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Case Study: Broadening the Client’s Possibilities; Instilling a Sharper Focus -
Developing a strategic clinical roadmap
A newly formed medical device startup needed to develop their clinical operations plan in support of their upcoming 510k clearance. While the team was awaiting approval of the device, strategic decisions on the department structure and staffing plan needed to be considered.
Emergent Clinical Consulting identified existing expertise and planned core competencies to support a staffing plan that considered their budget and future expansion. This included framing the necessary internal resources required (people, processes and clinical roadmap) while supplementing the plan with external partnerships and technology in support of the plan.
The company hired a strong Manager to execute on the clinical framework established in the strategic plan. This saved approximately 36% direct fees per year and provided a higher caliber employee to support the company’s clinical roadmap. In addition, vendor selection processes saved an additional 13%.
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