FINAL THOUGHTS

Dan Olivier is president of Certified Compliance Solutions Inc. (San Diego). He can be reached at dolivier@ certifiedcompliance.com.	Marta Chase is senior executive, quality assurance and regulatory affairs, at bioMerieux Inc. (Durham, NC). She can be reached at martachase@mac.com.

To stay competitive, manufacturers must continuously strive to shorten their new product development cycles and reduce manufacturing costs while achieving excellent customer service. The companies that have been successful with these methods focus on continuous improvement based on their experience, customer feedback, and internal measures.

Lessons Learned for Product Development

Reducing Time to Market. There is always a long list of new IVD product development approaches that claim to accelerate project schedules. Each of these new methods promises to be a panacea for new development projects. Although improper methods can clearly be a source of delays, problems are more often due to the introduction of defects and not the method itself. Although it is difficult to identify a single method that is an optimum solution for all projects, it is appropriate to identify strategies that have historically been successful in reducing defects. Such defects result in repeated rework-and-retest cycles that impede the ability to meet planned release schedules.

Optimizing Manufacturing Processes. The key to cost-effective IVD manufacturing includes a focus on assuring efficient and capable manufacturing processes. This focus must include manufacturing of instruments and reagents. To ensure instrument reliability, manufacturing processes must address the reliability of supplier parts and subsystems, and the robustness of assembly processes. The keys to reliable reagent manufacturing include assurance of the quality of raw materials, well-characterized manufacturing processes, robust process validation, and strict control over process changes. Measures such as process capability can monitor the extent to which the established processes can consistently achieve established quality requirements.

Managing Quality in the Outsourcing World. Outsourcing has become a necessity for most IVD companies that wish to reduce costs and focus on their areas of core competence. To prevent outsourcing problems, supplier qualification and monitoring of performance must be emphasized. Traditional supplier audits that focus on adherence to generic quality system standards are not enough to gain a full understanding of the quality of parts provided by such suppliers. Emphasis must also be placed on assuring that the supplier has established specific processes to assure the quality of the parts or reagents manufactured. In order to assure consistent quality for supplied parts, it is also essential to define measures of manufacturing process capability and focus on continuous improvement.

Leveraging Technology. If there is one constant in the world today, it is change. The tools and techniques that are the leading-edge technologies today are subject to obso­lescence in the future. The benefits of new technologies include better performance, improved interoperability with emerging products, more-powerful development environments, and improved reliability. Timely transition to new technologies (though not necessarily cutting-edge technology) can reduce product maintenance costs and help to avoid problems often experienced with legacy product obsolescence.

Learning from Others. Often problems that are encountered in one product line are also experienced in other, similar products. However, most IVD companies miss the opportunity to establish a system to capture the lessons learned from initial developments and share such lessons among other development and manufacturing teams. Establishing such a system can be invaluable in preventing recurrences of historical problems.