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“proactive Approaches To Health Insurance Approval And Claims Down Under” – The FDA’s traditional compliance requirements establish a uniform quality system framework, but they do not ensure device quality across the ecosystem. In addition, a compliance audit will tell a manufacturer whether the system has been established in compliance with current regulations, but it does not offer any insight into how the device, the system or the development process could be improved. Taking predictive and proactive measures to improve quality can have far-reaching effects – from more efficient resource allocation to reducing the likelihood of a recall. Conversely, manufacturers who do not implement quality objectives as value drivers may put their company’s future at risk. A 2017 McKinsey analysis revealed that the direct cost of quality is $26 billion to $36 billion annually, representing 6.8 to 9.4 percent of device industry sales. Of this total, two-thirds is the direct cost of poor quality – for example, “labor costs to repair failures, as well as material and financial costs of internal and external quality failures.” The other one-third was the direct cost of ensuring quality – for example, “organizational costs involved in preventing or evaluating quality problems.” FDA Steps to Promote Quality FDA’s regulatory approach to ensuring compliance among medical device manufacturers has historically consisted of a series of evaluations and enforcement actions. In its 2011 report, Understanding the Barriers to Medical Device Quality, the FDA found that this traditional compliance regime did not encourage agency investigators to “go beyond regulations to actively look for quality issues.” In addition, it was found that this approach focuses manufacturing resources on activities related to compliance, and quality investment de-incentives. As a result, in 2011, the FDA’s Center for Devices and Radiological Health (CDRH) launched the Case for Quality to change medical device manufacturing from a culture of compliance to a culture of quality, and competitiveness based on quality. CDRH prioritized engaging with industry stakeholders in this process, including groups such as the Medical Device Innovation Consortium (MDIC) and AdvaMed, to understand industry needs and what it would take to promote quality. As part of its 2016-17 Strategic Priorities, CDRH focused its internal efforts to foster a culture of quality and organizational excellence, and external efforts to “strengthen product quality and manufacturing in the medical device ecosystem.” A recent CDRH leadership report states that the agency “achieved its goals and met or exceeded” all individual goals for the 2016-2017 Strategic Priorities. The agency’s 2018-2020 Strategic Priorities take additional steps to improve device quality through culture change and process simplification, which manufacturers can also find cost-effective. In late 2017, CDRH announced its Medical Device Manufacturing and Quality Voluntary Pilot Program in concert with MDIC and the CMMI Institute. This pilot program leverages a proven maturity model – the CMMI framework – by which medical device manufacturers can measure their ability to produce quality devices and increase patient safety. Participating manufacturers can use this measurement approach to drive targeted and continuous quality improvement activities within their organization. Participation requires an upfront investment of personal and financial resources, as well as an annual program fee if accepted into the program, but CDRH believes that participating manufacturers should expect to improve their processes and reduce variability, which can lead to lower costs. quality and rework. In addition, the FDA communicated that there will be more confidence in companies that enroll in this voluntary program. The agency “intends to avoid monitoring and pre-approval inspections for participating sites” so that these companies can re-assign these resources to “innovation and improvement efforts.” With the success of the pilot in 2018, CDRH intends to expand the program in 2019 and will roll out a new name for the initiative: The Case for Voluntary Quality Improvement Program. For more information about the program, visit http://mdic.org/cfq/enroll/. Free Resource: Want to learn about the FDA’s exclusive findings, metrics and future program plans in the 2018 Quality Pilot case? Download the PDF here. Six Benefits of Investing in Quality Investing in quality means continuous improvement by identifying, prioritizing, and mitigating risks early in the total product life cycle (TPLC), instead of reacting to quality issues as they occur. This requires taking the time to think through all possible risks, maximize understanding of users and the usage environment, understand the significance of all risks and establish appropriate mitigations, and proactively improve operations and systems that deliver the highest quality products. . These efforts need not be restricted to small and medium-sized manufacturers who have the resources. Achieving a strong, proactive quality culture can match organizational and customer expectations. The benefits of this organization’s commitment to quality include: 1. Reduced Regulatory Burden Unexpected problems in the field lead to additional regulatory oversight and special inspections. Manufacturers who have effectively invested in quality, thereby reducing quality problems in the field, may face fewer corrective and preventive action (CAPA) problems. In addition, investments can be focused on driving organizational improvement, rather than managing the expectations or requirements of regulators. This translates into less regulatory overhead and a reduction in activities that do not add value to the product, customer, or business. 2. Direct value A focus on product quality and organizational excellence is one of the biggest levers a CEO can use to drive immediate value to the bottom line. Designing for quality and manufacturing in advance leads to a veritable cascade of benefits: higher production yields and rates, lower scrap rates and scrap costs, reduced overhead from ongoing product issues, and cost savings due to reduced inspections. A quality culture that is patient-focused and proactively engages employees to solve problems faster, identify new customer needs, optimize operations, and reduce waste. 3. Faster Problem Resolution Even the best programs cannot predict every possible product problem, address every way it could happen, and then prove that it won’t happen. However, an active quality focus can significantly increase awareness and response, as well as reduce the probability of significant risks occurring, minimizing the impact on patients and the business. 4. An Insurance Policy For Investors Major quality issues can easily put small and medium-sized companies out of business. Considering quality in advance, together with demonstrating increased quality and preparedness for quality problems, reassures both first-time and repeat investors, and increases their willingness to invest. 5. More growth for hospital systems With value-based purchasing systems, hospitals are not paid solely based on the number of services they provide. As hospital systems and providers are increasingly held accountable for value and quality, they will seek to move from transactional relationships with manufacturers to relationships built on transparency. Manufacturers that demonstrate a commitment to quality and a strong risk mitigation strategy may be more attractive to hospital systems. 6. Progress in Increasing Patient Trust A FasterCures survey revealed that, while patients trust providers and hospitals to use their health data to make decisions that will benefit their lives, they do not trust medical device manufacturers they do the same thing. A challenge to trust is transparency, especially when many patients only hear about medical devices when a recall is covered in the media. Consistently demonstrating quality — potentially through independent evaluation through CDRH’s pilot program and through education about how device data is tracked, shared, and used — may be one way that manufacturers can build a positive reputation among patients. Investing in Quality: The First Step Changing mindsets and actions toward better quality is not an overnight process. In organizations, quality champions must first create awareness that the value of quality, including the cost of poor quality, is real, measurable, and actionable. They must also communicate that insight into building a better product is not found in compliance audits, but rather through an investment in quality. Evaluating ongoing operations and activities by asking questions such as the following will increase the focus on continuous improvement and communication: What are the essential elements of the design or process? What are the likely ways the design or process could fail, including worst-case scenarios? What are the risks if the design or process fails in one of these ways? What mitigation actions will be taken to minimize the severity or probability of the failure occurring? How well and how quickly does the organization identify and resolve quality issues? How does the organization communicate and incorporate learning across organizational units and functions? If we consider our common goal to make products that are safe, effective, and improve the lives of patients, it is clear that investing in quality pays off. This article was originally published on Med Device Online and has been republished here with permission.

Stephanie Christopher, MA, has a background in health communication, public health project management and communication education and training. Stephanie joined MDIC in 2013 and manages MDIC’s patient-focused benefit-risk assessment, patient engagement and quality initiatives. Prior to joining MDIC, Stephanie worked…

“proactive Approaches To Health Insurance Approval And Claims Down Under”

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