Recent research results from our lab were showcased in the European Medical and Biological Engineering Conference 2017 (EMBEC’17), which took place from 11^th to 15^th June in Tampere, Finland.

Video: Dr Pecchia invited talk: "HTA of Medical Devices in LMICs"

Dr Pecchia represented the IFMBE HTAD in Geneve. IFMBE is an ONG in official relations with WHO and is entitled to present motions to the WHO General Assembly. Dr Pecchia is the focal point for WHO-IFMBE relations regarding HTA of Medical Devices

Dr Pecchia was responsible for selecting the papers submitted and organized the program of the HTA track. Moreover, he gave a presentation regarding his recent field analysis in Benin and was invited to present IFMBE HTA Division activities in plenary session.

HTA of Medical Devices in LMICs

BME contribution to HTA

WHO III Global forum of Medical Devices - proceedings and presentations

WHO III Global forum of Medical Devices - proceedings and presentations

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, Geneve): “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”

Dr Pecchia was invited to give a talk on Health Technology Assessment of medical devices in a panel organized by Prof Tammy Clifford, Vice-President of the Canadian Agency of Technology Assessment (CADTH). Approaches to the assessment of medical devices differs from that for drugs, and also differs across the various phases of the technology lifecycle. This session showcased several recent initiatives that support a lifecycle approach to technology assessment, and highlight linkages to HTA.

The moderator, Tammy, provided a brief reminder of the problem: what is the technology lifecycle, why does it differ for medical devices (vs drugs), and why HTA of medical devices has fallen short. This will set the stage for the subsequent presentations.

Dr Pecchia shared relevant perspectives from the International Federation of Medical and Biomedical Engineers (IFMBE) HTA division, with a focus on how much medical devices depend from operational settings and guided a reflection on how this affects HTA.

Dr Petra Inderst-Schnell described various European HTA initiatives that focus on medical devices.

Prof Peter McCulloch provided an overview of the IDEAL framework, including its genesis, case examples, and future directions.

Dr Danica Marinac-Dabic of the US FDA, provided a glimpse into the future International Infrastructure for Medical Device Epidemiology.

Finally, Sebastian Gaiser, Senior Director medical Devices Johnson and Johnson, presented a perspective from a medical device manufacturer, commenting on the utility of the suggested approaches.

The pannel, organized by Prof Rosanna Tarricone, Associate Dean of the SDA Bocconi School of Management (Bocconi University, Milano), aimed to provide a comprehensive overview of the specific challenges of current HTA of medical devices, discuss how the current regulatory scenario is likely to change in the near future, and disentangle the potential impact on access to valuable medical technologies. The different backgrounds of the panelists contributed to the ongoing discussion, providing in-depth and multifaceted insights on how to inform more transparent, evidence-based decisions on medical devices and how to steer innovation to generate greater value to healthcare systems and patients.

Five HTA experts from different professional backgrounds, participated to the discussion:

• Claudius Griesinger (European Commission): an overview on the upcoming regulation change in the MD sector in the EU.
• Marcella Marletta (Ministry of Health, Italy): main structure and preliminary results of the national program for the HTA of medical devices in Italy.
• Adriana Velasquez Berumen (WHO): an overview of how evaluation, procurement, and access to MD technologies is managed in LMIC, and how HTA in that setting can improve access to cost-effective technologies in the future.
• Leandro Pecchia (Warwick University): early HTA approaches to guide sustainable R&D investments in the MD industry.
• Richard Charter (BD): a manufacturer's perspective on the challenges posed by current HTA approaches, regulatory reform ongoing in Europe and limited access to LMIC.