Successful Medical Device Design Transfer Lifts One of the Largest FDA Mandates in History

Project Background

A global manufacturer received an FDA mandate on one of its medical devices to repair, retire, or replace all units (more than 200,000) within one year’s time, following several patient deaths. After correcting the product’s design defects, the firm had to transfer the new design from R&D to the firm’s Asia-Pacific manufacturing organization to start producing upgraded units; and to its U.S. service organization, so field technicians could start repairing, retrofitting, or replacing the thousands of customer units that were awaiting attention. Despite the time pressure, it was imperative that the transfer not disrupt the company’s many other manufacturing and field operations.

The company engaged Integrated Project Management Company, Inc. (IPM) to guide the technology transfer and implementation program.

IPM’s Solution

The IPM project manager used the company’s primary R&D facility as a central hub for the complex operation. Challenges included not only a tight timeframe, but also cross-continental logistics and intense regulatory scrutiny.
The cross-functional project team included R&D, regulatory, quality, manufacturing, and service personnel, as well as third-party component suppliers.

To ensure alignment among these organizations, IPM conducted several planning sessions that defined team member roles and responsibilities, project milestones, and logistics for communication across functional groups, which spanned time zones and languages.

Compounding the planning effort, the company was in the midst of implementing new corporate procedures for product development. IPM worked closely with the internal team to ensure compliance with new corporate guidelines and FDA regulations.

To control the information flow between the core and extended project team members, IPM established a communications system of regular project team meetings, electronic information sharing, and regular status updates. Due to the huge time differences separating project participants, accurate meeting planning and follow-up was critical to foster ongoing team communication and collaboration. IPM’s role as a primary contact and information source greatly alleviated this obstacle.

IPM also ensured that third-party suppliers fulfilled their commitments, identifying long-lead-time parts, and implementing “work-arounds” to compress the overall project schedule. For example, when one supplier was struggling with quality issues, members of the project team traveled to the supplier’s facility to plan and coordinate quality-improvement procedures in a gasket manufacturing line.

Project Results

The company completed its design transfer successfully and on time. The FDA has since allowed the company to start selling its product.

Service: Regulatory & Quality
Industry: Life Sciences