Industry News

Mack Molding Expands Orthopedic Business

Arlington, Vt.-based Mack Medical/Mack Molding, supplier of contract manufacturing services and injection molded plastic, is broadening its orthopedic business. The company built a new 2,000-square-foot modular clean room, has additional laser welding capacity, and a completely new business unit dedicated to orthopedics and disposable medical devices.

Mack Medical’s new clean room facility. Photo courtesy of Mack Molding.

“These steps represent the latest in a long list of investments Mack has made over the last 12 years in the medical market, which is now approaching 40 percent of overall sales for the northern division,” said Jeff Somple, president of Mack’s northern operations.

With removable panels, the new clean room is constructed in order to make future expansions easy. The doors are air locked when shut, and roll up easily to facilitate tool changes and product flow. The facility houses six, 100-ton electric injection molding machines made by Toshiba Machine Co. Ltd. The company previously used hydraulic presses, but these electric presses are expected to use 60 percent less energy. The clean room is certified to the ISO 14644-1 Class 8 standard, the company reported.

The new Litron-made, high-precision laser welding system is customized for laser welding Mack’s preferred bracket design for holding surgical instruments. The resulting hermetically sealed weld bead is free of gas, air and contaminants, producing a more robust and inherently cleaner assembly than traditional riveting methods.

Mack also has added staff to support its new orthopedic business.

“We have seen significant growth in orthopedics, so felt it necessary to establish a dedicated group that will focus solely on the needs of this market and its customers,” said Dwalin DeBoer, who is heading up the new unit. A chemical engineer, DeBoer has worked at Mack in several functional areas during the past 11 years. Her earlier experience includes stints with Saint-Gobain Performance Plastics, GE Plastics (now SABIC), and Monsanto Plastics. Joining her are Dawn Bacon, customer service representative, and Cassie Earley and Rich Hornby, program managers.

The new business unit also will be supported by Chris Wartinger, who, as part of the business development team, will continue to be responsible for spearheading growth in the orthopedic sector. Wartinger has been with Mack for 20 years and has focused on orthopedic market sales for the past seven. Prior to becoming a business development manager, he held a variety of other positions within the company, including program manager and production supervisor, giving him a broad understanding of new business development and product launch.

Mack specializes in plastics design, prototyping, molding, sheet metal fabrication, full-service machining and medical device manufacturing. Founded in 1920, Mack is a privately owned business that operates 10 facilities throughout the world.

Stryker Forms Environmental Coalition

Together with 17 other healthcare companies, Stryker Corp. has co-founded a coalition with Practice Greenhealth to advance the purchase of products and processes that are less hazardous to the environment. Named the Environmentally Preferable Purchasing (EPP) Business Leadership Coalition, it was founded in response to the increased demand from hospitals for greener products to support their sustainability goals.

Practice Greenhealth is a nonprofit membership organization founded in 1998, when the American Hospital Association and the U.S. Environmental Protection Agency signed an agreement to advance pollution prevention efforts in U.S. healthcare facilities. The organization collaborates with its members to provide sustainable healthcare that is good for the environment and good for patients and staff, while at the same time protecting revenues. It creates plans to eliminate mercury, reduce and recycle solid waste, reduce regulated and chemical waste, reduce energy and water consumption, create healing environments, and establish green purchasing policies.

“Hospitals can lower their environmental footprint by saving water or reducing greenhouse gas emissions, for example. But, they depend on suppliers when it comes to the environmental impact of the products they purchase,” said Brian White, president of Stryker’s sustainability solutions division.
“Hospitals are asking suppliers to step up and become partners in this effort. It is critical that as suppliers, we begin working towards more environmentally responsible products and solutions. In addition to developing new products, this coalition is about increased transparency and accountability to drive outcomes that lead to a more environmentally and financially sustainable industry.”
Stryker’s sustainability solutions division, formerly Ascent, was purchased in 2010.

The 17 companies in the newly formed coalition include medical device industry leaders such as Johnson & Johnson, 3M, Becton Dickinson and Company and Covidien plc. According to its statement of objectives, the coalition intends to:

• Identify materials of concern and develop more sustainable products;
• Devise strategies to reduce environmental impact of medical products through practices such as reusing and recycling; and
• Educate other institutions and companies, including hospitals, healthcare suppliers and group purchasing organizations about environmental best practices.

