International Experts Convene at MEDTEC 98 Conference

Norbert Sparrow

From the shop floor to the global marketplace, the myriad problems facing device manufacturers will find practical solutions at MEDTEC 98.

The transition period for the Medical Devices Directive (MDD; 93/42/EEC) officially ended on 14 June. Consequently, medical devices now may be placed on the market in most European countries only if they bear the CE mark. And that should be the end of the story. But, of course, the saga continues.

"Here we are, five years after the MDD was written, and there are still all sorts of uncertainties in the directive," notes Gordon Higson, former director of scientific and technical services at the UK Dept. of Health and current consulting director of Quintiles Medical Technology Consultants (Staines, Middx, UK). Articulating the major problem areas and suggesting practical solutions that manufacturers can implement will be one of the key themes of a session chaired by Higson titled "Regulation in Reality: The New EU Landscape."

Among the issues that remain to be settled, Higson draws particular attention to the varying transpositions of the MDD by national authorities, the vigorous debate over the use of animal and human tissues in medical devices, practical problems concerning language and labelling, and some of the more arcane aspects of design controls. "Our goal at the session is to focus on those areas that present the most difficulty for manufacturers at the present time and to provide the latest and best information that is available," says Higson.

Panelists at the 7 October session include Ancko de Vries from the Ministrie van Volksgezondheid (Rijswijk, Netherlands) speaking on legislation affecting products of human origin; Caroline Freeman, senior consultant at Medical Technology Consultants, discussing practical solutions to national language and labelling requirements; and Victoria Ann Dedrick, secretary general of the International Association of Prostheses Manufacturers (Brussels), who will address transposition and implementation issues related to the MDD.

Dedrick told EMDM that the thrust of her talk would largely be influenced by events that are currently unfolding."The French proposal to require premarket notification is going to be a hot issue, but that is in the standstill phase until 5 August," says Dedrick. The plan to introduce stringent national requirements for high-risk devices was postponed after seven member states officially complained to France in May about the proposal. According to European law, France must wait three months before enacting the legislation.

The other issue within the scope of her presentation that is certain to spark debate, according to Dedrick, involves the European Commission's communication regarding the status of non-CE-marked medical devices in the marketplace. The commission recently issued an official communication confirming that products currently in the distribution chain that meet preexisting national standards but do not carry the CE mark may continue to be sold after 14 June. "Despite the commission's recommendation, some member states have legislated not to accept non-CE-marked products," notes Dedrick. "And then there's the issue of how consumers respond to that." Many of the national ministries of health throughout Europe have conducted campaigns to raise awareness among hospital buyers of the value of CE-marked products. The ability to sell devices without a CE mark may be a hollow victory indeed for manufacturers if consumers opt not to buy their products.

"In my view," adds Higson, "some of these areas will remain unclear in development for years to come, much as there continue to be uncertainties in US regulations." Having said that, Higson stresses that session speakers will concentrate on the very real practical problems affecting device manufacturers and suggest the best ways to overcome them.

While the MDD may be experiencing some growing pains, Higson argues that its founding principles are sound. Proof of that can be seen in the wide-ranging influence the new-approach directive has had around the world. A session focusing on global harmonization and regulatory developments, also chaired by Higson, will discuss this and related issues, such as the recent US FDA Modernization Act and mutual recognition agreements.

"The key thing in this regard is to recognize that medical devices are not some funny kind of pharmaceutical, but that they are engineering products," says Higson, who will present an update on worldwide regulatory developments at the session. "You can write standards for devices and you can test the devices against standards in labs for the most part," he says. "This means you can start accepting regulations based on compliance with standards. Even the FDA Modernization Act starts to open this door," says Higson. "Save the heavy regulatory approach for the really novel new products .  . . we ought to be saving the expertise of organizations like US FDA for the serious problems."

