Learn 9 Steps to Medical Device Innovation
  4: Detailed Design 5: Engineering Analysis 6: Rapid Prototyping
God (or devil) is in details. Work out the mechanism, enclosure, power source, user interface and other key elements of design.

1. Create a 3D CAD model of core mechanism of the device.

2. Decide the specs of any electronics or software components.

3. Visualize how different parts of the device will work together.

4. Select the materials or specifications of different parts.

5. Get an early feedback from clinicians about the working mechanism.

Simulate the device under normal as well as extreme operating loads and conditions, to check its performance and safety.

1. Create a realistic Finite Element Model of the device.

2. Apply the necessary boundary conditions (constraints and loads).

3. Take special care of meshes, interfaces, and friction coefficients.

4. Verify the model under simple loads first, compare with manual calculations.

5. Validate the results with physical experiments (say, using UTM).

Quickly fabricate a plastic prototype to get a real feel of form, fit and function. Give it to end users and get their feedback.

1. Decide the prototyping material (rigid, flexible, transparent) for each part.

2. Select the appropriate 3D printing system based on part material.

3. Adjust the part dimensions based on expected accuracy and finish.

4. Fabricate the parts, remove support structures, if any, and clean up.

5. Given the assembled device to clinicians to check its form, fit and function.