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Medical Device Manufacturing Groups Address National Preparedness Issues

Originally Published MDDI November 2001

Medical Device Manufacturing Groups Address National Preparedness Issues

The tragic events of September 11 drew prompt responses from medical manufacturers, as well as from organizations representing the device industry. The Association for the Advacement of Medical Instrumentation, for example, notes that affected medical facilities received offers of equipment and supplies from healthcare facilities, equipment rental companies, and vendors across the country. Because most aircraft were grounded, supplies and equipment were transported by truck from as far away as Michigan, Wisconsin, and Dallas.

The federal government did permit an emergency shipment of a bioengineered skin substitute for treating burn victims. The Medical Device Manufacturers Association (MDMA) noted, however, that while the product was made available in New York City and Washington, DC, the company was unable to serve facilities in other parts of the country.

Industry associations have also attempted to identify a number of key issues they believe should be addressed in preparing for disasters of this nature and scale. While MDMA developed points to be considered by the Department of Health and Human Services (HHS) in planning for various contingencies, AdvaMed established a new council to assist federal agencies in responding to additional crises that may arise.

Recognizing the efforts made by member companies after the attacks, AdvaMed president Pamela G. Bailey announced that the group is following up with a sustained commitment to ensuring that healthcare needs can be met in times of natural disasters or military mobilization. AdvaMed's new Medical Technology Preparedness Council will help federal agencies ensure that the healthcare delivery system and the military are fully prepared to respond to crises.

Bailey said the Medical Technology Preparedness Council will include leaders from the medical technology industry with expertise in such areas as emergency care, supply-chain logistics, and science and technology development. Among the council's specific goals will be ensuring there is an adequate supply and distribution of needed medical technologies, including basic commodities and more advanced products—both domestically and to the military.

The council will work with federal officials to identify and address potential barriers that could impede distribution and access to needed medical technologies in emergencies. It will also work to foster development of new medical technologies to meet domestic and military trauma-care needs.

One week after the attacks, MDMA president Stephen Northrup sent a memorandum to HHS assessing the impact of the current crisis on its members and outlining recommendations for contingency planning. Northrup noted that member companies had been able to "keep products moving," although they had to curtail same-day and next-day deliveries because of government-imposed restrictions on cargo shipments on commercial flights from airports.

Northrup said an evaluation of emergency transportation mechanisms would be appropriate, and he identified a number of key issues that should be addressed in national emergency contingency planning. He also suggested that such plans allow for secure overnight air shipments of perishable and critical medical supplies in the event that passenger planes needed to be grounded, and that cargo space be provided on commercial passenger airlines for same-day deliveries.

Northrup also recommended that steps be taken to ensure that federal stockpiles of medical products include the latest critical trauma and emergency technologies and that these be located in logistically efficient locations for both air and ground transportation.

Copyright ©2001 Medical Device & Diagnostic Industry

Dip molding developments explained in product literature.

A new brochure is available detailing recent developments in nonallergenic alternatives to natural-rubber latex, with a focus on polyurethane and silicone applications. The brochure is offered by Polyzen Inc. (Cary, NC; 919/319-9599), a manufacturer of radiopaque polymer formulations for medical applications. Topics such as the limitations of latex, polyurethanes used in medical devices, biocompatibility of silicones, properties of polyurethanes and silicones, low-pressure balloon technology, and developments in dip molding and the processing of polyurethanes are addressed in detail. Readers will also find a comprehensive chart comparing the physical properties of dip molded materials, among other helpful guides.

Connections

Originally Published MX November/December 2001

ADVERTISING, DISTRIBUTION, & SALES

Connections

When planning for a patient recruitment study, there are several resources available that offer medical device manufacturers a wide range of services. The following is a list of recommended Web sites for this purpose.

CenterWatch
http://www.centerwatch.com/main.htm
A listing of more than 41,000 combined industry- and government-sponsored clinical trials.

ClinicalTrials.gov
http://clinicaltrials.gov/ct/gui/c/b
A place to search for research studies being conducted by the National Institutes of Health (NIH), other federal government agencies, and pharmaceutical companies.

National Institutes of Health Clinical Center
http://www.cc.nih.gov/
A searchable listing of research studies being conducted at the NIH Clinical Center.

Copyright ©2001 MX

Larry R. Holden Named to Lead MDMA in the Coming Year

Originally Published MDDI November 2001

Larry R. Holden Named to Lead MDMA in the Coming Year

Named as the new MDMA president, Larry R. Holden will assume office at the end of the years.

The Medical Device Manufacturer's Association (MDMA) has selected Larry R. Holden to serve as the next president of the association. Holden will replace Stephen J. Northrup, who plans to step down at the end of the year to pursue other opportunities.

Noting some of the key achievements of MDMA under his leadership, Northrup says, "I'm particularly proud of what we've done during my tenure to open up the Medicare coverage decision-making process and to build a new partnership with FDA based on implementation of FDAMA."

He adds, "I'm glad to see that our campaign for fair and equitable market access for entrepreneurs is starting to have some effect on the way the major group purchasing organizations conduct their business, though they've still got a long way to go before we'll be convinced that they've truly changed and aren't just making cosmetic alterations to try to stave off government investigations or actions."

Although Holden is originally from Colorado, he has worked in Washington, DC, since 1989. He has held several congressional and political advocacy positions. Most recently, he served as chief of staff for Congressman Christopher Shay (R-CT). Holden also worked on the staff of former Senator Hank Brown (R-CO), where he was responsible for national security issues.

