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The constant innovation in medical products can be both a blessing and a curse for healthcare systems. On the one hand, it is a key factor in improving patients’ lives, on the other hand, payers are confronted with justification for ever-increasing costs. To address this dichotomy, health technology assessment (HTA) has been widely established to evaluate innovative medical products and determine whether their implementation would be both beneficial and affordable. While the HTA process is generally well defined for pharmaceuticals, the methodology for the assessment of medical devices is underdeveloped.

In the past, medical devices were often treated exactly like pharmaceuticals when it came to HTA. However, in recent years researchers have started to question whether traditional HTA tools can meet the needs of medical device evaluation. Some commonly identified issues are:

  • Limited and low evidence

Randomized controlled trials are the gold standard of clinical evidence. However, blinding can be very hard or even impossible to achieve for medical device trials. Therefore, innovative study designs are needed to generate high-quality evidence.

  • Learning curve

Some medical devices require a considerable amount of skill to be used to their full potential. Capturing this effect in traditional studies has proven difficult.

  • Organisational impact

The implications of medical devices can go beyond clinical efficacy. They can, for example, combine several procedures into one, thus drastically changing the workflow of hospitals.

  • Incremental innovation

Unlike pharmaceuticals, medical devices tend to improve in relatively small but rapid steps, e.g. software optimization or longer battery life. This makes the timing of assessment that much more challenging and raises the question as to whether such innovations require another HTA round?

  • Diversity

Medical devices range from cheap, disposable syringes with repeat expenditure to expensive MRI machines purchased from capital budgets. This demands a considerable amount of individualization of assessment methodologies to tailor them to the product and question at hand.

While these issues are currently mostly academic discussions, some European countries (England, France, Netherlands, Sweden) have taken action to adjust their HTA guidelines to address at least some of the specific needs of medical devices. While the introduction of specialised medical device HTA guidance will likely be a slow and tedious process, it is very much needed for the fair assessment of the rapidly growing number of innovative medical devices. Failing to act on this issue could both hamper the introduction of beneficial new treatments and waste precious resources on ineffective products, due to a distortion of their actual value, based on inadequate assessment tools.