May 21st, 2012

Bone preservation is a key part of achieving implant success.

Through the years, tremendous demands are placed on our knees. In some people, the cartilage can begin to fracture or wear away. If the wear becomes significant, the rubbing of exposed bone can result in debilitating pain. The condition, called osteoarthritis (OA), affects millions of people worldwide. OA is very common in adults over the age of 50. People who have a history of past knee injuries, or those who have placed a lot of stress on their knees from heavy physical activity or weight are also at increased risk.

An example of a six-cut x-small model.
An example of a five-cut small model.
Total knee replacement has become a common major surgical procedure with more than 600,000 cases being performed annually in the United States. Twenty years ago, most patients who underwent total knee replacement were more than 68 years old; today’s average patient age is 62. As the patient population gets younger, their more active lifestyle will put additional demands on the implant systems they require. These additional demands, along with longer life expectancies, means that many patients who receive total knee replacements will require a revision later in life. There are two prevailing philosophies regarding designing devices for knee replacement revisions. One philosophy dictates to design the implant system to last as long as possible with no regard for how it will be revised in the event that a revision is required. The second and more broadly held philosophy is to design an implant with the next surgery in mind.  

Method

ConformMIS set out to design a patient-specific knee femoral component that was bone preserving in comparison to standard total knee components. Designing a total knee replacement that will fit a patient’s geometry requires detailed information that can only be provided by a CT scan. The CT data is postprocessed and converted into a CAD solid model using proprietary software. A secondary proprietary software system is then used to analyze the bone geometry and design the femoral component. User-defined attributes are applied in the design process as well as predefined design rules that are embedded into the software. The predefined design rules include the coronal radii for the trochlear groove and condyles, which are designed with low polyethylene wear in mind, employing radii that have been shown to produce low contact stress. The embedded design rules include recreation of the patient’s natural sagittal ‘J’ curves for the medial condyle, the trochlear groove, and the lateral condyle.
 

An example of typical load/constaints setup.

(From the archives): The Past, Present, and Future of Knee Implants. A Q&A with John Slamin.

A bone-preserving implant design requires thinner cross-sections of the femoral component and less bone removal in the implantation procedure. Fracture of the femoral component is not a common failure mode in total knee replacement, but fatigue strength can be compromised when attempting to make condylar sections thinner than standard total knee components. Traditional total knee replacement femoral components employ a multifaceted bone side geometry. ConforMIS hypothesized that adding an additional facet would reduce the thickness of the femoral component.
 
One study investigator reported on seven knee femoral fractures in his early press-fit-condylar (PFC) experience.1 Failure analysis of these components revealed that the fracture initiation site was on the inner bone surface at the intersection of the distal flat and posterior medial chamfer corner. This finding indicates that in these cases, femoral fracture was caused by the femoral component spreading apart in the anterior to posterior direction, concentrating peak stress at the medial distal and posterior chamfer intersections.
 
Using the knowledge of how the early PFC knee femoral components failed, ConforMIS and Farm Design set out to simulate the failure mechanism in a FEA model. Two implant sizes were analyzed: an extra small femoral component and an extra large femoral component. The intent was to develop a comparative study that examined the expanding forces of the femur, provided flexibility for multiple design iterations, and was capable of being fatigue tested in the laboratory.
 
Models of the implant and femur assembly were created in a worst case scenario with the condyle load pads oriented to mimic heal strike combined with a slight interference fit from the femur. Loads were applied to the condyle pads in a vertical direction parallel to the femoral axis while the top of the femur was fully fixed. The magnitudes of force were derived from actual patient weight data correlated to knee implant size. The loading distribution was based on biomechanical analysis conducted by another researcher with 60% of the load applied to the medial condyle and 40% of the load applied to the lateral condyle.2 Using this setup as the baseline (with and without a femur interference fit), the chamfer angles and number of cuts were modified for small and large implants.
 
