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Product Development & Design

3 IMPORTANT CONSIDERATIONS WHEN DESIGNING WEARABLE PRODUCTS

September 20, 2023 | by Tristan Dudik

My wrists were naked from 2005 to 2019. It was 2005 that I got my first cell phone, a flip phone with a secondary display which displayed the time on… Read More

Categories: Electrical Engineering, Wearables, Connected Consumer, Product Development & Design

10 EXPERT TIPS FOR SUCCEEDING AT MEDICAL DEVICE DEVELOPMENT

August 23, 2023 | by Dave Herrin

Having been associated with medical device development directly and tangentially for many years, I have witnessed and used a few things that make a difference. I would like to share… Read More

Categories: Molecular Diagnostics, Medical, Product Development & Design

PAN-TILT SECURITY CAMERA TEARDOWN – PART TWO

July 18, 2023 | by Tristan Dudik

Welcome back to the product tear-down of a Pan-tilt camera! This is part two, where we’ll open up the ball head and see what’s inside. In part one of the… Read More

Categories: Product Development & Design, Engineering & Analysis

PAN-TILT SECURITY CAMERA TEARDOWN – PART ONE

July 18, 2023 | by Tristan Dudik

I purchased a home security camera with the intent of taking it apart and learning how it works. The camera was inexpensive and mechanically complex, featuring a two-axis gimbal, a… Read More

Categories: Product Development & Design, Engineering & Analysis

THE WHAT, WHEN, WHY, AND HOW OF FMEA (FAILURE MODE EFFECTS ANALYSIS)

June 22, 2023 | by Theresa Ramirez

FMEA (Failure Mode Effects Analysis)

What is FMEA? FMEA (Failure Mode and Effect Analysis) is a structured approach used to identify potential failure modes in a system, process, or product, and to evaluate the potential… Read More

Categories: Product Development & Design, Engineering & Analysis

SHARK AI ULTRA ROBOT 2-IN-1 VACUUM AND MOP TEARDOWN

June 1, 2023 | by John Geile

The Shark AI Ultra 2-in-1 robot vacuum is a smart and innovative cleaning appliance designed to make your cleaning experience easy, effective and hassle-free. It comes with advanced features like… Read More

Categories: Product Development & Design, Industry Trends, IoT, AI, VR, & AR, Engineering & Analysis

IEC 60601 TESTING: AN OVERVIEW FOR MEDICAL DEVICE DEVELOPMENT

May 4, 2023 | by Andrea Pringle

If you are developing a medical device, knowing which testing standard will be used to evaluate the safety and effectiveness of your device is critical for obtaining FDA clearance or… Read More

Categories: Medical, Product Development & Design, Engineering & Analysis

CREATIVE PROTOTYPING TO ACCELERATE SCARA ROBOT DESIGN

April 7, 2023 | by Meindert Norg

SCARA Robot Design Blog

With time-to-market pressures often compressing design engineering cycles, being able to employ creative prototyping techniques to get through vital design hurdles is critical. Using a combination of CAD-based component selection,… Read More

Categories: Simplification, Prototyping & Manufacturing, Product Development & Design

DESIGN FOR TEST (DfT): STARTING WITH THE END IN MIND

February 2, 2023 | by Miles Thompson

Design for test (DfT) is a mindset, not a specific process or technology. The guiding principle of DfT is to consider and enable testability at all points in the design… Read More

Categories: Firmware & Software, Product Development & Design, Engineering & Analysis

SUCCESSFUL TEST SYSTEM DESIGN

January 20, 2023 | by Miles Thompson

Test System Design

Developing successful test systems and procedures is a critical component of product design. Good test system design leads to designs that meet requirements, reliable schedules, and smooth production ramps. Including… Read More

Categories: Engineering & Analysis, NPI (New Product Introduction), Electrical Engineering, Product Development & Design

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Recent Posts

  • 3 IMPORTANT CONSIDERATIONS WHEN DESIGNING WEARABLE PRODUCTS
  • 10 EXPERT TIPS FOR SUCCEEDING AT MEDICAL DEVICE DEVELOPMENT
  • PAN-TILT SECURITY CAMERA TEARDOWN – PART TWO
  • PAN-TILT SECURITY CAMERA TEARDOWN – PART ONE
  • THE WHAT, WHEN, WHY, AND HOW OF FMEA (FAILURE MODE EFFECTS ANALYSIS)

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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 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

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 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

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