Arne Carlson, the former governor of Minnesota, recently contributed an opinion column to the Minneapolis Star-Tribune, voicing concerns about increased Food & Drug Administration regulation of the medical device industry stifling innovation. The column came as Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, prepared to visit the state — one of the country’s biggest medical device hubs — for a town hall meeting to discuss CDRH’s 2010 Strategic Imperatives and hear feedback from industry officials.
Just last week, Dr. Shuren visited another of the country’s largest device hubs — Boston — and no doubt many device companies in the area are asking themselves the same question: Is increasing regulatory scrutiny of the device industry stifling companies’ ability to innovate in this market?
It’s a complicated issue, but I also think it is only half of the question the industry should be asking. Since the only certainty about the 510(k) review process for the foreseeable future is uncertainty, now is the perfect time for companies to gain competitive advantage by leveraging what they can control. It presents an opportunity for companies to ask themselves what they can be doing to streamline and automate critical internal processes to ensure that compliance is maintained with minimal impact on R&D and other facets of the business critical to innovation. In other words, it’s not an either-or proposition.
Rather than viewing the FDA’s scrutiny of the device industry as a potential hurdle to be cleared, companies instead should be taking a hard look inside their own houses to determine where new improvements can be made to their quality and compliance operations. This means taking the opportunity to make additional investments in quality systems, ensuring that critical processes are automated and running with the utmost efficiency and effectiveness.
Are your corrective and preventive action (CAPA) processes up to snuff? When a deviation occurs in the manufacturing process, are you prepared to track, collect and report the necessary data to the FDA? Do you have closed-loop processes in place to effectively resolve and report customer complaints? Are you effectively set up to comply with the electronic reporting (eMDR) mandate? What improvements can you be making in these and other processes that will enable you to divert resources to innovation that would otherwise be spent scrambling to comply with the FDA after the fact?
The responsibility of the FDA is, first and foremost, to protect the health of American public. The number of device-related incidents in recent years has made it necessary for the agency to take a look at its own processes for the review and approval of devices. Instead of viewing this as a challenge, device companies should look for new opportunities to take stock of their current quality systems and pinpoint where investments can be made to ensure greater compliance with changing regulations. In doing so, companies can streamline and automate critical processes, giving them the ability to continue innovating in the face of increased regulation. For its part, the FDA can continue to seek out new ways to keep consumers safe and healthy. When this happens, everyone benefits.
Tim Mohn is an industry principal in Sparta Systems’ product management group. Check him out at Tim.Mohn@spartasystems.com.