The load inputs were broken up into two steps for the interference fit FEA models. Time step-one looked at the stress results with no load on the condyle pads but with the interference fit applied. Time step-two looked at the interference fit plus the medial and lateral condyle loads. For the line-to-line model, there was only one time-step for the condyle load inputs. Maximum principal stresses and deflections were monitored for each setup and evaluated across design iterations.

Results

The results for the maximum principal stress were tabulated and in all femoral components. The maximum principal stress occurred at the intersection of the distal medial and posterior chamfer intersection. In our FEA model, the five-cut design increased the maximum principal stress on the femoral component by 24% in the XS size and by 32% in the XL size as compared to a six-cut design.
An x-small contour pilot example.

Fatigue Testing

 The FEA study showed that maximum principal stresses can occur at the intersection of the distal and posterior facets on the medial side of a femoral component. This result is highly consistent with the implant failure results reported by the first study in the article. Fatigue testing was conducted on the six-cut implant designs described in the FEA study. Femoral components were manufactured from cast cobalt-chrome alloy conforming to ASTM F-75 and then ground and polished to finished specifications. Special attention was paid to insuring that the thickness values of the component were at the low end of the acceptable tolerance range, thereby creating a worst case condition for strength. Each femoral component was measured for the anterior to posterior dimension on the bone cut side of the implant. This consistency was required to fabricate a holding block that would produce the prescribed interference fit that would cause the wedging affect to spread it apart in the anterior to posterior direction. Individual holding blocks were then printed in the selective laser sintering process in glass-filed nylon. The engineered interference fit for each femoral component was 0.5 mm at the proximal tip of the trochlear flange. The femoral components were cemented onto the holding blocks using polymethylmethacrylate (PMMA) bone cement. Loads were applied to the femoral component with 60% of the force passing through the medial condyle with the remaining load passing through the lateral condyle. A polyethylene liner approximately 8 mm thick, simulating a tibial insert, was placed between the femoral component and the load cell. The total load applied varied depending on what size femoral implant was being tested.
 
The implants and fixtures were loaded onto test frames that conform to ASTM E466. Cyclic loading was performed at 10 Hz and was run to 10 million cycles for each of five samples for each size. Each implant, a total of 15 samples, was inspected with standard metallographic methods to detect fractures at the conclusion of the 10 million cycle test. No fatigue cracks were observed in the dye penetrant inspection technique.

Conclusion

The FEA method that ConforMIS developed accurately reproduces the reported failure mechanism of an implant system with a long clinical history. In the company’s model, it demonstrated the exact location of failure of the PFC femoral components.1 Both sized implants showed maximum principal stress in the identical region as the failed PFC femoral components. Although the stress predicted in the company’s model is below any reported endurance limit for a cast cobalt-chrome implant, differences in actual implant thickness and/or magnitudes of the load applied could certainly raise the maximum principal stress above the endurance limit of the material. The company also showed that stress can be reduced substantially by adding an additional faceted cut, going from the traditional five cuts to the new six-cut configuration. We hypothesize that the stress reduction in the six-cut design is due to the additional corner imparted by the sixth facet, distributing the load over a greater area. The advantage of the additional cut is that the overall implant thickness can be reduced by approximately 2 mm compared to the traditional five-cut implant design.
 
Another researcher showed the endurance limit of cobalt chrome as derived from a rotating beam test to be between 345 mPa and 480 mPa.3 This thickness reduction can be achieved because the six-cut design shows a maximum principal stress substantially lower than the endurance limit for cast cobalt chrome as reported in the study. Any reduction in implant thickness can translate directly to bone preservation in total knee surgery, leaving more bone available in the event that a revision of the original implant is required. This six-cut configuration is the basis of the iTotal patient-specific tricompartmental knee replacement system, which enables a personalized femoral component that is thinner than traditional total knee replacements. A thinner implant preserves more bone, which may be beneficial for future treatment options.
 
