Health technology assessment of medical devices
Abstract Regulatory approval for requirements for medical devices varies widely across regions and countries. The evidence that is submitted by manufacturing companies in support of submissions for regulatory approval is of varied quality and substance. To ascertain the value of investing in health technologies, it is essential that healthcare providers contemplate health technology assessments (HTAs) prior to investing in medical devices and continuously during their use. There are important differences between medical devices and drug therapies that require healthcare providers to use different approaches when conducting HTAs on medical devices. They can be categorized by product life cycle, clinical evaluation, user issues, and costs and economic evaluation. HTA agencies need guidance on determining the basis for acquiring scientific evidence, identifying members from independent advisory groups, maintain transparency, and being inclusive of all stakeholders.