05.19.10
Secant Medical Expands Manufacturing Capacity
Greatbatch Medical opens new design center.
Secant Medical is investing in its future. The company has added a 40,000-square-foot facility in Quakertown, Pa., to its manufacturing operations. The new facility is just six miles from the firm’s headquarters in Perkasie, Pa.
Secant executives said the new facility was added to support current and future business growth in tissue engineering and transcatheter technologies. They predict the total market for tissue engineering—including heart valve repair and replacement; musculoskeletal bone and ligament repair and replacement; and urologic bladder slings—will surpass $11.5 billion by 2016.
“We are monitoring the healthy market growth of transcatheter technology for minimally invasive surgical procedures, which is driving an increased need for biomedical textiles,” said Karen West, general manager of the company’s Advanced Technology and Materials Group. “While we see an upward trend in the market, we are well aware of the challenges that device manufacturers face from healthcare reform and other events. We must carefully balance these market dynamics in our long term planning, particularly as it pertains to our clients’ needs.”
Besides adding to the company’s manufacturing capabilities, Secant executives redesigned the firm’s methodology for custom-developing and making medical device products. They named the redesigned methodology the Integrated Product Development Process.
“The resulting integrated process better leverages our continuum of services at every stage of the client’s development path,” West explained. “It’s a smarter, more streamlined approach to apply the quality, collaboration, and scientific support we bring to the table.”
Steve Chadwick, Secant’s president and CEO, said the revamped product development process allows the company to remain closely aligned with clients’ development requirements, from concept to commercialization.
Secant Medical provides design, development and custom manufacturing services for biomedical textiles.
Ankle Replacements Growing in Popularity as Procedures Improve
Medical technology is finally conquering one of the last frontiers in total joint replacement—the ankle.
Orthopedic surgeons traditionally have treated advanced ankle arthritis by removing the worn-out portion of the joint and replacing it with a metal implant that holds together the shin and ankle bones. As it heals, the bone surfaces fuse with the implant.
Though joints treated through this process (dubbed fusion surgery) usually are permanently stiff after the procedure, they also are pain-free and conventionally have had better outcomes than ankle replacements. Industry experts estimate that 25,000 ankle fusions were performed in the United States last year.
In existence for three decades, ankle replacements are more popular in Europe than in the United States. According to industry estimates, about 75 percent of European ankle fusion candidates undergo total ankle replacements compared with 10 percent of their American counterparts. Experts attribute the disparity to a variety of reasons, including a lack of comprehensive reimbursement coverage, the scarcity of next-generation ankle replacement devices, and the relatively low number of controlled studies that demonstrate the superior outcomes of ankle replacement procedures compared to fusion surgeries.
Orthopedic surgeons also have not yet fully embraced ankle replacement procedures. And for good reason: Previous devices have resulted in problems such as slow healing, infection and failure. The most severe complications have led to amputations (but such cases are rare).
“The big concern about ankle replacement is how often do they fail and how often do they loosen,” Jonathan T. Deland, M.D., chief of the foot and ankle service at the Hospital for Special Surgery in New York, N.Y., told The New York Times.
Such concerns, however, are becoming unfounded with new replacement models and improvements to surgical instruments. Deland is working on a new ankle replacement device with Zimmer Holdings that may be submitted to the U.S. Food and Drug Administration (FDA) for approval this year.
If approved, Zimmer’s device would join several others already on the U.S. market. They include the Agility LP Total Ankle Replacement System from DePuy Orthopaedics Inc.; the Salto Talaris Anatomic Ankle from Tornier; the INBONE Total Ankle System from Wright Medical Technology Inc.; and the Scandinavian total ankle replacement system (S.T.A.R.) from Small Bone Innovations Inc.
Approved last May by the FDA for ankle joint replacement due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis, Small Bone Innovation’s S.T.A.R. system is a three-piece mobile bearing uncemented, non-constrained total ankle replacement. Small Bone Innovations executives claim the design of the S.T.A.R. system is the first of its kind because it relies on movable bearings that glide across the surface of polyethylene. The bearings give the joint some natural movement, a characteristic that is missing in traditional fusion surgeries where the tibia (shinbone) is joined to the talus (the bone that fits into the socket formed by the tibia and fibula, the small bone of the lower leg). Fusing the tibia to the talus strengthens the ankle but severely limits motion.
DePuy’s Agility ankle was designed by orthopedic surgeons to imitate the structure and movement of the ankle joint, according to the Warsaw, Ind.-based company. The tibial component, which consists of a metal piece and plastic piece, supports both the tibia and fibula as it bridges the space between the two bones. After surgery, bone tissue grows into the space, surrounding the implant and holding it in place. The Agility’s design, company officials said, creates a solid base of support for the tibia and fibula in the new ankle and helps limit the chance of future sinking, shifting or loosening of the implant. The talar component sits in the talus bone, allowing the foot to flex up and down.
The Agility LP ankle implant is manufactured in six sizes to enable surgeons to choose the appropriate implant size for patients. It was approved by the FDA in May 2002.
Like the Agility implant, Tornier’s Salto Talaris Anatomic Ankle is modeled after the human anatomy to provide a more natural movement of the joint. The French firm received FDA approval for the device in 2006.