References
1. RD Scott, Total Knee Arthroplasty (Elsevier, 2006) 117.
2. RE Daley, “Measurement of the Distribution of Forces at the Human Knee Joint,” Ohio State University, PhD Thesis (1975): 75-19, 426.
3. RM Berlin, LJ Gustavson, and KK Wang, “The Influence of Post Processing on the Mechanical Properties of Investment Cast and Wrought Co-Cr-Mo Alloy,” Cobalt-Base Alloys for Biomedical Applications, ASTM STP 1365; JA Disegi, RL Kennedy, and R Pillier (American Society for Testing and Materials, West Conshohocken, PA) 1999.
 
John Slamin is senior vice president of knee implant engineering at ConforMIS Inc. He oversees all product engineering and development for the company’s line of knee implants. Prior to joining ConforMIS, Slamin spent more than 30 years in R&D at Johnson & Johnson's Orthopaedic Division, now DePuy. He was responsible for the product development activities that led to the PFC Total Knee System in 1986 and the Sigma Total Knee System in 1996. He coordinated the design and development of the world's first fully integrated and implantable electronic knee in collaboration with Clifford W. Colwell, MD of SCORE (LaJolla CA) and is the recipient of the Johnson Medal for outstanding Research and Development achievements. Mr. Slamin is the holder of seven patents related to knee implant engineering. He is a graduate of Wentworth Institute of Technology (Boston).
 
 

 

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May 8th

Biomedical Structures (BMS; Warwick, RI), a developer of biomedical textiles for medical devices, now offers a tapered medical textile service for tendons, ligaments, and other orthopaedic applications. The new weaving techniques allow for the creation of more lifelike structures that imitate natural tendon and ligament performance. The company shapes bioabsorbable and permanent fibers to resemble the human anatomy of tendons by developing precise dimensions and load-bearing performance characteristics within a functional shape that mirrors natural geometries. For tendon or ligament repair applications that require sutured tissue and subsequent regrowth of natural cells to replace damage, this textile engineering approach enables a new class of implants. The technique is facilitated by BMS’ high-precision medical textile R&D and advanced weaving equipment for synthetic polymers, including fibers such as polyester, UHMWPE, PLLA, and more. This enables enhanced strength and flexibility of even the finest fibers.

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May 1st

Dwalin DeBoer discusses the orthopaedic instrument conversion to disposable.

Capitalizing on its significant growth in orthopaedics, Mack Molding (Arlington, VT) has formed a business unit dedicated to this sector, along with for disposable medical devices. Dwalin DeBoer will oversee this new unit.

The company also added new services including cleanroom molding and additional laser welding capacity (a system custom made by Litron), which will help meet the growing demands of the orthopaedic surgical case and tray market.The 2,000-sq-ft ISO 14644-1 Class 8 standard modular cleanroom has removable panels to accommodate for future expansions and features dual air-lock, rapid roll-up doors to streamline product flow and tool changes. The new facility also has six 110-ton energy-efficient electric injection molding machines. The company anticipates that the machines will produce 60% less energy than their hydraulic counterparts. The presses also have high pressure water controllers that allow versatility in resin selection.

--Maria Fontanazza

Maria Fontanazza is managing editor at UBM Canon. Follow her on Twitter @MariaFontanazza.

 

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April 30th

Engineers at Tufts University have proven that their biodegradable scaffold for grafting works. The silk micron-sized fibers reinforces a silk matrix and can be used to repair bone and tissue, perhaps more effectively than current autologous grafts. The engineers created the 10- to 20-µm fibers in just one minute (typical processing creates microfibers that are more than 100 µm in nearly 12 minutes).

More on University Research
Rice University Stretches the Limits of Limb Lengthening

According to a research paper written by the researchers, about 1.3 million people in the United States undergo bone graft procedures annually (Their work can be found in the Proceedings of the National Academy of Sciences Online Early Edition this week). Donor grafts introduce potential complications such as disease and rejection; biomaterials used for bone regeneration (e.g. collagen) aren't strong.

