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

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

• 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.

I.	Universe of Learning	p. 3
II.	Executive Summary	pp. 4-11
	Demographics	p. 6
	Areas of expertise	p. 7
	Annual revenue	p. 8
	Number of countries with product sales	p. 9
	Portfolio complexity	p. 10
	Industries represented	p. 11
III.	Quality Resourcing and Span of Control	pp. 12-22
	Quality spend ratio	pp. 13-16
	Quality staff ratio	pp. 17-20
	Span of control range	p. 21
	Stock-keeping unit efficiency	p. 22
IV.	Operations of Quality Assurance and Quality Systems	pp. 23-29
	CAPAs, NCEs, field actions, and change requests	pp. 24-26
	Plants, distribution centers, direct material suppliers, and design centers	pp. 27-28
	FDA warning letters, and form 483s	p. 29
V.	Regulatory Affairs Operations and Resourcing	pp. 30-31
	510(k) clearances	p. 31
VI.	Post Market Surveillance Operations and Staffing	pp. 32-34
	Complaint volume, FTEs handling complaints, and complaint closure duration	p. 33
	MDRs	p. 34
VII.	Appendix	pp. 35-38

• 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

• 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

• Number of 510(k) clearances

• 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