Wright’s INBONE total ankle consists of a tibial and a tabular component. The tibial component, according to Wright officials, features a plastic piece in a titanium holder. A long titanium stem anchors half of the implant within the tibia. The talar component of the device is an anatomically shaped, highly polished cobalt chrome piece that also features a stem.
Industry experts estimate the current market size for total ankle replacement to be around 5,000 implants annually. A mature market could swell to 25,000 and potentially reach 50,000 annually. This growth most likely will be driven by an aging baby boomer population, an increase in the number of osteoarthritis cases, and a rise in patients’ need for surgery, industry experts said. Growth also will be tempered by increased confidence among surgeons and improvements in implants.
MCRA Forms Partnership to Maximize Clinical Trial Efficiency
The medical device regulatory process often can be a complex beast.
But two companies have joined forces to simplify that process and determine the best clinical trial strategy for clients. Musculoskeletal Clincal Regulatory Advisors LLC (MCRA) recently announced its partnership with Biomedical Statistical Consulting (BSC), a Wynnewood, Pa.-based company that designs and implements regulatory clinical trials for orthopedic devices.
“Medical device regulations and pathways are constantly evolving,’’ noted Glenn Stiegman, vice president of regulatory affairs at MCRA. “MCRA’s clients require cost effective approaches to drive their technologies from conception to market as expeditiously as possible. We have previously worked with BSC on multiple PMA/IDE (pre-market approval/ investigational device exemption) clinical trials and the combination of our skill sets will create efficiencies leading to best-in-class clinical trial execution.’’
Most clinical trials utilize the traditional statistical approach, otherwise known as frequentist. The frequentist philosophy is the cornerstone of classical mathematical statistics and hypothesis testing. Based on probability, it focuses on the relative frequency of the occurence of an event.
Sometimes, however, a different approach is needed to increase the chances that a clinical trial will be successful. Such an approach is known as Bayesian and it involves collecting data from past events or experiences in order to reach a conclusion about future events. The Bayesian method has grown in popularity in recent years, though it potentially can be controversial.
Officials at the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) issued a final guidance on the use of Bayesian statistics in clinical trials in February. The guidance states that Bayesian methods usually are less controversial when prior information is based on empirical evidence such as data from clinical trials. However, Bayesian methods can be controversial when the prior information is based mostly on personal opinion (often derived from “experts”).
The CDRH guidance document concluded that the Bayesian approach is not a substitute for sound science. “Scientifically sound clinical trial planning and rigorous trial conduct are important regardless of whether you use a Bayesian or frequentist approach,’’ the document read. “…remain vigilant regarding randomization, concurrent controls, prospective planning, blinding, bias, precision, and all other factors that go into a successful clinical trial.’’
BSC executives agree with the guidance document.
“A biostatistician’s toolbox should include frequentist, Bayesian and adaptive [clinical] design approaches,’’ said Greg Maislin, principal biostatistician at Biomedical Statistical Consulting. “BSC has specialized in applying statistical methodology in the orthopedics industry and our partnership with MCRA will enable us to bring solutions to the problems surrounding the clinical trial and U.S. regulatory processes.’’
The combined service offerings of MCRA and BSC include the strategy, development, and execution of regulatory submissions, as well as clinical trial set-up and implementation, in addition to quality assurance, reimbursement and compliance oversight, executives with both firms said.
Greatbatch Medical Opens New Design Center
Greatbatch Inc. is a familiar name in the cardiac rhythm management market. But it’s somewhat less recognizable in orthopedic circles.
In an effort to boost its presence in the orthopedic industry, Greatbatch Medical has opened a state-of-the-art design center Warsaw, Ind. The new facility is equipped with rapid prototyping capability and staffed with a team of orthopedic development experts, according to a news release from the Clarence, N.Y.-based firm. The center features 3-D rapid prototyping equipment that incorporates multi-polymer capability, direct metal laser sintering equipment and a printer that officials dubbed “one of the most advanced available.”
“The addition of these capabilities will expand both our service offerings and our ability to effectively partner with customers in developing and delivering effective solutions quickly,” said Susan Campbell, senior vice president, orthopaedics, at Greatbatch Medical. “This investment demonstrates our commitment to creating strong business partnerships to help meet our customers’ needs.”
Besides expanding its service offerings and strengthening its business partnerships, Greatbatch executives hope the design center will help solidify its footprint in the orthopedic industry, particularly in the Warsaw region. A report released last fall by BioCrossroads, a life sciences development group based in Indianapolis, Ind., called the Warsaw area the “undisputed capital of today’s global orthopedic device industry” due to its concentration of orthopedic device firms.
“Greatbatch Medical is committed to being the industry partner of choice for innovation and co-development,” said Charles Jaggers, vice president of technology and development, orthopaedics, at Greatbatch Medical. “Well known in the cardiac rhythm management business for reliability and innovation, Greatbatch Medical’s goal is to be a seamless extension of the design, development and manufacturing capabilities of our orthopedic customers.”
Greatbatch Medical is a division of Greatbatch Inc. The company designs and manufactures technologies used in medical devices for the orthopedic, cardiac rhythm management, neuromodulation and vascular access markets.