Abstract

Medical Device manufacturers are facing some of the most difficult challenges ever encountered by the industry. As competition intensifies, they must innovate and capitalize on new opportunities and expedite time to market. Additionally, they must manage risk, increase product quality and reduce costs.

These objectives pose a significant challenge as innovation, by its very nature, induces variability. This challenge is exacerbated by the organizational structure and technological state of many Medical Device manufacturers.

The dawn of personalized healthcare is increasing the tempo of innovation with the development of targeted therapies, combination products and mass customization. This individualized approach requires the development, manufacture and commercialization of more complex products. Contact lenses foreshadow this scenario. Today, contact lens prescriptions specify power, base curve, diameter, color (pretty much any shade in the rainbow) and for those patients with an astigmatism, cylinder and axis. In the not too distant future, joint replacements will be customized based on the patient’s individual anatomy and lifestyle needs. Drug-eluted stents will be coated with the specific compound based on a patient’s genetic makeup. “Have it your way” has a whole new meaning in Medical Devices.

This white paper provides direction on processes and technology platforms Medical Device manufacturers should consider in order to meet this new paradigm.

Interdepartmental coordination is the key to the exchange of information for better decision making and ensuring that processes are followed. This means the coordination of software applications as well as people. The integration of Product Life-cycle Management (PLM) and Manufacturing Execution Systems (MES) closes the loop between manufacturing and design, enabling rapid innovation cycles while at the same time managing the risk, hard-wiring compliance, increasing product quality, maximizing production yields and decreasing costs.