The scaffold created at Tufts bonds silk protein microfibers to a silk protein scaffold, creating a stronger material that mimics the mechanics of native bone.“By adding the microfibers to the silk scaffolds, we get stronger mechanical properties as well as better bone formation. Both structure and function are improved,” said David Kaplan, PhD, chair of biomedical engineering at Tufts University, in a university release. “This approach could be used for many other tissue systems where control of mechanical properties is useful and has broad applications for regenerative medicine.”

--Maria Fontanazza
Maria Fontanazza is managing editor at UBM Canon. Follow her on Twitter @MariaFontanazza.

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April 23rd

 

There is always room for improvement, and orthopaedic implants still have a way to go in materials development. Some of these opportunities to make implants better will be discussed at this year’s OrthoTec conference in Warsaw, IN in June.
When working with new materials, there are three main challenges—biocompatibility, regulation, and cost, according to Robert Hastings, director of research at DePuy Orthopaedics. Hastings is chairing the OrthoTec panel, “New Materials Technology and Applications” on June 6.
 
Biocompatibility. How do you determine the safety of biocompatibility of a material? When working with novel materials, manufacturers must assume a level of risk. “We just can’t predict and understand [exactly] what kinds of tests we would need to run on certain materials or products,” Hastings says. “As we continue to evolve, we become better at coming up with test methods, and biocompatibility, animal studies, etc. that allow us to better understand the [material’s] behavior.”
 
Cost. As manufacturers experience global price pressures, they are challenged to maintain a high level of performance and quality at a lower cost.
 
Regulation. “As the regulatory organizations around the world start to think twice about how they’re approving products for the market, the challenge is how do we work with them to figure out the best way to understand how these materials and products behave and allow them on the market without completely shutting everything down,” says Hastings.  
In a nutshell, the panel will provide an overview of a new opportunities and exciting materials for orthopaedic devices. There are some developments in the following key areas, so you won’t want to miss out on this session. Here are some of the topics:
 
  • Soft materials, including hydrogels in cartilage replacement. “The orthopaedics industry has never successfully conquered [the] ability to use a man-made or artificial material for the replacement of the softer structures in the musculoskeletal system—meaning cartilage,” says Hastings. “We’ve had some tendon replacement and ligament replacement, but all of those have issues.” Presenter: Gavin Braithwaite, vice president of research at Cambridge Polymer Group Inc.
  • New opportunities in porous structures for biological fixation. Presenter: Janet Krevolin, PhD, vice president of orthopaedic development at Bio2 Technologies.
  • Bioabsorbable materials. “When I started in orthopaedics 25 years ago, we were just beginning to look at absorbable materials,” says Hastings. “They’ve become a standard of the industry, but they have unique properties that I think industry or orthopaedic companies, suppliers tend to shy away from because they’re more complicated to manage than polyethylene or a metal alloy.”  Presentation by: Purac.
  • The world of PEEK and addressing the challenges in arthroplasty. “ I think we’re on the verge of starting to see it be successful in the use in total joint replacement in a variety of forms,” says Hastings. “We’ve had polyethylene wear debris issues for many years and as we’ve improved that through crosslinking, second-generation, and third-generation material; we’re getting to the point where some of these materials such as PEEK could be very effective possibly in doing the same thing.”  Presenter: Adam Briscoe, PhD, product development project manager at Invibio.

 

Maria Fontanazza
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April 18th

Earlier this year, Korea-based Corentec Co. Ltd. announced the creation of a U.S.-based wholly owned subsidiary, Corentec America Inc. Orthotec recently had the opportunity to speak with vice president of the subsidiary, Michael Y. Son. Previously, Son has worked at a number of global healthcare companies specializing in hip- and knee-replacement joints as well as spinal implants. At Corentec, he will oversee the subsidiary's sales and marketing operations.

