Implications of an Altered Regulatory Landscape By far, one of the greatest challenges the medtec

Implications of an Altered Regulatory Landscape

By far, one of the greatest challenges the medtech industry currently faces is the daunting, often confusing and always frustrating regulatory requirements companies must follow when seeking approval for their products. In recent years, the U.S. Food and Drug Administration’s (FDA) premarket approval process, otherwise known as the 510(k) program, has become a particular nuisance for many device firms due to its perceived complexity, lack of consistency and propensity for prolonging product clearances. According to Ernst & Young’s report, average 510(k) approval times soared 45 percent in the last three years, going from 3.1 months between 2003 and 2007 to 4.5 months in 2010.

Critics have pressured the FDA torevamp its 510(k) program, contending it allows potentially dangerous medical devices to reach consumers. The FDA conducted its own assessment of the system and asked the Institute of Medicine (IOM) to review procedures as well. In July, the IOM recommended scrapping the 510(k) process and replacing it with an “integrated premarket and post-market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device lifecycle.” The FDA, however, is refusing to discard the program and start anew, preferring instead to implement its own overhaul of the program.

Such infighting and power plays among government agencies only has added to the uncertainty and mystery surrounding the regulatory environment in the United States. As a result, medtech firms have fine-tuned their marketing and growth strategies to seek overseas approval for their products before embarking on a domestic regulatory journey, the Ernst & Young report claims.

Another “new normal.”

Compounding this uncertainty with a challenging regulatory process is an equally difficult reimbursement environment that is forcing medtech companies to prove health outcomes for patients.

“Payers—both public and private—have seen their budgets squeezed and are, in turn, pressuring medtech companies to demonstrate how their products improve health outcomes for patients and efficiently use healthcare resources,” Ernst & Young’s report reads. “Even if clinical trials are not required to get a product approved, payers will increasingly focus on post-marketing data on the comparative effectiveness of different interventions.”

Welcome to the “new normal.”