Completing IDE Clinical Study Milestone for New Product While Accelerating FDA Approval

The Client

The client is a large medical device company that specializes in helping post-amputation pain management.

The Challenge

Along the path to bring a new medical device to market to help individuals manage chronic post-amputation pain, the client needed to conduct an Investigational Device Exemption (IDE) clinical study to gather critical safety and effectiveness data required for submission to the FDA. This would be an essential milestone for the company, so it was imperative that they had a skilled team in place to help conduct the study effectively.

During previous attempts to manage similar hiring efforts in house, the client realized their internal team’s networks and resources simply didn’t provide the reach needed to identify and attract the right talent. Relying solely on online research and job boards would significantly narrow their candidate pool and put them at risk of not finding candidates who were best suited for the study. Additionally, the time and effort required to thoroughly screen and evaluate candidates within the constraints of a busy workday would also make it difficult to maintain quality and efficiency.

Failure to navigate these challenges could not only jeopardize the study and subsequently delay regulatory milestones, but it could also hinder the client’s ability to deliver life-changing innovation to its customers.

The Actalent Solution

During the COVID-19 pandemic, Actalent partnered with the client to help build out their clinical team, which was in its early stages of development. Our partnership quickly enabled them to rapidly adapt to the new hiring landscape. Knowing the client’s goal for long-term retention and hiring for growth potential, we prioritized finding candidates who were not only a strong cultural fit, but also had the skill sets and mindset needed to thrive in a remote setting.

After successfully placing three core team members who became instrumental to the client’s operations, the client trusted in our ability to deliver high-quality talent to support clinical site staffing needs to support the important IDE clinical study phase.

When seeking qualified clinical research associates and clinical data manager candidates to support the clinical study, our recruiting team would continue to prioritize finding and presenting candidates who not only possessed the necessary skills but also aligned with the client’s culture, ensuring new hires would be positioned to contribute over time and be successful long term.

Our specialized recruiting approach — paired with access to our extensive talent network across geographic regions — would enable the client to select top talent from a refined pool of qualified candidates and hire the skilled talent they needed for this critical phase of their product development.

The Results

With the support of the highly qualified clinical research associates and clinical data manager Actalent found, the client was able to complete a successful clinical study — a critical milestone in their journey to bring their new product to market. The strength of the overall team was evident in the client's ability to pass rigorous regulatory audits and ultimately secure FDA approval for their product.

The impact of this project went far beyond a typical business benefit — it was foundational to the success of the company and defining their future. Additionally, this critical achievement not only reinforced the client's internal processes and strategic decision to have Actalent support their hiring, but it also enabled the client to deliver meaningful innovation to the industry and value to their customers.

"Any recruiting firm can fill a position — but Actalent finds the right talent, the right fit, and the kind of people who become part of your professional family."