Below is an overview of the process flow of the EXCITE International approach...
Applications to EXCITE International are accepted throughout the year. Promising technologies that align with our mandate are recommended to apply. We work closely with innovators to help them complete and submit robust applications.
Our current focus is to evaluate innovative medical devices that can significantly improve patient outcomes and/or improve health system efficiencies. Both multinational enterprises (MNEs) and small and medium enterprises (SMEs) are eligible to apply.
Applicant technologies may be pre-market or already licensed by regulatory organizations.
In general, the technologies should:
We do not evaluate pharmaceutical products, however, applications for companion diagnostics to inform pharmaceutical development or pharmacogenomic-targeted therapies may be considered.
The cost to submit an application to EXCITE International is US$20,000. This fee allows applicants to gain access to EXCITE International’s global collaboration of payers and its Scientific Collaboration.
The value to industry of early signaling and feedback on the alignment of technology to relevant stakeholder priorities is invaluable. In this phase, comprehensive due diligence is conducted by the EXCITE International Secretariat before applications are brought forward to the various EXCITE International Stakeholder Committees:
A summary report encapsulating stakeholder views on the predicted ability of the innovation to add value to patient outcomes and health systems will be provided to industry upon completion of this phase.
High potential technologies are then presented to the EXCITE International Board. Prioritized technologies are recommended to continue through the EXCITE International process. It is anticipated that the review and prioritization phase will take about two months to complete, depending on the complexity of the technology.
In the Protocol Development Phase, industry is matched with one of EXCITE International’s global methodological research centres (GMRCs) whose role it is to develop a custom clinical trial protocol that meets the needs of industry. Multi-stakeholder feedback is gathered and incorporated into a comprehensive clinical trial protocol that reflects key endpoints of relevance. These include:
The cost for the Protocol Development Phase varies, depending on various factors including complexity of the technology, the scope of EXCITE International services to be included in the protocol, the number of sites and partners involved. Final pricing will be determined in collaboration with the GMRC and will be negotiated with and accepted by industry prior to initiation of work. Companies are encouraged to estimate approximately US$150 000-200,000 for this phase.
Following regulatory and Research Ethics Board approvals, the GMRC implements the clinical trial protocol and is responsible for completing data collection and analysis as well as final reporting. GMRCs leverage the network of EXCITE International Hubs to identify Key Opinion Leaders, clinical trial sites and potential pioneer sites for downstream uptake.
The cost for the Evidence Generation Phase is variable, based on project scope.
A unique feature of the EXCITE International process is early and ongoing engagement with payers, policy makers and healthcare delivery organizations. Each payer determines the process they will use for adoption decision-making and implementation. This will differ by jurisdiction the final decision on adoption being within the purview of each health system/organization. Although the EXCITE International process does not guarantee downstream adoption of innovative technology, we believe that our ongoing focus on multi-stakeholder collaboration and early engagement mitigates the risk of rejection by payers and decision makers. In this way, patients and health systems alike will benefit from early access to impactful technologies capable of improving health outcomes and health system efficiencies.
The process of an EXCITE International review terminates after the EXCITE International Executive Board reviews the final report.
Contact us now to discuss if EXCITE International can help you accelerate the adoption of your impactful health technology.