With the constant tightening of FDA regulations, one must wonder what impact greater regulatory scrutiny will have on companies within the device industry. Or, perhaps more accurately, what do companies need to be doing now to prepare for regulations when they can’t yet know just what form these regulations will ultimately take?


We’re just a quarter of the way into 2010, and already the medical device industry has seen a flurry of regulatory activity. The FDA is casting an ever more vigilant eye toward the industry in response to increasing public concerns around consumer safety of medical products, with evidence pointing to a tightening of regulations in the months to come.


It’s not yet clear what exact form this focus on the device industry will take, or what impact it will ultimately have on manufacturers. Evidence thus far points to more oversight of both the pre-market approval process for products (e.g., the recent review of the 510(k) process), as well as postmarket process for regulatory reporting (e.g., the electronic Medical Device Reporting – eMDR – mandate).


Tougher Regulations on the Horizon

The medical device industry is clearly going to be a priority for the FDA, not only in 2010 but also in 2011 and beyond. Make no mistake, greater regulation of medical device companies is coming, and in some ways we’ve already seen it enacted. On Feb. 1, the agency announced its annual budget request for the 2011 fiscal year, including the Protecting Patients Initiative to set aside more than $100 million in funds for strengthening “the FDA’s ability to act as a strong and smart regulator to address medical product safety challenges in the years ahead.”


This isn’t the only portent of greater scrutiny on the industry. As has been widely reported in recent weeks, the 510(k) review process for device approvals has been an immediate target of the FDA’s attention, with officials questioning the use of private companies by device makers in the pre-review process. On Feb. 18, the agency held a public hearing at which representatives from both the industry and the government discussed ways to strengthen the regulatory process for product approvals, as well as the agency’s lack of authority to recall products already on the market. We can expect that this focus on the pre-market approval process will ultimately have a significant impact on post-market processes as well, as the agency looks for new ways to track and monitor issues like adverse events and customer complaints, for insight to enact smarter regulation.


None of this should come as a surprise, and the FDA should be commended for seeking out new avenues to ensure the safety of the products it approves. The FDA’s foremost responsibility is protecting and ensuring the health of the American public, and any industry trends that arouse concerns about safety are inevitably going to bring stricter enforcement. Furthermore, the American public has long been demanding greater transparency in the healthcare system, leaving regulatory authorities with little recourse but to turn a more watchful eye towards industries that may lead the public to question its ability to provide this transparency.


How the Industry Can Prepare

Now that we’ve determined that the regulatory landscape for medical device companies isn’t going to get any less stringent in the months to come, the question becomes just what can and should companies be doing to prepare?


The first step is for device makers to conduct a thorough review of their quality systems to ensure that they are sufficiently equipped to detect and report any issues that may arise in either the pre- or post-market. This includes – but is not limited to – their capabilities for managing Corrective and Preventative Actions (CAPAs), automated complaint handling and adverse event reporting, supplier quality management, change and design control and audit management. These systems should be evaluated for enterprise-wide automation of quality and compliance processes, with careful testing to ensure they are in adherence with industry standards like GMP, GLP and GCP, as well as within standard operating procedures. Companies should have a risk-based system for evaluating and tracking suppliers, and must ensure that proper escalation procedures are in place in the instance of an adverse event, so that the correct personnel are notified and proper data is collected for submission to the FDA.


Additionally, companies need to be preparing to automate the process of adverse event report submission to the FDA in compliance with the eMDR regulation, likely to become mandatory within the next 12 months. Companies should adopt an automated system for collecting the necessary eMDR data in a careful, phased approach that encompasses discovery, planning, design, building, testing, and ultimately implementation of their eMDR system. Once successfully in place, such a system will ensure that reports are successfully submitted to, received and acknowledged by the Center for Devices and Radiological Health on time and with all the necessary data included, eliminating the possibility of problems that could significantly impact the brand down the road.


Finally, companies should recognize that FDA audits are going to become a more frequent occurrence in the 2010 regulatory landscape, whether or not their individual organizations have experienced product safety issues. Audits may be conducted on-site or remotely, but either way, companies can rest assured that the agency’s increasing vigilance toward medical device regulation will require greater transparency, and necessitate that companies have their product safety data available at a moment’s notice.



A thorough review of a med device manufacturing company’s system for managing quality and compliance across the enterprise will reap significant benefits for companies as the FDA looks to strengthen its regulatory oversight. Automating critical processes can alleviate a considerable amount of manual labor by ensuring companies’ processes are up to snuff, enabling daily operations to continue apace with minimal impact on innovation.


The signs from 2009 and already in 2010 point to significantly greater scrutiny on the device industry for the forseeable future. How companies prepare for the coming changes will have considerable impact on their businesses’ continued success and innovation regardless of current and future regulatory pressures.


Tim Mohn is an industry principal for Sparta Systems, a provider of enterprise quality management and compliance solutions for highly regulated industries including medical device, pharmaceutical and others.