ISO 13485:2016
Certified Product
Development

About
- Philosophy
- Team
- Company History
- Awards
- Core Values
- Careers
Portfolio
Disciplines
Services
Expertise
Resources
Contact Us

Events & Tradeshows

CONFERENCE REPORT: OPEN SOURCE HARDWARE SUMMIT

October 31, 2016 | by Doug Harriman

On October 7, 2016, I was lucky enough to attend the 2016 Open Source Hardware Summit in my hometown of Portland, Oregon. I attended along with Norvan Gorgi from Simplexity, who posted his conference report here…. Read More

Categories: Events & Tradeshows

WHEN BRAINSTORMING FAILS, THROW AN IMAGINARY CAT

May 18, 2016 | by Gabriel Aldaz

This past month, I was asked to speak on the topic of concept generation, also known as ideation, at Professor Larry Leifer’s 3D Printing and Design course – ME137/237 –… Read More

Categories: Events & Tradeshows, Product Development & Design

« Previous Page
1
2
3

Offices:

San Diego, California
Portland, Oregon Area
Seattle, Washington

Connect:

Careers at Simplexity
Employment Verification
Join our Mailing List!
Privacy Policy
Simplexity Product Development
Copyright © 2026 | All Rights Reserved

Production

Design & Engineering

Manufacturing design guidance and ongoing engineering support

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

Phase 3: Design Verification And Design Transfer

Design & Engineering

Software: Design Complete

Hardware: Pre-production units for design verification

Test: Design verification test

NPI

MFG. Readiness: CM schedule and budget, Unit build tracking

Quality: Quality metrics verification process, Process validation support

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
Contract manufacturing schedule and budget
Quality metrics verification

Gate definition:

Design verification complete

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

MFG. Readiness: CM onboarding Design transfer prep

Quality: Build Quality Plan

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
Verification/test plans and reports
Updated Bill of Materials (BOM) and Cost of Goods Sold (COGS)
Build Quality Plan development
Design transfer preparation
Contract Manufacturer onboarding

Gate definition:

Engineering confidence test reviews (integration tests)

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

MFG: Readiness: Project build plan CM selection

Quality: Critical manufacturing process identification

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 manufacturing input on the design. 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
Design failure mode and effect analysis
Test plans and reports
Project build plan – from prototype to pre-production
Initial Bill of Materials (BOM) and Cost of Goods Sold (COGS)
Manufacturing process identification
Contract Manufacturer (CM) selection

Gate definition:

Engineering confidence test reviews

Phase 0: Exploration

Exploration

Research

Concept Work

Architecture explorations

Feasibility study

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 & Planing

Design & Engineering

Project Plan Requirements

ID/UX Concepts

Risk Analysis

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
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

Hardware: Major Component definition & Proof of Concept subsystems build

Test: Characterization and qualification of high risk subsystems & components

NPI

Quality: Design for Manufacturing tradeoffs evaluation

2A. Architecture and Technology Feasability

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

Gate definition:

Client approval following hardware and software architecture reviews

Events & Tradeshows

Offices:

Connect:

Production

Design & Engineering

Manufacturing design guidance and ongoing engineering support

Ongoing quality metrics monitoring & optimization

Typical deliverables:

Phase 3: Design Verification And Design Transfer

Design & Engineering

<img class="wp-image-1805 alignleft" src="https://www.simplexitypd.com/wp-content/uploads/2020/07/simplexity_software_icon-150x150.png" alt="" width="40" height="40" />Software: Design Complete

<img class=" wp-image-1804 alignleft" src="https://www.simplexitypd.com/wp-content/uploads/2020/07/simplexity_hardware_icon-150x150.png" alt="" width="40" height="40" />Hardware: Pre-production units for design verification

Test: Design verification test

NPI

<img class="wp-image-1811 alignleft" src="https://www.simplexitypd.com/wp-content/uploads/2020/07/siplexity_manufacturing_icon-150x150.png" alt="" width="40" height="40" />MFG. Readiness: CM schedule and budget, Unit build tracking

