With health care reform so much in the news these days, cost containment is a big concern. Complying with the government’s regulations surrounding medical devices undoubtedly adds substantial cost to their development. How significant are those costs, though, in the overall scheme of caring for people’s health? Just about a year ago, former Congressional Budget Office Director, Peter Orszag, suggested that advanced medical technology is the major factor driving health care costs higher. This definition of “medical technology” comprises not only devices, but also drugs, tests, equipment and surgical procedures. Are the costs that regulatory compliance adds to device development a significant contributor to overall health care cost escalation? I can’t imagine they are. I’d be interested in what others think.

A 2002 study done by PricewaterhouseCoopers found that 3% of the 13.7% health care cost increase that year was due to technology and pharmaceutical advancements. The other drivers: 2.5% increased provider expenses, 2.5% general inflation, 2% increased consumer demand, 2% government mandates, 1% litigation and .7% for fraud and other costs. Is there more detailed data regarding regulatory compliance costs in medical device design?