Medical Product Outsourcing Breaking News

Cardinal Health to Spin Off Medical Products Business

Editor — Wed, 08 Jul 2009 08:28:00 -0500

Cardinal Health Inc. has launched a new brand, Carefusion Corp., which will be a spinoff of its clinical and medical products businesses, according to the Dublin, Ohio-based firm.

The medical device maker said it plans to make the transaction official in late summer, and it will be a public company. It has applied to have its shares of common stock listed on the New York Stock Exchange under the ticker symbol “CFN.”

CareFusion will develops technologies including Alaris IV pumps, Pyxis automated dispensing and patient identification systems, AVEA and Pulmonetic Systems ventilation and respiratory products, ChloraPrep and MedMined services for infection prevention, neurological monitoring and diagnostic products, V. Mueller surgical instruments and a line of products that support interventional medicine.

It employs more than 15,000 people worldwide and serves customers in 120 countries.

Panasonic Develops Drug-Dispensing Robot

Editor — Tue, 07 Jul 2009 13:06:00 -0500

Panasonic Corp. has manufactured a robot that dispenses drugs to patients, the Japanese electronic company’s first step into robotics.

The Tokyo, Japan-headquartered firm will sell the robot to Japanese hospitals next March and will market it in the United States and Europe later. Panasonic spokesman Akira Kadota said the robot will cost several hundreds of thousands of dollars.

“This robot is the first in our robotics project. It sorts out injection drugs to patients, saving time for pharmacists,” said Kadota. “It looks like a cabinet with lots of small drawers.”

Pharmacists put drugs into the robot, which stores medical data for patients. The robot will then sort out drugs for each patient and place them into respective drawers bearing the names of patients, according to the company.

Former AngioDynamics CEO Takes Helm at Delcath Systems

Editor — Mon, 06 Jul 2009 11:18:00 -0500

Eamonn Hobbs has been named president and CEO of Delcath Systems Inc., a New York, N.Y.,-based medical device firm that focuses on cancer treatments, according to the company.

Hobbs previously worked for AngioDynamics in Queensbury, N.Y., a medical company he co-founded that focuses on oncology, radiology and vascular devices. He replaces Richard Taney, who will remain with the company on its board of directors.

"Eamonn is a proven leader with extensive experience in all aspects of medical device commercialization and the entire Board feels that he is the best person to lead our Company through the next phase of our development," said Dr. Harold Koplewicz, chairman of Delcath's board of directors.

Hobbs stepped down from his role as president and CEO at AngioDynamics in March. He remained vice chairman until May 8, when he resigned and left the company.

Delcath Systems is testing a proprietary, patented drug delivery system for the treatment of liver cancers. The company is currently enrolling patients in Phase III and Phase II clinical studies for the treatment of liver cancers using high doses of melphalan.

St. Jude Medical Receives Warning Letter for Texas, N.J. Facilities

Editor — Mon, 06 Jul 2009 10:35:00 -0500

St. Jude Medical Inc. has received a warning letter from the U.S. Food and Drug Administration for non-conformities with Good Manufacturing Practice at Texas and New Jersey facilities, according to the company in a regulatory filing.

The letter, dated June 26, said the FDA would not clear pre-market approval applications for the company’s Class III devices until the violations are corrected, according to St. Paul, Minn.-based St. Jude Medical.

Firm officials said it initiated efforts to address the FDA’s concerns, and the Neuromodulation division provided written responses to the FDA detailing proposed corrective actions at its Plano, Texas and Hackettstown, N.J., facilities.

Galil Medical Sues HealthTronics Over Alleged Merger Agreement Interference

Editor — Tue, 30 Jun 2009 10:01:00 -0500

Galil Medical Ltd. has filed a lawsuit against HealthTronics Inc., asking the court to stop HealthTronics from interfering with a merger agreement between Galil and Endocare Inc.

Yokneam, Israel-based Galil Medical, a global cryotherapy company, wants HealthTronics, a urological services and products provider headquartered in Austin, Texas, to pay damages.

In the suit, Galil alleges Healthtronics helped Irvine-Calif.-based Endocare, which makes minimally invasive medical devices, in its recent attempt to terminate the Galil/Endocare merger agreement so that HealthTronics could then acquire Endocare.

