Smith+Nephew: Unpacking the Critical Roles of Clinical and Medical Affairs

As the medtech industry continues to evolve, organizations are increasingly recognizing the value of strategic alignment among cross-functional teams. Coordination between clinical and medical affairs, in particular, plays a pivotal role in bringing innovative devices to patients and ensuring long-term product success.

Matt Christensen, SVP of global clinical and medical affairs at Smith+Nephew, shared the company’s unique approach to organizing these functions to optimize collaboration, product development, and improve patient outcomes.

Smith+Nephew serves over 14 million patients annually, operating across three primary business units—orthopedics, sports medicine and ENT, and advanced wound management. Focusing on innovation and bringing life-changing technologies to market is a “team sport” for the organization that hinges on strong partnerships across functions including clinical and medical affairs, R&D, marketing, market access, legal, regulatory, and quality.

“We know that we can’t be successful in bringing high quality products to market with speed unless we work together across our clinical and medical affairs teams, but also other functions within the organization.”

Christensen outlined the five fundamental areas that the clinical and medical affairs teams at Smith+Nephew are focused on:

1. Clinical evidence generation
2. Regulatory and market access support
3. Risk management and patient safety
4.Scientific and medical expertise
5. Strategic engagement and advocacy

To deliver on their goals, with efficiency and speed, the company structures their clinical and medical affairs team into four categories:

• Clinical strategy: Focused on therapeutic expertise, evidence planning, and long-term data generation strategies from ideation to end-of-life of a product.
• Clinical operations: Responsible for managing all aspects of study execution, including site management, data collection, biostatistics, and regulatory documentation.
• Evidence and claims: Supports both regulatory submissions and commercial claims through literature reviews, analysis, and communication of findings.
• Medical affairs:
Dedicated to safety, risk management, medical input on product development, post-market safety review, and external scientific engagement.

This framework gives each team focused responsibilities and allows them to remain closely aligned in execution. Additionally, the company ensured they have the right people and processes in place, and robust software to drive automation and efficiency so they can focus on innovation.

Optimizing evidence generation

While there are several strategic options for generating clinical data and producing evidence, each has a purpose and a time to be used. Industry sponsored studies, investigator initiated studies, collaborative research, and virtual patient twin studies divide responsibilities between external and internal collaborators in unique ways.

Elaborating on a real-world example, Christensen explained how Smith+Nephew recently introduced a new hip replacement device to the Australian market. Given the unique market requirements, the team needed to complete a two-year clinical follow-up study and publish the manuscript for that study on a larger sample size.

Smith+Nephew decided to take a two-pronged approach in which they designed and executed an industry-sponsored study with full control over study parameters, site selection, and data quality to meet approval requirements. Then they leveraged existing national joint replacement registries to collect long-term data on a broader sample of patients, which reduced expenses and lowered resource burden.

Both pathways required intensive collaboration across functions, but Smith+Nephew’s integrated clinical and medical teams proved successful.

Benefits of an integrated approach

Finally, Christensen shared how Smith+Nephew uses this integrated model to realize continued benefits:

• Accelerated market access: Combining traditional studies with real-world data through cross-collaboration enables faster submission and reimbursement outcomes.
• Resource optimization: Strategic use of registries reduces internal resource demands while maintaining evidence quality.
• Improved risk management: Medical affairs involvement ensures patient safety and appropriate risk profiles at every stage.
• Better stakeholder alignment: Shared goals and workflows across clinical, medical affairs and all associated partners drives execution through shared goals.

  “Getting the product to the market, but then also unlocking the potential of that product so that more patients can benefit from it requires collaboration across clinical, medical affairs, and R&D.”

  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. 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.

  To learn more about Smith+Nephew’s digital transformation leveraging eTMF, watch this video interview.