Is Industry Ready to Meet FDA CDRH Top Strategic Priority?

By Axendia Staff

Today, FDA Center for Devices and Radiological health (CDRH) released its . Top of the list: Fully Implement a Total Product Life Cycle (TPLC) approach.

To determine the industry’s adoption of the Total Product Life Cycle (TPLC) approach advocated CDRH, we conducted a research study on this subject.

While the vast majority of organizations participating in this study report having key initiatives aimed at supporting TPLC, most have not taken all of the steps required to achieve a true TPLC environment.

Medical Device Manufacturers have consistently focused on bringing innovative products to market. To achieve this goal, many companies have traditionally relied on sequential design and manufacturing processes to facilitate regulatory compliance and manage quality.

The increasing tempo of innovation, coupled with the growing complexity of medical devices and the escalating trend to outsource and globalize, have made sequential processes inadequate. This new environment calls for closed-loop, Total Product Life Cycle approach across the Medical Device ecosystem.

Based on the study findings, the researchers recommend that companies improve cross-departmental coordination and collaboration to achieve the benefits of TPLC. This approach would also support enhanced product quality, reduced cost and boost overall business success. TPLC implementation will involve the implementation of appropriate technology to enhance visibility, data access, analysis and process improvement. Companies can also leverage integrated information systems to attain a single version of the truth, thereby minimizing regulatory burdens.

TPLC provides a strong foundation for managing every stage of a product’s lifecycle more effectively. It also supports visibility within product platforms and across subsequent generations of products. The implementation of a TPLC approach would support accelerated time-to-market, lower costs and higher quality. With TPLC, regulatory compliance would become the natural outcome of a robust, integrated and well understood Product Lifecycle collaboration process.

To read the complete findings from this research, download your copy of the report “Total Product Lifecycle Management: Lowering Costs while Increasing Quality

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