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?
- e.g. Has this product made a difference in the efficiency of care delivery, effectiveness of clinical outcomes for patients, reduction of length of stay in traditional institutions, and so on.
- Are you familiar with the content in current databases, such as interRAI, to be able to select appropriate outcome measures early on? You may find the following resources helpful:
Research may be necessary for obtaining regulatory licences and approval. See below for some licensing considerations you should make when developing your product.
Canadian Standards Association (CSA)
CSA provides products with certification marks that provide consumers, retailers and end-users with certainty that the product has been independently tested and has met the required standards for safety and performance. In order to sell electrical and electronic products, gas-fired products, and many other products in North America, they must be approved by a third party testing agency, like the CSA Group.
If your product uses a part that is already CSA approved, no action needs to be taken. However, if you can created a new product with parts that are not CSA approved, innovators must contact them by phone, email or a request for quote.
Devices that utilize any form of radiocommunication, wireless communication using WIFI or any frequency on the electromagnetic spectrum must consider the licensing options through Industry Canada and the Federal Communications Commission.
Industry Canada (IC)
Industry Canada (IC) is the regulatory body responsible for certification, permits and licensing of devices using the electromagnetic spectrum for communication and monitoring in Canada.
Innovators who purchase radiocommunications technology that has already been approved by IC of FCC need not worry about going through the licensing process again. However, if a radiocommunications device has been created or modified in this innovators product, licensing must be considered.
For more information, view Wireless Communication Licensing in the PRI-TECH Primer [link here]
Federal Communications Commission
The Federal Communications Commission (FCC) is an independent U.S. government agency that regulates communication by radio, television, wire, satellite and cable for all of the U.S. The FCC works with other bodies across North America to provide regulatory oversight, leadership, and cooperation and is responsible for managing and licensing electromagnetic spectrum for commercial and non-commercial use.
If an innovator is creating or modifying any type of transmitter to access any frequency in the electromagnetic spectrum, then they must license the device through the FCC.
IC and FCC Compatibility
If an innovator wishes to commercialize their device in both Canada and the United states, they must apply for authorization through both the FCC and IC. Both regulatory bodies work collaboratively, so often test results that meet standards for one body will be accepted by the other. It is recommended that the innovator consider the standards of the test facility that must be met for both regulatory bodies before choosing a lab location to complete the appropriate testing of a device.
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.