EPP members also have committed to reporting results of their efforts relative to Coalition objectives on an annual basis.

“We’re pleased to partner with Stryker because the company demonstrates leadership in the future of smart healthcare,” said Bob Jarboe, Practice Greenhealth executive vice president of business development. “Stryker is committed to providing hospitals options to address fiscal and environmental sustainability concerns. This is exactly the direction that the healthcare industry must go—and one that will benefit us all.”

Integra Expands Portfolio with New Spinal Implants; Bone Tips

Integra LifeSciences Corporation is rolling out more products from its seemingly chock-full pipeline this year. The company is introducing the Vu aPOD Prime intervertebral body fusion device (IBD), a standalone device for use in anterior lumbar fusion (ALIF) procedures, for a full market release. The device already has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

IBDs are small, hollow spinal implants that work by being inserted between vertebrae to provide stability for spinal fusion after a diseased lumbar disc has been removed. They restore physiological disc height and allow fusion between vertebral bodies while relieving pressure on the nerves. The graft window in the device is packed with autogenous bone (bone that has been grafted from the patient receiving the implant), making it possible for natural bone to grow, enabling fusion.

Because the device is zero-profile, surgeons will not have to use supplemental fixation to hold the IBD in place. Instead, the device uses two screws to stay in place, also reducing the number of steps and implants required to perform an ALIF procedure. Consequently, the Vu aPOD is a less invasive implant than the traditional anterior supplemental fixation implants with interbody construct, company officials claim.

“The Vu aPOD has gone through a controlled market release and was well received,” said design surgeon James Bruffey, M.D., from Scripps Clinic in San Diego, Calif. “The … device’s more rounded edge appears to reduce post-operative implant settling into the vertebral endplates.”

The company also has received 510(k) clearance from the FDA for its Cusa NXT bone tips, which are used with the company’s existing Cusa NXT ultrasonic tissue ablation system. The NXT system is used primarily in neurosurgical procedures for the removal of soft tissue and bone near critical structures, and the bone tips are intended to expand the surgical applications of the Cusa NXT system.

By removing the need for drills and other similar tools, the bone tips are expected to allow surgeons to use ultrasonic tissue ablation in procedures requiring precise, controlled bone removal near locations in the body where the rotational motion of a drill or frictional heat may be a concern. They feature a one-piece tip design, low profile silicone flue, and an ergonomic shroud that are all disposable.

According to Integra, the Cusa NXT system is used in more than 2,000 centers worldwide. Founded in 1989, Plainsboro, N.J.-based Integra LifeSciences produces orthopedic products that include devices and implants for spine, foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound repair. The company also offers a portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care.

Arteriocyte Begins Trial for Compartment Syndrome Treatment Technology

Arteriocyte Medical Systems Inc., a medical device company with offices in Cleveland, Ohio, and Hopkinton, Mass., has received approval from the U.S. Food and Drug Administration (FDA) to begin a Phase I clinical trial for its product Magellan MAR01 technology for the treatment of compartment syndrome. The technology already has received FDA 510(k) clearance.

Compartment syndrome is the compression of nerves, blood vessels and muscle inside an enclosed muscle compartment in the body. This can lead to tissue death and amputation if the pressure is not
released because the compression prevents blood from flowing through the affected area. The syndrome can occur after severe physical trauma or inflammation. Ateriocyte’s Magellan technology has been developed in partnership with the United States Army Institute of Surgical Research (ISR) and San Antonio Military Medical Center at Fort Sam, Houston, Texas, and Ohio State University as part of Arteriocyte’s Cellular Therapies for Battlefield Wounds Program.

The Magellan system produces autologous platelet rich plasma from a patient’s blood and bone marrow that can be applied to a surgical site as surgeons deem necessary. Arteriocyte has partnered with the U.S. military to develop the system for clinical use across three trauma platforms: extremity trauma, burn wounds and infection prevention. The company already actively is enrolling patients in a separate clinical trial for MAR01 treatment in critical limb ischemia (CLI) under an FDA approved Investigational Device Exemption. CLI is a severe blockage of blood with the patient experiencing extreme pain as well as possible ulcers or sores.

