Successful Reintroduction of a Company’s Recalled Flagship Product

The Setback

A large company and leader in the hearing device market had voluntarily recalled their flagship product, an implanted audiological device. The company is revered in the industry for its hearing devices and had never encountered a recall in its 20 years of operation.  While the company is well-established in the medical device industry, they didn’t have the recall experience nor staff to handle the situation.

The worldwide recall of their flagship product put them in a high-risk position and they needed the situation expertly handled, and quickly. Their current recall consultant was not prepared for the magnitude and acceleration the project required, causing the company to remain at a standstill. Furthermore, the company’s competitor recommended they completely discard their product and start from the beginning.

Once the company was in contact with the Waddell Group, our team of recall experienced project managers put together an attainable and aggressive plan to resolve the medical device recall within 18 months after finding the solution.

Waddell Group’s Process

The project required managing the 5 different teams that were a part of the overall project. Altogether, our project management team coordinated nearly 300 members’ efforts for correcting the issue.

To begin, our project managers conducted a comprehensive assessment of where the project stood. While the competitor suggested they start from scratch, we quickly determined that the company had created a solid foundation which we built upon and improved to develop a streamlined process.

Using our assessment, we determined where they needed to go in order to fix the recall issue and align the team. The project involved a facility move, new product development, an updated quality system, an analysis of the product issue, and the solution to the technical problem.

A schedule was developed for each of the 5 teams as well as an overarching project schedule. The schedules were developed through the collaboration between the Waddell project management team and the 5 teams. Using the input and information from the teams, Waddell’s team put together an achievable schedule while adhering to the imperative timeline.

Our project managers coordinated communication across teams to control resource allocation and provide status and planning updates. We hosted weekly meetings with each group, distributed weekly reports to all staff, and shared relevant weekly updates with specific groups. Since each project was key and relied on one another to fulfill the overall objective, this level of communication was integral to each project’s success and overarching project completion.

The Results

As proposed, the Waddell Group successfully managed the reintroduction of the company’s recalled audiological device after only 18 months of finding the solution.

Our team effectively managed around 300 people across 5 teams to consolidate efforts using attainable yet time-sensitive schedules, cross-company communication, and appropriate resource allocation.

Since then, the company’s flagship product is on the market and its stock has grown by 5x. Their quality management system was revamped to improve their quality process for reliable results and the manufacturing processes are housed in the new facility.

The Waddell Group not only solved the recall issue, but we also set up processes and integrated measures into the company team to ensure such a recall would not occur in the near future.

Do You Need Product Recall Project Management?

The Waddell Group team is experienced in medical device recalls and understands the importance of correcting the situation with urgency and accuracy. Contact us to learn more about our product recall project management services.

Date: 12 May, 2016

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