The global regulatory landscape will also be discussed at a special presentation by the Health Industry Manufacturers Association (HIMA; Washington, DC, USA), but within the context of international opportunities for growth. Chaired by HIMA's executive vice president for global strategy and analysis Ed Rozynski, who will present a paper on global market opportunities, the session's speakers will include HIMA officials discussing US regulatory and payment issues as well as emerging trends and technologies. Dee Simons, associate vice president of small company affairs at HIMA, shared some insights with EMDM regarding the paper she will be presenting on the managed-care environment in the United States.

"I believe that we will see an evolutionary step in the managed-care environment within the next five years," says Simons. "There is a lot of dissatisfaction with the current system, and I feel that more power and more say on patient care will be given back to the physicians. As the baby boom generation ages, we will also see this population wanting to take back greater control of its health-care decisions," she says. This convergence may result in more loosely constructed networks, suggests Simons, that will allow greater choice for patients and physicians and, in turn, will benefit the medical device industry.

Rozynski shares Simons's optimistic outlook for industry, particularly regarding manufacturers that seriously pursue an international growth strategy. Despite a number of grave concerns such as worldwide cost-containment pressures and the economic crisis in Asia, Rozynski points to the trend toward global harmonization and continued steady growth in medical device markets worldwide as indicators of industry's overall health.

Several MEDTEC 98 sessions will address sundry manufacturing-related concerns from material selection to sterilization validation methods. Here again, conference organizers stress that the emphasis will be on providing practical solutions to common challenges faced by device manufacturers.

A session devoted to the adhesive bonding of medical devices chaired by Brigid Byrne, who works on product research, development, and engineering for Loctite (Dublin), will bring together several adhesives researchers to discuss advances made in this field. Device manufacturers are demanding a lot from their adhesives—biocompatibility, sterilization resistance, processing ease—and attendees will discover how suppliers are anticipating their needs by developing more versatile formulations.

Certain materials that are commonly used in medical devices are particularly difficult to assemble. Experts will suggest ways to overcome these challenges at a session on joining applications in medical electronics and plastics sponsored by the Edison Welding Institute (EWI; Columbus, OH, USA). For example, George Ritter, principal research engineer at EWI, will discuss cost-effective surface preparation and bonding of fluoropolymers.

Surface preparation always adds cost to manufacturing, says Ritter, and there are limited returns from more painstaking preparation. A key thing to remember, he adds, is to use enough surface preparation without adding unnecessary cost or effort. Taking additional steps, he cautions, sometimes can even result in recontaminating the surface.

Ceramics are increasingly being used in medical devices, but knowledge of ceramics joining is not nearly as widespread as it is for metals, according to EWI senior research engineer Peter Hall. His paper on the joining of ceramic components will discuss such factors as calculating the proper coefficient of thermal expansion to avoid material stresses that can result in joint fractures. He will also outline the advantages of the various methods commonly used to join ceramics.

Some of the most respected names in polymer engineering will lead a two-part session on the selection of advanced thermoplastics for medical devices and their applications. Robert Portnoy, senior staff chemist at Exxon Chemical Co. (Baytown, TX, USA), will chair this special presentation by the Society of Plastics Engineers Medical Plastics Division. PEEK, metallocene-catalyzed components, polyurethanes, EVA, and many other materials will be discussed in this session that will stress practical applications and case studies.

A spate of regulations targeting packaging and waste management has prompted some observers to suggest that it may become as costly to dispose of a product as it is to make it. A special presentation by EUCOMED (Brussels) chaired by Jan Hoborn, director of medical sciences at Mölnycke HealthCare AB (Göteborg, Sweden), will examine health-care packaging in light of targets for reuse, recycling, and recovery that are set forth in the Directive on Packaging and Packaging Waste (94/62/EC). Strategies for offsetting subsequent costs will be discussed. A two-part session on medical packaging trends in Europe takes the debate beyond the legislative arena to address materials, validation, and labelling issues.

MEDTEC 98 will take place 7–9 October at the RAI International Exhibition and Congress Centre in Amsterdam. The event is organized by Canon Communications LLC and is sponsored by European Medical Device Manufacturer.