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Products & Services Quality, Compliance and Regulatory Structure,Staffing and Execution

Overcoming Medical Device Resource & Competitive Demands in Quality Assurance, Regulatory Affairs and Post Market Surveillance

ID: POP-299


Features:

2 Info Graphics

28 Data Graphics

320+ Metrics


Pages: 39


Published: 2018


Delivery Format: Shipped


 

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

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




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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
Medical device organizations ought to have robust Quality Assurance, Regulatory Affairs and Post Market Surveillance groups to meet regulatory requirements across different geographical markets and ensure product quality and safety. To achieve this, organizations need to optimize operations and resource allocation for these vital functions.

Best Practices, LLC undertook this benchmarking research to probe the staffing, spend, and operations of Quality, Regulatory, and Post Market Surveillance groups within high-performing medical device companies. This report also uncovers the number of CAPAs, NCEs, field actions, change requests, and complaints that medical device companies experience.

Industries Profiled:
Diagnostic; Medical Device; Biotech; Health Care


Companies Profiled:
Abbott Vascular; Accelerate Diagnostics; Aesculap; Alcon; Baxter Healthcare; Boston Scientific; Beckman Coulter; B. Braun; ConMed Corporation; Cook Medical; C. R. Bard; DePuy Synthes; eNeura Therapeutics; Fisher & Paykel Healthcare; FzioMed; Halyard Health; Haemonetics Corporation; Lifecore Biomedical; Medtronic; Meril; Molnlycke Healthcare; NeedleTech Products Inc.; NeMedIO; nSpire Health; Ortho-Clinical Diagnostics; ResMed; Smith & Nephew; Stryker; Teleflex; Wright Medical Group N. V.; Zimmer Biomet

Study Snapshot

Best Practices, LLC engaged 33 Quality, Regulatory, and Post Market Surveillance leaders from 31 world-class medical device companies in this benchmarking research.

Key topics covered in this report include:

  • Quality Staffing, Spend, Span of Control, and Stock Keeping Units (SKUs)
  • Quality Operations
    • Nonconforming Events, Corrective Actions, Field Actions, and Change Requests
    • Number of Manufacturing Facilities, Design Facilities, and Direct Material Suppliers
    • FDA Letters, Non-Conformances
  • Regulatory Affairs Staffing, Spend, and Span of Control
  • Regulatory Affairs Operations
    • 510(K) Clearances
  • Post Market Surveillance Staffing, Spend, and Span of Control
  • Post Market Surveillance Operations
    • Complaint Volumes, FTEs Dedicated to Handling Complaints, and Complaint Closure Duration
    • Number of MDRs

Key Findings

Sample key insights uncovered from this report are noted below. Detailed findings are available in the full report.
  • Number of FTEs: The combined quality function accounts for almost 8% of all company FTEs (5.8% on Quality Assurance, 1% on Regulatory Affairs, and 0.8% on Post-Market Surveillance).
  • Agile Operations: Leading companies operate lean with the proper balance between supervisors and front-line workers. It is recommended to keep no more than 7 direct reports for maximum communication and growth potential.
  • Account for Growth: As medical device firms increase in revenue they should allocate more FTEs to Quality Assurance relative to other departments to maintain their current level of quality practices and keep consistent device quality.

Table of Contents

I.
Universe of Learningp. 3
II.
Executive Summarypp. 4-11
Demographicsp.4
Areas of expertisep. 5
Annual revenuep. 6
Number of countries with product salesp. 7
Portfolio complexityp. 8
Industries representedp.9
III.
Quality Resourcing and Span of Controlpp. 12-22
Quality spend ratiopp. 13-16
Quality staff ratiopp. 17-20
Span of control rangep. 21
Stock-keeping unit efficiencyp. 22
IV.
Operations of Quality Assurance and Quality Systemspp. 23-29
CAPAs, NCEs, field actions, and change requestspp. 24-26
Plants, distribution centers, direct material suppliers, and design centerspp. 27-28
FDA warning letters, and form 483sp. 29
V.
Regulatory Affairs Operations and Resourcingpp. 30-31
510(k) clearancesp. 31
VI.
Post Market Surveillance Operations and Staffingpp. 32-34
Complaint volume, FTEs handling complaints, and complaint closure durationp. 33
MDRsp. 34
VII.
Appendixpp. 35-38

    List of Charts & Exhibits

    I. Quality Resourcing and Span of Control
    • Percentage of revenue spent on quality assurance-systems, regulatory affairs, and post-market surveillance functions
    • Quality spend as a percentage of total revenue
    • Regulatory spend as a percentage of total revenue
    • Post Market spend as a percentage of total revenue
    • Total number of FTEs employed in quality assurance-systems, regulatory affairs, and post-market surveillance functions
    • Quality FTEs as a percentage of total FTEs
    • Regulatory FTEs as a percentage of total FTEs
    • Post market FTEs as a percentage of total FTEs
    • Average number of direct reports at each supervisory level in the quality organization
    • Total number of stock-keeping units (SKUs) of sellable product codes distributed by benchmark companies

    II. Operations of Quality Assurance and Quality Systems
    • Number of open CAPAs
    • Number of open non-conforming events
    • Average number of change requests reviewed and assessed by benchmark Quality organizations and number of field actions experienced
    • Number of company-run discrete manufacturing plants, contractor-run discrete manufacturing plants, distribution centers, and direct material suppliers per $100m in revenue
    • Number of design centers per $100m in revenue
    • Number of FDA warning letters & form 483s per $100m in revenue

    III. Regulatory Affairs Operations and Resourcing
    • Number of 510(k) clearances

    IV. Post Market Surveillance Operations and Staffing
    • Volume of complaints and the number of FTEs handling complaints, and average number of days taken to close a complaint
    • Number of MDRs (medical device reporting) per $100m in revenue