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