91福利

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 (91福利 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.

During the 16th International Conference on Biomedical Engineering (), which will be heald in Singapore fromt he 7th to the 10th of Dicember 2016, Dr Pecchia will give a and a 90min training session on HTA to PhD students, early career researchers and academics interrested in this field.

This training session will introduce attendees to:

• Health Technology Assessment (HTA) mission and principles

• HTA modelling, simulations techniques and free tools

• Early stage HTA: how inform the design of new medical devices applying reverse engineering to health economics

• HTA case studies

• Presentation of the IFMBE HTA Division eLearning Platform

The 21^st of October 2016, the School of Engineering and the ABSPIE will contribute to the first IFMBE Clinical Engineering Global Day () broadcasting worldwide the Seminar of Prof Dan Clark, titled “Healthcare Technology Innovation & the Future” ().

The Seminar will be broadcasted using Webex. Those interested can login for free here: .

Project Overview: Health technologies are changing the model of care. In particular, medical devices are the main enablers of modern medicine. Several methods have been proposed to support political decisions regarding medical device in developed countries. Those methods are far from being perfect and are mainly the result of adaptation of methods, developed mainly for drugs, which fail to consider important dimensions that are relevant for medical devices. However, much less has been don for low and middle income countries. For instance, available economic evaluations of medical devices come predominantly from high income countries, and relevant methods and studies are urgently required in less resourced settings.

This research project will focus on development and validation of methods and tools for HTA of medical devices for low and middle income countries. After reviewing existing literature and methods (e.g. multicriteria decision analysis methods) for HTA of medical devices, few case studies will be identified, in collaboration with biomedical engineers working for the WHO or in LIMC (e.g. including Bosnia Herzegovina, South Africa, Mozambique). If relevant, the candidate will have to opportunity to visit those countries to perform field analyses, subject to budget availability, and will be proactively involved in the IFMBE Healthcare Technology Assessment Division (HTAD) activities ().

The idea candidate will be a strongly motivated and independent person with a degree in biomedical engineering, or other relevant field, with relevant professional or research experience in: medical devices design, assessment or management, possibly in LMIC; HTA for clinical evidence, reimbursement, pricing, public procurement or protocol definition; HTA methods, possibly for medical devices and/or LMIC. Experience of mathematical modelling for HTA would be particularly welcome.

For more information, please contact Dr Leandro Pecchia (l.pecchia@warwick.ac.uk) and send a CV and a motivational letter (why do you think you are a good candidate?).

Funding: one studentship is available. Self-Funded PhD applications can be discussed too.

Dr Pecchia has been invited to give a talk titled "HTA of medical devices: Challenges in design and adoption" at the Health Technology Assessment workshop during the Africa Health in Johannesburgh, Suth Africa, organized by Dr Mladen Poluta as collaboration between SAHTAS and IFMBE.

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