Design History File Integration via Acquisition

Background

A Fortune 500 medical device manufacturer acquired another medical device company to grow their Urology business unit from a $500 million to a $1 billion organization. ECI was commissioned to conduct a deep dive assessment and subsequent remediation of the Design History Files (DHF) of the acquired products. The objective of the engagement was to assess the quality of the DHFs of the acquired products to determine the best remediation pathway into the client's Quality Management System (QMS). The focus areas were:

• US Food and Drug Administration (FDA) Code of Federal Regulations, 21 CFR 820.30
• ISO 13485:2016 Section 7.3
• ISO 14971
• Device specific standards

Approach and Solution

ECI engaged a project manager to work with the client on determining product families in the scope of review. Sixteen discrete products were identified which included capital equipment, reusable and single use devices. These products were categorized into a priority order based on the client's overall business portfolio need. ECI engaged a team to review the legacy data associated with these products. ECI identified wide ranging DHF non-conformances, such as:

• Missing test method validations
• Non verifiable design inputs with no source
• Missing real time shelf-life data
• Gaps to current usability and risk management standards
• Missing training records, build records, calibration records
• Design verification data exists but original data source missing
• Lack of robust or valid statistical rationales

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Comprehensive Action

The conclusion of this assessment was that 12 product families would require remediation to be consistent with the client's quality expectations. The remaining families went to end of life and closed out per the client's QMS requirements. Before remediation was initiated, ECI developed a site level SOP to create a remediation pathway for the product families. This allowed our client to prioritize the appropriate elements for remediation. Additionally, a Quality Plan was developed per product so that the remediation pathway could be reviewed and agreed upon by quality management. For each product family, ECI completed a post market assessment of the device to ensure that the device could remain on the market while the remediation activities were being completed. Remediation activities consisted of:

• Design Inputs - remediation of user needs and design requirements. This included restating requirements in verifiable terms and ensuring devices specific standards were addressed.
• Design Outputs - drawings were remediated to identify essential design outputs and include the clients drawing standard requirements.
• Design Verification - design verification was conducted to address the gaps. This included the completion of test method development and validation as needed. Risk-based statistical sampling was used and statistical analysis to analyze data. In addition, real-time aging studies were initiated for all product families.
• Design Validation - design validation was satisfied using a combination of clinical literature and test activity.
• Risk Management - risk documentation was updated to comply with ISO 14971.

This undertaking was completed over a 24-month period and the activities completed by the ECI team included:

• # of Product Families Remediated = 12
• # of Document Change Orders Completed ~ 1250
• # of Documents Updated ~ 2500
• # of Specifications Updated or Clarified ~ 740
• # of Test Methods Validations Completed ~ 240
• # of Units Tested ~ 4800

Upon completion of the activity, ECI conducted a "Sustaining Transfer Meeting" for each product family to ensure that the client sustaining engineering team had the full history of activity conducted.

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Results

ECI successfully remediated 12 product families into the client's QMS and documentation management system using a methodical risk-based approach to ensure that the budget was allocated to the appropriate areas requiring review and remediation.