Perspectives: FDA and Innovation, Part II
Some might point to FDA as an obstacle to achieving true device innovation to provide enhanced healthcare. Others view the agency as a necessary element to help ensure patient safety and provide regulated oversight. In this month’s Perspectives feature, industry leaders shared their viewpoint explaining which side of the debate they fell and why. Are current FDA regulations inhibiting medical device innovation or requiring companies to work more effectively within the established parameters? Would FDA/regulation reform aid the situation?
Gabe Gurman VP of Research and Development, Sparta Systems
The question of whether or not current FDA regulations are inhibiting medical device innovation is somewhat irrelevant at this point. These regulations are necessary and are implemented, whether companies like it or not. For as long as the FDA has existed, companies have complained that its regulations and directives have hindered innovation, and, subsequently, business growth. Further, with new regulations, like eMDR, looming on the horizon, this isn’t likely to change any time soon.
So how can companies work within this framework to continue innovating despite intense regulatory scrutiny? By finding ways to streamline and automate processes and improve quality and compliance. Medical device organizations today are riddled with quality and process management issues that serve to create headaches when it comes time to report to the FDA and some of these process issues even have to do with the act of reporting itself.
There are many areas that companies can improve to ease the burden of FDA compliance issues. These can include supplier quality management (risk- and performance-based analysis of suppliers), Corrective and Preventative Action (CAPA) management, document management, complaint management, medical device reporting, escalation procedures—the list goes on.
By streamlining these processes down to the point where FDA compliance is automatic and accurate, companies devote less time to making sure every facet of their organization is compliant and more resources to research, development, and product innovation.
The answers to FDA scrutiny are simple: better processes, more efficient reporting, and streamlined management of quality initiatives. FDA regulations may take the chains off innovation in the short term, but force manufactures to deploy creative technology solutions that eventually reduce the complexity of their processes. By addressing these issues at a process level, companies can be prepared to confront them and continue their innovation regardless.
About Sparta Systems
Sparta Systems’ global quality management solutions enable high-value organizations to safely and efficiently deliver products and services to market. Its TrackWise® Enterprise Quality Management Software, a trusted standard among highly regulated industries, is used by quality, manufacturing and regulatory affairs professionals to manage compliance, reduce risk and improve safety across the global enterprise. Headquartered in Holmdel, N.J. and with locations across Europe and Asia, Sparta Systems maintains an extensive install base in the pharmaceutical and biotechnology, medical device, electronics manufacturing and consumer packaged goods markets. Read more about Sparta Systems and TrackWise software on the corporate website and blog: blog.spartasystems.com.