Expanded indications for bone morphogenetic proteins and new alternatives to those first-generation bone growth factors have the potential to grow the $2 billion market for bone replacement materials. This article is reprinted from the April 2010 issue of Medtech Insight (Also see "Bioactive Technologies for Bone Replacement" - Medtech Insight, 1 Apr, 2010.).

The global market for orthobiologics, comprised primarily of bone replacement materials, reached almost $2 billion in 2009 and is growing at an overall rate of 7%. Medtronic leads in bone replacement with a 45% market share, but overall growth in orthobiologics may come from emerging segments, particular synthetic and stem-cell based technologies.

A growing number of medical device start-ups are using a variety of strategies-angel investors, government grants, and corporate partners-to go all the way to commercialization or exit without relying on venture capital funding. The trend away from venture financing is gaining advocates, particularly among device start-ups with unconventional business models or products that play in small market niches. In the process, these new financing models are giving small device companies who have been turned down by VCs or found their terms difficult to swallow, some hope.

The successful commercialization of drug-eluting stents (DES) has done much to pave the way for the biocoating industy. DES not only helped establish a new regulatory body to facilitate device-drug reviews, the FDA Office of Combination Products, they also proved that biocoated devices could take market share from uncoated products, command premium pricing and premium reimbursement.