White Paper: MedTech must embrace Industry 4.0 to thrive in the outcome economy.

White Paper Series:

MedTech must embrace Industry 4.0 to thrive in the outcome economy.

Axendia White paper presented by Critical Manufacturing

The FDA supports and encourages the use of automation, throughout the product lifecycle of medical devices. The Agency recognizes that systems like MES provide manufacturers advantages for reducing or eliminating errors, increasing business value, optimizing resources, and reducing patient risk.

In addition to regulatory encouragement, other factors are driving medical device manufacturers to take notice of the benefits of Industry 4.0 including:

Support for patient-centered healthcare models to drive improved patient outcomes

Pricing and margin pressures due to new reimbursement and purchasing practices

The accelerated pace of innovation in the healthcare ecosystem

Increasing interest in customized and personalized products

Patient use of the Internet of Medical Things (IoMT) – smart, connected mobile health devices enabling patient monitoring

A new competitive landscape from the digital and mobile device industry

Regulatory strategies encouraging smart connected products simultaneously encouraging innovation.

This white paper series provides a roadmap to enable Industry 4.0 in MedTech. Each white paper in this series addresses one of following topics:

  1. AN INTRODUCTION TO INDUSTRY 4.0 FOR THE MEDTECH INDUSTRY
  2. MES IS THE BACKBONE THAT ENABLES INDUSTRY 4.0
  3. MODERN MES – FROM COMPLIANCE TO EXCELLENCE
  4. A STEP CHANGE FOR BUSINESS AND PATIENT OUTCOMES
  5. INDUSTRY 4.0 ACROSS YOUR MANUFACTURING NETWORK

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