A NOTE FROM THE EDITOR
Industry Must Take Its Message to the People
We are all painfully aware of how media-driven our society has become. If you are not in the public eye, you run the risk of irrelevance for a large segment of the population. The medical device industry is not immune to this, and it needs to find more effective ways of informing the public of its achievements. That was one of the overarching themes at the recent Global Medical Device Conference in Cancún, Mexico, where almost 200 regulatory and industry officials from around the world discussed the state of industry. Guidant CEO Ron Dollens set the tone when he introduced the first session of the two-day conference by urging industry leaders to become more media savvy.
"People don't know us," said Dollens. "They relate treatment to a procedure, a hospital, or a physician, not to a medical device. When it's made clear to the public what our contribution as an industry has been, they become incredibly supportive." That support can be leveraged to achieve goals that currently threaten to elude industry, Dollens stressed.
Gaining patient access to medical innovation should be the bedrock of the device industry. These efforts are stymied, however, by burdensome regulatory procedures and intensified government efforts to contain healthcare costs. Reimbursement was raised as a case in point.
EUCOMED and other industry observers have been sounding the alarm for some time on the trend to reinstitute national regulatory schemes under the guise of reimbursement. "That is the real Y2K bug," said Jacques Kinsbergen, managing director of the Belgium-based consultancy Jacoti. "Companies underestimate the importance that reimbursement has in their business strategy. How many firms do you know that have a reimbursement department?" he asked attendees.
The vogue for healthcare technology assessments (HCTAs) was also cited as an example of how industry's traditional low profile has enabled the proliferation of measures that may curb innovation. While these studies have the potential, in theory, to benefit innovative products, reality suggests otherwise. As Alan Kent, head of the UK regulatory authority for medical devices, noted: HCTA agencies never seem to look at products where the outcome might be that society would benefit from more devices of this type or from accelerated approval times. Instead, technology assessments add time to the approval process, said Ed Rozynski, executive vice president, global strategy and analysis, for the US-based Health Industry Manufacturers Association, which sponsored the conference. He echoed Dollens's call to arms, telling attendees that industry must promote its interests and build coalitions. "If we don't find a way to show payers that there are long-term cost savings in using these devices," added Rozynski, "we will be overrun by national initiatives."
"Policymakers must understand that in those cases where technology results in increased costs, those costs may well be a product of patients living longer, more productive lives," explained Dollens. "Death is often the least expensive outcome," he pointed out.
"This industry makes a difference in patients' lives," Dollens continued. "We need to engage in strong collaborative efforts. . . .Our customers can be our strongest advocates for innovation."
And it doesn't hurt that they happen to be voters.
By the way . . .
You may have noticed—and yes, that is meant to be an understatement—that this issue marks EMDM's 10th anniversary. So you might be wondering why I have neglected to address this milestone here. There is a perfectly reasonable explanation, and you will find it starting on page 44. In the unlikely event that you feel deprived of my musings on the past 10 years, the introductory note to this special section will, I hope, satisfy your cravings. Also in this supplement, Jeanette Marchant's perspectives on the future of the device industry and Paul Sim's analysis of the ISO 9000 revisions will provide you with more substantive food for thought on the opportunities and challenges that await industry in the new millennium.
Finally, I would like to express my sincere thanks to all of you for your continued support of EMDM. It is truly gratifying to know that this publication plays a part—however small—in an enterprise with as noble a purpose as the medical device industry.
Norbert Sparrow
