Part III: The Changing Medical Device Climate: FDA announces its 2016 – 2017 Strategic Priorities

As a result of a system that is in need of revamping, the FDA’s Center for Devices and Radiological Health announced its 2016 – 2017 Strategic Priorities that included a section titled “Promote a Culture of Quality and Organizational Excellence.” ⁽¹⁾

“A manufacturer’s ability to design and make high-quality, safe and effective devices and CDRH’s ability to provide the necessary oversight to assure devices on the market are high-quality, safe and effective will increase as manufacturers and CDRH embrace a culture of quality and excellence throughout our respective organizations.” – CDRH

They continue ” Our vision seeks to provide patients with devices that are not only safe and effective but also of high quality. It is widely recognized that a quality management system (QMS) is important to defining an organization’s policies, procedures and practices. This is why, in 2013, CDRH developed and then began implementing our Quality Management Framework. However, while a QMS provides some level of confidence about its products and services, a culture focused on quality and customer service is needed to truly achieve organizational excellence. Throughout our organization, quality must be a driving principle in everything we do. We strive to create an environment where our individual commitments to quality are evident, we consistently take quality-focused actions, and where quality is always part of the conversation. We intend to fully implement our CDRH Quality Management Framework, to the extent that resources permit, and achieve the measurable outcomes reflective of a quality-focused organization.”

EngiLifeSciences is a member of the MDIC (Medical Device Innovation Consortium). MDIC is the first-ever public partnership (PPP) created with the sole objective of advancing medical device regulatory science. This group of specialists was championed by the FDA, facilitated by Xavier University and conducted by work group members from 15 top firms. Its goal is to identify and/or develop predictive measures of product quality. This consortium helps the FDA achieve goals relative to the medical device industry.

GOAL: STRENGTHEN FDA’S CULTURE OF QUALITY WITHIN THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

• By September 30, 2016, increase by 10 percent the number of CDRH staff with quality and process improvement credentials to improve organizational excellence (compared to FY 2015 baseline)
• By September 30, 2017, increase by 25 percent the number of CDRH staff with quality and process improvement credentials to improve organizational excellence (compared to FY 2015 baseline)
• By September 30, 2017, have systems and procedures in place to be eligible for ISO 9001 certification.
• By December 31, 2017, submit to an Alliance for Performance Excellence member organization a formal application to assess our progress towards adopting the Baldrige Performance Excellence Criteria and achieving organizational excellence.

GOAL: STRENGTHEN PRODUCT AND MANUFACTURING QUALITY WITHIN THE MEDICAL DEVICE ECOSYSTEM

• By September 30, 2016, develop metrics, successful industry practices, standards, and tools that manufacturers can use to evaluate product and manufacturing quality beyond compliance with regulatory requirements.
• By December 31, 2016, pilot voluntary use of product and manufacturing quality metrics and evaluation tools.
• By December 31, 2017, propose a voluntary program to recognize independent evaluation of product and manufacturing quality.

A focus on optimizing product realization will be a critical component in weighing cost vs. patient outcomes and conforming to the new regulatory environment.

Companies that see the shifting climate as a way to prepare for the changes and create a competitive edge will decrease their costs, liability and strengthen their positioning for themselves and their products in the marketplace. Just as the FDA has evaluated their processes, transparency, data, and systems, so should medical device providers. The change should be embraced by the industry as a whole, encouraging all to become healthy and sustainable “quality-focused organizations.”