Research and development

The innovation process generally begins with research and development of an innovation. The initial research should show evidence in support of the clinical effectiveness of the innovation.

Innovators in the research and development phase can facilitate a smoother transition through the innovation process by looking ahead and considering:

  • Would this technology qualify as a medical device?
  • Who is the target end-user?
  • How will this device be marketed, and who will it be marketed to?
  • How will end-users inform development of the technology?
  • What reimbursement opportunities exist for this technology?
  • What performance indicators have you chosen to provide rationale for the investment of dollars in this product?

Research may be necessary for obtaining regulatory licences and approval. See below for some licensing considerations you should make when developing your product.

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Below is an overview of the key privacy legislation, noting that other legislation, regulatory guidance, and privacy best practices should also be consulted depending on your particular device. Bear in mind that devices that store a patient’s personal health data in order to better monitor, diagnose, or care for a patient fall under Canada’s privacy legislation.

Canadian privacy laws diagram

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