Reaching More of the World

“During total hip or knee surgery, it can be extremely challenging to control bleeding,” says surgeon Marco D’Imporzano, M.D. “The bleeding site is often difficult to reach, and it is difficult to control this bleeding with traditional surgical techniques.”

At Gaetano Pini Hospital in Milan, Italy, Dr. D’Imporzano now has access to a new hemostasis product from Ethicon, Inc. that can be used to stop bleeding. EVICEL^® Fibrin Sealant (Human), once thawed, is ready on-demand to help surgeons meet critical bleeding challenges.

EVICEL^® is a fibrin sealant approved for general hemostasis in surgery (that is, it can be used in any surgical setting) when control of bleeding by standard surgical techniques is ineffective or impractical. The human plasma-based biologics in EVICEL^® sealant allow it to work independently of the patient’s clotting factors, creating a simple solution for complex bleeding problems.

Often, surgical success depends on the ability to quickly and effectively control bleeding at the surgical site. EVICEL^® sealant has become a critical tool to assist surgeons in ensuring that bleeding during and after surgery doesn’t become life-threatening.

“The availability of so powerful a topical hemostatic product is extremely important,” says Dr. D’Imporzano. “Using a product like EVICEL^®, together with a minimally invasive surgical approach, can lead to improved outcomes for patients.”

EVICEL^® sealant is the first product from Omrix Biopharmaceuticals, Inc. that Ethicon is taking to more global markets. When Ethicon acquired Omrix in 2008, EVICEL^® sealant was available in one country. By the end of 2009, it was in 10 countries, and at the end of 2010, in 20 countries, including Italy, where it launched in October.

“This is a great example of how we’ve used our scale to quickly globalize important products,” says Randy Hubbell, Worldwide Vice President, Ethicon Biosurgery unit. “With EVICEL^® we’ve taken the best technology, leveraged the global network of Johnson & Johnson companies and provided a strategic plan executed by local teams. Now more doctors can access this leading technology and make meaningful differences for their patients.”

Because EVICEL^® sealant is both a biologic and a medical device product, knowledge and experience in launching pharmaceuticals as well as medical devices was needed to expand to so many markets so quickly. In markets like Turkey and Greece, Medical Devices and Diagnostics (MD&D) teams reached out to their counterparts in Pharmaceuticals. Local expertise was the best way to manage the complexity in Italy, which has 21 provinces with distinct regulatory bodies, each with specific requirements.

“Our strategy was to provide local leadership with comprehensive, cross-functional tools,” says Ron Horton, Group Product Director, Ethicon, Inc., who led the EVICEL^® sealant globalization efforts. “The approach we used is scalable and adaptable for other business units, which could prove beneficial for teams in both the MD&D and pharmaceutical segments as they work to achieve global business goals.”

GLOBALIZATION DRIVES BUSINESS

The ability to quickly globalize products is just one way the MD&D business segment is capitalizing on globalization. Another is by developing market-appropriate products.

Today the global MD&D market is worth approximately $350 billion, more than 50 percent of which is outside the United States, where markets are growing at a slightly faster rate. And emerging markets are growing still faster—two to three times the rate of the overall market.

In China, product offerings are being expanded to meet the unique needs of the mass market, which comprises hundreds of millions of people who now have access to some degree of health care. MD&D businesses have launched a number of market-appropriate products in China recently. Ethicon Endo-Surgery, Inc. introduced the Advant™ 55 Linear Stapler in 2008 and the HCS Disposable Curved Circular Stapler in 2010.

Designed for specific Asian markets, the ONETOUCH^® ULTRAVUE™ blood glucose meter from LifeScan, Inc. was successfully launched in Japan in mid-2008 and is now a popular meter there. The meter was introduced in 2010 in China, where diabetes is quickly becoming an epidemic. Recent data indicates that one in 10 people in China now have the disease.

To further accelerate progress in emerging markets, more research and development is being done outside the U.S.

PATIENT NEEDS DRIVE EFFORTS

Efforts to develop market-appropriate products and quickly globalize new and existing products rely on an ability to leverage capabilities throughout Johnson & Johnson. The result is reaching more of the world with products that can make a difference.

And that excites the Biosurgicals team too. “We’ve achieved an important market presence with EVICEL^®, paving the way for products we’re developing,” says Dan Wildman, Worldwide President of Ethicon, Inc., responsible for the Ethicon Biosurgery unit. “By meeting significant needs of surgeons, we’re meeting vital needs of their patients.”

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