Role of biomedical engineer in assessing medical devicesRole of biomedical engineer in assessing...

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Role of biomedical engineer in assessing medical devices Dr Leandro Pecchia University of Warwick IFMBE HTA Division Chairman

Transcript of Role of biomedical engineer in assessing medical devicesRole of biomedical engineer in assessing...

Page 1: Role of biomedical engineer in assessing medical devicesRole of biomedical engineer in assessing medical devices Dr Leandro Pecchia University of Warwick IFMBE HTA Division Chairman

Role of biomedical engineer in assessing medical devices

Dr Leandro Pecchia University of Warwick IFMBE HTA Division Chairman

Page 2: Role of biomedical engineer in assessing medical devicesRole 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

Page 3: Role of biomedical engineer in assessing medical devicesRole 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

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)

Page 4: Role of biomedical engineer in assessing medical devicesRole 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

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

N

http://htad.ifmbe.org/

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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/

Page 6: Role of biomedical engineer in assessing medical devicesRole 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

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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?

Page 7: Role of biomedical engineer in assessing medical devicesRole 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

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IFMBE HTAD: eLearning HTAD

• IFMBE HTAD eLearning: • http://htad.ifmbe.org/elearning/

http://htad.ifmbe.org/

Page 8: Role of biomedical engineer in assessing medical devicesRole of biomedical engineer in assessing medical devices Dr Leandro Pecchia University of Warwick IFMBE HTA Division Chairman

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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