The first thing that hits you when you walk in Elekta's Learning and Innovation Center (LINC) located in Atlanta, is that there is a lot of history here. From the Leksell Stereotactic System invented in 1949, to the Leskell Gamma Knife Perfexion - the advances in med-tech through the lens of a once small but now sizeable company are evident. But to merely think of this as a repository of the firm's greatest technological achievements and advancements in the treatment of cancer would be egregiously wrong. LINC is a learning center that links the past to future innovation. The 25,000...
When it comes to coverage and reimbursement, there are gatekeepers all over the place, but some keep bigger gates than others. Following are two stories about the Centers for Medicare & Medicaid Services and how it has kept its gate in recent weeks. CMS not wild about MILD CMS recently took it upon itself to review percutaneous, image-guided lumbar decompression for stenosis, proposing on Oct. 17 that it sees the evidence as insufficient to prompt coverage. Among the references found in the coverage...
There’s a lot to be said for gatherings like TCT. It brings device makers, doctors, and FDA together in a way that seems formulaic, but there’s nothing like face time to help people with sharply opposing views to hash out their differences without wanting to sling the phone through a window. Still, there are stories that remain untold, such as the following. PMA and 510(k) may rhyme, but … This year’s edition of TCT provided plenty of content about how well FDA and industry are getting...
It's tough to know what's "normal" for the natural history of a medical device, but it appears the path to maturity for those first-of-a-kind, high-risk circulatory system devices is more drawn out than in times gone by. Now that TCT 2013 is upon us, we might reflect on a third anniversary of sorts of the Sapien valve, a member of a class of devices that may or may not be described as a mature technology. The fanfare over the Sapien TAVR at TCT 2010 might seem...
It's no secret that it's harder and harder for med-tech firms to receive early stage funding. I think my last six blogs have been about that topic alone. But while its true that some venture capital firms are looking to invest in med-tech companies at a later stage in the development cycle, some firms are getting fairly creative and are going toward crowdfunding. Last week, I wrote a story about Amulyte (Markham, Ontario), a company that has developed an emergency response device that helps seniors live on their own terms, and its move toward the crowdfunding model. The company partnered...
Love it or hate it, social media has become ingrained in most of our lives both personally and professionally. LinkedIn has made it easier than ever for professionals across business sectors to connect with one another and forge potential working relationships. And for those of us in the news business—especially those of us covering the ever volatile healthcare industry —the rise of Twitter has both enabled and demanded the delivery of real-time news in 140 characters or less. The influence that social media, Twitter in particular, has on our professional lives was blatantly apparent in Cleveland last week where nearly...
Medical companies that are still entertaining the notion that business can continue as usual – that somehow the model of collaboration between firms and physicians is enough to foster innovation – are in for a rude awakening. We live in the “mobile information age,” where customers patients aren’t tethered to bulky computers or laptops to do the necessary research on a treatment method that might be suitable for them. All they need to do is need pull out their smart phone or tablet and at the touch of an ap, they have about 75% of the information they have...
As the debate over the continuing resolution persists, medical device makers are not the only ones wondering when and how it will end. The device tax repeal has been floated as a condition of a continuing resolution, but it might also be instructive to ask ourselves what the future holds for med tech. Part of the reason for the partisan nature of the CR debate is that the Affordable Care Act – the legislation that gave rise to the device tax – was itself the most partisan piece...
The Advanced Medical Technology Association (AdvaMed; Washington), the largest medical technology lobby group in the U.S., held its annual meeting last week in Washington DC. The meeting offered an excellent snapshot of all the exciting developments occurring in this critical sector of the healthcare field. While the med-tech market has encountered some challenging headwinds over the past few years on the regulatory and reimbursement fronts as well as in the venture capital markets, there are signs that the sector is headed for a dramatic rebound. A report released at the meeting provided by EvaluateMedTech forecasts the industry approaching $455 billion...
Until recently I, like most people, was under the misconception that chiropractic care was for people who have been involved in an accident or suffer from chronic neck or back pain. And, like most people, I never considered going to a chiropractor until I had a reason to. I first went to see Dr. Dean Jacks at Chiropractic Associates in Niceville, Florida, in July when I began having pain in my neck and upper back. Having never been to a chiropractor before, I really wasn’t sure what to expect....