Role of biomedical engineer in assessing medical devicesRole of biomedical engineer in assessing...
Transcript of Role of biomedical engineer in assessing medical devicesRole of biomedical engineer in assessing...
Role of biomedical engineer in assessing medical devices
Dr Leandro Pecchia University of Warwick IFMBE HTA Division Chairman
AHP
Leandro Pecchia. [email protected]
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3rd WHO Global Forum on Medical Device
James C. H. Goh, Singapore, IFMBE President
Shankar M. Krishnan, USA, IFMBE President Elect
Kang Ping Lin, Taiwan, Secretary General
Marc Nyssen, Belgium, Treasurer
Ratko Magjarevic, Croatia, Immediate Past President
IFMBE: scientific society but very close to real problems
54 national, 7 transnational BME societies 120k members IFMBE
AHP
Leandro Pecchia. [email protected]
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3rd WHO Global Forum on Medical Device
BME impact IFMBE
“Biomedical Engineering is not simply a subset of modern medicine. Modern medicine predominantly secures important advances through the use of the products of biomedical engineering” (Official Journal of the European Union 2015/C 291/07)
AHP
Leandro Pecchia. [email protected]
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3rd WHO Global Forum on Medical Device
IFMBE HTAD vision & mission IFMBE HTAD
SUMMER SCHOOL
HTA STUDIES MONITORING
SURVEYS IJCEHTA
BME in HTA Strat. Comun.
TRAINING CONTENTS
E-LEARNING PLATFORM
MOBILITY SUPPORT
IFMBE CONFERENCE
LMIC SUPPORT
HTA AWARDS
KNOW-HOW (skilled to
research, design, assess, maintain)
MULTI-disciplinary (employed in
R&D, manufacturing hospitals, agencies)
INTER-DISCIPLINARY (educated in eng., ICT,
math, physics, medicine, biology, HTA)
BMEs should be constantly involved in HTA of Medical Device
TRAINING RESEARCH PUBLICATIONS EVENTS
VISION
ENABLING VALUES
FOCUS AREAS
STRATEGIC GOALS
PROJECTS (2015-18)
1) Establish periodical training events on HTA for BME
2) Develop and share free high-quality training material for on HTA for BME
4) Create new spaces to facilitate BME publications on HTA
3) Reinforce collaborations on HTA among BME and with other HTA experts
5) Write IFMBE guidelines on HTA (i.e. HTA, early/predictive HTA, MCDA, HTA LMIC)
MIS
SIO
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http://htad.ifmbe.org/
AHP
Leandro Pecchia. [email protected]
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3rd WHO Global Forum on Medical Device
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IFMBE HTAD: guidelines IFMBE HTAD
• HTA guidelines hypothesis: • Medical Devices are strongly dependent from operational environments:
• HR, users, medical locations, maintenance • HTA should inform the design of medical devices (…life is too short!) • Medical devices are too complex to be assessed using only few dimensions,
there is a clear need for MCDA
• IFMBE HTAD is working on white papers/guidelines: • HTA of Medical Devices • MCDA in HTA • Early/premarket/predictive HTA
http://htad.ifmbe.org/
AHP
Leandro Pecchia. [email protected]
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3rd WHO Global Forum on Medical Device
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e.g.: plants in LMICs HTAD
http://htad.ifmbe.org/
What will happen when we will start moving care and devices at home?
AHP
Leandro Pecchia. [email protected]
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3rd WHO Global Forum on Medical Device
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IFMBE HTAD: eLearning HTAD
• IFMBE HTAD eLearning: • http://htad.ifmbe.org/elearning/
http://htad.ifmbe.org/
AHP
Leandro Pecchia. [email protected] 3rd WHO Global Forum on Medical Device
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IFMBE HTAD: Members, Co-opted members, Collaborators
Tank you for your attention!
Patricia TRBOVICH
Canada
Treasurer (2012-18)
Marjan HUMMEL,
The Netherlands
Secretary (2015-21)
Nicolas PALLIKARAKIS,
Greece
Past-Chair (2012-18)
Mario MEDVEDEC,
Croatia
Member (2015-21)
Kalliroi STAVRIANOU,
Greece
Member (2015-21)
Mladen POLUTA,
South Africa
Member (2015-21)
Leandro PECCHIA,
UK
Chair (2012-18)
Rosanna TARRICONE,
Italy
Co-opted Member (2015-21)
Julie POLISENA,
CANADA
Collaborator
Oriana CIANI,
Italy
Collaborator
Dan CLARK,
UK
Collaborator
Giuseppe Fico,
Spain
Collaborator