Medical Device Link.

The MX Q&A
New Cardiac Science head says the heart of his approach will be to run the company with 'greater speed and aggressiveness.'

Marver

Missing the forest for the trees will not be a problem for Dave Marver in his new job as president and CEO of Cardiac Science. “Our beautiful headquarters in Bothell, Washington, is blessed with an abundance of trees, wetlands, mountain views, and of course, rain,” notes Marver, who became chief executive on March 31.

Marver says the corporate neighbors in his new sylvan setting will keep him on his toes. “Don't think the gorgeous surroundings make us complacent. There are many successful medical device companies in the area,” he points out. “Having companies like Philips, SonoSite, and Physio-Control in close proximity constantly reminds us to bring our 'A' game.”

Physio-Control is a division of Medtronic. In October 2008 Marver left Minneapolis-based Medtronic after 14 years to join the $206-million manufacturer of automated external defibrillators (AEDs) and other advanced cardiology devices. During Marver's stint with Medtronic, he held a succession of vice president jobs that included leadership positions in strategy and business development and marketing. He also spent three years at the device giant's international headquarters heading up commercial activities for the cardiac rhythm management business in Western Europe. As business director for Medtronic's patient management business in the United States, Marver also gained expertise in the key areas of informatics and connectivity. Five months after joining Cardiac Science as COO and executive vice president, he was chosen to replace successful CEO John Hinson.

From his new office, Marver plans to keep his eyes on both the forest and the trees. “Our competitors are good companies with good people, and we expect to beat them,” he says. The new CEO took some time out of his busy first-week schedule to discuss a range of topics with MX, including the challenges of overseeing a healthy device firm in a sick economy, his expectations, the importance of medical connectivity, and his plans for the “vastly under-penetrated” AED market. [MORE]

Maximizing Value in Medical Device Launches

Singer

The importance of successful product launches in the medical device industry cannot be overestimated.

On the surface, launch delays appear to make a difference only during a product's first few years, when sales are relatively small. But closer inspection reveals the impact can be significant. A year's delay always costs a year of peak sales-which can mean millions of dollars in lost revenues-making a successful, on-time launch absolutely critical.

Pricing pressure and competition in medical device and diagnostic companies' existing business make successful new products even more critical to achieve short- and long-term growth goals.

Despite their importance, it is surprising just how often launches go wrong. That's because it takes more than just a great product, a sound marketing strategy, or even a standardized process to ensure success.

Based on their experience working with medical device and diagnostic firms, Matt Singer, Andrea Schulz, and Marshall Solem present a framework of 11 guiding principles for launch excellence. Applied as a whole, these principles can help ensure a company maximizes its product debut, whether it's for a breakthrough technology or a product line extension.

It takes more than a great device and a sound marketing strategy to ensure the success of a product debut. [MORE]

Which Type of IP Protection Is Right for Your Medical Device?

Diliberti

Choosing which type of intellectual property (IP) protection is right for your medical device is not always easy, especially when a device is eligible for more than one type of protection. This article discusses the types of IP protection that are generally applicable to medical devices in the United States. Knowing which types are available, appropriate, and most beneficial-as well as knowing the timing and method of making the right choices-is crucial to understanding how to protect your devices. We explore these issues through the following questions:

What types of IP protection may be available for medical devices?

What are the general advantages and disadvantages of each type?

Which types of IP protection can be used together, either successively or simultaneously, and which may be mutually exclusive?

Types of IP Protection

The following section explains the five different forms of IP protection and their application to a medical device. Medical devices can be of various types, such as imaging devices, sensors, analytical systems, clinical treatment devices, implantable products, and prostheses, to name a few. In each of these categories it is important to achieve optimum protection as well as the type of protection best suited for different categories of devices. Attorneys Mark J. Diliberti, Jeffrey S. Gundersen, and Jeffrey H. Greene reveal that the secret to safeguarding product IP lies in a good understanding of all available options. [MORE]

Court Upholds Award of $5 Million for Alaris Medical Systems

The U.S. Court of Appeals for the Federal Circuit has affirmed the rulings of the U.S. District Court for the Central District of California in favor of Alaris Medical Systems Inc. In its ruling, the Federal Circuit upheld the district court's award of $5 million in attorney's fees and costs to Alaris. Alaris, a subsidiary of Cardinal Health Inc., develops and markets products for the safe delivery of intravenous (IV) medications.

