Product Development Process
Simplexity uses a phase-gate process, based on decades of experience and industry best practices, to guide our product development process. Design is an iterative process, whereby unknowns and high-risk areas are best resolved through exploration and analysis, building prototypes and testing as early as possible.
The Phases of Product Development
Our approach is to identify the highest risk aspects of a product and devise effective ways of assessing those risks, usually through different levels of prototyping and analysis.
Phase 0: Exploration
Exploration
Research
Concept Work
Architecture explorations
Feasibility studies
Phase 0 is an optional phase for projects where the technical feasibility of the idea has not yet been fully proven. It can consist of research, concept work, exploring initial architecture, performing feasibility studies, and basic prototyping and testing.
Typical deliverables:
- Exploration report
Gate definition:
- Client approval on feasibility of idea
Phase 1: Requirements & Planning
Design & Engineering
Project Plan
Requirements
ID/UX Concepts
Risk Analysis
NPI
Manufacturing Strategy Identification
The business and user requirements are converted into engineering requirements for the product. The project planning activity is based on the schedule, budget, risk, and initial product requirements. This process is best done as a collaborative team effort with the client, who has the deepest understanding of the market needs and user requirements.
Typical deliverables:
- Product requirements document
- Manufacturing strategy requirements document
- Project development plan (including plans for software/firmware electrical, quality, systems, and mechanical)
- Risk analysis
- Industrial Design (ID) and User Interface (UI) concepts
Gate definition:
- Product requirements document complete
- Client approval of project development plan
Phase 2: Detailed Design
Design & Engineering
Software: Architecture design: block, sequence and state diagrams
Software: Architecture design: block, sequence and state diagramsHardware: Major Component definition & Proof of Concept subsystems build
Hardware: Major Component definition & Proof of Concept subsystems build
Test: Characterization and qualification of high risk subsystems & components
NPI
Planning: Project build plan, Manufacturing plan, Supply chain strategy
2A. Architecture and Technology Feasibility
The detailed design phase starts with defining options for the product architecture, with the goal of having the greatest chance of successfully meeting product requirements while best mitigating risk. Engineering activities in this phase include presenting options for hardware components, outlining the system block, sequence, and state diagrams, creating rough CAD, and breadboarding of high-risk subsystems. Results are presented with a description of the pros, cons, and key tradeoffs for each scenario.
Typical deliverables:
- System architecture design (including mechanical, electrical and software/firmware)
- Initial product risk analysis
- Breadboards or proof-of-concept prototypes of high-risk technologies or subsystems.
- ID concept models
- Manufacturing processes review
- Product requirements review
- Critical Performance Metrics (CPM) specifications review
- Project build plan
- Manufacturing plan
- Supply chain strategy
Gate definition:
- Client approval following hardware and software architecture reviews
Phase 2B: Detailed Design
Design & Engineering
Software: Core functionality implementation
Hardware: Prototype 1 units with rapid prototyped components
Test: Engineering confidence test, unit test
NPI
Planning: COGS worksheet
MFG. Readiness: CM selection, Tooling vendor selection, DfX evaluations
Quality: DFMEA & Tolerance analyses
2B. Prototype 1 Design, Build And Test
The detailed design phase usually has multiple, iterative sub-phases as the design progresses and representative prototypes are built. Phases 2B and 2C are typically the largest efforts in the product development process, where the specific implementation for all disciplines occurs (mechanical, industrial design, electrical, firmware, systems, software, manufacturing, and quality).
Simplexity typically engages with production component suppliers and contract manufacturing groups early in this phase to provide additional DfX evaluations on manufacturing, assembly, and serviceability of the design. Contract manufacturing and tooling vendors are selected in this phase and initial costing estimates are prepared. Our quality team performs DFMEA and tolerance analyses and, if the product has stringent testing or certification requirements, pre-screens are performed in this phase prior to formal regulatory agency testing.
