17. 01.2018

FDA releases top 3 medical device regulation goals

FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paper that FDA’s CDRH released today.

The agency said the priorities further its overall goal of providing Americans with more timely access to the latest high-quality, safe and effective medical devices. The strategic priorities, in fact, represent a recognition that FDA’s CDRH needs continue to make the medical regulatory process less burdensome if innovation is to take place in the U.S. versus elsewhere. CDRH officials say there is already a growing number of innovators intending to enter the medtech market – and do it in the U.S. market first versus Europe. By the end of 2020, nearly half novel technology makers expect to bring their devices to the U.S. market first or at the same time as other major markets, according to CDRH.

Here are more details about each of the three goals:

  • With employee engagement, opportunity, and success, CDRH said it recognizes the connection between taking care of employees and achieving the agency’s vision. Engaged employees are the most productive. However, engagement requires work life balance, open dialogue and opportunities to succeed.
  • Simplicity is about how CDRH will address the challenges around achieving its mission and vision. The document admits, “Our issues are often complex; our solutions and processes do not necessarily have to be.”
  • The collaborative communities goal acknowledges that CDRH must serve the American public better and achieve its vision for stakeholders in the medical device industry, as well as work together to “solve both shared problems and problems unique to others.”

CDRH has set metrics and implementation activities to measure each goal:

  • For employee engagement, the agency has said that by Dec. 31, 2020, it will achieve at least an 80% employee engagement level. The CDRH Engage Council will oversee the implementation of this strategic priority.
  • For simplicity, by the end of 2020, CDRH’s core processes will be at least 80% lean. CDRH’s Leadership Team will oversee the implementation of this strategic priority. Tasks will include the development of principles for applying the simplicity approach.
  • For collaborative communities, CDRH will establish at least 10 new Collaborative Communities by Dec. 31, 2020. CDRH will convene a cross-Center Steering Committee to oversee the implementation of this strategic priority. Tasks will include the development of a code of conduct and best practices for these communities.

If CDRH’s latest strategic priorities document reads more like a letter to shareholders than a government document, there is a good reason for that. Agency officials have made it their priority to increase transparency and accessibility to both citizens and medical device makers.

Since 2012, the agency has shifted its priorities to focus on customer service, organizational quality and quality management. At AdvaMed’s annual Medtech Conference in October, CDRH director Dr. Jeff Shuren told attendees that customer service is a top priority for the organization, including its service to the industry.

In using these approaches, the agency will continue to work and build on its 2016–2017 Strategic Priorities, such establishing the National Evaluation System for health Technology (NEST).

Source: MassDevice