Increased recalls, pricing pressures and a changing regulatory environment, have many Life Science firms wondering how to prepare for the future. We’ve seen change in the horizon after the FDA launched the Case for Quality Initiative. Couple this initiative with a new administration, and we can formulate one conclusion. There will be significant changes within our industry.
The industry has recognized the need to develop regulations and processes based on Maturity, Efficiency and Visibility. As a result, EngiLifeSciences has developed the MEV Grid™, which focuses on ensuring that Maturity, Efficiency and Visibility are embedded within processes and technologies. The grid was designed to position firms to adapt quickly, efficiently and cost effectively to change.
EngiLifeSciences MEV Grid™
Designed to reduce clients’ costs, improve quality, streamline operations, and reduce the probability of recalls.
MEV Maturity – There are four distinct cycles within a Medical Device lifecycle: introduction, growth, maturity, and decline. Balancing cost vs. quality while preventing the probability of compliance observations, recalls or other major cost inhibitors allows a product to enter the maturity cycle. A device that enters the maturity cycle untouched by major events and expenses creates long-term sustainability and profitability.
MEV Efficiency – Efficiency is at the root of profitability. It drives costs down and brings medical devices to market in a timely manner. Although efficiency may sound like a soft term, it impacts every aspect of an organization including: people, cost, operations, product quality, even the susceptibility to recalls.
MEV Visibility – Visibility is being able to view, understand and analyze critical areas of operations, manufacturing, supplier procurement and more. Visibility is a critical feature to both operational excellence and supply chain management. If processes are not streamlined and visible, initiatives become vulnerable to increased costs and risks, decreased profitability and an overall loss of efficiency.
EngiLifeSciences has developed EngiLifeSciences Mev GridTM to create Maturity, Efficiency and Visibility throughout the organization.