Orthotec: Can you give me some background on Corentec and walk me through how the firm was created out of the university hospitals in Korea?

Son: Our company was founded by a few different surgeons in 2000. One of the main orthopedic surgeons behind the company, Dr. D.H. Sun, specializes in hips and he owns a hospital in the Southern part of Korea. He got together with some of colleagues who are at some of the university hospitals around Seoul and decided to found the company. Dr. Sun has a very entrepreneurial mind. He had some unique ideas related to hip and knee implants and decided to pursue them and create a company.

 
Corentec's product portfolio includes a range of hip, knee (shown here), and spine products.  

Founding Corentec was his first foray into the field of medical device development. For him, it was a matter of doing surgery, wishing things were done a different way, and having original ideas and putting those ideas on paper with a group of colleagues and deciding that it was a business they wanted to get into.

Orthotec: How did the company choose Irvine, CA as its headquarters for its wholly owned subsidiary, Corentec America Inc.?  

Son: For one thing, I live there and I was living there before I joined the company. Our CEO's family goes to school in Irvine, so he is familiar with the area, as well.

The other reason is that it is on the West Coast, so it is a little bit closer to operation in Korea. And between Orange County and San Diego County, there are quite a few medical device companies, so it seemed to be a good fit. 

Orthotec: Can you explain how you see Corentec’s products fitting into the U.S. marketplace?

Son: The product portfolio centers around the hip, knee, and spine, but the details are still being worked out for the U.S. market. Right now, we have a total hip and a total knee available in the United States. We have a bipolar hip, which is a hemiarthoplasty hip. And we have a pedicle screw line that are all approved in the United States. We have several other extensions to those lines: for the hip, knee, and spine that are currently in submission to the FDA. We have several other things that also will be registered in the next six to eight months.

Orthotec: How does the regulatory environment in Korea compare to the system in the United States? 

Son: The Korean regulatory environment is very similar to the United States. To register a device in Korea, you need a minimum of a CE Mark. Otherwise, in terms of timelines, the clinical requiements and that sort of thing, it is very similar to the FDA. I think that, in many ways, the KFDA, as it is called, models itself after the FDA.

Orthotec: I understand that there are a lot of Asian patents on Corentec’s products. How do you see IP fitting into the company’s business strategy in the United States?

The Bencox stem provides wide range of motion, enhanced neck shape, and a trapezoidal neck design that allows wide angulations, and protects impingement and dislocation.

Son: The founders of the company didn’t want to make a product that was just the same as everybody else. When you start a company, you certainly benchmark what is available currently when designing products. And you want to take a look at all of the different ones and make things better.

It was very important that we had our own intellectual property for the technology. For example, with our hip, we have a patented technology on the neck design, which is slightly different than other products out there, which allows us to provide an increased range of motion and minimize impingement, which reduces the rate of dislocation. If you don’t impinge on the liner or the cup, there is less of a chance that the ball head and the stem can pop out and dislocate. And that is simply because of the offset design of the neck.

Orthotec: What do you think are the most important trends right now in the orthopedic space?

Son: The general answer is that there will likely be a shift in the way that business is being conducted—with regards to all that is going on with physician-owned distributorships (PODs) or the profit sharing that some hospitals have with surgeons, that will help to drive down prices of implants. Whether or not reps are going to be carrying the products or the manufacturers are going to be selling directly to hospitals, those are the types of business changes that are likely going to be happen that are going to be significant in the orthopedic industry.

Orthotec: What are your thoughts on the PODs issue?

Son: I believe that the whole POD thing is not necessarily going to grow much more than it is now. I think it has pretty much peaked. I think there is more fear of PODs and the legality of it. It is in the gray area but it is still legal if the surgeons can get around those types of issues.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

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April 9th

Leo's Top 3: Advice for manufacturers who work with (or want to work with) plasma spray technology.
  1. It could and should be considered a porous coating.
     
