Questions we need to answer - michaelrees/Trigeminal_Stimulation GitHub Wiki

What is the underlying biological and biophysical rationale for the approach?

What is the principle of operation of the device?

What are the components of the device technology?

What data are available to support the safety, efficacy and clinical utility of the device?

What are the claimed benefits of the device? What are the risks?

Are the claims supported by data?

What is the regulatory status of the device?

What intellectual property is in place to protect the principle of operation or technology?

Are there any peer-reviewed publications of the device? If so, summarize the author’s findings.

Does the device have a competitive advantage arising from unique technology?

Recommendation

  • The device is technically sound / unsound? What is the basis for your judgment?
  • J&J should / should not acquire? What is the basis for your recommendation?