Optimizing Clinical Evaluation Report (CER) Delivery for a Global Medical Device Company

Introduction

In the competitive landscape of medical device development, the creation of accurate, high-quality, and compliant Clinical Evaluation Reports (CERs) is essential to ensure product safety and meet regulatory requirements. Managing CER processes efficiently across multiple affiliates and regions is a persistent challenge for global medical device organizations. This case study demonstrates how a leading medical device company optimized its CER program by partnering with Vita Global Science (VGS) as a Functional Service Provider (FSP), resulting in operational excellence, talent optimization, and measurable cost savings.

Client Background

Our client, a global leader in the medical device industry, supports a diverse portfolio of products, including orthopedic implants, diagnostic equipment, and surgical instruments. The client sought to enhance the efficiency, compliance, and scalability of CER creation across multiple affiliate companies, while minimizing overhead and improving talent management in a highly specialized field.

The Challenge

The client encountered several challenges in managing CER creation at scale:

1. Decentralized Operations: Working with multiple outsourcing partners, staffing agencies, and freelancers led to fragmented processes and increased overhead.
2. Resource Constraints: Difficulty acquiring and retaining niche Medical Writing talent with regulatory expertise in CERs.
3. Regulatory Compliance: Ensuring legal compliance and inspection readiness across geographies.
4. Operational Inefficiencies: Lack of centralized reporting and governance slowed decision-making and reduced visibility.
5. Cost Pressures: Rising costs associated with managing a decentralized, multi-vendor network.
6. Scalability: Inability to scale resources effectively to meet growing CER demand.

Solution

To address these challenges, the client partnered with Vita Global Science (VGS) as an FSP, leveraging its deep expertise in medical writing, regulatory support, and workforce management. The solution included:

1. Supplier Consolidation: VGS assumed responsibility for consolidating multiple vendors, bringing the CER workforce under one unified FSP model.
2. Talent Acquisition & Transition: VGS onboarded highly specialized Medical Writers across the US, UK, and Germany and transitioned 11 existing resources into the FSP model to ensure legal compliance.
3. Workforce Expansion & Diversification: The team grew to 48+ professionals, including CER Medical Writers, Medical Information Specialists, Technical Writers, Project Coordinators, and SAS Programmers.
4. Process Optimization: Implementation of streamlined operational practices, including Resource Allocation Tracking (RAT) reports, internal resourcing systems, and governance programs to manage deliverables efficiently.
5. Retention Strategies: Focused on talent engagement and retention through professional development, competitive compensation, and alignment with client culture, resulting in 85% retention since 2015.
6. Compliance & Training: Delivered 100% training compliance and ensured all resources followed client SOPs while operating within client systems, achieving full inspection readiness.
7. Governance & Communication: Established a robust governance structure with bi-weekly Program Management and project resourcing meetings, as well as quarterly feedback sessions with client stakeholders.

Results

The FSP partnership produced tangible business benefits:

1. Operational Efficiency: Improved workforce management and process standardization enhanced the speed and quality of CER creation.
2. Talent Scalability: Rapid onboarding and scaling of a highly specialized workforce enabled the client to meet increased demand for CER deliverables.
3. Regulatory Compliance: Full alignment with client SOPs and regulatory requirements ensured seamless audits and inspection readiness.
4. Cost Savings: Achieved over 30% general cost savings compared to the previous decentralized outsourcing model, with an additional 2% rebate due to volume commitments.
5. Enhanced Collaboration: Transparent and consistent communication across teams drove alignment, agility, and cross-functional efficiency.
6. Global Reach: Successfully built a remote-capable workforce across the US, UK, and Germany, with 85% of team members working remotely.

Estimated Savings Model for Supporting 600+ CERs Annually

Based on an industry benchmark, the cost for developing a single CER through a traditional ad-hoc outsourcing model (e.g., freelance medical writers or agency model) averages between $15,000 – $30,000 USD per CER, depending on complexity and regulatory requirements.

Assumptions for Savings Estimate

• Previous model cost per CER (ad-hoc/freelance): $15,000 (at the low end)
• FSP model reduction: 30% general cost saving + rebate on volume
• CER volume per year: 600 CERs

Estimated Annual Savings

$2,880,000 USD in total annual savings for 600 CERs through the FSP model compared to the traditional approach.

Conclusion

By implementing the VGS FSP model, this global medical device company streamlined its CER operations, reduced costs by nearly $3M annually, and ensured regulatory excellence. The program continues to deliver scalable, compliant, and high-quality CER outputs while supporting the client’s broader goals of accelerating product development and market access.