Non-members: Click here to review a complimentary excerpt from "Benchmarking Medical Device Quality 2014-15: Compliance and Product Support"
Medical device organizations want the highest quality and safety standards for their company's products. At the same time, quality leaders face the dual challenge of ensuring compliance with federal guidelines and managing product support activities within tight budgets.
To help quality leaders manage this challenge, Best Practices, LLC conducted a study to benchmark the role of quality in the funding and management of key compliance and product support activities at medical device companies. The study also examines how much companies are utilizing low-wage markets for quality assurance and product support activities.
Research findings provide evidence-based benchmarks for quality compliance, product support and product design activities.
This study contains a Large Company Segment (LCS) that is made up of 11 companies.
- Degree of Quality responsibility across key compliance and product support activity areas
- Use of offshoring and outsourcing in low-wage labor markets for Quality activities
- Role of Quality in product design
- Scope of Responsibility of the Quality Organization in Compliance
- Compliance QA Activities Conducted at Company Sites in Low-Wage Markets
- Compliance QA Activities Conducted by Vendors in Low-Wage Markets
- Number of Objects (documents, BOMs, processes, routers, drawings) Reviewed by Quality Function
- % Documents Changed/Updated
- Change Requests Per $100 Million In Revenue
- Product Support Activities Conducted By Quality Function
- Integration of Clinical Quality into Core Quality Function
- Product Support QA Activities Conducted at Company Sites in Low-Wage Markets
- Product Support QA Activities Conducted by 3rd Party Vendors in Low-Wage Markets
- Extent Post Market Data Is Incorporated into NPD
- 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
SAMPLE KEY FINDINGS
- Design Control Involvement: Failure mode effects is one of the most used metrics to measure the effectiveness of risk management & design control process. LCS also heavily rely on Six Sigma standards and control standards (100% of LCS use these metrics).
- Best Practices, LLC designed and deployed a custom benchmarking survey to executives at 21 leading Medical Device companies. This study has two segments: Total Benchmark Class (TBC) made up of 21 companies and a Large Company Segment (LCS) that is made up of 11 companies.