In my first post on this subject, we took a hard look at the FDA’s role in hampering innovation in the medical device industry. Particularly damning was a comparison of company experiences with the FDA vis-à-vis its counterparts in the European Union. To be sure, increasingly conservative approval processes in the United States are both slowing innovation and the chance for American patients to take advantage of new developments in medical technology. What are companies to do to overcome these barriers and continue to drive innovation profitably?
Since regulatory compliance is key to driving new products to market, an essential step is establishing a closed-loop quality process across the enterprise to ensure that appropriate documentation is captured throughout the manufacturing process to facilitate FDA approvals. This means that all parties should be involved in this process, from research and development through operations all the way to service and support. Quality needs to be an integral part of innovation and product development, not simply a reactive measure put in place to limit liability.
Because of the challenges involved in FDA documentation, the generation of necessary documentation should be an automated process, and companies should look to software solutions that incorporate this functionality. The solution needs to part of a comprehensive, end-to-end, wholly traceable system that captures and records all relevant data throughout the design to manufacture to service and support process. It requires a significant commitment on the part of the enterprise.
Finally, companies need to have a product lifecycle management strategy that fosters growth and innovation in the face of the regulatory landscape. This means tying innovation to business goals, and establishing processes that can be monitored, measured, and optimized as market dynamics change.
While the FDA may remain a serious barrier to overcome on the way to successful innovation, establishing the proper infrastructure can keep it from becoming a roadblock. The industry’s history says this can be done.