Situation:
A mid-sized medical device company focused on developing class II surgical products needed assistance in developing clinical strategies for a number of products in their pipeline. The company also needed an interim Clinical Director to help build the clinical function.
Solutions:
- After conducting several cross functional interviews, engaging in an in-depth evaluation of the current portfolio, clinical gaps, current and future claims, and overall product strategy, a customized clinical development plan was developed for several different products.
- The clinical development plan included assessment of unmet need, description of targeted patient population, literature review, design and sequence of studies to support prioritized claims, study assumptions, study designs, timelines, budget and resource plan, risks, and risk mitigation plan.
- Halloran provided on-site interim Clinical Director and project management resources to implement established clinical strategy, build a clinical function within the organization, execute clinical trial activities, and strengthen communication with executive management, divisions, and surgeon KOLs.
Value:
The clinical strategy was aligned with the divisional business plan and set the foundation for a strong, collaborative working relationship across the various functions within the company. Several tools and processes were established for clinical strategy development and executional activities which increased their productivity, operational excellence, trust, and credibility with management and external stakeholders.