Legislation was reported out of committee last week, with some additional amendments under consideration as the user fee reauthorization bill moves closer to the Senate floor. House members still struggle to reach consensus.
The business of selling hip and knee implants is dominated by five principal players whose grips have been impossible to break as surgeons have become comfortable working with these market leaders. But health care reform, the sagging economy and other external interferences are putting pressures on hospitals to save money wherever they can, and these pressures could create openings for smaller players. These companies are pushing new technologies – such as robotics and customized implants – as well as different business models – including a plan to get rid of the orthopedic sales rep – to grab a larger piece of $11 billion industry in the next few years. But the Big Five are notoriously tough to beat.
There are signs that the field of deep brain stimulation (DBS) has gained a certain momentum of late: three start-ups raised venture rounds in 2011 and there have been two acquisitions in the space within the past year. DBS enables the giants in cardiac rhythm management – Medtronic, St. Jude Medical, and Boston Scientific –to leverage existing technology platforms from CRM to address a new area once served primarily by drugs, and start-ups can help them by validating new disease targets and increasing procedural accuracy and efficiency. The space is appealing because with a single platform, companies can address several diseases with large populations, such as depression and Alzheimer’s disease. But the opportunities remain far from certain with this highly complex technology.
Three years ago, only Ardian was publicly working on renal denervation devices for hypertension, but at last month’s ACC meeting, some said there were now anywhere from 16 to 40 companies in the space. Fast followers don’t want to miss out on an IP land grab in today’s hottest medical device space.
FDA’s device center is reworking its controversial draft 510(k) modifications guidance with the intent to issue a revised draft before finalizing a new policy.
It’s been a long road for MicroCHIPS, founded in 1999 to develop an implantable device capable of delivering discrete drug doses repeatedly over long periods of time. The company recently published results of its first clinical trial, establishing proof-of-concept and perhaps more importantly, indicating that after many years, it now has a focused plan, if not a timeline, for commercialization.
With the economy improving and the total joint market slowly recovering, one of the brightest spots in the orthopedics industry is the market for shoulder replacements. While 2012 growth rates of total hips and knees are forecast in the low single digits – at 3% and 1%, respectively – the US shoulder replacement market is growing at a brisk 9.7% pace and is expected to reach approximately $620 million in revenues this year.
Europe has historically been rich in physicians with innovative ideas but has lagged in turning those ideas into novel devices. MD Start, a new incubator, backed by a group of leading device companies and VC firms, hopes to turn those ideas into viable companies.
For biotech companies and their backers, the structured acquisition -- with contingent payments that stretch well beyond the close of the sale -- is practically the only exit available and, everyone agrees, a permanent part of the landscape. While it's certainly a buyer's market, the sellers have begun to adopt strategies and rules to help boost returns. Are they working?
