Medical Devices Today

MIS: Challenges in an Evolving Market

Article preview from Medtech Insight - May 1, 2011

Technology and techniques for minimally invasive surgery continue to evolve as medical device manufacturers and clinicians alike look for ways to further minimize the invasiveness, pain, and scarring associated with surgery. At the same time, the economy and health care reform have created challenges for medical device manufacturers. In response to these challenges, mannufacturers competing in the MIS market are developing new products and marketing strategies designed to ease both the economic and environmental impact for providers.

CortiCare Inc.

Article preview from Start-Up - May, 2011

In a perfect world, every critical care patient prone to seizures would be continuously monitored for brain activity. The reality, though, is that only a fraction of these patients are because of expense and medical priorities. CortiCare Inc. hopes to boost that low percentage by offering hospitals an outsourced service that remotely monitors brain activity. It will be promoted as a complete turn-key operation: patient set-up, equipment set-up and monitoring from a remote location.

EVAR Market: Challenges, Innovation and Growth

Article preview from IN VIVO - May 1, 2011

Endovascular aortic aneurysm repair procedures account for the majority of abdominal aortic aneurysm repairs performed in the US, and total worldwide revenues from aortic endograft systems now exceed $1 billion per year. Many believe that continuing improvements in endograft technology will drive EVAR penetration to 90% or beyond within the next five to 10 years.

Diabetes Researchers Say FDA Is Slowing Artificial Pancreas Efforts

Article preview from "The Gray Sheet"- June 27,2011

Developers of "artificial pancreas" devices for treating type 1 diabetes may gain insight from new FDA draft guidance on clinical trial design, but patients and advocates say the agency is standing in the way of greater advances in the space.

Total Joint Market: Slowly Recovering

Article preview from Medtech Insight - May 1, 2011

The $13 billion total joint market is facing a number of challenges coming off the recent recession. Although the demographics related to joint replacement remain strong, manufacturers continue to be plagued by downward pressure on implant prices, a slowdown in procedure volumes, and an ongoing shift in hospital purchasing. Many believe that J&J's recent acquisition of Synthes will spark a wave of consolidation in the industry.

Medtech Venture Capital: The View From Europe

Article preview from Start-Up - May, 2011

Medical device companies have always faced technological, regulatory, reimbursement and market risk, and a new risk has been recently added to this existing set of challenges: financing risk. Longer product development cycles mean sustained funding requirements, at a time when venture funds are less numerous and smaller, and syndicates have become difficult to assemble.

Leaving Medtronic: Bill Hawkins' Legacy

Article preview from IN VIVO - May 1, 2011

Prominently displayed in Bill Hawkins' office is a sword – a Viking sword, Hawkins points out -- a gift from Art Collins, the man who preceded Hawkins as CEO of Medtronic Inc. The gift was designed symbolically to help Hawkins "cut through the bureaucratic red tape" and "deal with the intense competitive environment." But for Hawkins, the sword had a different resonance – a kind of talisman of biomedical engineering.

User Fee Negotiators Far Apart: Industry Seeks To Delay New Fee Levels Until FDA Improves Performance

Article preview from "The Gray Sheet"- June 20, 2011

Device industry reps say industry-paid FDA user fees should be reauthorized for only two years, not five, to allow ongoing changes to FDA's pre-market review programs to sink in before a more meaningful user fee package is passed.

Neurointerventional Market Shows Strong Growth Potential

Article preview from Medtech Insight - May 1, 2011

The neurointerventional device market is one of the most dynamic areas in the field of neurology. Over the next four years, US neurointerventional procedures are expected to grow at a rate of nearly 18% compounded annually, reaching more than 197,000 procedures by 2015.

Sirius Implantable Systems Ltd.

Article preview from Start-Up - May, 2011

Intertwining technologies of a miniature left ventricular pacemaker with a leadless electrode from Israeli-based Sirius Implantable Systems Ltd. may someday improve the quality of pacing therapy and reduce the incidence of complications associated with conventional electrical wiring for standard pacemakers. Sirius' unique self-powered pacemaker and the leadless electrode will be implanted on the left side of the heart by minimally invasive surgery and can be matched with any standard pacing device in the market.