DEC. 9–SAN MATEO, Calif.– Deloitte Consulting and Siebel Systems, Inc. have collaborated to form Braxton and Siebel Systems Inc., a merger that will design and produce a complaints management solution prototype for medical device companies.
The prototype delivers an integrated process for tracking complaints by product, problem, symptom, outcome, geography, lot number and customer type. The solution will enable companies to report complaint details and resolutions to the appropriate regulatory agencies, as well as automate follow-up actions and communications between the complaints management and product development departments. Additionally, these departments will be able to communicate complaint information back to assigned field service and salespeople.
“The Food and Drug Administration, as well as other regulatory bodies around the world, have very strict regulations surrounding the handling of complaints received by medical device companies. The cost and effort required to meet these requirements is significant,” says Jonathan Horn, principal and leader of Deloitte Consulting’s Life Sciences CRM practice. “Our joint solution tackles that challenge head-on–by enabling companies in the industry to manage the complaints management process in a way that’s FDA-compliant, integrated, and can deliver cost efficiencies.”
The consequences of non-compliance for today’s medical device manufacturers can be significant. Complaint handling processes that do not meet FDA regulations can result in warning letters, restrictions, fines, recalls, litigation, and potential shutdown. Non-compliance can damage a medical device company’s reputation, its products’ position in the market, and its ability to market and profitably sell those products. But for most companies in the industry today, complaints management processes can be difficult to manage effectively since they are often divided across different functional areas within the company–resulting in increased risk of non-compliance, prolonged handling of incoming complaints, and misspent dollars.
“Ensuring that corrective and preventive actions are efficiently managed, tracked, reported, and analyzed is a critical business process for the medical technology industry,” says David Salazar, general manager, Siebel Medical. “Today, complaints management systems are often a fractured set of activities and information that burdens efficient business activities. We are collaborating with Deloitte Consulting to deliver customers a standard, automated best practice for complaints management that spans the enterprise