White Paper

Medtech Must Embrace Industry 4.0 to Thrive in the Economy

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.

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