  2. It can be applied to basically any kind of product—including PEEK [and] dissimilar materials, which gives it a unique advantage. You can vary the thickness, and for things that aren’t necessary to be called a “porous coating,” as FDA refers to it, we can still have very good coatings on substrates with tremendous gripping capability for the bone to hold them in place.
     
  3. [Manufacturers should] consider working with a coating supplier to develop the physical requirements of the device versus where the coating is applied—the quality requirements, thickness requirements, adhesion requirements. Because there’s difficulty masking, we [coating suppliers] should be included from the design phase and on.

 

If you’re not in the surface technologies business, it might sound like a dry topic. However, if you work with these technologies every day, you already know that they enable you to create more innovative options (and potentially more cost effective) for orthopaedic products.

In a recent conversation with OrthoTec, Leo Glass, president and CEO of Surface Dynamics LLC (Cincinnati), discussed his experience in working with plasma spray coatings, along with the general potential of surface technologies.
 
OrthoTec: Specific to orthopaedics, what’s the most exciting part of working with surface technologies?
 
Leo Glass: 
  • "On the DMLS-type rapid manufacturing/additive manufacturing technologies, the capability is almost limitless.
  • On the capability side, the true limit is the cost of manufacturing—can it compete [with comparable technologies on the market]?
  • On plasma spray side, I’m most excited about the potential to have a porous coating, specifically on a cobalt chrome substrate, which tends to be part of the market [where it] is really needed. There’s no way that you can produce a porous coating on cobalt chrome without doing some sort of diffusion bonding or other method. This gives us the opportunity to offer a lower cost high-throughput application for porous coating."
 
At this year’s OrthoTec conference in June, Glass will be chairing the "Applying New Technologies in Surfaces" panel. He will focus on the process capability of plasma spray and its reliability and strength as a thick coating due to its open structure porosity. Attendees will learn how to navigate through the regulatory challenges that manufacturers face when working with the technology.
 
Hip stems and other fatigue-sensitive devices are an optimal fit for plasma spray coatings, because the spray provides a porous coating without a major reduction in fatigue compared with centered-type coatings. Other applications include coatings on dissimilar metals such as cobalt chromoly, ceramics, and PEEK.
 
The OrthoTec panel will also discuss other methods in which manufacturers can create porous structures using surface technology, including direct-metal laser sintering (DMLS) and E-beam technologies.
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The market will driven by spinal orthotic devices and cold therapy.

While the knee bracing and supports market is anticipated to be the largest segment within the U.S. orthopaedic bracing and support market, by 2018 the overall growth of the market will be driven by spinal orthotics and cold therapy devices.

The U.S. bracing and supports market includes knee bracing and supports, ankle bracing and supports, spinal orthotic devices, back soft goods, upper extremity bracing, soft goods, and pain management products such as cold therapy and pain infusion pumps. These markets are expected to experience slow to moderate growth as a result of an aging U.S. population, increasing prevalence of obesity and osteoarthritis, and the increasing use of braces in the prevention of sporting injuries. The spinal orthotic devices segment is growing at a particularly fast rate due to the strong correlation between an aging population and the incidence of lower back problems requiring support devices. The pain management market is also expected to grow quickly, in large part due to the increase in cold therapy sales. Some contributors to the increase in cold therapy sales include the fact that cold therapy aid in the compliance for braces, as well as high average selling prices with low reimbursement rates.
 
The total U.S. bracing and supports market from 2008–2018.
Braces and supports play an important adjunctive role for many knee patients, despite effective treatment via drug therapy or surgery. Changes in average selling prices (ASP) and the competitive landscape of this market have lead to growth in several different U.S. market segments including the bracing and support markets for knees and ankles. Other initiatives that have also altered the market include cost containment efforts put forward by the U.S. healthcare system and the increasing popularity of high tech or multiuse braces due to factors such as the aging population.
More on the U.S. Market:
Bone & joints, and extremity devices to hit $2.4 billion by 2017.

