Medical device and diagnostics companies devote a significant amount of resources to ensure their products meet the highest quality standards at every stage of the product lifecycle, from R&D and product development through manufacturing, sale, and post-market activity.
Facing tight budgets and increasing regulations, Quality leaders walk a tight rope in balancing Quality and safety while managing costs and assessing risk. Consequently, quality leaders are gearing to shift resources, automate and outsource activities, develop and retain key talent, and build business plans that justify their budgets. It is also important for them to identify and standardize the best path for CAPA processes to evaluate and investigate deviations successfully.
Best Practices, LLC undertook this study to explore how leading medical device companies are defining and allocating Quality spend, identifying factors that impact spending levels, and investing in future mission-critical Quality activities. Research findings provide evidence-based benchmarks for Quality spending, staffing, change request levels, outsourcing, software quality, inspections, lab testing, complaint management, trend insights and more.
Table of Contents
I. Executive Summary Pgs. 3-14
· Research Overview Pg. 4
· Participating Companies Pg. 5
· Key Findings & Insights Pg. 6
II. Quality Spend Levels Pgs. 15-24
III. Future Quality Spend Drivers & Normalizers Pgs. 25-34
IV. Acquisitions & Quality Function Integration Pgs. 35-42
V. Top Challenge Areas for Quality Organizations Pgs. 43-45
VI. Quality Staffing Levels Pgs. 46-57
VII. Budget Allocation for Key Quality Activities Pgs. 58-62
VIII. Quality Activity Areas Pgs. 63-132
IX. Compliance Activities Pg. 64
X. Inspection & Production Pg. 74
XI. Non-Conforming Pg. 93
XII. Product Support Pg. 112
XIII. Additional Quality Activities Pg. 126
XIV. Quality Metrics, Improvement Approaches & Controls Pgs. 133-138
XV. Key Demographics of Participating Companies Pgs. 139-154
XVI. Appendix Pgs. 155-156
List of Charts & Exhibits
· Quality Spend as a Percentage of Revenue
· Top Factors Driving Quality Cost Changes
· Top Metrics Used to Monitor & Manage Quality Risks Across Distribution & Production
· Total spend of Quality function in 2014 for medical devices and related services
· Quality Cost over Revenues
· Quality Spend Reported as Gross or Net
· Change in Level of Quality Spend over the past 3 years (2012-2014)
· Forces or issues driving the percentage change of participants’ Quality spend over the past 3 years
· Administrative Charges Included in Quality Spend
· Quality Spend Inclusions
· Complexity Factors Increasing Quality Spend within the next 12 to 24 months
· Process Management Factors Increasing Quality Spend within the next 12 to 24 months
· Regulatory Factors Increasing Quality Spend within the next 12 to 24 months
· Current Regulatory Challenges for Participants
· Simplification Factors Driving Decreased Quality Support Spend within the next 12 to 24 months
· Continuous Improvement Factors Driving Decreased Quality Support Spend within the next 12 to 24 months
· Regulatory Factors Driving Decreased Quality Support Spend within the next 12 to 24 months
· Medical Device Acquisitions and Profitability since 2012
· Acquisitions with Realizable Revenue over Companies Acquired - Shown As %
· Quality Integration for Acquired Sites
· Current & Future Quality System Models
· Number of standard operating procedures and work instructions for the Quality organization at each level
· Effectiveness of Approaches for Supporting M&A Integration
· Key Industry Challenges/critical issues that Quality organizations will have to contend with in the next 12 to 24 months to achieve high performance
· Medical Device Quality Staffing - Total number of FTEs in Quality Function at the end of 2014
· Past Trend in Number of FTEs in Quality (2012-2014)
· Quality Function Staffing Trends
· Quality Staffing Over Med Device Employees - Shown As %
· Span of Control at Each Job Level
· Quality Cost per FTE
· Quality Staffing over UPNs/SKUs
· Active Clinical Quality Staff FTEs to Clinical Trials
· Total number of clinical quality assurance FTEs (Full Time Employee equivalents) currently employed by benchmark participants
· Ratio of Clinical Quality Staff to Total Clinical Headcount
· Allocation of Quality Spend by Channel
· Resource Allocation Trend
· Scope Of Responsibility of the Quality Function
· Managing QA Labor Costs Across Global Markets: Compliance
· Number of Objects Reviewed by Quality Function
· % Documents Changed/Updated in 2014
· Change Requests Per $100 Million In Revenue
· Managing QA Labor Costs Across Global Markets: Inspection/production
· Location of Toxicology/Biocompatibility Internal Inspections
· Active Clinical Trials to Internal Clinical Trial Audits Ratio
· Top Metrics Used to Monitor and Manage Quality-Impacting Distribution and Production Risks
· Direct Material Suppliers Per $100 Million In Revenue
· % Incoming Batches Requiring Detailed Inspections
· Production Floor Lab Testing
· Metrics Used to Assess Supply Chain Risk
· Effectiveness of Production Risk Metrics
· Document Types Reviewed by Software Quality Assurance
· Groups Owning Software Validation Activity
· Managing QA Labor Costs Across Global Markets: Non-conforming Activities
· Field Defect Density
· Number of Open CAPAs per $100M in Revenues
· Number of Open Non-conforming Events Per $100 Million Revenues
· CAPA Cycle Times
· Complaints Per $100 Million In Revenue
· Total number of inbound calls handled by self-service, automated or recorded systems
· Use of Virtual Inspection for Complaint Resolution
· Field Actions & Evaluations experienced in 2014
· Field Actions to Field Evaluations
· Defect Removal Rate
· Managing QA Labor Costs Across Global Markets: Product Support Activities
· Design Control Budget Management
· Risk Management/Design Control Process Measurement
· Impact of Design Control Metrics on Quality
· Level of Integration of Risk Management/Design Control & New Product Development Systems
· Managing QA Labor Costs Across Global Markets: Other Activities
· Benchmark Participant’s 2014 annual revenue from medical device sales and related services
· Total Number of FTEs engaged with medical device operations/businesses at benchmarked companies
· Total number of UPNs (Unique Product Numbers) or SKUs (Stock-keeping units) of sellable product codes distributed by benchmark participants related to their medical device or diagnostics business
· Number of company-run discrete manufacturing plants and distribution centers
· Sales Regions
· Maturity of Cost of Quality Function
· Manufacturing Plants Per $100 Million In Revenue
· Distribution Centers Per $100 Million In Revenue
· Number of Active Clinical Trials
· Number of Audits at Investigational Clinical Sites
· UPNs/SKUs per $100 Million in Revenue
· Approaches for Developing Fast Response Quality Systems
· Quality Control Approaches
· KPIs Included on Quality Performance Dashboards
· Effectiveness of Distribution Risk Metrics
· Integration of Clinical Quality into Core Quality Function
· Statistical Confidence Level in Process Validation per Product Class
· Extent Post Market Data Is Incorporated into New Product Development (NPD)
· Parameters that spotlight select factors most significantly driving quality performance in listed systems