The medical device case involved more than $2 billion in Alaris products that had been accused of infringement by ICU Medical Inc, a manufacturer of disposable medical connection systems for use in intravenous (IV) therapy applications. ICU asserted four patents related to valves used in IV setups.

The Federal Circuit affirmed the district court's decisions granting summary judgment of noninfringement and invalidity and the awards of sanctions and $5 million in attorney's fees and costs. The company was represented by the Chicago-based law firm of McAndrews, Held & Malloy. [MORE]

MD&M East — June 9-11, 2009 — Jacob K. Javits Convention Center, New York, NY

If you design or manufacture medical devices then you don’t want to miss MD&M East. Find all the resources you need to successfully design, develop, and manufacture medical devices and equipment for today’s increasingly competitive healthcare marketplace. For complete event details including expo hall highlights, a current list of exhibitors, information on the co-located MD&M East conference program, and easy online registration for free expo hall admission, visit www.MDMeast.com.

Maximizing Value in Medical Device Launches

The MX Q&A: New Cardiac Science Heads with Spped and Aggressiveness

Which Type of IP Protection Is Right for Your Medical Device?

Court Upholds Award of $5 Million for Alaris Medical Systems

Canon U.S.A. has acquired Virtual Imaging Inc., a Florida-Based diagnostic imaging firm. The acquisition provides Canon with capabilities to expand its services to the medical imaging market. Virtual Imaging has more than 100 employees that will continue to provide service to large hospital organizations, imaging centers, and private physician offices. It is the national distributor of Canon’s digital radiography systems. The current president of Virtual Imaging Inc. will continue to manage day-to-day operations at the imaging company.

Citing the company’s dominance in the market, global market analyst, Frost & Sullivan, has honored Siemens Healthcare (Malvern, PA) with the 2009 North American Magnetic Resonance (MR) Imaging Scanners Market Leadership Award. The analyst firm specifically called attention to the imaging firms introduction of ultra-short, open-bore MR imaging scanners as the new standard of care within MRI. According to Frost & Sullivan, Siemens has earned wide recognition among the MRI community as a company that delivers second-to-none technology and highly regarded customer support services. The huge success of its ultra-short, open-bore scanners and the ability to deliver actionable results to customers that lead to workflow and business improvement have powered Siemens to the number one spot in the MRI industry.

Baxter International Inc. (Deerfield, IL) has acquired a minority stake in SIGMA International General Medical Apparatus LLC (Medina, NY), with an option to purchase the rest of the company. Baxter has also entered a three-year distribution agreement with the pump manufacturer. The terms of the agreement enables Baxter to provide SIGMA’s Spectrum large volume infusion pumps to customers and also provides the company with access to SIGMA’s product development pipeline. Spectrum features wireless connectivity and smart technology intended to help reduce medical errors by using drug libraries. These libraries limit the need for clinicians to manually enter common drug and dosage rates. Baxter would provide the intravenous administration tubing for the pump.

The West Michigan Science & Technology Initiative, in partnership with the Grand Rapids SmartZone, has expanded its Venture Center with the availability of additional incubator space in Grand Rapids, MI. The building features laboratory space available from 300 to 1500 sq ft, equipped with amenities for life science and high-technology companies. The initiative will work with new tenants to customize the space to fit their needs, with specific focus on serving the medical device sector through advanced design and prototyping capabilities. The total space of the new facility is 6500 sq ft, which, when added to the existing space at Grand Valley State University’s Cook-DeVos Center for Health Sciences, provides more than 26,000 sq ft of incubator space dedicated to life science and technology industry growth in Grand Rapids.