Medical devices are dependent on users and some are designed to be used directly by patients. This panel contributed to the ongoing debate on how to capture and integrate the patient's view while performing HTA of medical devices and how this can help inform the design of future medical devices, as well as learning from low and middle income countries (LMIC) experiences.
Medical devices differ from drugs in several aspects. Among others, medical devices are much more dependent by users and their operational environment than drugs. Several aspects of medical devices real use and lifecycle requirements are not captured by traditional HTA methods. For instance, properly capturing the patient perspective while dealing with acceptance, usabililty, affordability, ease of use, ease of calibration, or maintenance is crucial to identify the optimal medical devices, beyond cost-effectiveness and willingness to pay. Moreover, the correct context-aware assessment (medical devices and the environment where it is supposed to be operationalized) of use and care is fundamental to ensure good levels of safety, quality, effectiveness, and performance.
Nonetheless, current methods of HTA are missing part of this information, which for medical devices is much more impactful than for drugs. This becomes much more relevant in two cases: when a medical device is designed to be used by patients, especially if older and possibly less skilled in the use of technologies; when medical devices are used in lower income counries, where minimum requirements (e.g., structural, organizational, and technological) are not guaranteed. For instance, medical devices designed in Europe to be used by highly specialized personnel in safe and clean medical settings are often used in LMIC by non-specialized personnel and in less safe or hygienic conditions.
Medical devices designed to be used at home or by non-specialized healthcare workers or in LMIC should be conceived to be independent by users and setting. Biomedical engineering, human factor methods, and user elicitation experts can help capture this information, which can be aggregated using multi-criteria decision making (MCDA) methods. HTA methods and experts should better consider those dimensions to properly respond to those challenges.
The panel session was chaired by Dr. Leandro Pecchia, Chair of the HTA Division of the International Federation of Medical and Biological Engineering (IFMBE, UK), and Neil Bertelsen, Interest Group Patient and Citizen Involvement (Germany), who introduced the problem from the patient perspective and facilitate the discussion among experts from different backgrounds:
- Adriana Velazquez Berumen (WHO, Ginevra): “An overview of the factors affecting medical device effectiveness and safety in low-middle income settings”
- Ken Bond (CADTH Canada): “Incorporating patient perspectives in Canadian HTAs”
- Rhona Mijumbi-Deve (Africa Center for Systematic Reviews and Knowledge Translation, Uganda): “Strategic user engagement in decision making in LMICs: Lessons from Uganda”
- Francesca Moccia (Cittadinanzattiva, Italy): “Patient involvement in HTA: opportunities and barriers”
- Leandro Pecchia (IFMBE HTA Division and University of Warwick, UK): “MCDA for user need elicitation in HTA and medical device challenges in LMICs”