The U.S. military has a vested interest in the Magellan clinical trial. “Compartment syndrome and the associated complications are a major challenge in combat casualty care, resulting in elevated rates of amputations,” said retired Army Col. John Kragh, M.D., orthopedic surgeon and researcher at ISR, and Arteriocyte’s program officer. “This treatment represents an important potential tool to improve success of limb salvage for these patients.”

Enrollment in the compartment syndrome clinical trial is expected to begin immediately following final approval by the Army’s Human Research Protections Office. The study will be performed at the Ohio State University Wexner Medical Center, led by Jason Calhoun, M.D., chair, Department of Orthopedics, and Frank J. Kloenne, chair of Orthopedic Surgery.

Arteriocyte produces stem cell related medical devices. The Magellan technology was built upon the foundation laid by Medtronic Inc.’s blood component therapies, according to the company’s website.

OrthoSensor Secures More Financing for Inaugural Product

Fort Lauderdale, Fla.-based OrthoSensor Inc. has secured another $15 million in series B preferred stock financing, the funds of which will be used to finance the company’s first product, the OrthoSensor Knee Balancer. Now totaling $36 million, the financing also will be used to support the launch of OrthoSensor’s line of additional orthopedic devices. OrthoSensor’s three product platforms are surgical, implantables and analytics.

“The strong interest in our latest round of funding demonstrates the continued investor confidence in OrthoSensor and the tremendous market opportunity for intelligent orthopedics,” said Jay Pierce, CEO of OrthoSensor.

The knee balancer is intended to ensure proper soft-tissue balance during total knee arthroplasty. It is embedded with sensors that provide surgeons with actionable data on implant fit and knee kinematics. The sensors wirelessly transmit key information to a graphic display, enabling surgeons to make informed adjustments to the soft tissues to optimize implant placement, according to the company. Accurate implant placement and soft tissue balance have been shown to extend the life of implants, reduce the incidence of revision surgeries and improve patient function.

OrthoSensor was founded in 2006 by Martin Roche, M.D., who set out to quantify correct positioning of joint replacement. Previous placement strategies would be whatever “felt right,” and Roche decided there had to be a better way. The company is exclusively focused in intelligent orthopedics, a new field that uses sensors, microelectronics and wireless communications with the goal of improving healthcare outcomes and reducing the cost of treating musculoskeletal disease. Devices such those in OrthoSensor’s portfolio are designed to communicate real-time information to surgeons and hospitals, enhance surgical implantation, as well as enable remote monitoring of implant function and overall musculoskeletal health. Beyond this first product, the Knee Balancer, there also are devices for hip and shoulder replacement procedures as well as in spinal and trauma applications coming down the company pipeline.

Arthrosurface Makes its First $100 Million

Franklin, Mass.-based Arthrosurface has reached the $100 million mark (specifically in cumulative net revenue). The company believes its increased revenues to be a sign of an increased need for joint replacement procedures, which often is the result of an aging population.

A provider of anatomic inlay implants for early joint disease, Arthrosurface also provides patient-matching metallic resurfacing, which are thin, contoured and sized according to the defect and shape and the patient’s native joint surface. The company is concerned mainly with providing minimally invasive surgical solutions for joint cartilage damage. It currently provides a range of devices for hip, knee, shoulder and toe joint treatments.

“We knew the idea of intervening sooner rather than later, when joint damage is limited, went against the conventional wisdom of traditional orthopedics. In the world of total joints, treatment is typically delayed until significant joint destruction has occurred,” said Steve Tallarida, president of the company. “We decided to take our cue from other disciplines, such as cardiology and dentistry, where stents and fillings are the first line choices for early intervention. Patients should have the option of considering an interim treatment in order to resume a normal lifestyle while hopefully delaying joint disease progression.”

Arthrosurface was formed in 2001 to provide surgical solutions for joint disease. It was formed out of the company STD Medical, an OEM and outsourcing company that is still active and located in Stoughton, Mass. Arthrosurface has recently ventured into the Mexican market and has plans to further expand globally, officials noted.