Industry Challenges

Current Environment

Medical device/pharma companies and their suppliers are facing an environment of ever-increasing regulatory scrutiny and pressure to perform in a dynamic, changing marketplace. The ability to increase profits and create growth is becoming ever more challenging.

Many organizations in the industry are burdened with compliance remediation efforts and intense global competition. While regulators focus on compliance, successful companies must not only develop and execute compliant processes and products, but must do so effectively and efficiently to be competitive. It is imperative to have a holistic understanding of how work is accomplished and how to eliminate bureaucratic barriers.

There are multiple strategies to increase profits and create growth for businesses. These may include:

• Introduce a New Product
• Increase Volume by Adding Customers
• Engage in Mergers & Acquisitions
• Drive Efficiency Improvements and Reduce Cost

Characteristics of Excellence

The key to long term success in profit and growth initiatives is to combine the appropriate approach with a compliant, effective, and efficient Management System that is a part of a comprehensive, holistic strategy. Characteristics of a Management System well positioned for profit and growth include:

• Clear Understanding of Key Requirements
• Comprehensive, Fact-based Strategic Plan
• Rigorous Management Review
• Well-designed Work System focused on Compliance, Effectiveness and Efficiency
• Compliant Quality System supporting a Management System Approach
• Robust Continuous Improvement Initiative

APEX Performance Excellence Group is well-equipped to partner with your organization on its journey in achieving your long-term profit and growth strategies, through the design and management of how you get work done.