Getting Medical Device Makers on Track
Yes, America’s health care technology may be the best in the world--but not after you’ve left the hospital. The truth is that Safeway probably does a better job of tracking who buys Fruit Loops than most medical device companies do in monitoring which patients get surgical implants.
Consequently, it’s easier today to track down and recall a flammable Ford Pinto than a flawed heart valve. Nevertheless, medical innovations are making more people more prosthetic. Artificially augmented with silicone breasts, pacemakers and ceramic joints, our growing bionic population creates an environment where monitoring inorganic implants is just as critical to health care as monitoring living tissue.
So, mandated by Congress, the Food and Drug Administration has announced regulations that will require manufacturers of medical implants to immediately start tracking who gets implanted with what. The Health Industry Manufacturers Assn.--while supporting efforts to monitor lifesaving devices--understandably fears that the new rules will add hundreds of millions of dollars in costs and put smaller manufacturers out of business.
“We did a spreadsheet analysis to determine the long-term costs of complying with the regulations over a 15-year period,” HIMA President Alan H. Magazine says. “Starting in 1989, the costs would have been $52 million in year one; the cumulative costs would be $500 million in year five, and the cumulative cost would be $1.6 billion by year 10. . . . We think these cost estimates are very conservative.”
But HIMA’s figures are cumulative costs, not annual costs. What’s more, even an annual tracking cost of $250 million would still represent less than 1% of the industry’s estimated $30 billion in sales.
To be blunt, if Safeway, Sears and Wal-Mart can track customers cheaply, why can’t hospital supply companies? That your supermarket has better scanning equipment and database tracking software than your hospital is a disgrace. It reflects a fundamental distortion in our medical care economy.
The information technology to create medical device registries and databases is getting cheaper all the time. Maybe putting bar codes on breast implants and Universal Product Code scan lines on pacemaker parts may seem odd, but there is no inherent technical reason why tracking a prosthetic device should be more expensive than tracking groceries.
These new FDA regulations challenge the information techhies to deliver that promise: Implementing these tracking rules shouldn’t add more than a few pennies to the price of a prosthesis. Perhaps the health care-oriented Robert Wood Johnson Foundation or the Henry J. Kaiser Family Foundation should convene a conference to help set up software and scanning code standards for the medical devices industry. Maybe HIMA should set up a special not-for-profit foundation to subcontract for data-tracking services for its members.
The point is simple: If the industry is smart, if people are willing to be just a little bit more innovative, there is no reason why these regulations should be economically burdensome in any way.
On the contrary, tracking can be more of a benefit than a burden. Instead of treating these tracking rules as precursors to product recalls--as the FDA has now foolishly positioned the regulations--companies could use them as vital market research tools.
“There is a great potential here for getting good information, not just tracking potentially flawed devices,” asserts Carl F. Blozan, the FDA’s director of planning, evaluation and information services at the Center for Devices and Radiological Health. Blozan observes that at least one pacemaker company has told him that its registry was an indispensable part of its product redesign efforts.
Wouldn’t it be interesting if implementing these information-driven regulations proved to boost U.S. medical device industry competitiveness at purely marginal costs? If industry and regulators collaborate on standards, that’s exactly what could happen.
