MEDICAL DEVICE PRODUCT DEVELOPMENT | ISO 13485 QUALITY SYSTEM | OEM / ODM
ID / MD / EE Integrated Design

Three Design Disciplines, Integrated in Parallel

Industrial design, mechanical design and electronic engineering collaborate within one development framework to reduce interface conflicts and late design changes.

ID | INDUSTRIAL DESIGN

Industrial Design

Product appearance and user interaction built around intended use, brand direction and production feasibility.

  • Product positioning and design language
  • Concept and form development
  • Human factors and user interaction
  • Material, color and surface treatment
  • Appearance model and design approval
MD | MECHANICAL DESIGN

Mechanical Design

Structures that can be assembled, verified and manufactured while controlling tolerance, material and process constraints.

  • Architecture and component layout
  • Mechanism, sealing and mistake-proofing
  • Material, process and tolerance analysis
  • DFM/DFA and assembly review
  • 3D/2D, BOM and engineering output
EE | ELECTRONIC ENGINEERING

Electronic Engineering

Electronic architecture developed according to function, size, power and reliability requirements, coordinated with industrial and mechanical design.

  • System architecture and function definition
  • Circuit, PCB and component selection
  • Power, sensing and control design
  • Electronic-mechanical interface integration
  • Prototype testing and verification
Cross-disciplinary Integration

ID, MD and EE in parallel

Rather than a sequential handoff, the disciplines remain aligned through concept, prototype and verification so appearance, structure, electronics and manufacturing conditions fit together.

ID User Experience & Appearance
MD Structure & Manufacturing
EE Function & Electronic Systems
Design for Manufacturability

DFM Analysis for Product Development

Design for Manufacturability reviews product function, structure, materials, processes, assembly and inspection before prototypes, tooling and production investment. The objective is to identify risks that could affect cost, quality, schedule or production stability while engineering decisions are still flexible.

What should DFM analysis resolve?

1
Avoid discovering design changes at production

Confirm machining, molding, demolding, assembly and measurement constraints before engineering drawings are frozen.

2
Convert critical requirements into executable controls

Translate functional and cosmetic requirements into materials, processes, tolerances, CTQs and inspection methods.

3
Reduce cross-part and cross-supplier risk

Review tolerance and assembly relationships across metal parts, plastic parts, surface treatments and mating interfaces.

REVIEW INPUTS

Recommended Review Information

Product & Engineering Data 2D/3D, BOM, functional requirements, mating parts and current revision
Material & Cosmetic Requirements Specified materials, color, texture, surface finish and appearance acceptance criteria
Production & Quality Conditions Estimated quantity, critical dimensions, inspection focus, assembly method and target schedule
DFM ANALYSIS OUTPUTS

Typical DFM Project Outputs

  • Design-risk and open-item list
  • Drawing, geometry, tolerance and material recommendations
  • Recommended processes, tooling, fixtures and assembly direction
  • CTQs, measurement methods and sample-verification priorities
  • Decision basis before prototypes, tooling or pilot production
DFM Review Matrix

DFM Review Matrix

01 | REQUIREMENT

Requirements & Interfaces

Confirm intended use, functions, operating scenarios, component boundaries, mating interfaces and fixed constraints.

02 | MATERIAL

Materials & Processes

Evaluate CNC, molding or combined processes against strength, appearance, resistance, cost and supply conditions.

03 | GEOMETRY

Geometry & Tooling

Review wall thickness, ribs, draft, undercuts, tool access, workholding and mold construction.

04 | TOLERANCE

Tolerances & CTQs

Establish datums, tolerance stacks and critical-to-quality characteristics without unnecessary tolerance or fit risk.

05 | ASSEMBLY

Assembly & Mistake-proofing

Review assembly sequence, location, fastening, fixtures, serviceability and manual-operation risks.

06 | INSPECTION

Inspection & Verification

Confirm measurement datums, gauge feasibility, cosmetic standards, first article and functional verification methods.

Design Transfer Package

Design Development Transfer Documentation

The value of design is realized when production can receive it completely. At project transfer, a structured documentation package supports production introduction and the customer's design-history and technical-file needs.

D-01

Engineering Drawings

Released 2D/3D files, tolerances, CTQ identification and revision records.

D-02

BOM & Specifications

Material list, specifications, surface finish and purchased-part definition.

D-03

Process Documents

SOP, Control Plan, tooling list and approved process parameters.

D-04

Verification Records

Test reports, FAI, pilot reports and design-freeze records.