health care technology diffusion: case medical devices · medical devices market • 3. needs •...
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Technology Diffusion(Geneva 24th January 2012)
Health care technology
diffusion: case medical devices
Invent for Humanity , Geneva
Adriana Velazquez-Berumen: Coordinator Medical devices
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agenda
• 1.What is a medical device?
• 2. Medical devices market
• 3. Needs
• 4. Landscape analysis
• 5. Who are the clients? Focal points?
• 6. Medical devices technical series
• 7. Call for innovative technologies
• 8. Follow up
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1. Medical devices arena
• Medical devices have a huge potential to
– improve health status of people
– support people with disabilities
• Are medical devices
– Available?
– Accessible?
– Appropriate?
– Affordable?
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What is a Medical Device?
WHO Definition (short v.)
"article, instrument, apparatus or machine that is either:
� used in the prevention, diagnosis or treatment of illness or disease, or
� used for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose"
Examples of types:
� From bandages to Nuclear Magnetic Resonance
� Over 15,000 different categories of medical devices
� From single use devices to more than 20 years of use
� From < $1 USD to > $1 million USD per device
� From no risk to very high risk devices
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Defining medical devices universe
Health care
Technology Health Technology
Medical
DevicesMedical Equipment
EngineeringBiomedical
EngineeringClinical Engineering
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WHO Mandate and Resolution on Medical Devices
�Strategic Objective 11 out of 13 from WHO:
� Improved access to safe effective, quality medical devices
�Resolution 60.29 approved in May 2007 on health technologies, particularly medical devices.
�Requires member states to have:
� available national information on medical devices
� professionals in biomedical engineering
� national units of health technology
�Requires WHO to have:
� Clearing house with information for selection of medical devices
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WHO Medical Devices Team Activities
�2008-2010 Priority Medical Devices project
�Assessment of availability and current use of medical devices
�Mismatch between device design context of use
�2008-2011 Global Initiative of Health Technologies
� 8 documents on management (policies, needs assessment, procurement, donations, maintenance, HTA, inventories, CMMS).
�Global survey on medical devices
�2011-2012 Global needs of medical devices
� List of medical devices by health care facilities and by clinical procedures
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World medical markets by sector (% sales revenu) 2009*
3. Public health needs
needs
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Epidemiological Changes: increasing NCDsEpidemiological Changes: increasing NCDs
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Non communicable diseases needs 2010:
• Diabetes
• Cardiovascular
• Respiratory
• Cancer:
– At least seven countries do not have any mammogram equipment;
– 25 countries lack any type of radiation therapy.
• Prevention
• Diagnostic and screening
• Treatment
• Rehabilitation
– Early diagnosis SAVES LIVES
– Late diagnosis increases complexity, costs with large social and economical impact
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MDG 2015: innovation is required in:
• Maternal
• New born
• Child care
• Infectious diseases
– TB
– HIV
– MALARIA
� logistics
� financing
� leadership
� Accountabililty
� Availability of technologies
� Point of care technologies
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New developments, rising costs:
need to allocate resources in rational way
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Less invasive technologies at point of care
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Mobile health: to retrieve information wherever you are
JCHM
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4. Landscape analysis
• Manufacturing
• IP issues
• Market information
• Regulations
• Taxes
• Supply Chain
– Logistics
– Access
– Pricing
– Installation
– User training
5. Who are the users? Clients?Needs?"Baseline country survey on medical devices"
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34% of 145 MS have a national HT policy as part ofthe national health programme or plan
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65% of 145 MS have a national regulatory authority for medical devices
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29% of countries have a national list of approved medical devices for procurement or reimbursement.
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First Global Forum for Medical Devices11 September 2010, Bangkok, Thailand
First Global Forum for Medical Devices11 September 2010, Bangkok, Thailand
122 recommendationsShort and long term actions planned
for the 15 priority recommendations
Safe & 4As:
Priority Medical Devices
Available
Accessible
Appropriate
Affordable
Medical devices technical series
English version PDF in website
French and Spanish February 2012
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Research and development based on needs
Health Technology Assessment
Regulations of medical devices
Needs Assessments/Selection
User training and clinical effectiveness
Decommissioning,Replacement
Installation,Inventories; Maintenance
Post market surveillance and Adverse event reporting
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Medical Devices Technical Series
• To ensure improved access, quality and use of medical devices:
• Regulations– HTR
• Assessment
– HTA
• Management– Clinical engineering
New and emerging technologies
Appropriate
Affordable
Ease of use
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Innovative technologies call 2010
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Example of innovative medical device forneonatal care in low resource settings.
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January 2011: First Compendium
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Health product
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Countries submission's
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New and emerging technologies
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REVIEW OF 150 INNOVATIONS IN MEDICAL DEVICES : TYPE OF ENERGY
Animal Pulled1%
Electricity Supply17%
Fire1%
Fuel Powered1%
Human Powered2%
Low power24%
Low power (mobile powered)
7%
No power required15%
Solar10%
No information22%
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RESEARCH FOCUS
The chart above shows the number of projects found by target disease, type of intervention, or end-use. It is also related to the
category of the devices: assistive device (AD), diagnostics (D), laboratory equipment (L), preventive (P), therapeutic (T), and
service support (S).
0 5 10 15 20 25 30 35 40 45 50
Cancer
Cardiovascular Disease
Contraception
Dermatology
Diabetes
Diahrreal Diseases
Drug Delivery
Hearing impairment
HIV/AIDS
Malaria
Maternal Health
Newborn and Child care
Respiratory Diseases
Surgery
TB
General Attention
Dental Health
Ophtalmology
Influenza
Dengue
Other
Laboratory
Prosthetics
Gastrointestinal diseases
Mobility
AD
D
L
P
S
T
E
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Call for innovative technology for low resource settings (2012)
Future work on the diffusion of health
technologies and way forward to increase access
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Future work
2012:
• Document on barrier to access, technology transfer and local production
• Regulations harmonization
• Nomenclature harmonization
• Lists of medical devices for procurement and reimbursement date base
• More liaison with other stakeholders to help: increase access of medical devices to where are most needed.
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Medical Devices To Do Publications
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Partnerships and Productive Collaborations
WHO Regions
Country PublicationsWHO Medical Devices Reports (2008-2011)
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Thanks for your Attention!