Actalent Helps Medical Device Manufacturer Avoid $5M in Non-Conformance Costs

women in white lab coat looking at medical charts

Documentation oversight helps to keep client in regulatory compliance.

Client Profile

 Our client is a leader in the development of surgical technologies, equipment, and solutions.

The Challenge

This client was looking to establish a Center for Raw Materials (CRM) within their Lifecycle Management Department to help manage and track changes in raw materials and the corresponding documentation changes to ensure regulatory compliance. 

Not only did our client lack the internal bandwidth to run this operation, but they struggled to find the expertise needed to manage the work efficiently. Without the right expertise and resources in-house, the CRM could not efficiently manage the large volume of design control updates required. Non-conformances were occurring on a frequent basis, creating more work and corrective and preventative actions that needed to be addressed and resolved. Technical subject matter experts (SMEs) had to resolve these issues, preventing them from focusing on core product development and driving potential business growth.

The Actalent Approach

Actalent was brought in to support the client's CRM and to globalize the effort to bring the client's other sites into the North American CRM. This effort would help boost communication and collaboration between the different sites while ensuring consistent, uniform procedures across locations.

Actalent assigned an SME and a global project manager to improve project stability, management, and overall communication. These additions increased the technical expertise on the project and enabled us to effectively support the growth of the CRM program. A team lead was also assigned to the project to ensure accurate deliverables, track consultant performance, and provide consistent feedback. This structure relieves the client of these responsibilities and enables them to focus their time and resources on other business development initiatives. We also received an ISO13485 certification that allowed us to build an offshore team in India to help support the CRM.

Our ability to scale our team to meet the needs of the CRM program enabled us to keep pace with demands and stay on schedule. Actalent's vast network of STEM talent and expertise positioned us to meet the client's needs and was essential to the success of the CRM program.

The Results

 Since the initiation of this program in November 2019, Actalent has supported the CRM to save the client an estimated $5M in non-conformance costs for North American sites.

By allowing Actalent to manage and support the CRM, the internal stakeholder's time was freed up by 50%, giving them the bandwidth to focus on critical new product development. Actalent's support enabled the CRM program to run self-sufficiently and globally expand while also increasing stability and efficiency. Since the program's inception, we have brought Brazil into the client's North American CRM, already delivering on our promise to help globalize this initiative.

The client is thrilled with the partnership that Actalent has worked hard to establish. They recognize Actalent's incredible ability to find the right talent and engage them through recognition and compensation. We are currently directing the CRM in conjunction with the client, enabling the client to utilize their SMEs for new product development in the medical device space.