Medical OEMs Pan FDA for 'Unclear' Approval Process

The Food and Drug Administration is getting a black eye from US-based medical equipment manufacturers. A major percentage of these OEMs believe the FDA approval process is so unpredictable and delay-prone that they are instead heading overseas in droves to get foreign endorsement first, according to researchers at Northwestern University.

The medical equipment market represents a major growth area globally for electronics OEMs and component suppliers, but it is also one of the more difficult segments to break into. Regulatory requirements are stringent, manufacturing conditions must meet tough standards, and testing periods can often be as lengthy as for pharmaceutical products. However, the payoff can be hefty for companies that successfully navigate through the maze of requirements.

It's getting even tougher to play in the area due to tightening conditions from the FDA and the realities imposed by the litigious environment in which companies serving the healthcare industry must navigate in the United States. OEMs polled by the Northwestern University research team believe FDA requirements for medical equipment approvals are not only onerous -- resulting in undue delays -- but they also argue many of the conditions are unclear and unevenly applied, adding to the uncertainties already built into the system.

Their conclusion is that the procedures for getting FDA approval are very challenging and best avoided initially, at least until other foreign regulators have endorsed the product. This has created a lot of concerns about the exact focus of the FDA's 510(k) pre-market notification product review process as it applies to medical devices. The research found that two-thirds of medical device companies believe that products get faster approval in the EU region than in the United States. Respondents attributed the delays to unclear FDA guidelines and inconsistent implementation of the guidelines.

The report's findings include:

• Three-quarters of respondents (76 percent) found preparation requirements for a 510(k) submission to be uncertain or unclear; 72 percent felt that information requests from FDA reviewers went beyond the requirements established in guidance documents; and 59 percent reported no guidance documents existed for their devices.
• During the past three years, respondents experienced changes in the lead FDA reviewer for approximately 14 percent of their submissions; of those, 60 percent felt the change negatively affected the product review.
• More than two-thirds of all respondents reported that FDA requests had a significant impact on their financial resources.

The stringent FDA conditions may be warranted, but regulators and medical equipment manufacturers need to find common grounds for getting products approved faster where endorsement is necessary. In order to market their products internationally, medical equipment vendors must not only get US FDA approval but also seek the endorsement of at least four other major regulatory bodies across the globe. This tends to result in higher costs, which are then passed on to medical equipment buyers.

Clearly, the FDA is not going to compromise on quality, and the other international regulatory organizations won't yield to one single body. So, everyone involved in the process will have to find a middle ground that includes standardization to reduce waiting time and total cost to the manufacturers, even while protecting consumers of the finished products.

The FDA itself has acknowledged it needs to review the protocols involved, and the regulatory body appears to be striving to meet manufacturers' expectations. Yet the regulatory organization also must be cautious because of past criticisms it approved products based on flawed research done outside the United States. For instance, two studies exposed the shortcomings of FDA approval processes on heart devices (pacemakers and stents).

There is some good news from FDA for manufacturers. The agency has initiatives in place geared towards approval of medical devices within 150 days instead of the current average of 330 days. I want to believe that medical equipment makers will make a u-turn to the FDA for approval once the system has been overhauled. Do you think the FDA is too strict on medical equipment companies, or is this griping only about trying to establish a market advantage without complying with regulatory conditions? Let me know your opinions below.