Project Team • Project development plan • Team member identification & responsibilities • Gantt Chart development • Formalization of project deliverables • Risk management plan
Design Inputs • User needs/Intended use • Marketing requirements • Product/System requirements • Software/Hardware requirements • Mechanical/UI requirements • Assay requirements • Hazard analysis/FMEA • Cost/Manufacturing requirements •Traceability matrix
Architecture • System architecture design o Software o Mechanical o Hardware • Critical component selections • Initial cost analysis vs. Business requirements • Human factors
Design and Development • Mechanical engineering • Electrical engineering • Software engineering • UI design + simulations • Engineering analysis • Breadboards + prototype • Subsystem test • Automation testing • Manufacturing testing • SQA/Bug tracker/Defect log
Integration + Debug • Prototype + build • Functional testing • Usability testing (device/GUI) • Software test and verification • UL CE 60601-3rd compliance assessment
Design Review • DFM/ DFA/DFS
Business andProduct Strategy
Project Planning and Product Definition
Design Outputand Verification
Verification and Testing • Verification and validation plan • Testing strategies (Automation/ Manual/Protocol) • Protocol development • Agency testing ID & execution • Sterilization requirements • Biocompatibility testing
Design Outputs • Test results from verification • Design reviews • FMEA/FMECA • Updated requirements • BOM, ASD, SCD • Vendor selections
Labeling • IFU • Product graphics • Packaging • Training materials
Manufacturing Equiv. Units • Procurement • Inspection • Build
Verification to Requirements • Bench • Agency • Sterilization • Biocompatibility • Reliability analysis
Transfer to Manufacturing
DMR Transfer • Cell build-up • Secure supply chain • Process testing system completion (IQ,OQ,PQ) • Work instruction validation • Operator training • Pilot build • Process validation
Validation toUser Need
Validation • Protocols • Usability testing • Preclinical studies • Clinical studies
DMR + DHF Control
Regulatory Submission
Completion of Manufacturing Readiness Assessment
Brainstorming/Ideation • Identification of user needs • Market drivers • Critical features & differentiation • Screening User Needs/VOC • Persona development • User experience requirements • Product features drivers • Human factor constraints Market Opportunity • Product line strategy • Marketing analysis and plan • Competitive analysis • Emerging markets strategy • Operation freedom • Manufacturing strategy
Core Technology • Rapid prototyping • Intellectual Property development • Feasibility assessment • Research and development
Business Model • Business plan • Supply chain strategy • Financing
Risk Management • Project risk • Marketing risk • Engineering technical risk • Biological and material risk
Regulatory Plan