The suit against HealthTronics follows Galil's recently-filed lawsuit against Endocare, which also arose out of Endocare's alleged breach of the Galil/Endocare merger agreement. A trial is scheduled for July 9 and 10 in Chancery Court in Georgetown, Del.

HealthTronics agreed earlier this month to buy Endocare in a deal worth about $1.35 a share.

Stanford Researchers Publish Medical Device Development Model

Editor — Tue, 30 Jun 2009 09:43:00 -0500

Researchers at Stanford University have published a model representing the medical device development process in the June issue of the Journal of Medical Devices.

The model was constructed based on best-practice analysis and interviews with more than 85 experts involved in the development, commercialization, regulation, and use of medical devices.

“Medical devices contribute significantly to the continuous improvement of healthcare,” said lead author Jan Pietzsch, Ph.D.,consulting assistant professor in the department of management science and engineering at Stanford University. “Depending on the type and complexity of the technology, the device development process can take anywhere from 15 months to several years. As a result, successfully bringing innovative products to patients hinges on knowledge of and planning for this process.”

According to the authors, the developers of both highly sophisticated premarket approval (PMA) and premarket notification 510(k) devices use the model.

The five major phases and decision gates include:

• Phase 1/Gate 1: Initiation, opportunity, and risk analysis.

• Phase 2/Gate 2: Formulation, concept, and feasibility.

• Phase 3/Gate 3: Design, development, verification, and validation.

• Phase 4/Gate 4: Final validation and product launch preparation.

• Phase 5: Product launch and post-launch assessment.

Pietzsch added that the medical device development process has become increasingly complex in recent years because of the advent of advanced technologies, stricter regulatory requirements and the increasing importance of reimbursement decisions.

Among the key results of the study is a detailed explanation of the significant differences between medical devices and pharmaceuticals and the corresponding differences in their development processes and regulatory requirements.

Researchers also pointed out that the U.S. Food and Drug Administration’s quality system regulations don’t always permit product developers to streamline their processes where it would make sense.

Go to http://asmedl.aip.org/getabs/servlet/GetabsServlet?prog=normal&id=JMDOA4000003000002021004000001&idtype=cvips&gifs=Yes to view the abstract of the article published in the Journal of Medical Devices.

Survey: At Least 32 Medical Device Firms Adopt AdvaMed Ethics Code

Editor — Mon, 29 Jun 2009 12:43:00 -0500

A survey by Pricewaterhouse Coopers LLP shows that the medical device industry has been quick to adopt the Washington, D.C.-based Advanced Medical Technology Association’s (AdvaMed) Code of Ethics.

According to the study, 90 percent of respondents, representing 32 companies, have implemented policies that address all portions of the AdvaMed code.

AdvaMed developed the code to assure a high standard of ethical conduct by the medical technology industry. A major update to the code was unanimously approved by the AdvaMed board of directors in December 2008 and will go into effect on July 1.

The 2008/09 survey included an electronic survey, follow-up interviews, and webcast polling on topics such as policies and procedures, auditing and monitoring, fair market value and sales compensation, according to AdvaMed. Highlights of the survey include:

• Ninety percent of respondents have policies in place that address all provisions of the current AdvaMed Code of Ethics.

•Thirty-eight percent of respondents apply the code globally, with revisions for legal and cultural differences based upon geography, while 43 percent apply the code to U.S. operations only, with international having its own policies.

• Ninety-four percent plan to implement new policies and procedures to reflect the changes of the new 2009 AdvaMed Code of Ethics.

See the complete AdvaMed Code of Ethics at www.advamed.org/NR/rdonlyres/FA437A5F-4C75-43B2-A900-C9470BA8DFA7/0/coe_with_faqs_41505.pdf.

ev3 Acquires Chestnut Medical Technologies

Editor — Fri, 26 Jun 2009 07:56:00 -0500

ev3 Inc., a global endovascular device company, has closed the acquisition of Chestnut Medical Technologies Inc., a Menlo Park, Calif.-based company focused on developing minimally invasive therapies for interventional neuroradiology, according to the company.

The purchase by the Plymouth, Minn.-based firm broadens ev3's neurovascular product portfolio by adding the Pipeline Embolization Device for the treatment of cerebral aneurysms and the Alligator Retrieval Device for foreign body retrieval to ev3's existing embolic product and access technologies.

