer entry into the hip replacement market. Its flagship iTotal hip system was released in 2017. The firm’s iFit image-to-implant technology uses proprietary imaging and design software to create patient-specific hip replacement options. Since rolling out the iTotal hip the company has since released a next-generation version, the Cordera hip in 2021, and the ACTERA hip earlier this year.“Due to demographic and activity level changes, total hip replacement patients are increasingly younger, driving an industry focus on longer lasting implants,” said James Paiva, Conformis’ VP of marketing. “While hip surgery in general has a very high success rate, proper sizing and positioning is more important when it comes to the longevity of any implant. As a result, both enabling technologies and software planning techniques that provide more accurate sizing and placement opportunities contribute to longer implant durability. Implants with aligning features are in high demand, with surgeons adapting to these newer approaches and technologies.”
“There’s also been a shift toward minimally invasive surgical techniques and performing orthopedic procedures at Ambulatory Surgery Centers (ASCs),” Paiva continued. “Outpatient sites of care appeal to the younger generation of patients undergoing total hip arthroplasty, as they provide an earlier return home post-operatively and reduce infection risk.”
The Actera hip hit the market in September, featuring a tri-taper femoral stem design. It added another personalized alternative to cementless hip stems on the market, utilizing the company’s advanced surgical planning and “surgery in a box” delivery model.
“Our recently FDA-approved ACTERA implant utilizes an advanced tri-taper femoral stem design that facilitates minimally invasive total hip arthroplasties, such as the direct anterior approach,” said Paiva. “It provides our surgeon customers with a stem option designed to fit well with their patients’ anatomies and/or preferred surgical techniques.”
“Our Personalized Hip System is the only primary total hip replacement system on the market designed with 3D imaging technology,” he continued. “This system provides a stem (Cordera) with a dual taper femoral geometry, and an acetabular cup size that matches each patient’s specific anatomy. In comparison, generic, off-the-shelf implants can only provide a limited number of femoral neck options, which can inhibit the surgeon’s ability to provide patients with the measurements needed to return them to their anatomical leg lengths and offsets. Studies have shown leg lengths are commonly shorter post-operatively, or the patient’s gate is affected due to widening or shrinking of their hip width (offset). Our implants are designed to provide the patient with the surgeon approved leg length and offset, as well as accurate implant sizing. Because the patients’ sizing needs are determined pre-operatively, our product offerings enable lower inventory of both implants and instruments at medical centers. This model has the potential for cost and resource savings for surgical processing departments and warehousing, which is especially appealing to ASCs.”
For a newer firm like Conformis, breaking into an established market full of legacy products like hip replacements means addressing a clinical need that has been left unfulfilled. The strategy for Conformis in all of its markets has been personalization, which has thus far propelled the company into quite substantial growth.
“Conformis focuses on delivering best-in-class personalization options,” said Paiva. “We are a data-driven company that leverages our novel clinical database and automated surgical planning software to maximize surgeon and patient choice by using this developing a full breadth of solutions—from standard implants to fully personalized solutions through our Image-to-Implant technologies. We will continue to be a pioneer in the personalization space while keeping an eye on developing technology and trends aligned to our mission.”
Joined at the Hip
Hip replacement technology’s continued innovation puts pressure on manufacturing partners to keep their own manufacturing capabilities at pace. Complex designs and new materials require refinements or innovations in the manufacturing process to produce each new generation of hip replacement technologies.In order to gather insights on hip implant and instrument manufacturing, ODT spoke with the following experts over the past few weeks:
- Ryan Aleshevich, medical sales manager, Cadence Inc.
- Mark Allen, managing director, Orthoplastics, a Viant company.
- Serdar Omur Goren, VP, Sayan Orthopaedics.
- Guillaume Henry, VP of sales and operations, Viant.
- Seann Nichols, senior engineering manager, Viant.
- Scott Reese, VP of business development, Orchid Orthopedic Solutions.
Sam Brusco: What are the most significant market forces at play for hip implant manufacturing at present?
Ryan Aleshevich: The raw material supply chain, which is likely a universal answer today. Lead times have gone up due also to capacity constraints, and there are price increases due to recent and ongoing inflation. There is demand fluctuation due to COVID’s impact, where most items today are needed due to lack of inventory, thanks to reduced demand and so many unknowns from COVID.
Serdar Omur Goren: MDR is a game-changer not only in hip, but in all OEM manufacturing. MDR restricts the change of validated or ongoing manufacturing processes with a history of safety from the market, without any further validation/clinical proof of safety on the change. Therefore, it’s nearly impossible to change even the machining shop, as addressing change of manufacturing requires new validations for biocompatibility and cleaning tests. Most of the market thinks of MDR as the end of innovation and new processes for European manufacturers or companies interested to sell in Europe.
