Implementation

Target Product Profile

Our collaborators at the Foundation for Innovative New Diagnostics (FIND) advised us on the necessary considerations that would be required from a device such as ours to see it actually go to market. The first step is to develop a Target Product Profile (TPP) detailing the intended use, an explanation of function and procedure, how results are interpreted as well as performance characteristics. Our TPP is detailed below:

Intended Use Statement

Summary and Explanation of the Test

Summary of the Test Procedure

Interpretation of Results

Performance Characteristics

Although our research was mainly concentrated on Tanzania and Ethiopia, our device can be implemented in many other developing countries. Depending on what disease is most common in the region, our system can easily be adapted to identify different target diseases. Because our system is robust, affordable, and adaptable it can benefit many different regions all over the world.

Implementation Procedures

Our team contacted several agencies to learn more about what steps would need to be taken to implement the device in developing countries such as Ethiopia. In order to implement in Ethiopia, for example, the first step is get registered with Food, Medicine, Health Services Administration and Control Authority by submitting an application with required technical documentation and specifications details of the product. If the product is already registered with the World Health Organization (WHO) then FMHSACA usually registers the device provided all of the required documentation is submitted. Otherwise, FMHSACA might choose to run its’ own safety and quality control tests with the help from Ethiopian Public Health Institute. It is also recommended that the device has Certificate of Good Manufacturing Practice to ensure successful implementation. Upon completion of the registration process, the device might be included in health care workers’ trainings. The device would also have to be listed in National Guidelines in order for health care professionals to use the product.

Implementation process can vary from country to country. However, in general, if the device meets the standards set by WHO then it would also satisfy the country’s requirements.

Policies Associated with Synthetic Biology and Genetically Modified Organisms

GMO organisms and synthetic biology related issues are getting more attention from the policy-makers. Many countries have related laws and regulations in place. In order to implement the device, it is also important to make sure that it follows GMO laws and regulations in the region. Ethiopia, for example, has a Biosafety law in place. The Biosafety Law requires an application to be submitted to Ethiopian Environmental Protection Authority. EEPA must confirm that the devices satisfies biosafety laws and an Advance Informed Agreement must be obtained before GMO organism/device using GMO organisms is brought in to the country. Some required information that might be requested in this process include product information, environmental and human health risk assessments, social and economic impact assessment and risk management plans.