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Intro to capstone project
Two terms
Waterfall design process
Design Concept
Design Input
Design Output
Verification
Validation
Design Transfer
Waterfall
• The design and development process starts with the Design Input. This includes the Design Concept document, the Requirement and Design Constraints. The requirements are a measurable description of what is to be designed. This description might have certain design constraint due to the environment in which the device is being developed.
Waterfall
• Based on the Design Input the device is designed resulting in a high level hardware and software design. This is followed by the detailed design of the device including instructions on how the device may be manufactured, operated and serviced.
Waterfall
• Once the design is completed it is implemented, typically by means of a prototype. This is referred as Design Output. The Design Output now needs to be verified and validated. The Design Verification verifies the requirements and the Design Validation validates the user’s needs.
Waterfall
• Finally the design is transferred to manufacturing for production.
• The waterfall method is more theoretical method than a practical method. Engineering development is not as simple and certainly not linear. JIT and Risk Assessment and Mitigation plan are added
Feedback added to each phase
Modify
Design
Construct
Evaluate
Identify
Transfer
More realistic model
Architectural
Design
Final
Architectural
Design
(c) 2002 A.Kindsvater
Release
Design Transfer
ValidationClinical
Trials
Mock-up
Operational
Prototype
Concept
Initial
Requirements
Proof of
Concept
Verification Verification
Evaluate
Identify & Modify
DesignConstruct
Refined
Requirements
System
Requirements
Detailed
Requirements
Final Detailed
Design
Design
Reviews
Des
ign
Pla
ns
Bench Test
System Tests
Concept
Design
n-th
Prototype
'robust'
Build
Breadboard
/ Bench-top
Detailed
Design
Product
Brief
Design
Reviews
Design
Reviews
Design
Reviews
Risk
Management
RM
RM
RM
THE DESIGN AND DEVELOPMENT (DESIGN CONTROL) PROCESS
Design & Development Phase
Design Concept
Development Plan Requirements Risk Management
Architectural Design
Detailed Design
Implementation
Verification
Validation and Certification
Design Transfer: DHF
Production
Clinical Use, Services
Note: DHF design history file, DMR design master record, DHR design history record
Design Concept:
• The Design Concept is the starting point of the development phase as shown in the figure above.
•
• Content: general information (scope, indication for use, intended use, device name); system concept (device: enclosure, display, pc board, software, accessories, options and variations), display and user interface concept, competitor’s concepts; principle of operation; design constraints; preliminary system requirements
Development Plan:
• The basic idea is that careful planning will improve on the safety, efficiency and quality of the device.
• • Experience shows that no or poor planning often increases
the potential for design errors. • • The development plan is formulated based on the business
case/plan and the design concept. • • The plan is the foundation of any development. It provides
an overall understanding of what, who, where, when and how the device will be developed.
An acceptable development plan typically includes the following content:
● Description of what is to be developed in terms of goals, objectives, scope and deliverables. ● Defining responsibilities and authorities relating to the project. ● Identifying the resources and formulating a budget for the development of the device. ● Stating the underlying assumptions, dependencies and constraints that might affect the management of the project. ● How will the project be managed? This will include the design control method, design reviews, regulatory safety testing and documentation. ● Identify and define the tasks to be carried out and the scheduling of those tasks. Each major task will be broken down in terms time, dependencies and resources required as well as who is responsible for completing it.
Most elegant engineering design