Chestnut's Pipeline technology is designed to divert blood flow away from an aneurysm in order to provide a complete and durable aneurysm embolization while maintaining patency of the parent vessel.

ev3 acquired 100 percent of the equity interests of Chestnut for $26 million in net cash and about 5 million shares of ev3 common stock for total upfront consideration of approximately $75 million.

An additional milestone-based contingent payment of up to $75 million is payable in a combination of cash and ev3 common stock upon the receipt of U.S. Food and Drug Administration pre-market approval of the Pipeline device.

ev3 financed the upfront cash payment at closing through cash on hand.

Boston Scientific Names New President, CEO After Tobin Retires

Editor — Thu, 25 Jun 2009 09:54:00 -0500

Jim Tobin, who has served as CEO of Boston Scientific Corp. for 10 years, will retire from the Natick, Mass.-based company, and Ray Elliott will become president and CEO effective July 13, according to the firm.

“Ten years ago this month, I began my tenure as CEO of Boston Scientific, and two months from now, I will turn 65,” said Tobin. "Over the course of the past decade, we have built a stronger, more diversified company that is well positioned for the future. We have achieved this due largely to the support of our employees, customers and investors, and I would like to take this opportunity to thank them. Now is an appropriate time for me to turn over the leadership of the company to Ray Elliott, our new CEO. Ray is an outstanding choice, and he has my full and enthusiastic support. We will have a smooth transition, which will culminate with Ray taking over next month.”

Elliott, 59, has more than 35 years of experience leading healthcare and consumer products companies. He led orthopedics company Zimmer Holdings Inc., based in Warsaw, Ind., for 10 years, joining the company as president and rising to chairman, president and CEO. Prior to joining Zimmer, he served as president and CEO of Medway, Mass.-headquartered Cybex International Inc., a medical rehabilitation and cardiovascular products company.

He also has served as president and chairman of various divisions of Southam Inc., a communications group in Canada, and as group president of food and beverage company John Labatt Ltd in London, Ontario. He began his career in the healthcare industry with American Hospital Supply Corp. in Deerfield, Ill.—now Baxter International Inc.—where he served for 15 years in sales, marketing, operations, business development and general management positions, leading to his appointment as president of Far East divisions, based in Tokyo.

During Elliott's leadership of Zimmer, sales and market capitalization quadrupled. Sales increased from approximately $1 billion in 1997 to approximately $4 billion in 2007. Elliott oversaw taking Zimmer public in 2001, with an initial market capitalization of approximately $5 billion. At the time of his departure in 2007, the company's market capitalization was more than $20 billion. In 2005 he was named “Best CEO in America” for Health Care (Medical Supplies and Devices), by Institutional Investor magazine.

“We are delighted that Ray will be joining us as only the third CEO of Boston Scientific,” said Pete Nicholas, chairman of the board. “His long and proven track record in leadership positions has prepared him well for this role. Ray is an extremely capable leader with extensive experience running global health care companies. We have gotten to know Ray well as a leader and colleague in the industry, as well as from his service on our board. We are confident he offers the right combination of experience, results and talents for Boston Scientific going forward.”

Trial Shows Cardiac Resynchronization Therapy Can Slow Heart Failure

Editor — Tue, 23 Jun 2009 10:54:00 -0500

A trial sponsored by Boston Scientific Corporation has concluded that early intervention with cardiac resynchronization therapy can slow the progression of heart failure, according to the Natick, Mass.-based company.

Preliminary results find that using Boston Scientific cardiac resynchronization therapy defibrillators result in a 29 percent reduction in death or heart failure interventions when compared to traditional implantable cardioverter defibrillators.

The trial, called, MADIT-CRT, included more than 1,800 patients enrolled at 110 centers in 14 countries. The trial is being conducted under the leadership of Dr. Arthur J. Moss, professor of medicine at the University of Rochester Medical Center in Rochester, N.Y.

"We are very encouraged by these initial positive results, and we are hopeful they will eventually lead to a wider population of heart failure patients being treated with CRT-D therapy," said Fred Colen, executive vice president and group president of Cardiac Rhythm Management at Boston Scientific.

FDA Chief to Review Medical Device Approval Process

Editor — Tue, 23 Jun 2009 10:22:00 -0500

U.S. Food and Drug Administration Commissioner Margaret Hamburg recently told lawmakers that she wants to take a good look at the agency’s medical device division.

