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LEAD STORIES
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Economic and Clinical Value: Key Drivers for New Product Development Strategy
Sackman |
Numerof |
Being successful in today’s dynamic and increasingly cost-conscious healthcare environment requires medical device companies to fundamentally change the way they think about their products. Companies need to develop an understanding of how their products contribute to improved clinical outcomes against existing therapies and what data they will need to prove it.Government agencies are increasingly resistant to providing reimbursement at premium—and sometimes even par levels—without solid data showing significantly improved outcomes. Even with solid outcomes, if the product fails to demonstrate critical economic and clinical value against existing technologies, reimbursement decisions can be less than favorable.
As national agencies try harder to contain the cost of healthcare, adaptation to the new rules of pricing and reimbursement will continue to be a major challenge for medical device companies. In this article, Jill Sackman and Rita Numerof of Numerof & Associates explore the increasing focus on economic and clinical data for reimbursement that is requiring many medical device companies to look for ways to integrate payer reactions earlier into product design and development to be successful. [More]
Afterthoughts: Protecting Aftermarket Sales
Hansen |
In this economy, it is critical to squeeze every drop of value out of your intellectual property. You can be sure that your competitors are wringing every last drop out of theirs. One area that is sometimes overlooked in the medical device arena is the aftermarket for disposable or consumable components. Many devices are systems or assemblies that include both a reusable component and one or more disposable or consumable components. For example, a biopsy system may include disposable needles or cannulae that come into contact with patient tissues and bodily fluids as well as reusable components such as motors and gears that do not.
Patenting efforts often focus on the broader system, i.e., the combination of reusable and disposable components. This is especially true if the combination—and not any one component—appears to be what is new and worthy of patent protection. In such cases, it can be difficult to obtain patent claims that cover individual components, or claims that cover them broadly.
Patenting efforts often focus on the broader system, i.e., the combination of reusable and disposable components. This is especially true if the combination—and not any one component—appears to be what is new and worthy of patent protection. In such cases, it can be difficult to obtain patent claims that cover individual components, or claims that cover them broadly. [More]
An American ‘Intervention’
Springer |
After operating for 12 years as a successful Italian-based manufacturer of vascular interventional devices, Invatec opened its first office in the United States in September 2008. Tapping its expertise in industrial plastic-forming and extrusion, the medical device company launched in 1996 under the leadership of cofounders Andrea Venturelli and Stefan Widensohler. Invatec sells coronary, supraortic, peripheral, and RF products in Europe, Asia, and now the United States. Today, the privately held company offers 35 product families, including a full PTA balloon line, in 70 countries.
To oversee its new U.S. operations in Bethlehem, PA, Invatec tapped industry veteran Jack Springer as president. Springer comes to Invatec with more than 15 years of experience in endovasuclar therapies at Abbott Laboratories and Cordis Encovascular, where Springer worked his way up to general manager. Most recently, he served as president and CEO of Neuromonics (Edina, MN), a supplier of reagents.
Springer talks with MX about how his previous experience will help him in his new post, the challenges he faces, Invatec’s working alliances with physicians, and the company’s plans for the next few years. [More]
BIOMEDevice • April 22–23, 2009 • Boston Convention & Exhibition Center, Boston, MA
Attend New England’s new MD&M event! The BIOMEDevice exposition will include 300 leading suppliers to the medical device industry and the nation’s top resources for biopharmaceutical and medical device design and manufacturing. For complete event details including expo hall highlights, a current list of exhibitors, information on the co-located BIOMEDevice Executive Forum, and easy online registration for free expo hall admission, visit www.BIOMEDeviceBoston.com.
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| INDUSTRY IN BRIEF |
Medtronic acquired two firms this week, one of which is for a record-setting sum. The medical device firm agreed to pay $700 million for CoreValve (Irvine, CA), plus two potential $75 million milestone payments. It is believed to be the largest acquisition of a venture-backed medical device maker since 1998, according to data from Dow Jones VentureSource. In addition, Medtronic also agreed to pay $325 million for Ventor Technologies Ltd. (Netanya, Israel). Both VC firms develop replacement aortic valve systems. This is the third acquisition made by Medtronic in 2009. In January the firm bought Ablation Frontiers Inc. for $225 million.
MEDRAD’s Intego PET Infusion System has been named one of Medical Imaging magazine’s top eight most innovative products of the year. The magazine designated its top eight based on what its readership considers to be the most far-reaching, game changing, or groundbreaking medical devices on the market. The Intego automatically measures and delivers patient-specific fluorodeoxyglucose doses on demand. MEDRAD is based in Warrendale, PA.
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Baxter International Inc. was recently recognized among the Global 100 Most Sustainable Corporations in the World. In addition, several of the firms' locations have received recognition for efforts to advance diversity and environmental initiatives. In Asia Pacific, Baxter received the Catalyst Award for its diversity and inclusion initiatives. Baxter’s Thousand Oaks, CA, facility was honored with the “Flex Your Power Award.” In addition, the Cleveland, MS, facility was selected to participate in the state’s enHance program, and the Round Lake, IL, facility was recognized with a Pollution Prevention Award.
Merit Medical Systems (South Jordan, UT), a manufacturer of disposable devices, has signed a definitive agreement to acquire the assets of Alveolus, a provider of nonvascular interventional stents located in Charlotte, NC. The purchase price of the Alveolus assets is approximately $19 million, subject to post-closing adjustments. The Alveolus assets consist primarily of an intellectual property portfolio, inventory, receivables, and manufacturing equipment. Merit intends to fund the purchase price from its existing cash reserves. |
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