Quality: Quality metrics verification process, Process validation support

Typical deliverables:

Gate definition:

Phase 2C: Detailed Design Prototype 2

Design & Engineering

<img class="wp-image-1805 alignleft" src="https://www.simplexitypd.com/wp-content/uploads/2020/07/simplexity_software_icon-150x150.png" alt="" width="40" height="40" />Software: Full feature implementation

<img class=" wp-image-1804 alignleft" src="https://www.simplexitypd.com/wp-content/uploads/2020/07/simplexity_hardware_icon-150x150.png" alt="" width="40" height="40" />Hardware: Prototype 2 units with production-representative materials and processes

Test: Engineering confidence test, integration test

NPI

MFG. Readiness: CM onboarding Design transfer prep

<img class=" wp-image-1803 alignleft" src="https://www.simplexitypd.com/wp-content/uploads/2020/07/simplexity_quality_icon-150x150.png" alt="" width="40" height="40" />Quality: Build Quality Plan

2C. Prototype 2 Design, Build And Test

Typical deliverables:

Gate definition:

Phase 2B: Detailed Design

Design & Engineering

<img class="wp-image-1805 alignleft" src="https://www.simplexitypd.com/wp-content/uploads/2020/07/simplexity_software_icon-150x150.png" alt="" width="40" height="40" />Software: Core functionality implementation

<img class=" wp-image-1804 alignleft" src="https://www.simplexitypd.com/wp-content/uploads/2020/07/simplexity_hardware_icon-150x150.png" alt="" width="40" height="40" />Hardware: Prototype 1 units with rapid prototyped components

Test: Engineering confidence test, unit test

NPI

<img class=" wp-image-1811 alignleft" src="https://www.simplexitypd.com/wp-content/uploads/2020/07/siplexity_manufacturing_icon-150x150.png" alt="" width="40" height="40" />

MFG: Readiness: Project build plan CM selection

<img class=" wp-image-1803 alignleft" src="https://www.simplexitypd.com/wp-content/uploads/2020/07/simplexity_quality_icon-150x150.png" alt="" width="40" height="40" /> Quality: Critical manufacturing process identification

2B. Prototype 1 Design, Build And Test

Typical deliverables:

Gate definition:

Phase 0: Exploration

Exploration

Research

Concept Work

Architecture explorations

Feasibility study

Typical deliverables:

Gate definition:

Phase 1: Requirements & Planing

Design & Engineering

Project Plan Requirements

ID/UX Concepts

Risk Analysis

Manufacturing Strategy Identification

Typical deliverables:

Gate definition:

Phase 2: Detailed Design

Design & Engineering

<img class="wp-image-1805 alignleft" src="https://www.simplexitypd.com/wp-content/uploads/2020/07/simplexity_software_icon-150x150.png" alt="" width="40" height="40" />Software: Architecture design: block, sequence and state diagrams

<img class=" wp-image-1804 alignleft" src="https://www.simplexitypd.com/wp-content/uploads/2020/07/simplexity_hardware_icon-150x150.png" alt="" width="40" height="40" />Hardware: Major Component definition & Proof of Concept subsystems build

Test: Characterization and qualification of high risk subsystems & components

NPI

<img class=" wp-image-1803 alignleft" src="https://www.simplexitypd.com/wp-content/uploads/2020/07/simplexity_quality_icon-150x150.png" alt="" width="40" height="40" />Quality: Design for Manufacturing tradeoffs evaluation

2A. Architecture and Technology Feasability

Typical deliverables:

Gate definition:

Software: Design Complete

Hardware: Pre-production units for design verification

MFG. Readiness: CM schedule and budget, Unit build tracking

Software: Full feature implementation

Hardware: Prototype 2 units with production-representative materials and processes

Quality: Build Quality Plan

Software: Core functionality implementation

Hardware: Prototype 1 units with rapid prototyped components

Quality: Critical manufacturing process identification

Software: Architecture design: block, sequence and state diagrams

Hardware: Major Component definition & Proof of Concept subsystems build

Quality: Design for Manufacturing tradeoffs evaluation