The device center plans to finalize all the 510(k) program guidances it issued last year, among a boatload of 2012 priorities. Many of this year's top goals spring from the 510(k) and “science in regulatory decision making” reform programs that commanded attention in 2011.
The effectiveness of a product is only one aspect of how well a device will succeed in the aesthetics market. In the following interview, Steven H. Dayan, MD, a noted Chicago plastic surgeon, tells Medtech Insight that manufacturers seeking to enter this space need to spend time on market research and fully understand where their products will be used and who will use them.
A long-time darling of venture capital, the gastrointestinal sector has yet to meet expectation of VCs who wagered on technologies to treat gastroesophageal reflux disease, Barrett’s esophagus and even obesity. But some notable acquisitions, including Covidien’s purchase of privately held Barrx, may present a ray of hope for investors in GI companies.
Privately held DFINE Inc., a supplier of tools for treating vertebral compression fractures in the spine, is trying to reposition itself from being a spine company to an “interventionalist company” that provides tools necessary to interventional radiologists, neuroradiologists, and oncologists.
Device industry experts say a seemingly minor footnote to the recent 510(k) program draft guidance could create a new requirement for nonclinical studies.
The cardiac interventional suite has historically welcomed high-tech, cutting-edge tools. But with hospitals scrutinizing expenditures more closely than ever before, such tools must now prove themselves. Hospitals are now placing a premium on technologies that can improve safety, efficiency, and flexibility while streamlining workflow. A handful of companies are now offering products designed to meet these needs, and providers are starting to take notice.
Solta Medical was formed by the merger of two aesthetic device start-ups targeting the same customer with complementary technologies: Thermage in skin tightening and Reliant in skin resurfacing. Solta Medical’s product and marketing strategy has made it more immune in the economic downturn than its peers in aesthetic energy devices. What’s helped it most these past few years is its reliance on high margin disposables, rather than capital equipment, for the majority of its revenues.
Consumers of aesthetic procedures are still looking for the perfect option – one that produces a more youthful looking face, but does not require much, if any, downtime. Ideally, these consumers also would like something that offered a long-lasting effect and was delivered with minimal pain and discomfort. At the 2011 AAFPRS conference, held recently in San Francisco, CA, the Emerging Trends and Technologies session focused on new and developing technologies that could meet some of these demands.
As of last month, FDA and industry were several hundred million dollars apart, according to recently released negotiation meeting minutes. And insiders suggest the two are still haggling over the total amount companies will need to shell out in the five-year user fee reauthorization.
As researchers work to more fully understand the risks and durability of transcatheter aortic heart valve implantation (TAVI) procedures, device innovators are already attempting to engineer solutions to some of the more obvious areas of unmet need.