Typical deliverables:
- Prototypes (3D printed or other rapid prototypes, electrical PCAs, and/or preliminary code)
- Software and hardware design documentation
- Initial product firmware or software binaries and source code
- Electrical schematics and layout
- 3D CAD files
- Cost of Goods Sold (COGS) worksheet
- RACI chart
- Subassembly strategy development
- Process flow documents
- Test plans and reports
- Design failure mode and effect analysis (DFMEA)
- Tolerance analysis
- DfX Evaluations (for manufacturability, assembly, and serviceability)
- Test plans and reports
- Contract Manufacturer (CM) quote package and selection
- Tooling vendor selection and schedule
Gate definition:
- Engineering confidence test reviews
Phase 2C: Detailed Design Prototype 2
Design & Engineering
Software: Full feature implementation
Hardware: Prototype 2 units with production-representative materials and processes
Test: Engineering confidence test, integration test
NPI
Planning: Quality assurance plan, Design transfer prep
Quality: Assembly fixture & QC tool development
Mfg Readiness: Manufacturing release package, CM onboarding
2C. Prototype 2 Design, Build And Test
Phase 2C iterates on the learnings of Phase 2B and involves a refined prototype build of a fully integrated system. Some projects also benefit from additional iterations of the product based on prior learnings through additional phases (2D, 2E, etc), which are not represented in this graphic. All requirements are intended to be tested, and at the end of Phase 2 there will be confidence that the units will pass verification in Phase 3. The Bill of Materials is further refined, and the team updates estimates for the per unit cost of the product by receiving pricing from vendors and suppliers.
Typical deliverables:
- Updated prototypes
- Software and/or firmware binaries and source code
- Updated schematics and layout
- Updated 3D CAD files and 2D drawings
- Design transfer preparation
- Contract Manufacturer onboarding
- FAI and first article reports
- Quality assurance plan
- Manufacturing release package
- Assembly fixture & QC tool development
Gate definition:
- Engineering confidence test reviews (integration tests)
Phase 3: Design Verification And Design Transfer
Design & Engineering
Software: Design Complete
Hardware: Pre-production units for design verification
Test: Design verification test
NPI
Planning: Vendor management, Unit build tracking
Quality: Quality metrics verification, Process validation, Regulatory certification, Reliability Testing
This phase occurs once the detailed design is complete, and prototypes are built with manufacturing-representative quality and detail. More extensive, formal testing is performed, such as life, reliability, safety, environmental, drop, and vibration.
The design team works closely with the manufacturing team to enable a smooth transfer, often with Simplexity engineers traveling to the contract manufacturer sites to ensure product quality. The design is transferred to the client based upon specific needs, most often after all tests are complete and the design is verified.
Typical deliverables:
- Pre-production units
- Formal verification test reports
- Design transfer package, including Design History File (DHF) if needed for FDA submittal
- Process validation support
- Unit build tracking
- Quality metrics verification
- Vendor management
- Root Cause Analysis (RCA) Defect Resolution
- Regulatory certification
- Reliability testing
Gate definition:
- Design verification complete
Production
Design & Engineering
Manufacturing design guidance and ongoing engineering support
NPI
Ongoing quality metrics monitoring & optimization
The Simplexity team can be as involved in the production phase as requested by our clients. For clients with internal manufacturing or established relationships with contract manufacturers, our engineers are available to ensure quality is maintained and provide ongoing engineering support as needed.
Simplexity has a dedicated New Product Introduction (NPI) team that can guide the transition from design into production. The NPI team presents multiple options for manufacturing to the client, allowing clients to choose the solution that best suits their needs. This can involve Simplexity performing initial builds in-house prior to full handoff to a contract manufacturer or building the product via established relationships with contract manufacturing partners either domestically or overseas early in the process.
Typical deliverables:
- Manufacturing guidance and ongoing engineering support
- Ongoing quality metrics monitoring and optimization
Product Development Workflows
The diagram below indicates typical workflow volumes that relate to each of the Phases described above for ID/UX design, engineering and New Product Introduction (NPI)
