Recovering a Product and Improving Usability to Receive FDA Approval

The Setback

Urologix is known for providing an in-office, less invasive benign prostatic hyperplasia (BPH) treatment. During the design of a urological treatment system, the process was not meeting the company’s desired timeline. Encountering multiple setbacks, the project needed a medical device project management team that could quickly understand where the project was at and create a strategy to lead the product to market.

Once Urologix connected with the Waddell Group, our project manager was able to evaluate the project to recognize the importance of recovering the product and leading it to a successful market launch. Relying on their extensive medical device knowledge and technical project management experience, our project manager went to work.

Waddell Group’s Process

To begin, our project manager reassessed the current project management process and timeline. We took a deep dive into how operations were currently working in order to identify areas of strengths and places for improvement. Next, we constructed a clear definition of where the project was going and how it was going to get there.

Furthermore, we requested feedback from everyone on the project to fully understand the scope of the project. Through everyone’s contribution, our project managers developed a realistic yet time-sensitive schedule that was reinforced with the commitment of the team.

Our project manager directly managed 5 team members and indirectly oversaw nearly 30 other individuals. The scope included managing the device design, vendors, testing, marketing manuals, creation of FDA submission, and ultimately FDA approval.

We focused on the ongoing reevaluation of the schedule and tasks, regular check-ins with the direct and indirect teams, and continual, open communication so every player was informed on the progress and responsibilities. Our medical device project manager’s areas of focus included:

  • Coordinating with the company’s in-house design team
  • Pivoting the design upon learning the LED screen was being discontinued halfway through the design to stay on schedule
  • Managing external equipment manufacturers

Since this was a complicated electromechanical system that included RF energy, heating, and liquid cooling at the same time, the project manager coordinated extensive product testing. From component to functional tests, software QA, and system testing, our project managers lead the project through the product development process to be submitted and eventually approved by the FDA.

The Results

Our medical device project manager successfully launched the urological treatment system on schedule and within budget. We also improved the usability of the product as compared to the previous product model.

Our team enhanced the trust in the development organization with the supporting cast by expanding communication and building a sense of partnership among the different organizations. Our approach to medical device project management strives to create alignment across teams for continual collaboration.

In addition to managing the design, development, and testing of the product, the project manager worked alongside the company’s marketing, quality, and finance teams. Our goal was to ensure the development of a successful – and compliant – marketing plan. We developed manuals, labels, packaging, and shipping for the product, all to ensure the product’s success beyond the conclusion of our involvement in the project.

Through our project management services that guided a successful and improved market launch, we developed a trusted partnership with Urologix. Since then, Urologix has relied on the Waddell Group to manage the production of three more medical device products.

Is Your Project Meeting Deadlines?

Waddell Group develops informed schedules with deadlines that each team member agrees with and commits to in order to establish an ongoing, unified team effort. Get in touch to learn more about how we can accelerate your medical device project.

Date: 12 May, 2016
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