She said she will look into the division's 510(k) regulatory approval process for devices. Earlier this year, agency scientists have said some companies should have been required to show more data on safety and efficacy.

Former FDA Commissioner David Kessler, who described the device center as “dysfunctional” and “in meltdown,” said he has discussed the crisis at the device center with Hamburg.

The Advanced Medical Technology Association (AdvaMed), the Washington lobbying group for the device industry based in Washington, D.C., doesn’t think the regulatory process needs fixing.

“The current system for medical device regulation is fundamentally sound and gives FDA the flexibility it needs,” said Janet Trunzo, an executive vice president at AdvaMed.

An editorial (see http://content.nejm.org/cgi/content/full/360/24/2493 ) appeared in the New England Journal of Medicine on June 11, co-authored by Hamburg and chief deputy Joshua Sharfstein, arguing that the main mission of the FDA is to be a public health agency.

Hamburg will be the closing keynote speaker at the 2009 Annual Conference of the Regulatory Affairs Professionals Society (RAPS) Sept. 19 at the Pennsylvania Convention Center in Philadelphia, Pa. For more information, visit www.raps.or g.

Synthes, Four Execs Indicted

Editor — Mon, 22 Jun 2009 12:30:00 -0500

Synthes Inc., based in West Chester, Pa., and four of its executives have been indicted on federal charges of promoting off-label use of a bone filler not approved by the U.S. Food and Drug Administration.

The orthopedic device maker, which is the American subsidiary of a multinational company of the same name in Solothurn, Switzerland, is defending its record, saying that it hasn’t taken any illegal actions with regards to Norian XR, a fast-setting, injectable, cement material used as a bone void filler in surgery to repair certain fractures.

“As a global leader in the medical device industry, Synthes has a long reputation for setting the highest legal and ethical standards in the development and commercialization of medical products,” a statement by the company says.

The indictment charges that from May 2002 until fall 2004 Norian conspired with others, including Synthes, its parent company, to conduct unauthorized clinical trials of two versions of Norian in surgeries to treat vertebral compression fractures of the spine. These surgeries were allegedly performed “despite a warning on the FDA-cleared label for Norian XR against this use, and in the face of serious medical concerns about the safety of the devices when used in the spine,” the indictment said.

The four executives, Michael B. Huggins, president of the Synthes spinal division; Thomas E. Higgins, the company’s senior vice president for global strategy; Richard E. Bohner, a vice president for operations; and John J. Walsh, a regulatory affairs executive, were charged with criminal misdemeanors involving the shipment of unapproved medical devices. Those charges carry a possible prison sentence of one year.

Norian, based in Cupertino, Calif., faces possible fines of $28 million, while Synthes, its parent company, faces fines of $8 million.

Economy Forcing Venture Capitalists to Shift Strategies

Editor — Tue, 16 Jun 2009 12:59:00 -0500

The lingering recession is forcing venture capitalists to change their investment strategies, according to a recent survey.

More than half the venture capitalists who participated in the 2009 Global Venture Capital Survey said they would invest in fewer companies in the near future. But 13 percent claimed they would increase the number of companies in which they plan to invest.

The survey polled more than 700 capitalists throughout the world. It was conducted by Deloitte Touche Tohmatsu and the National VentureCapital Association (NVCA).

The survey results indicate U.S. venture capitalists will most likely invest in other countries in the next three years: Half of the respondents said they would increase investment inAsia (excluding India); 43 percent predicted they would boost investment in India; 36 percent plan to focus onSouth America; and 25 percent named Europe and the UnitedKingdom. Only 17 percent of respondents said they would increase investment in NorthAmerica.

NVCAPresident MarkHeesen said the results prove that the industry can expect to experience globalization in the next decade, both in investments and fundraising. Countries that can nurture entrepreneurs and investors, and offer customers an attractive exit opportunity will experience the largest economic gains by 2020.

Most venture capitalists predicted that a greater number of their limited partners would come from foreign countries. Thirty-eight percent, however, do not expect the number of foreign limited partners to change.

Congress Members Tout Benefits of Medical Imaging to President

Editor — Tue, 16 Jun 2009 11:23:00 -0500

When it comes to health care reform, Democrats and Republicans may not agree on much. But there is one area where both parties seem to be on the same page: the benefits of medical imaging.

