1<!DOCTYPE html>
2
3Anonymous
4/bestp
5/bestp/domrep.nsf
6E7AF60B71FAB5C44852579BB00540C17
8
9
10
11
12
13
140
15
16
17/bestp/domrep.nsf/products/quality-staffing-performance-report-cost-staff-for-maintaining-quality-medical-device-companies?opendocument
18
19opendocument
2054.226.58.177
21
22
23www.best-in-class.com
24/bestp/domrep.nsf
25BMR




» Products & Services » »

Quality Staffing & Performance: Ensuring Quality & Safety While Managing Cost Effectiveness for Medical Device Companies

ID: POP-241


Features:

35 Info Graphics

87 Data Graphics

750+ Metrics

28 Narratives

2 Best Practices


Pages: 143


Published: Pre-2013


Delivery Format: Shipped


 

License Options:

close

Single User: Authorizes use by the person who places the order or for whom the order was placed.

Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.

Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.

Buy Now

Buy this research as part of a

 

919-403-0251

  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
Medical Device and Medical Technology companies often devote significant resources to ensuring that their products meet quality standards and regulations at every stage of the product life cycle, from R&D and product development through manufacturing, sale, and post-market activity. Consequently, optimal resource levels, staffing, and structure can help quality function leaders in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth and sustainability.

Best Practices, LLC conducted this study to provide insights into how medical device companies are mobilizing resources to support meeting quality standards and regulations throughout the product life cycle. This research establishes meaningful metrics around Quality cost and staffing as well as organizational structure for the function in the U.S. and globally.

The study also contains insights from five medical device leaders around the quality function and its future direction. Medical device leaders in quality or a related function can use this study to compare their spend and FTE levels as well as their organizational responsibility with those of leading companies.

Industries Profiled:
Consumer Products; Medical Device; Health Care; Orthopaedics


Companies Profiled:
Bausch & Lomb; Boston Scientific; Covidien; Edwards Lifesciences; Ethicon; Medrad; Medtronic; Nitinol Devices & Components; Roche Diagnostics; Terumo Medical; Zimmer


Study Snapshot

For this study, Best Practices®, LLC gathered insights and performance data from eleven executives from 11 leading medical device companies.

All study participants contributed data through a field survey and representatives from several leading benchmark organizations also provided additional insights through deep-dive interviews.

Key Findings

Quality Staffing: Quality function FTEs total about 6 to 7% of total FTEs working in medical devices and related services. For 64% of companies, Quality staff increased by an average of 8% in the past three years.

IT Solutions: An IT solution for CAPA is most common with 82% of benchmark partners indicating that they use one global system in their respective companies. In contrast, Quality Management Review systems remain manual for nearly two-thirds.

Deploying Quality Training: On average, 36 training sessions were performed per Quality FTE last year. Reviewing documents accounted for more than half of the training, followed by classroom training at 26% and e-learning at 18%.

Quality System: Most companies do not maintain a standardized software platform to facilitate risk assessment across products. For nearly 60%, business units take primary responsibility for tracking product risk throughout the lifecycle.

Table of Contents

Research Objective & Methodology  p. 3-15
  • Quality Organization Cost & Staffing  p. 16-24
  • Quality Organization Structure  p. 25-37
  • IT Solutions for Quality Activities  p. 38-46
  • Managing Document Control  p. 47-56
  • Employing Quality Audits & Management Reviews  p. 57-67
  • Deploying Quality Training  p. 68-72
  • Managing Software Quality  p. 73-79
  • Managing Supplier Quality & Incoming/Receiving Inspections  p. 80-87
  • Managing Manufacturing/Outgoing Inspections  p. 88-95
  • Managing Laboratory Testing & Scientific Quality Processes  p. 96-103
  • Complaint Management & Resolution Activities  p. 104-118
  • Managing NCE Activity  p. 119-124
  • Managing Corrections & Removals  p. 125-127
  • Supporting R&D Clinical Trials  p. 128-131
  • Quality System  p. 132-135
  • Future Directions for Quality Organization  p. 136-143