Looking for answers to your questions about MaRS EXCITE? Read our frequently asked questions below.
What is MaRS EXCITE?
MaRS Excellence in Clinical Innovation and Technology Evaluation (EXCITE) is an innovative program that streamlines the pathway to health system adoption of breakthrough technologies. Using a unique collaborative stakeholder engagement model, MaRS EXCITE helps healthcare startups navigate lengthy regulatory and reimbursement processes, enabling them to get their products to market and generate revenues faster.
EXCITE makes this process possible by bringing the appropriate stakeholders to the table to provide feedback at various touch points, facilitating the inclusion of the right expertise for conducting the evaluations, and providing some degree of oversight to ensure that the interests of all parties are respected, while maintaining a credible and objective approach to technology assessment.
What is included in an evaluation?
The evaluation, or EXCITE Evidentiary Bundle, includes:
- A field evaluation to identify clinical utility
- A systematic review to identify comparative effectiveness
- An economic analysis to identify cost effectiveness
- A human factors scoping review
- Health System Implementation Planning
If a Health Canada license is required for the technology, the field evaluation will be combined with a clinical trial to also address safety and efficacy. Extra services to address other factors influencing market penetration may be provided at an additional cost. Examples of these services include: a human factors full analysis, the creation of a comprehensive training program for end users, the assessment of any barriers to uptake by the health system, protocol input from international payers, and patient preferences.
How will the EXCITE collaboration, comprising the health system, industry and academia, work together?
After a company submits an application, the EXCITE Management Board will review and select technologies for EXCITE participation through a process that takes into account the needs of the health system. The EXCITE Management Board, accountable to the MaRS Board, includes representatives from industry, government, the health system and academia. Selected technologies will participate with the methodological centre (MC) in developing the evaluation protocol. MCs will provide feedback to industry and EXCITE on a regular basis.
Appropriate contracts will be signed between the various parties upon the initiation of a study protecting and clarifying the roles, rights and responsibilities of each party.
How does EXCITE help a company navigate reimbursement?
EXCITE facilitates discussion with key decision makers and funders from planning through to implementation. The outcomes are identified and aligned with what a decision maker would want to have for uptake decisions.
What are the advantages of conducting clinical trials in Ontario?
For more information, please visit Clinical Trials Ontario.
How can EXCITE help a company looking to enter international markets?
EXCITE evaluations can include global sites to meet other jurisdictions regulatory requirements. Industry can take the robust data generated during the evaluation phase to regulators and payers across the globe for uptake in international markets. EXCITE also offers an option to receive input on protocol development from international payers, including the US and UK, to ensure their perspectives and feedback are reflected in the protocol before entry into their market.
What are EXCITE Methodological Centres (MCs)?
EXCITE engages seven methodological centres (MCs) located across Ontario. MCs are units that have demonstrated experience and excellence in clinical trials methodology, health technology assessment and/or conducting complex, multi-centre trials with proven capacity for data collection, synthesis and reporting. They are responsible for overseeing the design and execution of EXCITE studies, sometimes in collaboration with one or more other institutions that have the appropriate capabilities/experience to complete evaluations successfully. View our MCs here.
What is the intake cycle? How many Calls for Innovation will there be per year?
Applications to the MaRS EXCITE program are accepted throughout the year on a rolling basis. Review cycles for applications occur on a quarterly basis, with application deadlines that are aligned with EXCITE Management Board meetings for their review and prioritization. Find the application deadlines on our “How to Apply to EXCITE” page.
Does the program have a quota for each cycle?
Can a single applicant apply to EXCITE for more than one technology?
Yes. Each technology must submit a complete application with all relevant materials and, if selected, must pay the full cost for each evaluation.
How long after the application deadline can a company expect to hear back?
A company can expect to hear back about whether or not their technology has been selected for EXCITE within 5-6 weeks after an application deadline.
What stage of product development does EXCITE require for program applicants?
Proof of concept or preliminary data is required for EXCITE to consider an applicant.
What criteria are considered most important for assessing a technology’s fit for this program?
The EXCITE Management Board uses the following prioritization criteria to assess if an innovative technology is a fit for the program:
- Relevance to health system
- Disruptive potential
- Opportunities for obsolescence
- Estimated magnitude of impact
- Stage of readiness of technology
- Potential benefit to Ontario and Canada
I’m a startup or SME. How do I obtain funds to cover the costs of the evaluations?
