Changes
== Phase 1: Landscape overview ==
=== Ureteral Stent: Concept ===
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.
== Phase 2: Deeper dive ==
=== Design Input ===
Verify if design input documents are sufficient and also verify if these input documents have been adequately linked to the product performance specifications.
=== Product Performance Specifications (PPS) ===
Verify that design inputs correlate adequately to the specifications and that appropriate design verification and validations (DV&V) are performed. Also verify if DV&V criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans. Verify that product performance specifications correspond to appropriate design output documents.
=== Risk Management documents ===
Review Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation. Verify that DFMEA links appropriately to the PPS. Also verify that appropriate DV&V reports and design output documents are reference correctly as risk mitigation activities in the DFMEA. Similarly verify that PFMEA links appropriately to the process validation protocol acceptance criteria and that in-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA.
=== Design Output documents ===
Drawings would be reviewed for completeness. We would recommend that Company X perform a First Article Inspection in order to verify the dimensions on the drawings.
=== Manufacturing documents ===
Review manufacturing procedures, component specifications, raw material specifications, in-coming and in-process inspection procedures for completeness. Review linkage between component and raw material specifications and appropriate in-coming inspection procedures. Ensure inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials. Review of calibration records and preventive maintenance records would be also performed. This would also include a review of the in-process / incoming inspection test methods and related test method validations.
=== Validation Report Review ===
DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports would be reviewed. This would also include a review of the design test methods and related test method validations.
Based on a review of the above DHF documents a potential outcome for the uretral catheter 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 for eg. 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.
