Case Study: Global Medical Device Manufacturing Company Harmonization and EUMDR Staffing Program

Written By Oxenham Group

Business Challenge

In late 2020, one of the world’s leading medical device manufacturing companies* announced its acquisition of a $4.7B medical device company focused on extremities and biologics. The Oxenham Group (OXG) partnered with this parent company to spearhead the strategic placement of Project Managers, Subject Matter Experts and Execution Level Resources at the onset of their quality system integration.

Goal: Merge the quality systems of two world class medical device manufacturing companies without compromising the integrity of either system through the strategic recruitment and hiring of top talent. 

Process

Performed a comprehensive gap assessment of the two quality systems which formed the project charters of a dozen quality system workstreams. These workstreams were charged with authoring new or revising procedures governing the parent company requirements while maintaining the integrity of the acquired company’s manufacturing processes. OXG provided the project manager for the assessment  and 16 contractors through staff augmentation over the course of 18 months. 

Workstreams:

  • Design Controls (incl., dFMEA, DMR/DHF/CTQ definition, and Design Transfer)

  • Supplier Qualification (incl., Agreements, PPAP, and Performance Monitoring)

  • Production Process Controls (incl., Process Flow, pFMEA, Control Plan, and Validation)

  • Inspection Measurement & Test Equipment (incl., MSA/GR&R and Calibration)

  • Sterilization and Cleaning Validation (incl., EO/Gamma, and Environmental Monitoring)

  • Quality Systems (incl., Quality Manuals, Management Reviews, and Internal Audits)

  • Document and Engineering Change Controls (incl., Record Archive, and Training)

  • Regulatory Affairs (incl., Product Labeling, Lot/Serial/UDI Identification, and PMA)

  • Acceptance Activities (incl., Incoming, In-Process, and Final Inspection)

  • Post Market Surveillance (incl. Complaints, Non-conformance, and CAPA)

Results

1. The successful integration of parent company requirements into five U.S. and E.U. based manufacturing facilities within its two-year non-GAAP budgeted period. 

2. Files were supplemented with remediated internal and outsourced process documentation on numerous product families; collectively driven across integration work streams and base-business functions.

3. Project saw a  91% consultant retention for talent, largely due to a highly engaged workforce, whose personal goals aligned closely with the mission of the project and larger organization. 

As the integration program has reached its conclusion, OXG now has highly trained talent available, versed in various areas of quality system integration and EUMDR remediation. *Featured client available as a reference upon request. 

Learn about the talent from this project:

Quality Engineer 1
Quality Engineer 2
Manufacturing Engineer

Connect with John Glynn to see a list of available full-time and consulting resources.

Oxenham Group
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