Startups or SMEs that have been accepted into the program may have an easier time obtaining funds from venture capital and funding agencies because EXCITE acceptance reduces investment risk by:
- Providing a clear path toward market,
- Engaging with the end users and “payers”
- Providing early feedback from OHTAC (the health system) regarding the perceived relevance and likelihood of adoption downstream
Possible sources of funding include:
MaRS Investment Accelerator Fund offers $500,000 in early-stage companies that have the potential to be global leaders in their field and provide sustainable economic benefits to Ontario.
MaRS Health Venture Services provides connections to investors and capital for high-potential companies.
- Canada Business Network
- FeDev Ontario and Investing in Business Innovation (IBI)
- Grand Challenges Canada
- Health Technology Exchange (HTX) REACH (later staged, market ready devices partner with a procurement partner)
- OBIO CAAP (when ready for private financing)
- OCE Programs and OCE SmartStart (require referral from a Regional Innovation Centre, like MaRS)
- ONE Programs
- National Research Council – Industrial Research Assistance Program offers financial assistance to eligible companies.
- Scientific Research and Experimental Development Tax Incentive Program (SR&ED)
The Funding Portal– Use this tool to access more than 4,500 federal, provincial and municipal government funding programs for businesses, non-profits, charities and research institutions. Information on all funds is updated 24/7/365.
Fundica (another search portal search portal)
Futurpreneur Loans (key word LOAN, with BDC)
How long does the entire EXCITE process typically take?
The length of the EXCITE process depends on your technology and patient population. It can range anywhere from 2 years for a digital technology to more than 5 years for an invasive medical device. These timelines are dependent on technology invasiveness, patient population and length of follow-up in the cillnical trial. Every innovation and trial is different, and is subject to a different timeline.
Are there any fees associated with the program?
Please click HERE to see our current fee schedule. Please note the full study budget is developed by the MC in collaboration with industry during protocol development.
How is EXCITE different from a traditional Contract Reserch Orgnazation (CRO) or reimbursement consultant?
EXCITE addresses the complexities of the full spectrum of technology evaluation required by regulatory authorities and the health system, including reimbursement decision-making, through an expedited, single, harmonized, pre-market process. It is also expected that acceptance for evaluation through the EXCITE process will mitigate risk for investors, which may be of special importance to SMEs.
EXCITE provides advantages that extend beyond the scope and capability of a standard CRO. Some of these advantages include:
- The ability to test the product in the intended application fields (i.e., in the final destination where it would actually be used).
- Through EXCITE’s involvement in the evaluation process, projects have credibility and objectivity, which can help gain acceptance in the intended market.
- EXCITE and its affiliate collaborators are not-for-profit. A key success metric for EXCITE is seeing technologies through toward adoption.
- EXCITE evaluations are designed to address potential barriers to market. EXCITE’s core evidentiary bundle covers the clinical utility/effectiveness/economic impact needed for reimbursement and procurement decisions (outside the scope of CROs). Further to this, EXCITE’s additional offerings can be accessed to mitigate potential barriers to market, such as patient preferences and human factors, services that are less commonly offered through CROs.
- Approved EXCITE applicants gain the opportunity to discuss implementation planning pre-market with the MoHLTC and other parts of the health system, as appropriate. While EXCITE cannot make any guarantees regarding adoption, engaging the health system during the formative stages of evaluation provides opportunities for overcoming barriers through discussion of topics such as adoption rates, infrastructure readiness, fee code adjustments, and procurement.
Who is the Sponsor?
Sponsorship responsibility and shared liability terms are to be decided upon in the contract between the methodological centre (MC) and the company, but typically the company is the sponsor. EXCITE is not the sponsor.
What is the contract structure?
- Master agreements are in place between the methodological centre and MaRS, to which specific projects are appended as schedules.
- A matching master agreement is executed between MaRS and the health technology company, to which the specific project is attached as a schedule. If the company wishes to bring forth additional technologies in future years, these would be amended to this master agreement as additional schedules.
- For each specific project, a contract is required between the methodological centre and the technology company, which outlines, for example, delegation of sponsorship responsibilities and distribution of the technology for testing.
- The methodological centre then contracts each of the investigator sites across the province.
What is the flow of funds?
Typically, funds flow from the technology company to MaRS, then from MaRS to the MC and the investigator sites.
Who owns the data arising from the trials?
Industry owns the data from clinical trials.
Who publishes the data arising from the trials? (right to publish)
These terms are to be decided upon in the contract between the MC and the company, but typically the right to publish first rests with the methodological centre and the investigators. It is expected that any publication related to the health technology will be shared with the company prior to submission for publication.
MaRS may publish aggregate data, performance metrics, names of the participants and collaborators, and indicators such as rates of success.
If you can’t find the answers you need, please contact us at EXCITE@marsdd.com.