HTA Guidelines for Medical Devices: What are the Gaps and how can We Address Them?
Health Technology Assessment (HTA) of biomedical devices requires different methods than those usually employed for pharmaceuticals. In fact, there are important differences between medical devices and drugs that can influence the assessment of their cost-effectiveness.
Pecchia and Craven 2012(17)  highlighted the main differences between devices and drugs impacting HTA, grouping those into five categories: product lifecycle, clinical evaluation, user issues, costs and economic evaluation, and intellectual property.
In November 2016, as part of the 2015-2018 International Federation of Medical and Biological Engineers (IFMBE)-HTA Division program, a focus group was held at the University of Warwick, aiming to contextualize and extend those differences and:
- propose recommendations that address this gap
- compare current HTA medical device guidelines with the highlighted gaps, and
- to start a project aiming to reach a consensus among the drafted recommendations by means of a modified Delphi survey.
A follow up meeting took place in Finland during the EMBEC conference in June 2017.
A modified Delphi survey has been designed, piloted and circulated in November 2017 explore the consensus around the recommendations proposed. The survey consists in exploring expert opinion (mainly BMEs and clinical engineers) about the IFMBE HTAD recommendations. This will represent the base for a whitepaper of IFMBE on recommendations on current HTA guidelines limits.
If you would like to know more or to be part in our survey, please contact: firstname.lastname@example.org
 L Pecchia, MP Craven, “Early stage Health Technology Assessment (HTA) of biomedical devices. The MATCH experience”. World Congress on Medical Physics and Biomedical 2012, 26-31 May 2012, Beijing, China.
MAFEIP tool: Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing.
Since August 2014, Dr Pecchia is supporting the European Commission in developing, piloting and disseminating the Monitoring and Assessment Framework for the EIP on Active and Healthy Ageing (MAFEIP) tool.
The European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) is a policy initiative aiming to improve active and healthy ageing sharing and scaling up innovative health technologies, to face challenges arising from demographic changes in Europe. The EIP on AHA ambitious ambition is to increase the health and quality of life of European citizens, improving the sustainability of health and care systems and to contribute to more economic growth in Europe.
In order to provide a reliable tool for monitoring the EIP on AHA commitments, DG CNECT and DG SANTE commissioned the DG JRC IPTS a web-based tool within the "Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing" (MAFEIP) project. The MAFEIP-tool was launched in September 2015 during a workshop hosted by DG CNECT in Brussels.
The MAFEIP tool rests on a generic three-state Markov model and allows adaptation to various health and care settings, target populations, and innovations under assessment.
In particular, Dr Pecchia contribution has been functional to application of the MAFEIP tool for the so-called early stage Health Technology Assessment (or more precisely, early health economic evaluations). This field of research consist in applying reverse engineering to health economics to inform the research and development of innovative health technologies.
Link 1 (an intro to the MAFEIP tool)
Link 2 (The Warwick case study)
Pilot study on Health Technology Assessment (HTA) of Medical Devices, with a specific focus on low and middle income countries (LMIC).
This project aims to steer the discussion within the international biomedical engineering (BME) community, creating an international working group that will influence European and WHO policy on HTA of Medical Devices, with a specific focus on LMIC.
The main activities of supported by this project have been:
1) to host a meeting of an international working group, aiming to draft a white/paper on HTA of Medical devices.
2) support field studies in Benin, aiming to explore the operational condition of medical devices in a sub-Saharan country
3) support the dissemination of those preliminary results in scientific conference and discuss the preliminary findings with relevant European Institutions and with WHO.
This project has been conducted with the support of:
1) the World Health Organization (WHO)
2) the International Federation of Medical and Biological Engineering (IFMBE)
3) Warwick Impact Fund
4) EPSRC IAA
COST Action TD1301 Development of a European-based Collaborative Network to Accelerate Technological, Clinical and Commercialisation Progress in the Area of Medical Microwave Imaging
One of the most promising emerging medical imaging modalities is Microwave Imaging (MWI), which is a low-power, low-cost, non-ionising imaging modality and also has therapeutic capabilities. Most of this MWI research to date has been accomplished in simulation and laboratory studies, with only limited translational research into the clinical environment.
European researchers have been at the forefront of the development of MWI. With respect to medical applications, these (mostly independent) efforts have lead to the design of several microwave-based imaging devices, most of which are currently undergoing or poised for clinical trials. Such a reserve of knowledge constitutes a unique opportunity for European researchers to leverage existing experience and expertise to streamline the transition from simulation/phantom testing to full clinical trials and clinical adoption of MWI devices.
Dr Pecchia was invited to give HTA seminaires, workshops and lectures during the 7th meeting for MC, WG and Workshop (Belgrade, March 2016) and during the "European Training School on Health Technology Assessment", organised in Rome in March 2016.
COST Action BM1309: European network for innovative uses of EMFs in biomedical applications (EMF-MED)
COST EMF-MED provides a cooperative framework to support the research on beneficial biological effects of non-ionizing electromagnetic fields (EMFs) and their use in biomedical applications. Research on biological effects of EMFs has traditionally focused on health risks. Inspired by promising recent studies on useful biomedical EMF interactions and applications, this Action focuses on beneficial effects, aiming for breakthrough results, new discoveries and innovative biomedical technologies. The Action will provide a better understanding of underlying physical and biological interaction mechanisms, related to both cancer and non-cancer applications, filling the gaps in present state of knowledge. Ultimately, the Action aims to contribute to development and optimization of innovative EMF-based medical devices and procedures, which will be safer, more efficient and less invasive. Interdisciplinarity of the proposed topic and significance of the expected outcomes require a concerted research network at the European level.
Dr Pecchia is a member of the working module on Early Stage Health Technology Assessment of EMF Medical Devices.
Dynamic mechanical properties characterization of an implantable medical device for spinal surgery