While many larger med-tech firms might be tightening belts to cope with the challenging economic climate, a smaller spinal device company continues to produce new products and report on expansions at a steady clip.
"We are continuing to grow at a rapid pace since we started in 2004," Lane Major, VP of marketing at K2M (Leesburg, Virginia), told Medical Device Daily. "We've had well beyond double-digit growth. So far this year is looking to be no different."
K2M – which produces devices to treat complex spinal pathologies – has just launched the Caspian Spinal System, an all-inclusive system for rigid posterior fixation in complex cervico-thoracic spinal conditions.
This latest news follows a steady string of other progressions for the company, highlights of which include:
• In April, K2M launched an injectable polymer, with testing indicating that the polymer may have various applications for treating a variety of spinal disorders. The polymer will serve as a platform for the development of new implantable technologies, such as spinal nucleus replacement, or micro-access surgical approaches for annular decompression and repair (MDD, April 30, 2009).
• Last fall, K2M formed a new biomaterials division for bone grafting to substitute for the metals commonly used in spinal fusions. Biological materials allow for increased cellular activity, growth and differentiation which may increase bone formation and stimulate a spinal fusion (MDD, Oct. 15, 2008).
• Around the same time, the company expanded its facility to include an additional 13,000 square feet of space, 2,500 of which will make up a conference and training amphitheater. K2M's facilities will now total 49,000 square feet (MDD, Oct. 8, 2008).
• These moves followed receipt in September 2008 of ISO 13485 certification and CE-mark clearance for its spinal devices marking the company's entrée into the international markets. It started with the introduction of its products in Spain and the UK. The product portfolio cleared for sale encompasses an array of devices developed to treat complex spinal conditions, including stabilization systems, minimally invasive systems and motion preservation systems (MDD, Sept. 3, 2008).
How is K2M able to forge ahead while other companies might be missing a few steps or worse?
"It's challenging in that we're a growth company," Lane said. "Although the market is being hit, we have such great opportunities that we're not seeing some of the same challenges other companies do to date. We're hitting our forecasted plan; we're doing well."
The Caspian Spinal System targets the trauma and deformities portion of the orthopedic spine market.
"It's intended for the upper thoracic spine for traumatic events like whiplash and for different forms of degenerative pathologies," he said.
The new system builds on the technology behind existing spinal devices. In fact, it combines the best of two completely different polyaxial screw options, Mini Denali and Mini Mesa, as well as Mini Hooks, Mini Connectors and 3.5 mm rods.
The Mini Denali screw is an improved version of a traditional set screw designed implant featuring off-axis screw height adjustment, whereby the screwdriver does not need to be co-linear with the screw shaft to adjust the screw during surgery.
The Mini Mesa screw includes the company's flagship Zero-Torque Technology, which applies zero twisting forces, to the spine when locking the system.
When asked "what's new?" compared with existing similar devices already on the market, Lane explained that by consolidating the two systems, surgeons get the best of both worlds in one package.
"We had such interest in both of those that we took those product lines and downsized them, made it simple for our customer base so surgeons can have a choice," he said, adding that the product development is a result of surgeon feedback on devices needed to treat the upper thoracic spine.
According to Juan Uribe, MD, co-director of spinal neurosurgery at the University of South Florida, "The low profile feature [of the Caspian System] is unlike any other posterior cervical system and offers a significant clinical advantage."
So, while K2M may not be launching the next killer app technology, it's delivering what's requested and needed by surgeons. And that business plan is exactly in line with what industry analysts are suggesting: skip the fancy technologies that may have more "wow" factor than "value-add" to the healthcare system, according to Michael Thompson, principal at PricewaterhouseCoopers' (New York) global human resource solutions group, whose Health Research Institute just released projections that healthcare costs for U.S. businesses are expected to grow by 9% next year.
"Long term, the focus is going to be on value," Thompson told MDD. "New medical technologies will have to be focused on adding value to the system and weeding out technologies that are costly and don't add as much value" (MDD, June 22, 2009).
Lane said K2M expects to keep up the pace with more new product lines launched before the end of this year. Next up for K2M: spinal products that address the need for a more minimally invasive approach.