Advancing the Case for Quality in Medical Device Manufacturing

We look for quality in the products we buy, the teams we are part of, and the service we receive and provide. The question is, how can quality be ensured?

As a consumer, quality is a key aspect of consideration when purchasing or using a product. If quality levels are not met, consumers aren’t happy. Businesses run the risk of losing customers and harming their reputation, not to mention the legal or safety issues that can arise. Would you climb a ladder that you knew was poorly made? Would you ride a bike that you knew had a high probability of falling apart? The answer is mostly likely, no.

Manufacturers of all kinds of products must comply with applicable regulations in order to produce and market their products, but not all manufactures prioritize high quality as a defining characteristic of their product or their manufacturing practices. When it comes to medical device manufacturing, high-quality devices play an important role in public health, and today, the U.S. Food and Drug Administration (FDA) has made the focus on quality a top priority.

In 2011, the FDA’s Center for Devices and Radiological Health (CDRH) launched the Case for Quality to transform medical device manufacturing from what used to primarily focus on regulatory compliance to a focus on quality, inclusive of regulatory compliance. An in-depth review of device quality data and feedback from both FDA and industry stakeholders revealed that the FDA’s compliance requirements did not ensure uniformity in device quality across the ecosystem. For example, a device could be regulatory compliant, but also low quality or conversely high quality, and yet non-compliant and therefore non-marketable. It became clear to the FDA that compliance was not enough to ensure quality.

Solution: Make Quality a Benefit, Not a Cost

That same FDA review determined that businesses that effectively managed manufacturing quality risks by driving quality at the organization level, were more productive, experienced fewer complaints and investigations per batch, and employed smaller quality units with lower quality-related costs than their competitors.

To support the shift from compliance-focused to quality-focused, CDRH awarded the Medical Device Innovation Consortium (MDIC) a contract in 2015 to pool people, resources and ideas to develop and research the tools, methods and practices that would make it possible to assess medical device quality.  MDIC’s Case for Quality (CfQ) offers a unique forum for medical device stakeholders to move beyond baseline regulatory compliance activities and collaboratively develop sustained predictive practices that may advance medical device quality and safety to achieve better patient outcomes.

In December 2017, CDRH launched the Voluntary Medical Device Manufacturing and Product Quality Program Pilot, utilizing a maturity model refined in collaboration with the Capability Maturity Model Integration (CMMI) Institute, MDIC, and regulatory and industry partners. The maturity model is leveraged as a resource for medical device organizations to measure their capability to produce high quality, safe and effective devices. This measurement can then be used by organizations to drive targeted continuous improvement activities throughout their facilities. 

For manufacturers who complete the independent (third party) appraisal of quality maturity, the FDA will adjust their engagement activities and modify their submission requirements.

Why Participate in the CDRH Voluntary Quality Pilot Program?

Industry participation is critical to long-term implementation of the maturity model as an alternative to the traditional path of a routine FDA inspection. The FDA is seeking to leverage the maturity model program as a method to drive potential improvements in areas that are also beneficial to manufacturers, such as:

• Increased manufacturing and product confidence
• Faster time to market
• Better information to drive regulatory decisions
• Improved resource allocation
• A continuous improvement process focused on what is most important to patients

The FDA will remove participating companies who have completed the appraisal from some routine FDA inspection plans. Quarterly progress checks will then be used to monitor sustained performance.

Additionally, the agency’s confidence and assurance in a company’s quality system and performance (from program participation) means modifying and reducing the premarket approval (PMA) submission requirements for the following manufacturing reviews:

• 30-Day Notices
• Site Changes
• PMA Original manufacturing module

The FDA will also benefit from this program by potentially reducing the internal resources required for evaluation of inspections and manufacturing review submissions. That capacity can be used for manufacturers who have not demonstrated high maturity and quality capability and to engage earlier in the development life cycle of new products. The benefits provided can also accelerate the implementation of quality improvements at a faster rate and reduce time to market of product improvements and enhancements for patients.

Participation in the CDRH Voluntary Quality program will require an investment, both of personnel and money. However, companies will receive many valuable benefits. Participating companies can expect to improve organizational processes and reduce variability that could lead to increased costs of quality and decreased rework. Companies will be able to estimate a direct cost benefit by utilizing their own internal data and determining appraisal costs as part of appraisal scheduling with the CMMI Institute. Companies can estimate potential saved costs for quality, submissions and audits.

Medical device companies have already begun to appreciate the benefit of focusing on quality. Boston Scientific shared at one of MDIC’s CfQ forums its estimate that if the company participated in the CDRH program, they could potentially redeploy $500,000 in resources assigned to write and submit Boston Scientific’s sixty-nine 30-day notices for the year 2016. Representatives from Edwards Lifesciences and CVRx also attested to the benefits their companies received by enrolling in the CDRH Voluntary Medical Device Manufacturing and Product Quality Program Pilot and recently shared the following statements with MDIC.

“As Edwards Lifesciences discussed participation in the FDA Case for Quality, we realized that both organizations have a shared mission to make sure patients have access to safe, effective, high quality medical devices,” said Rob Decker, director of quality at the company’s Draper, Utah, facility.  “Edwards Lifesciences also recognized that the FDA is interested in making changes to current practices in support of this mission and that the proposed benefits offered opportunities for Edwards Lifesciences to improve compliance, provide higher quality levels, and realize positive economic benefits.  To us this was a win-win opportunity.”

 Al Crouse, senior quality director with CVRx, reported a similar experience with the pilot program. “CVRx initially decided to participate in the pilot of the Voluntary Medical Device Manufacturing and Product Quality program as a means to identify areas of improvement in our products and quality system,” he said.  “As a result of the appraisal, we have not only seen opportunities in these areas but also in other business practices outside of the quality system. These results have allowed us to take actions that improve not only product performance and patient safety, but also business performance and work group interactions within the company.”

In addition to MDIC’s work supporting the CDRH pilot, four new working groups have been created to encourage the ongoing advancement of quality in medical device manufacturing. These workstreams focus on the following areas:

• Redesign the CAPA (Correct and Preventative Action) process as a continuous improvement framework – Leverage cross-industry best practices and collaboration to fundamentally recast CAPA as a continuous improvement framework.
• Create a cross-industry “safe space”– Create a non-competitive, collaborative and sanction-free environment enabling open discussions on a variety of critical improvement initiatives.
• Ensure that 85 percent of medical device CEOs are engaged in quality initiatives by 2020 – Influence CEOs of medical device companies to participate in quality initiatives in a meaningful way that will effect change in their organizations and the industry. Promote quality as a “strategic priority” being integral to all parts of an organization through strong leadership, strategic alignment and tone at the top.
• Make quality an attractive first step in your career – Establish a quality discipline at the college/university level and educate students as to the benefits of making quality a foundational start to a successful career within the medtech industry.

MDIC continues to work together with the medical device industry and CDRH to advance the case for quality and to encourage an industry ecosystem that moves beyond compliance to high-quality manufacturing and products. For eligibility requirements for the CDRH launched the Voluntary Medical Device Manufacturing and Product Quality Program Pilot, visit the Federal Register’s website.

For additional information about MDIC’s CfQ or for information on how your company can get involved, please visit www.mdic.org/cfq.