PHASE 5.3:



No / HTA

Most new health products can be classified as non-disruptive innovations and often do not require an HTA. Instead, innovators as well as device/technology manufacturers can provide the information needed to demonstrate the properties, effects, and/or impacts of a health product. A product may already have enough compelling evidence to go straight to market in after moving through one or more of the following phases: Phase 2: Product Development, Phase 3: Regulation, Phase 4: Evidence Generation.

HTAs are needed when a market does not yet exist for a product. This often means a product is a disruptive innovation.  Disruptive innovations introduce something brand new to the system, and they often require new infrastructure, funding models and policies for successful implementation.  However, most innovations are incremental or, non-disruptive, and are likely improving upon a product and/or service that already exists. Non-disruptive innovations are less likely to need an HTA and can often bypass this process. This is because the market and infrastructure to support the adoption and implementation of a product is already in place.


innovator's checklist

  • Determine whether the product is a disruptive or non-disruptive innovation. This will determine the HTA pathway.

  • Engage and leverage relevant stakeholders (i.e., clinical champions, patient advocates) to promote the utility and value of the product.

  • Target the market segment and user to promote adoption wide spread dissemination. 




To determine whether your product requires an HTA, refer to information provided by these agencies:


Last update: 2018-Nov-26

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