Looking Towards the Future of Regulatory Affairs Within Medical Device Companies


In order to keep up with all of the global regulations and laws pertaining to marketing medical device products, Regulatory Affairs groups must remain efficient and effective in order to be productive. Understanding the expected future trends of the function can help leaders to prioritize the roles and responsibilities that will be most beneficial to industry growth.

One of the key areas that leaders in the Regulatory Affairs function for medical device companies must focus on is the future of the function. As regulatory scrutiny increases, resource levels will also change. Due to the many expected changes within the function, it is critical for leaders to look towards the future of the function in order to ensure success. Key areas to pay attention to include:

  1. Future Growth: Most respondents from Best Practices’ research expect the Regulatory Affairs function to grow during the next three years through a combination of internal and external resources. However, few expect outsourcing and off-shoring to increase beyond current levels.
  2. Future Concerns: Regulatory Affairs leaders believe increased regulatory requirements around the world will heavily impact organizations over the next three years. Some regulatory changes identified included:
  • FDA changes to regulations
  • Closer connection between product performance and payment by third party payers has resulted in potential linkages between licensing and payment decisions
  • Increased regulations outside the US

3. Future Staffing Levels: Battles about Regulatory Affairs’ headcount are expected to continue as companies face spending cuts. Lower resourcing is already causing stress and some delays in requested work.

As previously mentioned, the majority of Regulatory Affairs leaders expect the function to grow throughout the next three years. Due to this, it is becoming more important than ever for executives to fully understand how their Regulatory Affairs function is performing in comparison to those at other leading medical device organizations.

How do you expect Regulatory Affairs to change in response to reform?

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