Smith+Nephew Enhances Evidence Generation Through Integrated Clinical and Medical Affairs Approach

In a strategic move to optimize product development and improve patient outcomes, Smith+Nephew has implemented a highly integrated organizational structure that aligns its clinical and medical affairs functions. This approach, detailed by Matt Christensen, Senior Vice President of Global Clinical and Medical Affairs, aims to break down silos and foster collaboration across various departments, ultimately leading to more efficient evidence generation and product launches.

Unified Framework for Clinical and Medical Affairs

Smith+Nephew's integrated model categorizes its clinical and medical affairs division into four interconnected groups:

1. Clinical strategy: Responsible for overall evidence generation strategy
2. Clinical operations: Manages day-to-day execution of clinical trials
3. Evidence and claims: Translates data into regulatory submissions and marketing materials
4. Medical affairs: Engages externally with healthcare professionals and key opinion leaders

This structure ensures that all teams work towards common strategic goals while maintaining clear individual responsibilities. The integrated approach provides a holistic view of the product lifecycle, enabling proactive management of challenges and opportunities throughout clinical trials.

Optimizing Evidence Generation: A Case Study

The benefits of Smith+Nephew's integrated approach are exemplified in their strategy for introducing a new hip replacement device in Australia. To meet local regulatory requirements, the team employed a dual-pronged approach:

1. Conducted a traditional, industry-sponsored clinical study to gather specific data on device performance
2. Leveraged existing data from the Australian national joint replacement registry to supplement long-term data on a broader patient sample

By combining these data sources, Smith+Nephew created a comprehensive dataset that satisfied regulatory requirements while reducing the burden and cost associated with evidence generation. This strategy demonstrates the company's ability to navigate complex regulatory landscapes and address market needs efficiently.

Benefits and Outcomes of Integration

The alignment between clinical and medical affairs has yielded several advantages for Smith+Nephew:

• Accelerated market access
• Improved alignment of evidence generation with regulatory requirements
• Streamlined approval processes
• Reduced risk
• Optimized resource utilization
• Enhanced stakeholder alignment

The collaborative structure also facilitates consistent and accurate information sharing with internal and external partners, including regulatory bodies and healthcare providers. This integrated approach positions Smith+Nephew to deliver innovative, safe, and effective products to patients more rapidly and at scale, ensuring product and patient success in global markets.