Seann Nichols: The biggest market forces we see today are skilled labor availability, supply chain disruptions, and predictable demand. The level of quality for an implant drives very tight requirements, which historically has demanded highly skilled machinists and talented finishers to achieve the end results. The pandemic has made it harder to recruit and retain this level of labor across the industry. We’re not the only ones, referring to supply chain disruptions, our suppliers are facing many of the same labor challenges, which has driven longer lead times and disruptions in availability of raw materials and consumables.
Despite the elective nature of hip implants, we actually saw an increase in demand during the pandemic, which I don’t think any of us could have predicted off-hand—including our customers. This puts further strain on the supply chain and unlike in some industries, there is a patient in need of our support at the end of that supply chain. We partnered with one of our customers to transfer a significant portion of their internal manufacturing of a hip implant and integrate it seamlessly into our production. They were facing similar labor challenges and constraints, and needed help addressing this without having to invest significant capital on internal improvements. Utilizing us as a partner gave them a runway to address those labor challenges.
Scott Reese: Our customers constantly look for ways to improve surgical outcomes. In hips, we support a number of OEMs offering more refined implant designs that aid in surgical efficiency and accuracy. This is a major driver for rapid adoption of “fit and fill” or Anterior First tapers hip stems. These designs help maximize the benefit of cementless fixation while reducing the potential for stress shielding. These designs accomplish this by very closely matching the implant shape to that of the broaches used to prepare the IM canal. This close match requires a high degree of manufacturing precision that hasn’t been typical of legacy hip stems. The industry has also been learning how and where to locate ingrowth surfaces to maximize near and long term fixation and limit the potential for stress shielding. The added design features resulted in more complex designs that require many different manufacturing technologies. Because these hips differ significantly from their predecessors, we must look at the process under new lenses. We have to consider the effects of downstream operations and how they can be tailored to improve process capability, repeatability, and cost.
Brusco: What recent technological/operational advancements have most benefitted your hip implant manufacturing business?
Aleshevich: Bio-absorbable implant materials have been the most impactful.
Mark Allen: In the past 10 years our developments in direct compression molded processing capabilities of UHMWPE yielded a composite structure that can reduce potential failure via implant loosening. In addition, this new evolution can promote bio-integration and bone ingrowth, shortening procedure and recovery time. We invest in research and development programs with an eye toward a 10-year vision. By constantly assessing material and implant failure modes, we utilize data and our team’s expertise to drive programs and spur innovation.
Goren: 3D printing, I should say—but 3D printing should already be a validated manufacturing process for that particular implant or instrument. On the other hand, Sayan started to receive more orders from our existing customers in a wider range of products, as we’re already in their approved supplier list complying with MDR.
Guillaume Henry: As many in this industry know, recalls often stem from quality, such as labeling or mix-up issues. We’ve developed a process to avoid product mix up: When it reaches laser marking, we have an automated recognition system that compares the real profile with the DHR number and the part drawing to ensure we’re laser marking the right part. When we begin actually marking the parts, we mark a 2D barcode that serves as a unique identification number for this part. At the last stage of production, just before packaging, we perform a free-weight check to ensure we’re packaging the right product with the right label. By cross-checking the 2D barcode, the DHR, and the patient label, there is no mix-up or mislabeling.
We’ve also worked with customers to reduce the number of labels we need to include. More labels provide greater risk for error or mix-up, so it was important to run this initiative in tandem with our inspection process to reduce that risk. With a key customer we were able to reduce the amount of labels on the finished product by four times the original amount.
Reese: We have been manufacturing hip stems for over 20 years. Today’s hips are intended to serve a younger and more active (high demand) patient. Our operations had previously worked as individual sites working under the Orchid umbrella. This worked well for less complicated products but was not ideal for new devices. We have since realized dedicated value streams allow for greater collaboration across our broad manufacturing modalities. These conversations now consider the entire process, which makes for a better product and more predictable project timelines.
We are also tasked to develop new technology that enhances our customers’ designs. One such example is HA coating—over the years our customers defined a need for an HA coating that delivers HA’s benefits but is not so thick it reduces the implant’s initial stability. They also wanted a strong coating that can survive impaction and stay on the device though the patients recovery.
Our HA coating does this without clogging up the pores of the ingrowth surface. Our thin HA coating was designed specifically for use over a Ti ingrowth surface and has very strong adhesion to the implant surfaces—much higher adhesion strength than the standards developed many years ago, long before these new hip stem designs were even a consideration. This advanced technology is now being used by many of the leading hip brands and we expect to see greater adoption across industry as awareness grows around the importance of adhesion strength of coatings in these new high-demand situations.