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: email@example.com
 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)
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.
Summer School on Health Technology Assessment (HTA) - September 2015
This Summer School spoke directly to Warwick PhD students, early career researchers and academics with a technical background (i.e. physics, chemistry and/or engineering), who were working on healthcare technologies, and aimed to provide them with theoretical and practical multidisciplinary training on HTA principles.
This will included methodology, modelling, mathematics, laboratory based training and relevant case studies (i.e. medical devices and not only drugs). The learned principles, methods and tools that have been important to inform their activities, maximizing the uptake and impact of their research outcomes. In fact, informing the research and the design of new healthcare technologies with scientific methods for early stage HTA will have a considerable impact on a number of important elements (i.e. cost-effectiveness, ethical issues) during the research process, when with small changes it is possible to achieved big results.
This School was organised in Collaboration with:
- the Institute of Advanced Study (IAS), University of Warwick
the School of Engineering, University of Warwick
the Global Research Priority on Science and Technology for Health, University of Warwick
- the HTA Division of the International Federation of Medical and Biological Engineering (IFMBE)
the Institute of Biomedical Technology, Patras, Greece.
- the COST Action BM1309 “European network for innovative uses of EMFs in biomedical applications”.
Moreover, the school has been endorsed by:
- the European Alliance for Medical and Biological Engineering (EAMBES)
- the COST action TD1104 “European network for development of electroporation-based technologies and treatments”
- the COST action TD1301 “Development of a European-based Collaborative Network to Accelerate Technological, Clinical and Commercialisation Progress in the Area of Medical Microwave Imaging”