Compendium 2012
Compendium of innovative health technologies for low-resource settings 2012
SUBMISSION FORM
Deadline: January 31st, 2012
The Medical Devices unit of WHO invites you to submit your solution to the Call for innovative health technologies for low-resource settings. Selected submissions will be published in the WHO Compendium of innovative health technologies 2012. The annual publication serves as a neutral platform to introduce health technologies that have the potential to improve current health outcomes or to offer a solution to an unmet medical need in low-resource settings. The Compendium series specifically focuses on innovative technologies that are not yet widely available in under-resourced regions and countries.
The submission of the applications, the subsequent selection process and outcome will not be subject to any claim of any kind whatsoever, or appeal. WHO will not be held to offer applicants any explanation as to why their proposal had been rejected. Please read carefully section "Terms, conditions, and disclaimers" at the end of this document before filling out the form.
General instructions
- The word count limitation in this form will be strictly implemented. Please be clear and concise in your answers.
- It is required that you choose a generic name for your technology. Pleasedo not use the brand name, website, or company namein your answers, except where specifically requested.Please make sure that neither brand name, nor company name or symbol is visible on the picture of your technology.
- To be considered please make sure you answer all questions. If not relevant to your technology, please state NA.
- For those questions requesting pictures, drawings or evidence, please eitherprovide references or attach the documents as separate items when submitting this form. If the files you wish to send exceed5 MB, please notify us to provide you with an FTP site.
- Please return to us by email
- the filled-in MS word submission form;
- a scanned copy of the form including your signature.
- For question-specific instructions and exemplary answers please refer to the end of the questionnaire.
A - Contact information
Please make sure that neither the company name nor the technology brand name appears in the generic email address.
Names of academic institutions are accepted.
1. Contact person
2. Inventor
3. Generic contact email address / 4. Company/affiliation email address
5. Contact telephone number
Please include country code. / 6. Contact fax number
B - Technology details
Please make sure to use the generic name for your technology throughout this form. The name must not containthe company or brand name.
1. Generic name
2. Brand name
3. Country of origin
4. Generic one-sentence description of technology
5. GMDN code / 6. UMDNS code
C - Health problem
1. Summary of health problem
Please provide a summary of the health problems that your technology aims to address. Please describe the scale of the problem in the region where it is intended for use - (no more than 350 characters).
This could include the specific disease to be tackled, numbers of people affected,assessment of the quality of life of those affected, symptoms of the healthcare problem, curability of the disease etc. If possible, please provide references to support your answer.
Reference(s):
If attachment included, please specify file name:
2. Target population
Please provide a brief description of the target population- (no more than 350 characters).
D - Product description
1. Description of proposed solution
Please write a short description of your technology. Please provide a brief technical explanation of how your product works bearing in mind that the information you provide could be published. If possible, please provide references and/or diagrams or other visuals to support your answer. - (no more than 700 characters).
Reference(s) title(s):
Please specify file name(s) for provided references/visuals:
2. Operation of technology
Please provide a step-by-step explanation of the operation of your device - (no more than 350 characters). If available, please attach a manual or other kind of instructions that explain the user-device interaction.
Instructions included Yes No / File name of the use-instruction:
3. Image of technology
Please attach a picture illustrating the technology(single image, no brand names, high resolution (300 dpi)).
File name of the picture:
4. Does the device require the use of consumables? / Yes No
5. If yes, please list the consumables:
6. Does the technology require electricity? / No
Batteries
Continuous power supply
Power supply for recharging
Other ______
7. Requirements of the facility in which the product will be used.
What infrastructure is required to use you product? This may include clean water supply, stable power supply, specific temperature and humidity, clinical waste disposal facilities, maintenance personnel, specialized operator, radiation isolation, gas supply, access to sterilization equipment, access to the internet, access to a cell phone network, connection to a laptop, other (please specify).
