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Scoping and Research, Feasibility and Planning
33
Assay Definition
3
Product Initiation Questionaire Completed
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Algo - General
High
Initial Intended Use Draft
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Algo - General
Medium
Initial Design Requirements Draft
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Medium
Scoping
8
DDP Completed
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Low
Research and WL development plant
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Medium
Regulatory Plan Complete
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Algo - General
Low
Quality Plan Complete
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
SW development plan drafted
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Risk Managment Plan Complete (IVD only)
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Product/Eng Development Plan Draft
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Customize General project deliverable checklist for project complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Project Management
5
Key stakeholders Identified
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Project Teams Assigned
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Coda(Research) / Algos Grid / Engineering / Other projects launched
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Recurring team meetings scheduled
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Customize General project deliverable checklist for project complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Feasability Assessment
8
Finalized Intended Use Approved
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Finalized Design Requirements Approved
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Finalized Commercial Requirements Approved
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Finalized Operational Requirements Approved
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Finalized Other Scientific Objectives Approved
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Complete Scientific Risk Assessment (algo tool)
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Initial feasibility assessment complete/reported if applicable
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Impact Assessments (Regulatory, Operational, Business, Product/Eng)
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Marketing Assessment
4
Competative Landscape and Market Assessement Complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
KOL assessments complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Marketing Plan Draft/Complete?
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Sales Strategy Draft
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Operational Assessement
5
Automation Strategy Draft
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Clinical Staffing Plan Draft
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Capital Equiptment Plan
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
LAB SPACE AND CAPCITY PLAN?
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Data Storage Capacity Plan?
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Assay Development
19
Assay Development and Optimization
19
Assay Chemsitries Finalized
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Writing of Clinical Workflow SOPs (including equipment, reagents, batch records, checklists)
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Reagent passing criteria defined
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Assay WL/Automation process Finalized
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
QC Materials Selected and Requirements Defined
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
QC thresholds established from minimum of 3 runs or lots as applicable (QC, Controls, etc)
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
QC handling process finalized (e.g aliquoting of positive controls)
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Equipment List Defined
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Facility layout updated and utilities installed
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Equipment Purchased / Allocated
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Automation Scripts Finalized in Github
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Analytical Pipeline Built / Trained
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Analytical Pipeline Trained
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Initial Validation Plan Draft
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Critical targets list from Medical Complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
dFMEA (IVD only)
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
sFMEA (IVD only)
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Demonstrate concordance across all instruments/analyzers
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Competencies built
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Assay Transfer
29
Assay Transfer
29
E2E Map Completed
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Clinical Workflow SOPs approved (including equipment, reagents, batch records, checklists)
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
All reagent lots to be phased in provided to QC
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
pFMEA (IVD only)
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
LIMS/LAMs builds complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
OPUS build complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Orderhub build complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Other
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
E2E of engineering systems Complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
BOM / Reagents Complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Netsuite setup all items complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Netsuite Forecasts Complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Supply Dashboard?
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Supplier Approvals Completed
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Supplier Agreements in Place
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Supplier WI SOPs finalized (eg IDT probe formluation)
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Cost Sheets Finalized
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Supplies ordered
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Clinical Staffing Plan Complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Clinical and QC Staff Training Completed (including equipment use/maintenance)
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Clinical Staff Compentencies Completed
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
IQ/OP/PQ all Equipment and creation of maintenance logs
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
IQ/OP/PQ all Automation Scripts/Methods
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Min 1 (prefered 3) manf lots phased in / min 3 month post lauch supply (preferred 6 mo)
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
QC Material Requirements Documented and Approved
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Validation plan approved
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Process Verifications Completed
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
All Change Control Complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
DMR Draft (IVD only)
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Validation
12
Validation
12
Analytical Validation Report Complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Marketing Data / Materials Finalized
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Sell Sheet Completed
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Validation 1 Pager Compelted
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Branded Reports completed
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Sales/MA/Other FAQ Completed
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Website Draft Completed
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Report gen Draft/Mocks Complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
End to End Run Successful (Operational Validation Complete - Part of Validation)
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Close out remaining training items
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Transfer all R&D reagents to Clinical Inventory Completed
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Launch
24
Launch
24
Report gen Builds complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Portal and Mobile
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Customer Interface - Ordering Build Complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Customer Interface - Portal Build Complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Customer Interface - Mobile Build Complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
EMR Integration Sign off
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
OPUS UAT complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
LIMS UAT complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Engineering Validation Report Approved?
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Clinical Team Sheets Final
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Sales Stragey Finalized
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Sales Team Trained
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Website Completed
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Other deliverables
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Accessioning Team Trained
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Returns Team Trained
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Order Processing Traiing (Zendesk and Lab) Complete
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Anything to register with CAP/NYS/MOLDX?
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Post Launch
2
Post Launch
2
Incorporate new common deliverables back into general sheet
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
Lessons learned review
Assay - Liquid
Assay - Solid
Assay - IDE
Assay - CDx
Algo - External
Algo - General + Wet Lab
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