Local startup Arrowhead Medical Device Technologies LLC is rapidly growing a presence in the medical device industry thanks to its Arrow-Lok Digital Fusion System, an innovative toe implant device used for the surgical repair of a painful condition commonly referred to as “hammertoe,” or proximal interphalangeal joint flexion deformity.
Arrowhead, a privately funded company based in Collierville, has expanded into more than 20 markets across the country in the past 27 months by utilizing the abundance of Mid-South resources in the biomedical field.
“Memphis is a hotbed for medical devices for a myriad of reasons,” said Arrowhead president Patrick Mullaney, who said he feels Arrowhead’s product taps into a huge market potential considering that approximately 500,000 hammertoe surgeries are performed annually in the U.S., according to a June 2011 report from iData Research.
Arrowhead formed in August 2010 as two entrepreneurs combined talents to launch the Arrow-Lok device developed by podiatric surgeon Dr. Scott Roman of the Ankle and Foot Centers of Georgia in Atlanta.
The gold standard for correction of hammertoe is to perform an osteotomy, where the surgeon cuts the bones, puts them in the correct orientation and fuses them in place using a K-wire. Roman’s Arrow-Lok device is inserted where the bone is fused and keeps the segments of bone stationary so healing takes place faster and more securely than with some other treatments.
Roman developed the device to be easy for surgeons to use and more comfortable for patients than traditional K-wire devices, which have been used for more than 40 years. He said a major problem he had with using K-wire was that the wire stuck out of the patient’s toe for four to six weeks while healing. The K-wire would also sometimes slip or move during the healing process, resulting in misalignment or dislocation.
“Patients were very anxious about having a wire sticking out or possibly bumping the wire,” Roman said. “They were also worried about pain when having the wire pulled out in the office, and any time you have an external wire it increases the chance of infection.”
So one night in February 2010 Roman stopped at a hardware store, bought some brass wire, went home and hammered out an improved design in his garage. His new invention added “barbs” on both ends of stronger metal bar that would lock the device in place and eliminate external wires.
“I wanted it to be simple, simple, simple,” said Roman, who then took his design to an engineer to create a prototype.
Arrowhead received U.S. Food and Drug Administration clearance to market its product in October 2010. Roman performed the first surgeries in his clinic that December, and Arrowhead commenced unrestricted distribution by February 2011.
“We then listened closely to physician feedback, and that led to the design of a second-generation hybrid implant that was cleared by the FDA for use in October 2011,” said Roman, who added that the second-generation implant is longer to enable fixation of the implant in the region of the bone most likely to be of the highest quality.
“It is also able to fit a wider variety of anatomies, fit all four of the lesser toes and can be used when revising other intramedullary devices. The new design made the operative technique simpler and faster by eliminating one of the more technically demanding and time-consuming steps.”
Roman joined forces with Mullaney and Tom Twardzik, vice president of sales and marketing, taking advantage of nearly 40 years of combined industry experience that includes Mullaney’s expertise in sales and Twardzik’s marketing knowledge.
Mullaney had also previously co-founded ExtraOrtho Inc., bringing a successful trauma-related orthopedic external fixation device to market.
Twardzik worked for many years locally at Smith & Nephew, and he credits the richness of Memphis as integral to Arrowhead’s success.
“One of the benefits of being in Memphis is the existence of such a large amount of expertise in musculoskeletal medical devices that other parts of the country simply do not have,” Twardzik said. “The different support functions that we need are all here in Memphis, offering resources in technical areas like regulatory affairs, quality assurance, intellectual property, finance, product development, engineering, logistics and transportation.”
One of the most challenging areas for Arrowhead as a new company is developing a strong distribution channel in a market that is becoming more crowded.
“Our responsiveness to both our surgeon and distribution customers offsets the fact that we are competing with large companies working with massive budgets,” said Mullaney, who cites the local presence of large players in the foot and ankle market like Arlington-based Wright Medical and Smith & Nephew as well as multiple smaller startup companies like Arrowhead.
Arrowhead plans future expansion of its product lines to include additional sizes and applications for the Arrow-Lok technology and actively seeks other new innovative medical device technologies for development and commercialization.
“The extremity market is one of the fastest growing areas of the musculoskeletal industry,” Twardzik said. “Our product sets itself apart from our competitors with a design that is both versatile and easy to use. Such a combination of benefit is difficult to achieve with any product in any market.”