8. Does the technology use software? / Yes No
9. Is the device a telemedicine solution? / Yes No
10. Weight of the device (kg): / kg
11. Dimension of the device (mm3): / mm x mm x mm
12. Is the device portable? / Installed stationary
Portable (hand-held)
Mobile (e.g. between wards)
13. Type of use: / Single-use Reusable
E - Intended user
1. Who is the intended user? / Self-use/ Patient
Physician
Technician / Nurse
Midwife
Family Member / Other:
2. Is training required in addition to the expected skill level of the intended user? / Yes No
3. Please specify who will deliver training, the training tools, and the duration of training required:
4. Does the device require maintenance? / No / Yes
Please specify type and frequency:
5. Who are the intended personnel for maintenance? / Self-user / Patient
Nurse / Physician
Technician / Engineer
Manufacturer / Other: ______
6. Where will the device be used? / Rural settings
Urban settings / Ambulatory
At home
Primary (Health post, Health center)
Secondary (General hospital)
Tertiary (Specialists hospital)
7. Ease of use
Please provide a description of any testing that has been conducted to establish ease of use - (no more than 350 charaters).
Reference(s):
If attachment included, please specify file name:
F - Improvement over existing solutions
1. Existing solutions
Please provide a summary of existing technologies or methods (if any) that are available to address the health problem in the regions specified - (no more than 350 characters).
Reference(s):
If attachment included, please specify file name:
2. Benefit of your solution
Please provide evidence of why your technology is an improvement over existing solutions - (no more than 500 characters). This could include cost effectiveness, ease of use and maintenance, reduced training requirements, labor saving, improved safety, more acceptable to local context, reduced resource requirements, technical superiority, better accessibility etc. If possible, please provide references to support your answer.
Reference(s):
If attachment included, please specify file name:
G - Product evaluation and approval
1. Regulatory status of technology
Please provide information about the regulatory approval of your technology (CE mark, FDA approved, conformity assessment, other)
Reference(s):
If attachment included, please specify file name:
2. Technical evaluation of technology
Please provide information and references about the studies your technology has undergone.This could include clinical trials, utility/safety studies, information about where and when, how many patients were involved, if the studies were double-blind, peer-reviewed etc.
Reference(s):
Please specify file name:
3. Health technology assessment review
Please provide information and reference if your technology has been evaluated in a health technology assessment review or similar.
Reference(s):
Please specify file name:
4. Technology's suitability for low-resource setting
Has you technology been tested in the country or region where it is intended to be used or in a similar setting? Please provide a short description.
Reference(s):
If attachment included, please specify file name:
H - Economics
1. Date of initial commercialization (dd/mm/yyyy)
2. Countries in which the technologyis currently sold
3. Retail Price (USD) / USD
4. List Price (USD) / USD
5. List price of consumables (USD) / USD
6. Shelf life of the device / Days / Months / Years
7. Life time of device / Days / Months / Years
I - Future challenges
Please provide information on your strategy and foreseen challenges making your technology available and accessible to your intended user group - no more than 700 characters.
J - Additional information
I hereby acknowledge that WHO reserves the right to format and select the information provided as necessary to suit the layout of the publication.
Signature:Date:
I hereby acknowledge that I am the inventor of the technology or authorized by the entity owning the rights to the inventions to provide given information and act as contact person. I acknowledge that the information provided is a true representation of the status of the described technology and that I have provided appropriate evidence to support my claims. I agree that the information disclosed can be made public by WHO.
Signature:Date:
Instructions
- Contact information
3. Generic e-mail address: Please provide your email address. If your principle address has a business affiliation, pleasealso provide a generic address. Example:
- Technology details
4.Generic one-sentence description of technology: Please provide a generic descriptor for your technology.
Examples:"Lab-in-a-backpack: point of care screening/diagnostics";"Transcutaneous bilirubin measurement system for infants"
5.-6. UMDNS and GMDN code: If the standard nomenclature of this product is known, please list the appropriate code. (
- Health problem
1.Summary of health problem: The statements about the health problem addressed should be comprehensive and significant.
Example: With an increase inhospitalized patients worldwidethere is a demandfor the provision of fluids and the accurate dosing of medicines intravenously. Human errors due to manual administration lead to asignificant number of deaths. Most developing countries rely on the manual administration of fluids by a health professionalmaking the process impractical and expensive.
- Product description
1.Description of proposed solution:To start with, the proposed solution should be described in short sentences and help readers to grasp the concept easily.Next, the technical function of the device should be described clearly and concisely. Little specialist knowledge should be required to understand its function.
If appropriate, please submit a picture that best represents the technology. Logos, brands and websites will be blacked-out.
Example: The device is a pump which administers fluids intravenously into a patient's circulatory system. The 'infusion pump' can deliver fluids to a patient at a rate and volume specified by the clinician and set by the attending nurse.
