Changes
=== Startup activity ===
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.
== Phase 2: Deeper Dive ==
=== Scenario ===
Client wishes to acquire a ureteral stent company.
=== Deal analysis for a target company ===
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]
=== Design History File Review: Review components ===
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0"
|- style="background:lightgrey"
!align = "center" bgcolor = "#00CCFF" width="15%"|Review
!bgcolor = "#00CCFF" width="30%"|Verification
!bgcolor = "#00CCFF" width="40%"|Tasks
!bgcolor = "#00CCFF" width="15%"|Expertise
|-
!rowspan="2"|Design Input
| Design input documents for sufficiency
|
# Access electronic data room.
# Check what documents are provided.
# Compare document list with standard client document list.
# Check whether each specified document has appropriate content.
| rowspan="2"|Quality systems
|-
| Design input documents linked to the product performance specifications
|
# Compare product specifications to design inputs
# Check whether appropriate verifications and validations are performed
# Establish if all specifications are linked to design inputs
|-
!rowspan="3"|Product Performance Specifications (PPS)
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans
|
# Compare product specifications to design inputs
# Check whether appropriate verifications and validations are performed
# Establish if all specifications are linked to design inputs
| rowspan="3"|Quality systems, CAD
|-
| Appropriate design verification and validations (DV&V) are performed
|
# Show DV&V criteria are based on risk management requirements
|-
| Product performance specifications correspond to appropriate design output documents
|
# Correlate design drawings with the specifications
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range
|-
!rowspan="4"|Risk Management Documents
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation
|
# Check whether documentation is available
# Check whether it adheres to appropriate ISO 14971 standards
# Check whether it adheres to appropriate client standards
|rowspan="4"| Quality systems
|-
| DFMEA links appropriately to the PPS
|
# Verify whether DFMEA and product specifications are correlated
|-
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA
|
# Validate the process and correlate with design inputs
# Validate that sizes used are within range of risk mitigation criteria
|-
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA
|
# Validate the process protocol
# Validate the inspection procedures used
|-
!rowspan="2"|Design Output Documents
| Completeness of drawings
|
# Check if the CAD diagrams overlay and "fit" perfectly
# Check tolerance stackups
|rowspan="2"| Quality systems, CAD
|-
| Correlate First Article Inspection data to the dimensions on the drawings
|
# Obtain First Article Inspection data
# Check if this data correlates with the completeness of drawings
|-
!rowspan="4"|Manufacturing Documents
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness
|
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures
# Correlate incoming and in-process inspection procedures with the process specifications
| rowspan="4"|Material science, manufacturing engineering, quality systems
|-
| Linkage between component and raw material specifications and appropriate incoming inspection procedures
|
# Identify any missing documentation for inspection procedures
|-
|-
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials
|
# Review supplier audit reports for compliance
|-
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations
|
# Check the entire equipment-related lifecycle
# Check if machine operational qualification was performed
# Check if the measurement equipment was validated
|-
!rowspan="2"|Validation Report
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports
|
# Ensure all reports are available and linked together appropriately
# Identify all inconsistencies across different reports
| rowspan="2"| Quality systems
|-
| Design test methods and related test method validations
|
# Compare test methods used to those in client and ISO standards
# Identify inconsistencies across test methods
|-
|}
=== Sample report ===
==== Performance/Functional Characteristics ====
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0"
|- style="background:lightgrey"
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)
|-
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale
|-
|Provide antimicrobial resistance for up to 2 weeks
|Ureteral Stent User Survey (Document #XXXXX)
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks
|Document #XXXXX
|Test Document #XXXXX
|Report 01-005-06-007
|P
|Report 01-005-06-007
|P
|-
|}
=== Potential DHF Review Outcomes ===
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.
# Updating drawings based on results from the FAI data.
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device.
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.
