Relocated the Heart Valve’s Manufacturing Facility and Improved the Production Process

The Setback

When a small medical company noticed discrepancies in their manufacturer partnership, they decided to bring their manufacturing in-house. The company created mechanical heart valves in various sizes and they needed their new medical device manufacturing facility to have the capabilities, technology, and skilled team to develop the heart valves at the capacity and precision needed.

When the company started the project, they were concerned that the current project manager did not have the experience to handle such a complex and time-sensitive project. With such a critical project, the company needed a medical device project manager that understood the minute details of the entire manufacturing and production process. Since there was not an existing facility or process in place, it needed to be led by someone who could expertly handle the foundational development of a robust manufacturing system.

Within a couple of weeks of Waddell Group taking over the project, the company’s manufacturing partner stopped producing the components they needed to continue creating their heart valves. While the manufacturing relocation was underway, this added a new level of urgency to the project.

The medical device company relied on Waddell Group’s extensive knowledge in the industry to plan, manage, and launch an in-house manufacturing facility. And within 18 months and no shortage of products, our project manager had led a successful manufacturing relocation project, and in a cost-effective manner.

Waddell Group’s Process

Waddell followed their trusted process by first identifying where the project was and where it needed to be to fully understand the parts of the project. From there, our project manager had the background information needed to put together an exhaustive plan and schedule.

Since the manufacturing project was starting from the ground up, the plan outlined the crucial elements that needed to be accounted for to keep the project on its tight timeline. Some of these tasks included:

• How many people needed to be hired, what skills were needed, and how long each position’s training took
• What equipment and technology was needed to operate a complete medical product manufacturing process
• What regulatory items were required and how long the FDA process took

The company started with 5 employees and needed to grow to over 80 people within 6 months. To comply with medical device manufacturing requirements, there was a variety of training and skills required for the facility to start operating. Therefore, the positions that required longer training were prioritized during recruitment while balancing the onboarding of dozens of other employees.

Meanwhile, our project manager facilitated the purchasing and installation of all the equipment that not only met the existing requirements, but improved the manufacturing volume and quality. For example, an electron microscope with automated testing capability was purchased for inspection, which allowed for a more efficient and accurate testing process.

Our project manager meticulously planned the new manufacturing site while preparing for expected developments, responding to unpredictable events, and keeping everyone and everything moving forward. The project relied heavily on the project manager’s experience and technical expertise to plan every small component to every large step of the process.

The Results

When the company’s manufacturing company stopped producing parts to their heart valves, they had a limited supply of products to make them through the manufacturing relocation project before their products went out of stock. With Waddell Group’s project management, the company was able to develop a new, in-house manufacturing facility in time to ramp up production without any shortage of their product.

Furthermore, the new medical device manufacturing facility improved the heart valve production by implementing a more efficient process. All while meeting the intense regulatory demands of opening a manufacturing facility.

With the onboarding of 80+ employees within a very short period, our project manager was committed to cultivating a welcoming environment. Using badges with the employees’ face and name it provided a sense of belonging to their new company. Every Friday afternoon, our project manager would personally grill for the growing team; at the end of the project, that was over 80 burgers! This allowed employees of different teams and departments to get to know each other and build a company-wide comradery.

The Waddell Group focuses on the high-level goals while ensuring attention is given to the often overlooked parts of a medical device project because we build lasting results from the bottom to the top.

Are you starting a medical device manufacturing project?

The Waddell Group has a technical understanding of the medical device production process and can lead your team through the regulatory, operational, and employee aspects of your project. Contact us to learn more about our services!