| Medical devices are indispensable in health care delivery as tools for prevention, diagnosis, treatment and rehabilitation. However, despite the exponential growth of scientific and technological development, availability of and access to appropriate and affordable health technologies in low- and middle-income countries are still insufficient. Objectives One of the goals of the WHO Department of Essential Health Technologies is to help make available the benefits of core health technologies by developing a framework for health technology programmes and by challenging the scientific and business community to identify and develop innovative technologies to address global health concerns. The call for innovative technologies aims at identifying and evaluating innovative medical devices, either existing or under development, which address global health concerns and which are likely to be accessible, appropriate and affordable for use in low- and middle-income countries. Key dates - 11 September- Opening date for applications
- 31 January 2010- Deadline for submission of applications
- 27-29 April 2010- Selection of applications
- 30 June 2010- Posting of selected technologies on the WHO website
Eligibility The call for innovative technologies is open to manufacturers, institutions, universities, governments, individuals and non-profit organizations. One submission per applicant will be accepted. Medical devices Eligible health technologies are limited to medical devices as defined by the Global Harmonization Task Force (GHTF). They include instruments, medical equipment, implants, disposables, assistive devices and software, used mainly for the purpose of prevention, diagnosis, monitoring or treatment of disease, control of conception, rehabilitation, or measuring, restoring or correcting physiological functions. These technologies may be commercialized/-sable or in a non-commercialized/-sable stage. The call does not cover clinical procedures, medicinal products, vaccines, biological therapeutic products or tissue engineered medical products. Innovative technologies To qualify for consideration, a technology must be deemed to be "innovative" by providing evidence that the solution: - Has not previously existed;
- Has not previously been made available in low- and middle-income countries;
- Is safer and/or simpler to use than earlier solutions; and/or
- Is more cost effective than previous technologies.
Categories Category 1 is for commercialized products or products which are commercialisable. This includes new products; products which have been commercialized for less than five years in high-income countries and which are not (yet) widely used in low- and middle-income countries; recent adaptation of existing non-health products for a health purpose; and/or recent adaptation of an existing medical device for low- and middle-income settings. Category 2 is for products in a non-commercialized or a non-commercialisable stage. This includes products which are under development or otherwise in a conceptual stage. Health concerns Applications can be submitted for solutions to the following global health concerns: - Lower respiratory infections
- Diarrhoeal diseases
- HIV/AIDS
- Malaria
- Prematurity and low birth weight
- Neonatal infections
- Birth asphyxia and birth trauma
- Unipolar depressive disorders
- Ischemic heart disease
- Cerebrovascular disease
- Tuberculosis
- Road traffic accidents
- Chronic obstructive pulmonary disease
- Alcohol use disorders
- Refractive errors
- Deficient maternal health
- Infant and child (under 5) mortality
- Cancer
- Disability.
The application form should be completed in English, signed and e-mailed as a PDF document to medicaldevices@who.int.
Receipt of applications will be confirmed by e-mail.
The deadline for submission is 31 January 2010. Step 1: WHO will screen all applications. The ones which are incomplete will, in principle, not be processed further. An identifier code will be assigned to the application and all information about the applicant will be removed to maintain confidentiality. Step 2: Application (without identification data) will be sent to selected WHO collaborating institutions for a second screening with respect to conformity to the scope of the call for innovative technologies. Those applications which do not fall within the scope of the call will not be sent to the selection committee (Advisory Group on Innovative Technologies). Step 3: Proposals will be evaluated and selected by the Advisory Group on Innovative Technologies, which is composed of experts in the field of health technologies. A confidentiality agreement will be signed by the members of such advisory group. Any expert reviewer with a declared conflict of interest will not be authorized to participate in the review. The following considerations will be taken into account in the selection of the applications: - Level of safety for the user, patient and the environment;
- How effectively the technology addresses the health concern in question;
- How well the technology is adapted to local infrastructures in resource-limited settings;
- Ease of use and maintenance;
- Total cost of ownership, cost-effectiveness and affordability; and
- Cultural and social acceptability of the technology.
Each applicant will be notified in writing (by e-mail) whether or not it has been selected in June 2010. A list of the selected innovative technologies will then be posted on the WHO web site. Governments, donors and other stakeholders will be informed about which technologies have been selected with a view to fostering the development, availability of and access to innovative technologies, particularly in low- and middle-income countries. RELATED LINKS Brochure [pdf 188kb]
Poster [pdf 88kb]
Application form [doc 400kb]
Frequently asked questions | 
No comments:
Post a Comment