All Case Studies
New Medical Device Development, FDA 510K Submission and company scale up
The speedy rollout of a medical device during Covid and the recruitment efforts it took to get there.
Services provided include:
Recruitment Outsourcing, Employer of Record, Executive Search
Name of Company
Large Medical Device CompanySector
Life ScienceLocation
EMEA, NAProject Background
We were approached by a Medical Device company at the early development stage of their first product—a device aimed at the early detection and monitoring of respiratory conditions. This innovation quickly gained attention as the need for advanced medical equipment surged during the COVID-19 pandemic, with respiratory monitoring becoming a key area of focus for health organizations worldwide. The company’s product was seen as a potential game-changer in the healthcare industry, and they sought to rapidly scale operations to meet increased demand. Their goal was to navigate regulatory pathways, particularly the FDA 510K submission process, and expand their workforce to support the accelerated development, production, and commercialization of their device.
The Brief
The client came to us with a pressing need to scale their operations in several critical areas. They required assistance in securing top-tier talent across multiple regions, including regulatory experts, engineers, and senior leadership positions. At the same time, they needed guidance to ensure their product met the stringent regulatory standards required for FDA approval, particularly the 510K process. Furthermore, given the urgency of the pandemic, they required a fast and efficient expansion strategy that included not only recruitment and staffing solutions but also executive search services to help them establish a leadership team capable of navigating these challenging demands.
The Solution
To address the client’s multifaceted needs, we deployed a range of services:
Recruitment Outsourcing (RPO):
We partnered with the client to manage their recruitment process across multiple regions, streamlining hiring procedures and helping them scale quickly without compromising on quality. We handled the end-to-end recruitment, from sourcing candidates to managing interviews and negotiations.
Employer of Record (EOR):
For their international expansion, we provided an Employer of Record solution that allowed them to hire talent in EMEA, North America, and the Middle East without the need to establish a local entity in each country. This solution ensured compliance with regional employment laws and provided quick access to global talent.
Executive Search:
We assisted in sourcing key leadership roles, including regulatory affairs experts, senior engineers, and other critical positions, ensuring that the right leadership was in place to manage the scale-up. These experts were crucial in navigating the FDA 510K submission process, establishing manufacturing protocols, and managing the product's entry into the market.
Regulatory Support:
In tandem with recruitment efforts, we offered guidance on the FDA 510K process, connecting the client with regulatory experts who had in-depth knowledge of medical device approval pathways and could help navigate complex regulations for timely market entry.
Scalability Strategy:
Our solution extended beyond recruitment to advising on the structure and processes required for scaling the company rapidly. This included recommendations on operational workflows, distribution strategies, and global market entry plans.
The Outcomes
By working with us, the client successfully scaled their operations to meet the demand for their product across multiple regions. Key outcomes include:
Regulatory Approval and Market Entry:
The client achieved FDA 510K clearance in record time, allowing them to market their device in North America while also receiving certifications for European and Middle Eastern markets.
Global Talent Acquisition:
We successfully filled critical roles in leadership, engineering, and regulatory affairs, enabling the client to quickly establish a high-performing, cross-functional team capable of supporting their rapid scale-up. The use of our Employer of Record services ensured seamless expansion into new regions.
Increased Production and Distribution:
With the right talent and a solid regulatory framework in place, the client was able to ramp up production to meet urgent demand from health authorities. Their product became highly sought after by hospitals and healthcare systems in Europe, North America, and the Middle East, especially during the peak of the COVID-19 crisis.
Long-term Strategic Growth:
Beyond the immediate success of meeting pandemic-driven demand, the client’s leadership team, bolstered by our executive search service, established a strategic vision that would support continued growth and innovation in the medical device sector. This positioned the client for long-term success in an increasingly competitive market.