Coordination of a Large Cross-Functional Effort Lifts FDA Device Recall


PROJECT BACKGROUND

A division of a leading global healthcare company suffered an FDA product recall of one of its critical medication delivery devices. During its internal investigation, the company initially identified the issue as one of label claims accuracy. Company management determined that they needed to immediately revalidate the device’s accuracy to meet regulatory requirements and to reintroduce the device to the marketplace as quickly as possible.

The client decided to engage Integrated Project Management Company, Inc. (IPM) to provide urgent, focused resources to help them correct the problem at hand, minimizing disruption to ongoing operations. IPM worked at the client’s site throughout the project and accepted direct responsibility for time sensitive execution.

IPM’S SOLUTION

Early in the initiation phase of the project, IPM lead a multi-functional team through an exercise, which identified that the design history files (DHF) of the device needed to be updated to be in compliance with 21CFR 880.5440, and Class II Special Control Guidance. This resulted in a major shift in the project’s objective. With a team of internal and external subject matter experts, IPM developed an expeditious approach to achieve Design and Special Control compliance. The project was divided into two phases:

  • Identification of the DHF Gaps
  • Remediation of the DHF Gaps

IPM coordinated the efforts of the client’s regulatory subject matter experts in reviewing the existing DHF data to recognize and quantify the gaps. Based on the outputs from this first phase, IPM prepared an integrated Project Plan and Schedule of the remediation scope and effort. Remediation of the DHF deficiencies would be an extensive undertaking requiring coordination of a large number of activities, supported by numerous cross-functional resources. IPM conducted a stage gate review with the client leadership team, assuring its endorsement of the undertaking.

The initial gap identification process directed the remediation effort to focus on the label accuracy, special control compliance, design control compliance, minimum configuration requirement for the device, and the complaint and service handling system. During the execution of these activities several changes in scope were identified, which were either required to meet regulatory or quality compliance standards. IPM promptly analyzed these additional tasks, justified the requirement, assessed impact on the project, solicited management concurrence, and incorporated them into the project schedule, when appropriate.

Team members had to interact across functions and time zones, so efficient communications became crucial to meeting project objectives. IPM established a crystal-clear system for sharing information utilizing daily stand-up meetings, frequent project status review meetings, weekly status dashboards, and leadership presentations to promote awareness at the project team level and throughout the client organization. In addition, IPM use practiced facilitation skills to build trust and team unity, and to work through friction and political pressures to reach urgent decisions in support of project goals.

In the process of meeting its commitment to timely completion of the project deliverables, IPM also provided technical expertise for processing engineering changes, and planned for and procured the components necessary to upgrade the devices. In addition, IPM actively participated in the development of the FDA strategy, prepared the necessary documentation, and supported FDA communications.

PROJECT RESULTS

Regulatory compliance issues often throw a wedge into schedule and workflow, as everyone galvanizes into action. IPM provided much needed focus, coordination, and support, enabling this client to accomplish the following:

  • Completion of a comprehensive medication delivery device DHF, achieving regulatory compliance.
  • Timely reintroduction of the device to the market place, regaining its market share.
  • Development of a new accuracy testing method with greater precision, lowering device rejection rate.
  • Introduction of a post-market device performance-monitoring plan.
  • Inception of a structured preventive maintenance program, improving operational reliability.


Additionally, unsolicited feedback for milestone achievements and IPM’s efforts from the team and client leadership was tremendously positive.