Chapter 12 - Compelling vision

Abstract

A medical device company faces ever-increasing demands. Customers demand quality, reliability, and value. Regulators expect compliance with the regulations and evidence of safety and effectiveness. Employees and business stakeholders require careful use of resources to ensure business success. Meeting these ever-increasing challenges requires a strong vision, strategy, and detailed plans. Understanding your current situation and challenges is vital to a successful strategy. Evaluating strengths, weaknesses, opportunities, and threats (SWOT) is necessary to manage risks and capitalize on opportunities. Ongoing stakeholder alignment and change management are needed to ensure alignment, progress, and results. It is important to define the current situation, develop a vision of the future, and create enabling plans and organizational alignment. Creating an efficient and effective quality system requires careful analysis of the current business situation. It is important to understand your current situation and scan the internal and external environments. In this chapter, we define typical quality and business situations that a management representative might encounter. Using SWOT analysis, it is possible to understand your strengths, weaknesses, and MEDICS capabilities to prepare for threats and capitalize on opportunities. This sets the stage for developing a vision and creating action plans.