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An internationally harmonized approach to regulation has long been a goal of device manufacturers — especially in such thoroughly globalized sectors as the IVD industry — and the approach of the European Union is often considered the model for such a regulatory regime. But a few stress fractures appeared in that model this March, when French authorities broke ranks with the rest of the EU to order a recall of glucose monitors (see story). After initially objecting to the order, manufacturers eventually gave in, "in part because we believe it's in the public's best interest to have access to the latest technologies," according to Richard Naples, director of regulatory affairs at Roche Diagnostics (Indianapolis).
Makers of the affected glucose meters will pay for that decision, literally. According to the terms of the French order, the government health service will cover replacement costs only for monitors obtained more than four years ago. Newer monitors must be replaced at the manufacturer's expense.
Manufacturers may be smarting after such treatment at the hands of the French authorities—but they may also have been smart. According to one industry source, sales of handheld glucose monitors account for little of the profit seen by manufacturers. The real money comes from sales of the disposable lancets and test strips required to operate the current generation of monitors. Moreover, with noninvasive monitoring technologies on the way (however far off they may be), manufacturers of current monitors undoubtedly viewed the French recall and replacement order as a means of solidifying their hold on a loyal customer base.
Industry sources admit that, in this case, manufacturers may not have had a lot of "wiggle room." But situations such as this come up every day, as part of the normal course of business in the medical device industry. And knowing when to fish and when to cut bait, when to bend and when to stand firm, can be a significant test of a manufacturer's management skills and knowledge of the current business climate. The plain fact is it's easy to misstep, to make a decision that can cost the company customers, money, or even its very existence.
Company leaders can minimize the chances for such missteps by keeping themselves informed about the trends that are influencing their markets, and by learning about strategies for guiding their companies in today's complex and unforgiving environment. Because access to such essential business information is so critical, Canon Communications, publisher of IVD Technology, has announced the creation of a new publication devoted exclusively to the business needs of top-level medical technology executives.
With its first issue scheduled to appear on June 15, Medical Device Executive Portfolio will offer in-depth business analysis and essential market strategies to 15,000 readers with direct responsibility for corporate planning and finance, marketing, business development, regulatory and legal affairs, management information systems, advertising, distribution, and sales. Feature articles in these areas will be supplemented by business resource guides to professional services in a variety of fields.
While IVD Technology will continue to cover the topics that most directly influence the development and manufacturing of diagnostic products, Medical Device Executive Portfolio will offer complementary coverage of business topics of importance to device manufacturers. To subscribe, visit the publication's Web site.
Steven Halasey
steve.halasey@cancom.com