Holden states, "I originally came to Washington because I hoped to make a difference in people's lives. By pursuing [its] agenda to eliminate burdensome regulations, streamline reimbursement systems, and ensure open access to closed healthcare marketplaces, [MDMA] will ensure public health is served by providing rapid delivery of cutting-edge medical technologies to the market. I look forward to this new and exciting opportunity."

Copyright ©2001 Medical Device & Diagnostic Industry

Release films designed for ceramic casting.

Saint-Gobain Performance Plastics (Wayne, NJ; 888/225-2717) offers a line of high-performance release films for casting of ceramic passive electronic components. The films are especially useful for components requiring consistent, smooth release and ultrasmooth flat surfaces. Both casting liners and cover sheets are available on a variety of popular polyester base films. Proprietary antistatic coatings and color-identification coatings can be incorporated into custom formulations for both water- and solvent-based ceramic slurries.

Winning at Clinical Trials: It Takes a Lot of Patients

Originally Published MX November/December 2001

ADVERTISING, DISTRIBUTION, & SALES

Winning at Clinical Trials: It Takes a Lot of Patients

Effective strategies for recruiting people for investigative studies are based on empathy.

Matthew Kibby

A healthcare product manufacturer setting up a campaign to market a new device or drug must recognize that potential customers do not so much shop for a treatment as make a decision about their healthcare. It is imperative that a sponsor make the same distinction when undertaking to recruit patients into a clinical trial for its investigational product. Overlooking the emotional context in which healthcare decisions are made, the manufacturer could alienate its target audience even before introducing the first patients to the product during the clinical trial phase of development. Product marketers organizing a patient-recruitment campaign for a clinical trial must, put simply, understand the patients’ point of view and communicate in the language of their experience.

But how can they know what is going through the mind of a person suffering with

HHS Will Invest $50 Million to Improve Patient Safety

Originally Published MDDI November 2001

HHS Will Invest $50 Million to Improve Patient Safety

On October 11, 2001, Health and Human Services Secretary Tommy G. Thompson announced that $50 million would be released to fund a series of new research grants, contracts, and other projects to reduce medical errors and improve patient safety.

The funding has been earmarked for 94 projects that will be carried out at state agencies, major universities, hospitals, outpatient clinics, nursing homes, physicians' offices, professional societies, and other organizations nationwide.

According to Thompson, "Nothing could be more important than making sure patients receive quality care that doesn't cause unintended harm, and our investment in this kind of research will pay off in terms of improved patient safety for all Americans." The secretary explained that "these grants will help [researchers] identify the causes of medical errors and develop effective solutions to strengthen quality of care across the country."

The funding initiative will be administered by the Agency for Healthcare Research and Quality (AHRQ). The agency intends for the projects to address key unanswered questions about how medical errors occur, then provide science-based information on potential strategies to make the healthcare system safer.

The $50-million research initiative is considered to be the first phase of an effort that will span a number of years. The projects being funded reflect input that was gathered from consumers, healthcare providers, and policymakers during a national research summit last year. The meeting was led by AHRQ and its partners on the Quality Interagency Coordination Task Force.

Copyright ©2001 Medical Device & Diagnostic Industry

Agreement signed for development of drug-coated stent.

STS Biopolymers (Henrietta, NY; 716/321-1130) has agreed to develop a Medi-Coat drug-delivery coating for stents manufactured by B. Braun Medical (Bethlehem, PA; 800/359-2439). The coated stents will be designed to inhibit restenosis in patients. Medi-Coat drug-delivery technology makes possible the release of single drugs or multiple-drug combinations over times ranging from days to weeks. The drugs are delivered from the polymer matrix directly to the vessel wall. When used in combination with primer, the Medi-Coat drug-delivery coating will adhere permanently to the stents while providing the necessary flexibility, without cracking or flaking.

Goodbye, Goodwill

Originally Published MX November/December 2001

FINANCE

New accounting rules could have a significant effect on reported earnings and company valuations for medical device manufacturers.

E.W. (Sandy) Purcell

The 1990s witnessed quite a sharp rise in mergers-and-acquisitions (M&A) activity in the healthcare equipment and supplies market. Moreover, the pace of deal-making has remained robust over the past year. In the 12 months ending July 31, 2001, deal-makers in healthcare announced 120 transactions, a 58% increase over prior-year activity and a new high in deal volume (see Figure 1). As a result, many medical device manufacturers today carry large legacies of goodwill on their balance sheets.

The Financial Accounting Standards Board (FASB; Norwalk, CT) recently enacted a sweeping reform of the treatment of goodwill and other intangible assets. FASB’s new rules apply to all companies reporting on a generally accepted accounting principles basis. These changes will directly affect the reported bottom line for many companies, especially in the medical device industry.

U.S. Trails in Use of Electronic Patient Records

Originally Published MDDI November 2001

U.S. Trails in Use of Electronic Patient Records

Efforts to significantly reduce the risk of medical errors have targeted the implementation of electronic patient records and prescription system. Healthcare systems are finding, however, that adopting such technology-based systems can be slow, difficult, and expensive. In the view of some experts, U.S. healthcare providers are not implementing these systems as rapidly as they should. In fact, there are some indications that the United States is moving more slowly than some other English-speaking nations.

Harris Interactive research suggests that relatively few U.S. physicians use electronic records or prescriptions. A physician survey conducted last year for the Harvard School of Public Health and the Commonwealth Fund's International Health Care Symposium found that the use of such systems is much more advanced in Britain, New Zealand, and Australia than in the United States.

The biggest differences between countries were found in the use of electronic systems by primary care physicians in comparison with specialists. For example, 17% of primary care physicians in the United States reported "sometimes" using electronic medical records, compared with 25% in Australia, 52% in New Zealand, and 59% in the United Kingdom.

Copyright ©2001 Medical Device & Diagnostic Industry