Case For Quality CDRH Quality Metrics Project
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1 14th Annual Medical Device Quality Congress Case For Quality CDRH Quality Metrics Project Bill MacFarland FDA/CDRH/OC/Division of Manufacturing and Quality March 28, 2017
2 Agenda Background CDRH Vision and the Case for Quality Getting to today s Case for Quality Barriers to Quality FDA s role in the Case for Quality (CfQ) Metrics to date and feedback received Moving towards a 3 rd party program Questions & feedback throughout 2
3 CDRH Vision Patients have access to high quality, safe, effective medical devices, of public health importance, first in the world. Case for Quality promotes that vision through a shared FDA-industry goal to provide patient access to high-quality medical devices. In 2016 it matured into a CDRH Strategic Priority. 3
4 What is the Case for Quality? The Case for Quality is collaborative effort within the medical device ecosystem to shift the primary focus of the medical device sector from regulatory compliance to a state of sustained product quality in order to enhance patient safety and access to high quality medical devices. 4 4
5 Barriers to Quality The focus of the relationship between FDA and industry may have been on managing compliance rather than on a shared goal for continuously improving quality. A perceived and real lack of transparency and comparative data hampers informed decision making by users, purchasers, and the FDA, and thwarts rewarding good performers. Note 1 cm htm 5
6 FDA s role in the Case for Quality CDRH Strategic Priority Goal: Strengthen Product and Manufacturing Quality within The Medical Device Ecosystem Develop metrics, successful industry practices, standards, and tools that manufacturers can use to evaluate product and manufacturing quality beyond compliance with regulatory requirements Pilot voluntary use of product and manufacturing quality metrics and evaluation tools Propose a voluntary program to recognize independent evaluation of product and manufacturing quality 6
7 Today: The Case for Quality Voluntary Third Party Program Elements Credentialing Requirements Certified MDv Resources Maturity Model Metrics Product Quality Outcomes Are device companies Maturity Capability continuously improving, maintaining, or decreasing? 7
8 Today: the Case for Quality Maturity Model: Strengthen Product and Manufacturing Quality within The Medical Device Ecosystem and focus on quality execution beyond compliance Continuous Improvement Data-driven Decision making Useful Process Infrastructure Plan your work; Work your plan Work happens 8 8
9 Today: the Case for Quality Value Analysis Teams: What is quality? 9
10 Categories for Draft CDRH Device Metrics Metric Category I. Quality System (capability) Preproduction Production Postproduction Index II. Critical Device Specific Characteristics Factor 1: Risk Mgmt Factor 2: Control Factor 3: Monitoring What is evaluated Trending Approach to Control Trending 10
11 QS Metrics for Pilot Study Phase/Metric Name Pre- Production: Design Robustness Indicator Assess the number of product changes that are related to product or process inadequacies or failures Production: Right First Time Rate Assess the number of production failures related to product and process inadequacies or failures Metric Calculation total # of product changes total # of products with initial sales in the period # of units mfg. without non-conformances # of units started Post- Production: Post-Market Index Assess an aggregate of post-market indicators with root causes of product or process inadequacies or failures Index: Complaints * (0.20) + Service Records * (0.10) + Installation Failures * (0.20) + MDRs * (0.20) + Recalls (units) * (0.20) + Recalls (total) * (0.10) 11 11
12 CDRH Draft Metrics High Level View What FDA would need to evaluate Indicators of activity with increasing impact on quality 1. Essential activities 2. Proactive activities 3. Preventive activities 12
13 Feedback Received There is a tradeoff between a generalized metrics approach and the value of the metrics themselves Value in integrating into maturity model assessments Where outcomes data/analytics data is available, that tends to be preferred over leading indicators of quality. 13
14 Today: The Case for Quality Voluntary Third Party Program Elements Credentialing Requirements Certified MDv Resources Maturity Model Metrics Product Quality Outcomes Are device companies Maturity Capability continuously improving, maintaining, or decreasing? 14
15 Seeking More Feedback Promoting interest in participation in this approach? Metrics/tools to prepare for maturity model assessment? Standardized metrics the line on cost/benefit? Incentive(s) for feeding outcome/analytics? 15
16 Contact Information Bill MacFarland Director, Division of Manufacturing and Quality Tel: FDA, Center for Devices and Radiological Health Office of Compliance Division of Manufacturing and Quality Building WHITE OAK # New Hampshire Avenue Silver Spring, MD Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received: 16
17
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