Medical Device Daily Associate

NDI Medical (Cleveland), a leader in the development and commercialization of neurostimulation products for the medical device industry, reported that it has formed a new business unit to help companies and researchers develop and market neurostimulation products for neurological and cardiac applications that use implantable pulse generator (IPG) technology.

The company's new wireless, rechargeable IPG, the Micropulse, sits at the core of the Micropulse business unit. It is the smallest device of its kind available to companies and researchers developing neurostimulation products, the company said.

“The Micropulse IPG can be customized to achieve the clinical, therapeutic and business objectives of our customers,“ Richard Kuntz, general manager of NDI's new business unit, told Medical Device Daily.

He also emphasized the importance of the wireless component to the IPG technology. “The advantage of wireless is that when you go into surgery you don't have a wire that has to cross the blue line into the sterile field,“ Kuntz said.

“It's also a major advantage to the physician as the patients return to have their device systems' programs changed,“ he said, adding that the wireless technology is designed to use the dedicated medical frequency, thus preventing problems associated with other frequencies used for devices such as cell phones and medical imaging systems.

NDI works with other companies, establishing licenses in the specific field of use and then entering a development program to customize the software, lead electrode, surgical tools, surgical kits or any other applications that the customer requires.

Kuntz also noted that NDI produces the products for the company long-term, from design, development all the way through to commercialization.

“The Micropulse technology platform is a complete neurostimulation system, including the IPG, implantable leads, surgical delivery tools and devices to program and control the IPG. Our system makes NDI an ideal one-stop solution for companies and researchers pursuing the neurostimulation market,“ he said.

NDI's customers represent a wide range, “from start-ups that have two employees to Fortune 500 companies.“

While it is obvious how the company could help smaller entities, Kuntz explained why a powerhouse device maker might benefit from their expertise. “A lot of the large companies find that they just cannot develop in a timely manner technology fast enough with their internal issue unlike someone fast and nimble like NDI,“ he said.

The company noted that neurostimulation is being used increasingly by clinicians to treat a variety of medical problems, including pain management, cardiac therapies, obesity management, mental disorders, respiratory illnesses, pelvic healthcare and paralysis.

Privately held NDI, which stands for Neurostimulation Design and Innovation, was founded by President and CEO Geoffrey Thrope in 2002 to take advantage of this popular new technology.

Thrope said NDI is exploring opportunities with start-up neurostimulation companies, medical device companies pursuing the neurostimulation market, neurostimulation researchers and clinicians, and neurostimulation companies seeking product advancements.

“NDI Medical's mission is to deliver the client's clinical application to market as soon as reasonably possible by customizing our Micropulse platform technology to fit the application,“ Thrope said. “Additionally, our core competencies in neurostimulation product development and commercialization provide added strategic value in technology development, reimbursement assessments, project management, regulatory and clinical studies support.“

Kuntz said, “NDI Medical is the only company with the requisite technology, products, clinical expertise, and regulatory experience to get companies and researchers from development to market efficiently.“

NDI Medical hired Kuntz, a 15-year medical device industry veteran, last year to head the new business unit. He previously was vice president of operations for Cyberonics (Houston) and Northstar Neuroscience (Seattle) and has worked for Johnson & Johnson's (New Brunswick, New Jersey) subsidiary, Codman & Shurtleff (Raynham, Massachusetts), and Spacelabs Medical (Issaquah, Washington).

He said he was attracted to the smaller NDI because of what he termed the company's “well-designed platform technology.“

Kuntz noted that the company has had a particularly close affiliation with the nearby Cleveland Clinic for a number of years during the development of the platform.

“A number of physicians, and surgeons and researchers [at the Cleveland Clinic] were instrumental in providing guidance to NDI for the development of our technology,“ he said.

Other universities helping to develop the platform included Case Western University (also Cleveland) and Duke University (Durham, North Carolina).

Kuntz said that the company is just beginning to commercialize the Micropulse platform after several years of development and is eager to get the product out to the business world while still continuing to evolve and refine the technology for future use.

“I think it's important for a company to continue to develop their next generation technology, integrating future software, hardware capabilities to meet the demands of our clients.“ To this end, he said the company would continue to invest heavily in research and development “to remain cutting-edge and world-class in providing technology.“

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