1. Problem Definition

The first step is to understand as much as possible about your project regarding:

• Goals of the project -- what is the client asking for?
• Necessary background information, including:
1. Medical issues -- understanding of constraints due to medical use of the device (e.g., is patient data being stored confidentiality issues)
2. Biological and physiological issues -- basic knowledge of the medical specialty to which your device is targeted including demographics
3. technical issues -- understanding of the engineering aspects of the project (e.g., no metals if device is to be used in MRI chamber) as well as the details of competing technology.
• You will do this by:
1. Meeting with client
2. Meeting with advisors
3. Literature searches (web, library, technical literature)
4. Development of the Product Design Specification (PDS)

Everything you find about the project should be documented in your notebook with all sources cited.

2. Preliminary Design

Ideas should first be developed by brainstorming alternate solutions -- the key is to use your imagination to think of as many independent design concepts as possible (nothing is out of bounds yet).

At this point, there should be no evaluation of design yet, just idea generation.

Sketches are VERY important here to illustrate your ideas (and should be in design notebook).

3. Choose Single Design to Pursue

Compare each design against the items in the PDS to see which idea best meets specifications. Use a design matrix to evaluate your designs against the PDS criteria

At this point, you may combine the positive aspects of different designs to form a single, final design.

Once a decision has been made, go back and evaluate your choice -- remember it is much easier to change things on paper than if something has been built!

4. Design Detailing

As you fill in the details of the design, you should continually evaluate your design choice.

Here, you will consider items such as:

• Dimensions
• Materials, fasteners, etc.
• Analysis (loads, flow rates, etc.)
• More sketches and drawings

It is also useful at this point to build simple models. This is useful for understanding spatial relationships of the design -- how different parts fit together, etc. Be creative in using everyday materials for model building; you can use anything from popsicle sticks to coat hangers and anything else that works.

From there you should consider creating a 3D graphic rendering to further validate your design.

5. Evaluate Design

Once a single design has been chosen, there should be continual evaluation throughout the entire process; here, you should look over the design in its entirety before building.

6. Prototype

Finalize all the design drawings and build a fully operational prototype of the device. You should consider 3D printing at the Makerspace or other fabrication methods (consult the COE Student Shop/TEAM LAB). Before requesting a 3D printed part, be sure that a similar part does not already exist / can be purchased (e.g. a box for your circuit).

Find Fabrication Resources

7. Evaluation of Prototype

Test your device in the field, under conditions it will encounter in practice.

Document all parts of the design process in your notebook such that an unfamiliar but qualified reader can understand and replicate your work.