The infusion pump works by using computer controlled rollers to generate a peristaltic action which forces fluid through a small silicone tube. By compressing the tube the rollers draw intravenous fluids from a bag and deliver them to the patient via a catheter in a continuous, controlled and accurate manner.
2.Operation of the technology: In order for potential users to understand the level of difficulty in operating the technology, we require applicants to describe the one by one the basic steps of its use.
Example: Set up the intravenous set, load the tubing in the pump, turn the pump on, set the required rate and volume, release the roller clamp, press the start button to begin infusion.
- Improvement over existing solutions
1. Existing solutions: Information about the state-of-the-art should support clarify what technologies are currently available to address the health problems and what the short-comings are.
2.Benefit of your solution:The improvements that the technology provides should be stated with regard to existing best practice.
Example: The infusion pump allows for automatic infusion of intravenous fluids to a patient in shock. The device controls the administration of fluids more accurately than achieved manually by healthcare personnel. The automatic nature of the device means that nurses are assured their patients receive the correct dosage while they perform other tasks on the ward. The infusion pump makes it possible to administer very small dosages which can be difficult to accomplish manually. In summary, in addition to being labor saving for clinical staff attending to a busy ward, the device is technically superior to manual methods of fluid administration.
- Economics
1.-2.Commercialization: Please indicate the date of commercialization and the countries in which the technology is soldand if the product has been sold in the jurisdictions where it has obtained regulatory approval.
- Future challenges
Many potential obstacles can be encountered when bringing innovative technologies to new markets. The applicants are invited to identify challenges that they foresee to the successful future of their product. The publication is intended to generate dialogue between readers and applicants to contribute to the success of the technologies.
Terms, Conditions and Disclaimers
Compendium for innovative health technologies for low-resource settings 2012
WHO reserves the right not to select any application or to annul the solicitation process at any time, without thereby incurring any liability or any obligation to inform the applicants of the grounds for the WHO's action. WHO reserves the right, at any time during the solicitation process, to modify the scope of the Call. At any step in the evaluation process, WHO reserves the right to issue an amendment to the Call detailing the change to only those applicants who have not been officially eliminated at that point in time. Applications will be evaluated by WHO, in collaboration with partner experts and institutions, in its sole discretion, taking into account the criteria outlined above. There is no obligation by WHO to reveal, or discuss with any applicant, how a submission was assessed, or to provide any other information relative to the selection process.
Incomplete applications and applications submitted after the deadline will, in principle, be disregarded unless WHO, in its sole discretion, decides otherwise in respect of such incomplete or late application. WHO may request applicants to submit complementary or additional information as a condition for consideration. Any possible requests to submit complementary information and/or to submit a more detailed application, as well as any discussions ensuing therefrom, will be exploratory only, and do not mean that the applicant concerned will be selected.
WHO will not be held to offer applicants any explanation or justification as to why their proposal has been rejected and/or why they have not been selected. The list of selected applications will not necessarily be made public as such. The submission of applications, the subsequent selection process and outcome of the selection process will not be subject to any claim of any kind whatsoever, or appeal. Each applicant will be notified in writing by WHO (by e-mail) whether or not the submission has been selected.
Any and all costs and expenses incurred in relation to, or ensuing from, the submission of an application (including the possible complementary information and/or a more detailed proposal, if so requested by WHO) will not be subject to claims for financial compensation of any kind whatsoever.
WHO does not warrant that any medical devices, innovations, concepts or products that may be used, identified or otherwise developed from selected proposals will be successfully commercialized in target countries, or that WHO will finance or otherwise support the development or commercialization of any product. By selecting applications, WHO will not be held to endorse any product but will solely aim at drawing stakeholders' attention to innovative technologies with a view to furthering development and availability of, and access to such innovative health technologies.
The mention of specific companies or of certain manufacturers’ products at any stage of the selection process or subsequently will not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned, nor that they have been found to be safe and efficacious.
Without WHO’s prior written approval, selected applicants shall not, in any statement of an advertising or promotional nature, refer to their selection under this Call for innovative health technologies. In no case shall selected applicants use the name or the emblem of the World Health Organization, or any abbreviation thereof, in relation to their business or otherwise. The same applies to all applicants during the selection process and thereafter.
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