Learn 9 Steps to Medical Device Innovation
  5: Engineering Analysis 6: Rapid Prototyping 7: Pilot Production
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.

Manufacture and test one sample of the device in lab. Then go for pilot production, preferably with industry partner, to establish GMP.

1. Create production drawings with material specs, tolerances and finish.

2. Select appropriate manufacturing processes and equipment.

3. Manufacture and assemble the device; fine-tune the process.

4. Document Good Manufacturing Practice, including quality control.

5. Partner with industry to produce a batch for bio-mechanical testing.