The importance of collaboration
The successful development and launch of new devices are dependent on strong cross-functional collaboration across clinical and medical affairs, R&D, marketing, market access, legal, regulatory, and quality. Matt Christensen, Senior Vice President of Global Clinical and Medical Affairs at Smith+Nephew highlights how the company strategically organizes clinical and medical affairs to optimize collaboration, product development, and improve patient outcomes.
Clinical teams are responsible for generating the necessary evidence to support a product’s safety and efficacy, while medical affairs teams act as a bridge between the company and the broader healthcare community, providing scientific and clinical insights. This alignment ensures that every step of the product lifecycle, from initial research to post-market surveillance, is supported with a unified strategy.
By working together, these teams can navigate complex regulatory landscapes, address market needs, and deliver innovative solutions to patients with greater speed and efficiency.
Taking an integrated approach
Smith+Nephew’s highly integrated organizational structure breaks down silos and allows the clinical and medical affairs functions to operate under a single, cohesive framework. Their clinical and medical affairs division is categorized into four distinct but interconnected groups:
- Clinical strategy – overall strategy for evidence generation
- Clinical operations – day-to-day execution of clinical trials
- Evidence and claims – translating data into regulatory submissions and marketing materials
- Medical affairs – external engagement with healthcare professionals and key opinion leaders
This integrated model provides clarity on each team’s responsibilities while ensuring that they are all working towards the same strategic goals. The structure allows for a holistic view of the product lifecycle, enabling the company to proactively address potential challenges and opportunities throughout the clinical trial.
Optimizing evidence generation
One of the most significant advantages of this integrated approach is the optimization of evidence generation. Christensen references a compelling example of introducing a new hip replacement device in Australia.
To meet local regulatory requirements, the team deployed a two-pronged strategy: 1) conduct a traditional, industry-sponsored clinical study to gather specific data on device performance, and 2) leverage data from the existing Australian national joint replacement registry to supplement long-term data on a broader sample of patients.
This registry provides a rich source of real-world evidence on the long-term performance of various devices. By combining these two data sources, Smith+Nephew was able to create a comprehensive data set that satisfied regulatory requirements while reducing the burden and cost associated with generating evidence.
Benefits of an integrated approach
The integration between clinical and medical affairs has enabled Smith+Nephew to maintain a more holistic clinical trial strategy. The partnership provides more visibility throughout a trial to address challenges and opportunities as they arise. They have successfully accelerated market access, aligned evidence generation with regulatory requirements, streamlined approval processes, reduced risk, and optimized resources and stakeholder alignment.
Smith+Nephew’s approach to a collaborative structure between clinical and medical teams plays an essential role in delivering innovative, safe, and effective products to patients at speed and scale. The alignment also fosters further collaboration with other internal and external partners, from regulatory bodies to healthcare providers, to receive consistent and accurate information. By aligning strategy, operations, evidence generation, and safety oversight between clinical and medical affairs teams, the company ensures product and patient success in global markets.
