Charting Our Course for 2018-2020

By: Jeff Shuren, M.D., J.D.

Since 2012, we at the Center for Devices and Radiological Health have set as our North Star the vision of patients in the U.S. having access to high-quality, safe, and effective medical devices of public health importance first in the world. “First in the world” is not about a competition between countries but rather a measure of timely patient access.  Since then our strategic priorities have been laser focused on achieving this aim, continually building on one another, with measurable goals that we report on to the public.

Jeff ShurenToday, I’m pleased to report that we achieved our goals and met or exceeded all our individual targets for our three 2016-2017 strategic priorities. Our actions include, but are not limited to the following:

Establish a National Evaluation System for Medical Devices (NEST): We developed the foundation for the National Evaluation System for health Technology, including giving a $3 million grant to the Medical Device Innovation Consortium in 2016 to establish a NEST Coordinating Center, and developed a framework for the incorporation of real-world evidence into regulatory decision making.

Partner with Patients: We established the Patient Engagement Advisory Committee, had over 96% of our employees participate in patient engagement events with 48 patient groups, increased the use of patient reported outcomes in device clinical studies, and increased the conduct and use of patient preference studies in our decision making.

Promote a Culture of Quality and Organizational Excellence:  More than 900 CDRH staff enrolled in formal quality training; 46 received new auditor certifications, 120 new quality associate certifications, and 18 new lean six sigma certifications. We also launched the Pre-market Approval (PMA) Critical-to-Quality Pilot Program to streamline the pre-market approval process while assuring a company’s quality system includes controls for features and characteristics considered critical to the safety and effectiveness of the device. As a result, FDA will be able to conduct a post-approval inspection rather than a pre-approval inspection where appropriate.

It is important to note that innovation and safety are two sides of the same coin: FDA fosters innovation in order to spur the development of safer, more effective technologies and assure timely patient access. New devices make less-invasive treatments possible and provide new options to patients whose conditions would have been considered untreatable in the past.

Our actions have already produced tangible, meaningful results. For example, between 2009 and 2017 the annual number of devices CDRH has approved has steadily increased almost 4-fold – from 24 to 95 – to reach an all-time high during the user fee era.

Now it’s time to look ahead to the next three years. So today I am announcing the three strategic priorities for 2018-2020, which we have laid out in more detail in our roadmap for this period. The new plan is based on internal input and feedback about goals, targets, and actions, and builds on the actions of our past priorities which we will continue to work on.

The three priorities are:

Employee Engagement, Opportunity, and Success. The dedication, expertise, and innovative spirit of our people are the bedrock of the Center and of our success. This priority recognizes the connection between taking care of our employees and achieving our vision. When our staff is engaged, they are the most productive, creative, motivated, less likely to leave, and committed to the mission and vision. However, we recognize that engagement requires work-life balance, open dialogue, and opportunities to succeed. We are grateful to our staff for their deep and abiding commitment to ensuring U.S. patients have access to high-quality, safe and effective medical devices and believe that by making this one of our strategic priorities, we are not only making a formal commitment to our staff but also supporting their ability to deliver on their commitment to patients.

Simplicity. Our issues are often complex; this priority acknowledges that our solutions and processes do not necessarily have to be, and that this complexity can sometimes serve as an impediment to ensuring that patients have access to the safest and most innovative products. Simplicity means that in everything we do, we continually streamline our policies, processes, programs, and approaches, as appropriate, to more effectively, efficiently, and quickly achieve our mission and vision.

We are already striving to streamline and modernize CDRH into a better aligned Center that enables us to work more efficiently. Our Total Product Life Cycle approach and reorganization, which integrates our pre-market, post-market surveillance and quality-compliance management Offices and functions, is an example of this. By having our teams look at products throughout the entire life cycle, we’re enhancing their understanding of the products and their impact on patients. Additionally, we are expanding the application of the Least Burdensome principle to reduce unnecessary burdens on industry and leaning our processes to reduce unnecessary burdens on ourselves.

We have one of the most rigorous regulatory standards for protecting public health – reasonable assurance of safety and effectiveness. And simplicity does not in any way mean sacrificing our commitment to these standards. In fact, we believe that applying an approach of simplicity will enhance our decision making and allow us to make better use of our resources to focus more on what matters most to patients.

Collaborative Communities. This priority acknowledges that we serve the American public better and achieve our vision when stakeholders in the medical device ecosystem, including CDRH, proactively work together to solve problems. The hallmark of a Collaborative Community is a continuing forum where public and private sector members proactively work together to solve both shared problems and problems unique to other members in an environment of trust and openness, where participants feel safe and respected to communicate their concerns. The role of CDRH will be to foster a community spirit and responsible choice through the creation of Collaborative Communities with broad and fair representation to solve problems and proactively build for the future. We will enable our customers to take a more active role in the advancement of smart regulation and the rise of Patient Scientists — those scientists, health care professionals, engineers and others who focus on serving the unmet and developing needs of patients and who incorporate their own experiences as or with patients into their work in industry, health care, and government.

Admittedly, these goals take a more holistic approach to improvement than our priorities of the past. They will require holding ourselves accountable to setting our employees up for success, streamlining processes and policies, and fostering collaboration between members of the public and private sectors.

By applying these three approaches more systematically we believe we will arrive at the threshold of achieving our vision in the next three years. Therefore, as a measure of success, we aim to have more than 50 percent of manufacturers of novel technologies for the U.S. market intend to bring their devices to the U.S. first or in parallel with other major markets by December 31, 2020.

I am convinced we can do this with the dedicated work of our excellent staff and the support of our customers – while continuing our ongoing efforts with NEST, our work with patients and our pursuit of quality and organizational excellence.

In addition to our strategic priorities, we will soon unveil our “Medical Device Safety Plan,” which among other objectives helps chart a path to a future state where the medical device ecosystem is inherently focused on device features and manufacturing practices that have the greatest impact on product quality and patient safety. We look forward to providing more information about this plan in the coming weeks.

Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health

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