Medical Devices Today

Retinal Disease: Much Progress, Some Pain

Article preview from Medtech Insight - February , 2012

On many fronts, 2011 was an event-filled year for the retinal disease market, beginning with the publication of the CATT trial comparing off-label intravitreal Avastin versus Lucentis for the treatment of AMD, and ending with several important milestones for device manufacturers operating in this space. But while the retinal device field is making progress in many areas, companies continue to struggle to meet shifting FDA approval requirements.

ConforMIS Gets Personal With $89 Million Round

Article preview from Start-Up - February, 2012

ConforMIS last month closed on an $89 million Series E round to help pay for the company’s commercial launch of iTotal, customized, patient-specific total knee implants.

At AAOS, Large Joint Makers Are Making It Personal

Article preview from IN VIVO - February, 2012

At AAOS’ 2012 meeting, one attention-grabbing strategy centered on the personalization of large joint implants to match the specific anatomies of patients. Several large joint manufacturers have introduced tools for achieving “custom fits” for new joints, knees in particular. Advances in robotics and customized manufacturing are enabling smaller companies to take personalization to the next step. MAKO featured its MAKOplasty Total Hip Arthroplasty (MAKOplasty THA), an advancement of its partial knee MAKOplasty procedure. In another approach toward customizing knee surgeries, ConforMIS manufactures a line of knee implants that are custom made for each individual patient.

Inventor Thomas Fogarty’s Newfound Optimism About FDA

Article preview from "The Gray Sheet"-  March 26, 2012

In an interview with “The Gray Sheet,” renowned inventor and entrepreneur Thomas Fogarty says he is encouraged, based on his recent experience with FDA, that regulatory trends slowing U.S. device innovation can be reversed.

Emerging Diabetes Technology Driven By Patient Demands

Article preview from Medtech Insight - February , 2012

Integration has become a key driver in the development of a new wave of diabetes tools that have either recently hit the market or will become available in the next few years. Many diabetics, who have a great deal of influence on the success or failure of products in this space, are seeking devices that work seamlessly with the smart phones and cellular technology that are so prevalent today. A number of start-up companies are poised to compete with the bigger diabetes manufacturers as the market continues to evolve.

Larger VC Deals Could Become More Common In Devices

Article preview from Start-Up - February, 2012

Big venture capital investments … scratch that … really big venture capital investments catch our attention these days. After all, venture capital firms are slowly beginning to fade away, and the pool of venture capital is said to be drying up with it.

How Incentives Are Shaping Medtech’s Future

Article preview from IN VIVO - February, 2012

The US health care system is undergoing substantial change as payors increasingly flex their muscles to move the system from a Fee-For-Service model to an Outcomes-based model. The end result is likely to be a medical device industry comprised of fewer, larger companies working closely with hospitals and physicians to provide integrated patient care. This will impact the types of medical technology companies that will be launched and venture financed going forward. Companies that embrace and enable these industry changes will fare relatively better than those that do not.

Draft User Fee Bills Aim To Streamline And Strengthen Device Regs

Article preview from "The Gray Sheet"-  March 19, 2012

Details on draft legislation circulating in the House and Senate.

Diagnostic Industry Trends Hinge On Gene-Based Tests

Article preview from Medtech Insight - February , 2012

In 2011, sequencing was once again the big story in diagnostics. But unlike 2010 when the big news was the successful IPOs of next-generation sequencing companies Pacific Biosciences and Complete Genomics, the tone in 2011 was more nuanced.

Percutaneous Mitral Valve Therapy: The Next Decade

Article preview from Start-Up - February, 2012

After more than a decade, the field of transcatheter mitral valve therapy is still in its infancy, yet it is surprisingly crowded. The first percutaneous mitral valve company was founded in 1999, the same year that the first transcatheter aortic valve implantation (TAVI) company was founded, but while TAVI is now on the market in Europe and in the US, the leading transcatheter mitral valve therapy has only just completed clinical trials. The anatomy of the mitral valve is much more complex than its aortic counterpart, patients with mitral valve disease make up a heterogeneous group, and the anatomical environment for mitral valve implants is much more challenging.