Throughout the product development and commercialization life cycle, life science companies need to serve two masters: regulatory requirements and business requirements. Integrating the interests of both requirements into one business practice increases productivity, improves time-to-market, and provides a higher quality product.
True information integration, from the lab bench all the way through final manufacturing, labeling, and FDA clearance/approval, can lower costs and produce operating efficiencies that result in a faster response to government regulators and customer needs.
These days, however, most life science firms are bogged down with processes that were created back in the early 1970s, when in response to expanding FDA requirements, companies focused on building quality systems that were separate from their other business practices. Designing the business around meeting the FDA mandates may have been a well-intentioned strategy at first, but it also led to additional burdens and more overhead.
Revamping operations requires an integrated approach that centers around sharing information to take advantage of other departments’ knowledge and skills. Information integration allows departments to enhance their performance by functioning like a true team, while taking full advantage of each person’s expertise.
For example, a device company’s regulatory staff’s work comes at the end of the R&D chain, when they write the new product application for the FDA. But if the information from R&D and clinical trials was integrated, productive discussions during early product development might benefit final regulatory submission and ultimately help to get the product to market quicker and with fewer post-market problems.