Fifty-seven members of Congress have written a letter to President Barack Obama touting the benefits of medical imaging, urging him to consider the "value of these life-saving technologies." The June 11 letter mentions X-ray, computed tomography (CT), radiation therapy, diagnostic ultrasound, and nuclear medicine, including positron emission tomography (PET) and medical resonance imaging (MRI) as examples of cutting-edge health technologies that have helped improve the diagnosis and treatment of diseases.

The letter asks Obama to reject attempts to cut imaging services or restrict coverage to medical imaging services in his quest to reform the nation's health care system. The bipartisan letter notes that medical imaging can reduce health care costs and ensure "high-quality clinical results" for patients.

"Medical imaging often reduces the need for costly medical services and invasive surgical procedures,"the letter states. "Overall, we know that every $1 spent on imaging services correlates to approximately $3 in total health care savings."

Congress members cited a New England Journal of Medicine article that proclaimed medical imaging as one of 11 developments that changed the face of clinical medicine. Attempts by policymakers to restrict coverage of medical imaging services would only cause the level of patient care to deteriorate and drive up the costs of health care, the letter charged.

Legislators also noted that Congress has been working to reduce unnecessary scans. The Medicare Improvements for Patients and Providers Act of 2008, signed into law on July 15, 2008, mandated the development of "appropriate criteria for imaging services as well as accreditation requirements for facilities and providers.

The letter urged the Obama administration to "move forward with the continued implementation of these important policies and reject arbitrary cuts to imaging services or changes to the utilization rate assumption."

Legislators Want Artificial Joints Registry Created

Editor — Tue, 16 Jun 2009 10:23:00 -0500

TwoDemocratic congressmen have introduced legislation that would create a national registry of artificial joint recipients.

The bill, introduced June 10, would create a government-backed registry to track patients' results and help detect ineffective surgical practices and faulty devices. Other countries use such a system to monitor patients' progress with artificial joints, reduce unnecessary surgeries, and detect faulty products.

Co-sponsored by U.S. Reps. BillPascrell of New Jersey and Lloyd Doggett of Texas, the Knee and Hip Replacement Act of 2009 would establish a national registry to collect and analyze data on patients with hip and knee replacements. The registry would be established within the Agency for Healthcare Research and Quality (AHRQ) at the U.S. Department of Health and Human Services and require the collection of data begin no later than five years after enactment.

"The simple, practical step of registering knee and hip replacement devices ensures not only that patients get the high quality care they deserve, but also that financial gain never stands in the way of healthy outcomes and patient safety,” Doggett said. "By registering these devices, we can detect problems much sooner than we previously were able. This in turn will give patients the peace of mind to know that their knee or hip replacement procedure will not become part of the estimated $700 billion Americans spend every year on procedures that don’t result in better health outcomes.”

AHRQ would work in consultation with the Center for Medicare and Medicaid Services, the U.S. Food and Drug Administration, the National Institutes of Health and the Office of the National Coordinator for Health ITto develop policies and procedures for the registry. The Government Accountability Office would be required to submit a report on the registry to Congress every other year.

Companies that manufacture artificial joints support the idea of a registry but claim a private system would be more effective than one operated by the federal government. Zimmer Holdings, the nation's largest manufacturer of artificial hips and knees, said in a written statement to The New York Times that it has been discussing the creation of a national registry with the American Academy of Orthopaedic Surgeons (AAOS).

In a letter sent to Pascrell, the AAOS said it preferred a privately-run registry that included both Medicare and non-Medicare patients. AAOS has tried for more than a decade to set up such a registry but has been unable to secure financing for it. The group and another orthopedic organization recently earmarked $450,000 to pay for start-up funding. Long-term financing for the registry has yet to be secured though, and device manufacturers have not agreed to pay for it, according to Dr.Daniel Berry, chairman of the orthopedics department at the Mayo Clinic in Rochester, Minn.

Pascrell, however, argued that the orthopedic industry has had more than enough time to create a registry. He also said the legislation would help ensure product safety and reduce "wasteful" health care spending.

“Creating a knee and hip registry is a common sense way to reduce wasteful Medicare spending,” stated Pascrell. “With half of all knee and hip replacements occurring right here in the United States where billions of dollars are lost every year on faulty medical procedures and treatments, it is time that the medical device industry be held accountable for the expensive products they implant in patients. Creating a registry would put a premium on performance and help patients make an educated decision before they enter into a major medical procedure.”