Request For Information - Describing the Impacts and Costs for Stakeholders Associated with the Potential Health Canada Implementation of a Unique Device Identification System for Medical Devices

The purpose of this Request for Information (RFI) enquiry is as follows: Health Canada requires the services of a Contractor to develop a report describing the qualitative and quantitative impacts and costs to stakeholders that would be incurred with the potential implementation of a Unique Device Identification (UDI) system for medical devices in Canada. Health Canada is interested in the impacts and costs on the following stakeholder groups: hospitals, clinics, medical device manufacturers, and provincial/territorial governments. Through the implementation of this Contract, Health Canada hopes to:

Gain more information about the impacts and costs incurred by the various stakeholders when considering the potential implementation of UDI; Assess the readiness of the various stakeholders that could be impacted by UDI; and Help to determine the utility of UDI to the Canadian medical device landscape.

Health Canada is interested in knowing what the potential impact of implementing UDI will be on the various stakeholders and how UDI will be received by various stakeholders (particularly small medical device manufacturers and small clinics). This information will help Health Canada weigh the costs of UDI in comparison to the benefits, and thereby inform next steps, including whether Health Canada should continue to invest in UDI implementation in Canada. In order to inform next steps with respect to the UDI initiative, Health Canada has determined that it needs additional information on the costs and impacts of UDI on a wider range of stakeholders, in addition to industry. The stakeholders would include hospitals, clinics, medical device manufacturers, and provincial/territorial governments. Health Canada is looking to this Contract to fill the gap in both qualitative and quantitative information. Health Canada expects the Contractor to address the relevant issues with the stakeholders in order to receive qualitative feedback, and further request quantitative information, as to how the introduction of UDI would impact either their business or their line of work. Health Canada anticipates using the results of this report to inform their decisions about whether, when and how to introduce UDI into the Canadian regulations, and how to best work with stakeholders in order to mitagate potential negative impacts that the introduction of UDI would have on stakeholders. Health Canada also hopes to learn from this Contract about the positive impacts and potential success stories that might occur through the use of UDI, throughout the system. Health Canada is particularly interested in the impacts of UDI on small medical device manufacturers, small independent medical clinics and individual doctors offices. The Contractor would be responsible for the following: 1) Conducting background research to understand UDI and the potential impacts on stakeholders (background research may be incorporated into the report as context); 2) Developing a list of potential interviewees from the affected stakeholder groups; 3) Developing a list of questions to ask interviewees from the affected stakeholder groups; 4) Conducting stakeholder interviews to discuss the costs and impacts of UDI on stakeholders, as well as the positive and negative impacts of UDI on their business; 5) Travelling to up to three (3) healthcare sites to speak to interviewees and review how UDI is used in a healthcare setting; 6) Analyzing and synthesizing the qualitative and quantitative data received from the interviewees, including validation of stakeholder responses as necessary; 7) Preparing a report, with both quantitative and qualitative elements, that describes the costs and impacts of UDI on stakeholders; and 8) Submitting the report to Health Canada and making themselves available to discuss the findings of the report.