Of all the industries facing serious challenges around regulatory compliance, the medical device sector appears to be caught in a particularly thorny trap.
On the one hand, manufacturers in this space are up against unprecedented pressures to get more and more innovative products to market faster on a global basis. At the same time, however, new regulations continue to emerge, making it increasingly difficult to balance the call for innovative engineering with the ongoing demands for proven and rigorous compliance practices.
The problem has become so acute it’s caught the attention of the C-level suite. According to a January 2012 survey by Emergo Group, the No. 1 concern among CEOs in the medical device sector is changing regulatory requirements (53 percent)—a bigger priority and problem than access to capital and credit (40.9 percent), new product development (38.9 percent), and increased competition (23.2 percent).
Tougher measures put forth by the Food and Drug Administration (FDA) over the last few years have further complicated matters. To wit: During the period from 2007 to 2010, reports show that the average time for approval on a medical device application has increased by 43 percent, and the increased pace of regulatory change means that 15 percent to 20 percent of all medical device companies’ R&D budgets are now being allocated to help manage change, not necessarily facilitate new product introductions (NPI).
Read the full article from Design News.