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MedTech Outlook | Wednesday, March 29, 2023
The main traits associated with effective, mature HTA organizations are their propensity for openness, inclusivity, communication, and procedural justice. All HTA agencies should strive to achieve this.
FREMONT, CA: All across the Middle East and Africa as well as globally, there is a steady shift towards value-based healthcare and the optimization of healthcare budgets and spending. This presents serious difficulties for the healthcare ecosystem. Despite being developed and well-established in the pharmaceutical industry, health technology assessment (HTA) is still growing in the area of medical technology.
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Core themes that highlighted the distinctive aspects of HTA for medical devices emerged throughout the assessment. The variation in evidence generation is one of these themes. In contrast to the typical phase three evidence acquired in clinical trials of drugs, comparative efficacy evidence is frequently lacking for medical devices at launch. Moreover, hardly any medical gadgets are subjected to randomized controlled trials. This raises the question of what evidence could be used to back up claims of efficacy, safety, and quality. One approach is a flexible approach to evidence generation based on real-world data (RWD).
The learning curve effect that is seen in many medical devices where there is a device-operator contact is another significant difference. The operator (healthcare professional) typically improves their proficiency with operations over time. For instance, robotic surgery would initially take longer in the operating room while the operator gained experience, but over time, with more proficiency, the operating room time would be quicker than with conventional surgery. Following a lifecycle approach by considering the economic impact at different stages in the device's lifecycle, individuals should approach this learning curve effect when performing economic modeling.
Incremental innovation is yet another significant distinction that should be taken into account. Not every advancement in medical technology is a game-changer. Many are minor improvements or gradual advancements. In comparison to pharmaceuticals, this results in an extremely short product lifespan. These small improvements frequently have an indirect impact on health outcomes since they may be advantageous to the operator. It is not practical to submit an HTA for each incremental innovation in the medical device industry given the fast rate of innovation.
Predominantly, the evaluation demonstrated the difficulties encountered when doing HTA for medical devices are supported by a sizable body of evidence. It is crucial to work towards mitigating the possible risk that HTA could bring about, adding a new barrier to ensuring that patients in need get access to innovation and ensuring that HTA is the vehicle for rewarding real-world innovation. At all stakeholder levels, capacity building and expanding the HTA knowledge base for devices should begin as soon as possible. This will pave the way for constructive partnerships between HTA agencies and the industry.
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