Non-members: Click here to review a complimentary excerpt from "Quality Management & Product Development: Ensuring Supplier Excellence and Scientific Quality Processes for Medical Device Companies"
Rising concerns about the quality of products and the management of the processes within the Quality function are forcing Medical Device companies to evaluate their resources and structure. As a result, supplier management protocols and the level of staff and budget allocation for different inspection activities and processes are becoming more valuable metrics to evaluate the efficiency of product release.
Best Practices, LLC conducted this study to the investigate how medical device companies manage important processes such as laboratory testing and outgoing inspections. In addition, the research presents benchmarks around the allocation of support product design and the manner in which it provides assistance across the commercialization lifecycle. The study provides meaningful metrics, such as the the optimal product mixes required at different testing levels within Quality function, coupled with key insights provided by leading executives through interviews.
Medical device leaders can use this study to evaluate their management of activities such as supplier quality and manufacturing inspections as well as the support they provide R&D.
- Executive Summary
- Managing Supplier Quality & Incoming/Receiving Inspections
- Managing Manufacturing/Outgoing Inspections
- Managing Laboratory Testing & Scientific Quality Processes
- Supporting R&D Clinical Trials
SAMPLE KEY METRICS
SAMPLE KEY FINDINGS
- Number of suppliers currently serving the quality function
- Number of supplier audits conducted annually
- Number of suppliers managed at each organizational level
- Level of integration for Supply Quality activities
- Percentage of incoming batches requiring a detailed inspection
- Percentage of suppliers certified to conduct Quality audits at the source
- Standardization of protocols for managing supplier performance
- Percentage of total budget and FTE resources dedicated to different Inspection Activities
- Involvement of Quality organization in verifying day-to-day manufacturing performance
- Percentage of products destructively tested
- Percentage of product batches inspected by Quality organization that are released without rework
- Percentage of production batches that undergo substantial quality analysis in an off-floor laboratory
- Percentage of products requiring toxicology tests
- Percentage of products requiring bicombatibility tests
- Location of analytical and microbiology lab tests
- Method of allocation for support of product design
Managing Supplier Quality & Incoming/Receiving Inspections: Most suppliers are managed by a centralized corporate group or specific manufacturing sites. A profile or self-survey is the most common supplier audit performed. Additionally, 54% of companies inspect more than 60% of incoming batches.
Managing Laboratory Testing & Scientific Quality Processes: For 43% of companies, 10% of or fewer of production batches undergo substantial analysis in an off-floor laboratory other than routine microbiology. On average, 69% of analytical lab tests and 65% of microbiology lab tests are performed at manufacturing sites.
For this benchmarking study, Best Practices®, LLC gathered insights and performance data from eleven executives from 11 medical device companies. Five executives participated in interviews.