Transfer of Power

Allegations made by Joe Schulman, former president of the Alfred Mann Foundation, regarding the role that the profit motive has played in determining the choice of power supplies in implanted medical devices [see article p1] are as troubling as they are untimely. Whether or not his estimate of $2 billion wasted by the U.S. government annually for replacement of cardiac pacemakers is accurate, the device industry should take a careful accounting, particularly in an election year and particularly at a time when budgets for CMS and other healthcare agencies are being stretched to the limit.

Schulman has played a major role in the development of many different implanted devices, beginning with the cardiac pacemaker in the early 1970s. His conclusions are based on years of conversations with physicians, patients, and manufacturers. And they are consistent with comments we have heard from others about planned obsolescence in medical devices. That approach might work for light bulb manufacturers but is totally unacceptable when extra surgeries are involved.

Fortunately, Schulman’s observations about the neuromodulation device industry are much more positive than his indictment of cardiac devices. Today, all three major manufacturers of spinal cord stimulation systems offer the option of a rechargeable battery, though Schulman believes that industry leader Medtronic only introduced its rechargeable SCS system in response to offerings from Advanced Bionics and ANS.

That said, we see no reason why the recommendations made by NBR senior technical editor Warren Grill last month about improving stimulation efficiency [NBR Jan08 p1] should not be followed, whether a primary cell or rechargeable battery is in use. It does not escape our notice that Schulman is not exactly an impartial observer, since Al Mann companies, including Quallion, Bioness, and others, stand to benefit from sales of rechargeable Bions and other implanted devices. And Mann’s companies have done quite well over the years peddling many implanted devices without rechargeable batteries.

We recognize that vendors of implanted stimulation devices must satisfy the needs of their clinician customer base if their products are going to succeed in the market. But if those needs include suppressing a product design that would reduce the number of times a patient has to undergo surgery for a replacement device then something is wrong with the practice of medicine and the conduct of commerce in this country.

Though the choice of product specifications and power supplies rests with the manufacturer, in the end, it is the patients that must hold the power over what device, if any, is implanted in their bodies and how often it is replaced. The role of the physician—and the medical device industry—should be to adhere to that power.

James Cavuoto
Editor and Publisher



site design by shalatdesign |