Ankle Bracing and Supports Market: Demand Up, ASPs Decline

The ankle bracing and supports market includes rigid ankle braces such as ankle stirrups and trainer braces; and ankle supports including semirigid supports, lace-ups, and elastic and neoprene supports. Growth will be driven by the increasing use of ankle braces for prophylaxis to treat injuries and for postoperative support. The increasing prevalence of sports injuries and obesity will have a positive effect on this market.
 
Prices are declining in all ankle support markets, as well as in the rigid stirrup market. Most competitors in this specific segment price their products lower than DJO’s well-known premium devices in order to compete effectively. As sales of these competing products grow, the total ASP is expected to decline. Prices are also expected to decrease as healthcare facilities seek less-expensive stirrups with all the same benefits of existing designs as a result of increasing cost constraints.   

        
Spinal Surgery Boosts Spinal Orthotic Devices Market

Unit sales of spinal orthotic devices are increasing as a result of an aging population, a corresponding growth in the number of spinal surgeries and rising interest in conservative treatment options. This market includes cervical, thoracolumbosacral (TLSO), lumbosacral (LSO), lumbar (LO) and sacral (SO) orthoses in both prefabricated and custom formats. The number of spinal surgeries performed each year is also increasing as a result of technological advancements, including major improvements of minimally invasive surgical techniques. The total spinal orthotic devices market is expected to grow at a compound annual growth rate of more than 6% through 2018. However, the demand for custom devices is growing at a slower pace due to higher prices—prices that are prohibitive for many patients.

Aging Population Helps Pain Management Market

The pain management market consists of cold therapy devices and infusion pumps. The aging population wants a greater degree of main control, and this demand is contributing to the market’s rapid growth. In 2011, the largest segment of the pain infusion pump market was the single-use ambulatory pump segment, which represented more than 68% of the total market. Market growth will be driven by increased ASPs and unit sales in the ambulatory infusion pump segments due to new technological innovations that increase medication safety, such as the development of single-use devices which are ideal for administering single or combination drugs in alternate and home care settings where the purchase of larger and more expensive infusion pumps may not be an economical choice.
 
Unit sales of traditional cold therapy devices also grew last year, while sales of powered devices increased significantly. Growth will be driven by the increased use of both traditional and powered cold therapy units as a result of improved patient compliance when the products are prescribed as an adjunct therapy to orthopaedic bracing, as well as for postoperative and post-injury pain relief.
 
Both segments are expected to experience growth over the forecast period. The powered cold therapy market is anticipated to grow faster than the traditional market because of the convenience and ease of use of powered devices. 

DJO, Aspen, and Ergodyne Battle for Dominance

In 2011, DJO was the leading competitor in the U.S. bracing and supports market and was a dominant player in every major segment analyzed within a report by iData Research (Vancouver). DJO offers knee bracing solutions under the Aircast, DonJoy, and ProCare lines, and cold therapy solutions under the Aircast, DonJoy, and Chattanooga lines. Other notable competitors include Aspen, the market leader in the spinal orthotic devices segment, and Ergodyne, the largest competitor in the occupational bracing segment. The dramatic effect of the company’s Aspen cervical collars on patient care is well documented. From 1999 to 2011, Aspen has expanded into the thoracolumbar and sacral spine markets, bringing more than a dozen products to market.

Conclusion

The U.S. orthopaedic bracing and support market will experience change in the next few years with respect to evolving demand and innovation in many different market segments. The knee bracing and supports segmentis expected to play a large role in the market until there is a shift towards spinal orthotics and cold therapy devices in the overall growth of the market. The pain management market is also anticipated to grow at an accelerated rate, offering another opportunity for advancement of the orthopaedic bracing and support market in the United States.
 
