Medical Device DailyWashington Editor
The coming surge of healthcare spending in mainland China was not entirely unanticipated, so the world's most populous nation has been on the radar screens of firms in the life sciences for years, long before the recent announcement that Beijing would give healthcare spending a huge boost (Medical Device Daily, Feb. 12, 2010). Among the firms whose plans include entry into this market is Vycor (Bohemia, New York), maker of surgical instruments – including a brain retractor – which has started the process of registering its ViewSite brain access system with China's State Food and Drug Administration.
However, the firm has at least one thing going for it that not all device makers have: the cost of its offering can be bundled as part of a procedure and will not require a separate reimbursement decision. Contrast this situation with that faced by makers of capital equipment, such as medical scanners, who obviously have a tougher row to hoe because of the need for a full-blown reimbursement review process.
Ken Coviello, Vycor's CEO, told Medical Device Daily that the ViewSite is a 510(k) product in the U.S. and hence is not backed by reams of clinical data. He said a PMA would not necessarily be easier to get past SFDA, partly because the existence of predicates gives the agency more familiarity with the idea of the product, and potentially less anxiety about novelty. In any event, “the end result is you want clearance to market,“ he said.
As for the picture for reimbursement, Coviello said, “most of the cost in the state hospitals is picked up by the government. The challenge will be showing the clinical efficacy of the product,“ he noted. The idea is “with surgeon input, to be able to say this helps . . . to contain costs,“ which will help prompt officials to go along with including the device in a hospital's surgical inventory. “Our device is designed to help the surgeon with the procedure, and the charges [that pay for the ViewSite] are for the entire procedure“ rather than for the device, he noted.
“We plan to offer data that shows the potential for speedier surgery, less surgical times, and possibly quicker discharges, Coviello said.
There is often a tendency to think that informal channels are as important as formal channels in a society like China's, but Coviello seemed to see this as a less-than-crucial consideration. “I think expertise is the key factor in China healthcare marketing as well as the regulatory path. That's the reason we chose to work with Devon International [King of Prussia, Pennsylvania],“ he said, citing Devon's demonstrated success in getting outside firms' products into the Chinese market.
Coviello was hesitant to offer a firm forecast of unit sales of the ViewSite in this market. “Because the product is new [to providers in China], projections are hard to be certain about,“ he said, but “based on the number of craniotomies done in China, unit sales will be sizeable in comparison to the U.S.“ He said the ViewSite can be used to gain access to a number of deep-brain lesions as well as those occurring closer to the surface, making it a tool that can be used for a variety of tumors and other resectable tissues.
Gaining physician buy-in is always a fair amount of work, and specialty societies often play a significant role in that process in the U.S. Among the specialty societies that make their homes on the Chinese mainland is the Chinese Neurological Society, so this route is not without some potential. However, Devon opted for a more granular approach, making use of “face to-face-meetings with surgeons. That's been one of Devon's primary roles,“ Coviello said, remarking that neurosurgeons in the U.S. served as references. “That helps with credibility,“ he said.
Coviello pointed out that his company's access to China's market is not a done deal. “We don't have approval yet. We're in the early stages, but so far it's gone smoothly,“ he observed.
All the same, “it is a process, and we're hoping for a relatively speedy decision,“ Coviello said, and the interest expressed by distributors in China “has us quite pleased.“ Part of the device's appeal is that it is “a fairly simple product, a low-tech product, that solves a serious problem for the surgeon and a potential complication for the patient.“
Coviello said that the ViewSite, a transparent, roughly conical retractor, offers a reduction in trauma to tissue compared to other types of retractors, including blade and ribbon retractors. According to the firm's web site, the unit comes in a variety of lengths, widths and heights, and reduces the number of times a surgeon must push aside intervening brain tissues. This conic cross-section is said to limit the pressure “exerted on the surrounding brain tissue“ at the point of insertion, which is intended to reduce vascular “compromise and resultant cerebral damage“ by means of “maximiz[ing] the surface area of displaced brain“ so as to “reduce the local tissue pressure,“ the firm's web site states.
Vycor won an FDA clearance for the product in 2006 with the indication of “to provide access and allow for visualization of the surgical field during brain and spinal surgery.“ The firm obtained approval by Health Canada in 2008 and a CE mark the following year.
Still, Coviello said he believes in the device, as apparently do many Western brain surgeons, which means that access to this new market could have an enormous impact on his firm's prospects. “I believe the sheer numbers and the fact that . . . China's healthcare programs are about to explode is exciting,“ he said.
Mark McCarty, 703-268-5690