Urological Treatment System

Urological Treatment System

A small company approached Waddell Group with a project to improve a prostate ablation system. The scope included managing the device design, vendors, testing, marketing manuals, creation of FDA submission, and ultimately FDA approval.

The project initiated with the company’s in-house design team, whom the project manager coordinated along with an external equipment manufacturer, driving the project forward using focus, alignment, and excellent communication to ensure the final product would be delivered on schedule. When the project hit a bump in the road, such as the LED screen being discontinued halfway through the design, the project leader pivoted with the team so the project would continue on schedule.

Because this was a complicated electromechanical system that included RF energy, heating, and liquid cooling at the same time, the project manager also coordinated extensive product testing. From component to functional tests, software QA, and system testing, our project leaders provided the path for the product to be submitted and eventually approved by the FDA.

In addition to managing the design, development, and testing of the product, the project manager also 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.

Date: 12 May, 2016

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