Keeping Acquisition Integration and CAPA Project on Track While Revitalizing FDA Submissions

The Client

The client is a leading global medical technology company specializing in developing, manufacturing and selling innovative medical devices and therapies. They operate across various medical fields, including cardiac, diabetes, neuroscience and minimally invasive surgery.

The Challenge

Following the acquisition of a leading manufacturing company specializing in custom conveyors and metal fabrication, the client encountered significant hurdles. Initially, they had onboarded regulatory affairs personnel from the acquired company, but this individual shortly transitioned into a new role. Adding onto the challenge, other staff members were occupied with another project, leaving the organization without the necessary bandwidth to fully integrate the two companies. The lack of resources and personnel hindered the integration progress, complicating the merging operations and regulatory frameworks.

Additionally, the client lacked a formal process to track regulatory progress, procedures and assessments. This deficiency led to the initiation of a major Corrective and Preventive Action (CAPA) project aimed at addressing insufficient regulatory affairs decision-making processes, documents and assessments.

The client was under immense pressure to complete both the full integration and CAPA project within a tight 12-month timeline. Failure to meet this deadline posed extreme risks, including the potential for adverse outcomes during agency audits. These risks included the loss of additional revenue streams due to the delays in the 510(k) regulatory pathway for medical device market approval, extended project timelines and increased workloads.

The stakes were high; without a viable solution, the organization faced the possibility of not being able to launch the acquired company’s product globally. This would not only impact their market position, but also deny patients access to critical life support systems used during surgeries. The urgency to resolve these issues was paramount to ensure both regulatory compliance and the successful release of the acquired company’s innovative products into the global market.

The Actalent Solution

Faced with a challenging regulatory affairs hiring market, primarily due to the Great Resignation in 2021, which saw 38% of professionals leave the field, and the significant demand created by EU Medical Device Regulation (MDR) changes, the client urgently needed specialized support. Actalent met the challenge by providing a senior regulatory affairs specialist who had previously worked with the company, ensuring familiarity with internal processes and goals. This consultant’s skills aligned to the client’s requirements, enabling seamless integration and effective contribution from day one.

Actalent’s ability to deliver a highly qualified professional with relevant experience and a deep understanding of the client’s needs was pivotal in addressing the urgent demand for expertise. Our solution not only met their immediate needs but also reinforced the client’s confidence in our capability to provide top-tier talent in challenging circumstances.

The Results

The consultant was initially engaged to manage the integration of the acquired company and oversee the CAPA project. Leveraging their high-level expertise, the consultant not only ensured the integration and project remained on track but also revitalized two new product approvals and a product change that had been previously idle. These initiatives are now prepared for submission to the Food and Drug Administration (FDA), demonstrating the consultant’s significant impact on advancing critical projects.