Learn 9 Steps to Medical Device Innovation
  6: Rapid Prototyping 7: Pilot Production 8: Clinical Trials
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.

Clinicians test the device, after necessary approvals (depending on class of risk), leading to certification or further improvements.

1. Establish device classification (based on risk and duration of contact).

2. Prepare detailed protocol of proposed testing, and get ethical clearance.

3. Conduct the tests in partnership with a clinical research organization.

4. Collect results, prepare reports and submit to certification authority.

5. Provide clarifications, if needed, to the authority.