Learn 9 Steps to Medical Device Innovation
  7: Pilot Production 8: Clinical Trials 9: Technology Transfer
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.

The technology (design, GMP, test data, final patent) is made available to an industry partner for regular production and end use

1. Finalize the patent and any other IPR documentation.

2. Prepare a complete 'technology package' - know-how and know-why.

3. Depending the nature of device and team, decide how to translate:

4. Incubate a company / transfer technology / license core technology.

5. Provide the necessary technology support, and continuously improve the design.