To give you an idea of  what should be included in a design proposal, here is an example device design proposal that outlines the key deliverables and documentation items that a full proposal should address in detail.


Voler Systems div. of Strawberry Tree Inc.

Example Device Design Proposal

Date: February 12, 2009
Proposal No.: V-XXX

Key Customer Contact:
John Doe
XYZ Corp
123 Main St.
San Jose, CA 94000
Phone: 408-123-4567
Email: john.doe @ xyzcorp. com
Key Voler Systems Contact:
Walt Maclay
President and Chief Engineer, Voler Systems
Email: waltermaclay @ volersystem. com

Voler Systems Division of Strawberry Tree Inc.
949 Cascade Drive
Sunnyvale, CA 94087
Tel. 408-245-9844 / Fax. 408-245-8608

1. Summary
This is an example proposal for the development of an example medical device. Voler Systems has many years of experience with electronic and mechanical design for medical devices. We have a Design Control process that has been approved to meet FDA and CE requirements.

2. Problem Statement
The design will be according to Example Design Requirements, XYZ Corp dated 1/15/09. Example design feature X is based on proprietary IP of XYZ Corp. It incorporates a custom module to be provided by XYZ Corp. The remainder of the technology uses standard components and standard design procedures.

The design process will be as outlined in section 3. Voler Systems will work with XYZ Corp to develop a specification that incorporates all the requirements that have identified in a way that is measurable. This document will be used as the basis of design verification and validation. Voler Systems will be responsible for verification. XYZ Corp will be responsible for validation, with assistance from Voler Systems. Voler Systems will create the Device Master Record and assist in transferring the design into manufacturing.

Voler Systems will provide the following project deliverables as part of the Device Master Record.

Device specification
Schematic
Bill of materials
Gerber files of layout
PCB Assembly drawing
Mechanical drawings
Compiled firmware
Firmware source code

XYZ Corp will provide the following documentation for the Device Master Record.

Production process specification
Quality assurance procedures
Acceptance criteria
Packaging and labeling specifications
Installation, maintenance, and servicing procedures

3. Schedule and Cost
This project can be completed in about xx weeks. A schedule will be agreed upon at the time an order is placed. Voler Systems will schedule the work in consultation with you. Voler Systems realizes the urgency of meeting the terms of this contract and will make its best efforts to complete milestones early.

This schedule will be updated with dates at the beginning of the design, no later than the first design review meeting.

    Ending 3rd Party
Description Hours Week Cost
Specifications      
Design Review      
Analog circuit design      
Digital circuit design      
Schematic      
Preliminary mechanical design      
Design Review & Commit to Next Phase      
Firmware      
Parts purchasing      
Breadboard assembly      
Breadboard testing      
Mechanical design      
Design Review & Commit to Next Phase      
Parts purchasing      
Layout preparation      
Layout      
Layout checking      
PCB fabrication      
PCB assembly      
Fabrication of prototype enclosure      
Testing of PCB      
Testing of prototype unit      
Design Review & Commit to Next Phase      
Electrical design changes      
Mechanical design changes      
Layout changes and checking      
PCB fabrication (final)      
PCB assembly (final)      
Fabrication of enclosure (final)      
Testing of PCB (final)      
Testing of complete unit (final)      
Final design review      
Totals      

4. Terms
Terms and conditions are arrived at by negotiation and mutual agreement between Voler Systems and our customers. Specific terms and conditions will very depending upon our customer’s needs.

5. Signature
Walter N. Maclay, President ______________________________ ____ Date _________

Acceptance by ______________________________ ______________ Date _________

Printed name ______________________________ ______ Title ____________________