Health Technology Assessment (HTA) of medical devices is perceived in Europe and the developed world as an integral part of market access activities and, consequently, the advocacy of the real value of innovation in healthcare. Rigorous scientific analyses demonstrating the value of innovation for patients and society should not be perceived a burden for manufacturers and distributors. These are pro-innovative tools for fair communication between manufacturers and payers that catalyze an equitable position for both parties.
In the realm of healthcare, the distinction between devices with minimal true innovation and those representing groundbreaking advancements is pivotal. The process of gaining market access, particularly through HTA, becomes a critical juncture that sets apart devices of genuine innovation from those with more modest contributions as compared to comparator technologies.
Devices that bring limited or no innovation may seek expedited access, often bypassing rigorous evidentiary requirements. This approach can be attributed to a desire for a swift market presence without the burden of exhaustive research and validation.
On the other hand, devices embodying substantial innovation must invest the effort to amass comprehensive evidence that substantiates their uniqueness and demonstrates tangible benefits. This commitment is not merely a regulatory obligation but a fundamental responsibility towards patients and the healthcare ecosystem. Primarily, however, it should be perceived as a hallmark of genuine quality and innovation. The evidence becomes a testament to the device’s capacity to enhance the quality of life for individuals, emphasizing outcomes that go beyond basic functionality.
The value of true innovation in medical devices should be assessed not only in terms of clinical efficacy but also through its impact on the holistic benefit of patients and the society. Devices should contribute to an improved quality of life by addressing unmet needs, minimizing invasiveness, and enhancing user experience. Evidence, in this context, extends beyond clinical metrics to include patient-reported outcomes, real-world data, and long-term health-related quality of life assessments.
Ensuring that the benefits of innovative devices are well-evidenced serves as a safeguard against the potential introduction of inferior competitive technologies that may not significantly contribute to patient well-being. Robust evidence becomes a cornerstone for transparent communication between manufacturers and stakeholders, fostering a shared understanding of the device’s unique value proposition.
If you feel that you are entering the market with genuine innovation, which has its value determined not only by the cost of development and production but also by its benefits, compromising on HTA evidence is not the right path. Consult with experts from CEEOR and Czech Technical University and enhance your argumentation with expertise and erudition.