Health care technology diffusion: case medical devices · Medical devices market • 3. Needs • 4. Landscape analysis ... Hearing impairment HIV/AIDS Malaria Maternal Health Newborn

Technology Diffusion(Geneva 24th January 2012)

Health care technology

diffusion: case medical devices

Invent for Humanity , Geneva

Adriana Velazquez-Berumen: Coordinator Medical devices

Technology Diffusion

(Geneva 24th January 2012)2

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



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?



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



Defining medical devices universe

Health care

Technology Health Technology

Medical

DevicesMedical Equipment

EngineeringBiomedical

EngineeringClinical Engineering



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



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



World medical markets by sector (% sales revenu) 2009*

3. Public health needs

needs



Epidemiological Changes: increasing NCDsEpidemiological Changes: increasing NCDs



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



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



New developments, rising costs:

need to allocate resources in rational way



Less invasive technologies at point of care



Mobile health: to retrieve information wherever you are

JCHM



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"



34% of 145 MS have a national HT policy as part ofthe national health programme or plan



65% of 145 MS have a national regulatory authority for medical devices



29% of countries have a national list of approved medical devices for procurement or reimbursement.



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



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



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



Innovative technologies call 2010





Example of innovative medical device forneonatal care in low resource settings.



January 2011: First Compendium



Health product



Countries submission's



New and emerging technologies



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%



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



Call for innovative technology for low resource settings (2012)

Future work on the diffusion of health

technologies and way forward to increase access



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.



Medical Devices To Do Publications



Partnerships and Productive Collaborations

WHO Regions

Country PublicationsWHO Medical Devices Reports (2008-2011)



Thanks for your Attention!

Documents

Health care technology diffusion: case medical devices · Medical devices market • 3. Needs • 4. Landscape analysis ... Hearing impairment HIV/AIDS Malaria Maternal Health Newborn