Ever grilled over 80 burgers to build camaraderie among a new project team? We have. We have also planned, managed, and launched an in-house manufacturing facility within 12 months, under budget and with no shortage of products.
It began when a small medical device company uncovered discrepancies with their manufacturing partner and made a bold decision to bring their manufacturing in-house. Their product? Precision-engineered mechanical devices in multiple sizes.
This high-stakes, high-pressure project required a facility built from the ground up that had the capability, technology, and skill to develop the devices at the capacity and precision it required.
When the company started bringing their medical device manufacturing in-house, they were concerned that the current project manager did not have the experience to handle such a complex and time-sensitive project. The company needed a medical device project manager who understood the minute details of the entire manufacturing and production process. Since there was no 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.
That’s when the Waddell Group stepped in.
Within weeks of our involvement, the stakes grew even higher. The company’s manufacturing partner abruptly stopped producing critical components, leaving them with a dwindling supply of the medical device. They had a limited supply of products. They had to complete the manufacturing relocation project before their products went out of stock. The clock was ticking, and failure was not an option.
The immediate question wasn’t just how to build a manufacturing facility but how quickly it could be done without compromising quality or volume.
Our blueprint for success
While urgency demanded swift action, success demanded a thoughtful plan. Our plan included following our trusted process designed to address both immediate challenges and long-term goals.
Our first step was to thoroughly evaluate the project’s current status, identify the gaps, and determine the desired outcomes. This included understanding key requirements like:
- Staffing needs and timelines for training. (How many people needed to be hired, what skills were needed, and how long did each position’s training take)
- Equipment and technology essential for seamless production. (What equipment and technology was needed to operate a complete medical product manufacturing process)
- Regulatory compliance, including FDA timelines. (What regulatory items were required, and how long was the FDA process for the same)
With these insights in hand, our project manager put together an exhaustive plan and schedule and outlined the critical steps needed to get there, balancing urgency with precision. Every task was broken into actionable milestones, ensuring nothing fell through the cracks.
We scaled the people, processes, and technology medical device manufacturing in-house.
People: The company started with five employees and needed to grow to over 80 people within 6 months. To comply with medical device manufacturing requirements, a variety of training and skills were 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.
Technology: 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.
Processes: Implementing regulatory and operational workflows, including FDA compliance timelines, was baked into the project’s foundation.
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. This wasn’t just about laying bricks—it was about building a foundation capable of long-term sustainable success.
And that also meant a company culture that attracted and retained employees
A manufacturing facility isn’t just equipment and processes; it’s the people who bring it to life. 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’ faces and names, 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 results speak for themselves
In just 12 months, the company transitioned from dependency on an unreliable partner to operating their own in-house manufacturing facility. 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.
- new technologies and workflows enhanced production capacity and quality. All while meeting the intense regulatory demands of opening a manufacturing facility.
- employees reported feeling valued and motivated, thanks to the thoughtful, human-centered approach Waddell brought to every stage of the project.
Are you starting a medical device manufacturing project?
At Waddell Group, we understand that the success of a medical device project depends on more than just meeting deadlines. It’s about creating systems, processes, and environments that thrive long after the project ends. We focus on 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. We won’t promise to cook you lunch, but we will handle everything else.
Is your company facing a critical project? Let’s talk about how we can help you lead with confidence.