PHASE 4:

EVIDENCE GENERATION

description

ev·i·dence / gen·er·a·tion

Evidence generated for Health Canada licensing approval is oftentimes not enough to support the adoption and reimbursement of a new product within the Ontario healthcare system. Health Canada requires evidence proving the safety and quality of a healthcare product. To support the implementation of a product, however, additional evidence that extends beyond regulatory requirements may be needed. In Ontario, payers (government, hospitals, alternative sources) may require specific evidence that supports a product and its ability to address a real-world health care need. Payers are discussed in more detail Phase 6: Payer. This evidence should demonstrate the ability to increase healthcare productivity by reducing healthcare costs while improving patient health. In order to get something implemented, innovators must also reach the people and organizations who do the actual implementing: clinicians, policymakers, and patients; hospitals, local health integration networks (LHINs), and government.

Evidence collected should demonstrate:

  • Clinical utility and effectiveness for your target user

  • Feasibility and system readiness

  • Stakeholder demand

  • Cost effectiveness

A summary of this evidence is often required via health technology assessment (HTA). Refer to Phase 5: HTA.

Health innovators can utilize several pathways and stakeholders to generate this evidence:

Hospital Pilots: Collaborate with hospitals, healthcare providers or research institutions to conduct a pilot study. Several Ontario hospitals house innovation centres and incubators to test and implement new healthcare products. Collaborating with these centres provides access to clinically advanced, full-service hospitals to test new products and to generate feedback from experts in health care while increasing user and product engagement.

Product Testing in International Jurisdictions: Penetrate international jurisdictions to conduct testing or to commercialize to gain capital, market value and usability. Generating data and verifying the market value of a product within international jurisdictions (e.g., United States, Europe) can be leveraged to support adoption of a product in the Ontario market.  

Government Funded Clinical Trials: Partner with the government or strategically apply to funding opportunities in Ontario. This pathway provides a source of funding to test and evaluate a product and its market value. It’s important to note that clinical trials are lengthy and expensive. Many small companies may not have the capital to conduct large trials without additional financial or resource support. To overcome this barrier, health innovators may seek partnerships with contract research organizations (CRO), innovation brokers, incubators and accelerators, or venture capital investment. Many of these resources specialize in evidence generation or aim to support health innovators with resources and tools to commercialize a product.


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innovator's checklist

  • Engage with key stakeholders (clinicians, policy makers, patients) and related organizations to determine demand and value of a product.

  • Determine additional evidence requirements to demonstrate clinical utility and economic value of the product.

  • Determine a pathway or set of pathways to generate evidence to support the value of the product.

  • Engage research contract research organizations (CRO), Innovation Brokers (IB), incubators and accelerators, or venture capitalist firms.

 

 

Last update: 2018-Nov-26

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