The information contained in this article is taken from a detailed and comprehensive report published by iData Research titled “U.S. Markets for Orthopedic Bracing and Support Devices 2012.” More information and a free synopsis of the above report is available by contacting iData Research at orthopedics@idataresearch.net.
 
Kamran Zamanian, PhD, is president and CEO of iData Research Inc. (Vancouver).
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April 3rd

 

Thompson
As the prevalence of patient-specific surgical instruments and the number of implant procedures rise, orthopaedic manufacturers are challenged to achieve speed, volume, and accuracy requirements. Although there are business benefits that come with patient-specific technology, there’s also a need for a robust infrastructure to deal with the manufacturing process, especially where speed and accuracy is concerned, according to  James Thompson, PhD, director, life sciences industry solutions, Siemens PLM Software. Thompson, who has expertise in automation and software technology, is speaking at this year’s OrthoTec conference in June.
 
“Most of the big orthopaedic companies have a brand and a surgical procedure that is a variant of their normal procedure, involving the use of patient-matched surgical instruments," Thompson says. He predicts this is a first step in an evolution toward greater availability of both custom implants and customized instruments, a shift that demands a new platform for efficient business operations for this new way of doing business. During his presentation: “Technologies for Automating Design and Manufacture of Patient-Specific Orthopaedic Products,” he will identify key technologies that must be stitched together to enable an automated environment that can scale and accommodate the speed and accuracy requirements that are necessary for high-volume patient-specific implants and instrumentation.  
 
“The manufacturing process benefits from systems that are integrated and make handoffs electronically, feeding manufacturing execution systems and controllers on the manufacturing equipment that deal with the electronic definition of the manufacturing operations,” says Thompson. “Additionally, quality assurance CMM checks can be automatically preprogrammed to validate that the implants or surgical instrumentation are manufactured to specifications.” All of the applications and automation technology must be tied together with an engineer-to-order process management platform to track progress and maintain electronic records for regulatory compliance, and serve as a means to route the work to different global departments throughout the company.
 
Thompson wants manufacturers to understand that design and manufacturing automation technology has reached a point in which customized implants and instrumentation is possible at a reasonable cost. “It’s not that there aren’t investments that need to be made and bottlenecks in the overall process chain, but given that most of the components chave matured to the point where they’re available, the question is what direction does the orthopaedic industry head?” asks Thompson. The main point he hopes to drive home is that customized surgical implants and instruments are an inevitable evolution, so manufacturers should be taking steps to familiarize themselves with the benefits of implementing automated processes.
Maria Fontanazza
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March 20th

Up-to-date information about OrthoTec 2012, including registration, the list of exhibitors, travel information, and interviews with speakers at the conference.

OrthoTec 2012 returns to the center of orthopaedic device manufacturing, Warsaw, IN this June. The event will be held June 6 and 7 in Winona Lake (Warsaw), IN at the Orthopaedic Capital Center at Grace College.

  • Register for OrthoTec 2012. More than 1000 professionals are expected to attend and network with 80 exhibitors.
  • How do I get to Warsaw? Get essential travel information, including hotel arrangements and directions.
  • General information about OrthoTec 2012.
  • Interested in exhibiting?
Conference
Sneak Peek		 Exclusive discussions with experts who you'll meet at the OrthoTec 2012 conference.

Robust Processes Enable Better Product Design. Christopher Scifert, PhD, opens up about lean design and healthcare economics.
  Technologies for Automating Design and Manufacture of Patient-Specific Orthopaedic Products. James Thompson, PhD, discusses the speed and accuracy demands introduced by custom implants.
  Applying New Technologies in Surfaces. Leo Glass, president and CEO of Surface Dynamics explores the limitless possibilities and regulatory challenges that manufacturers face when working with surface technologies.
  New Materials Technology and Applications. Robert Hastings discusses materials development in the pursuit of the ultimate implant.

 

Maria Fontanazza
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