Innovations for Integrated Diagnostics Systems (Round 20)

The Opportunity

Diagnostic services are essential to guide patient treatment and care for a variety of health conditions. In the developing world, diagnostic services are provided in a tiered framework that ranges from centralized laboratory settings in highly populated regions to remote health outposts that have limited resources (Figure 1). A well implemented centralized laboratory has the potential to achieve high throughput testing with multi-purpose platforms, often at low cost. To date, the function of existing laboratory services in the developing world remains poor due to multiple factors including low instrument utilization rates, poor data management, supply chain issues, human resource challenges, low rates of results returned, poor quality systems, poor sample transportation systems and low quality specimens.

The obstacles to making this a reality include but are not limited to the following areas:

Digital Tracking & Connectivity: one of the key failures of local testing is due to the fact that sample drawing, patient data, test results are either recorded on paper based systems or not recorded at all.   As a result, specimens and results are often lost throughout the system. 

Simplified/Streamlined Workflow: numerous high performance testing platforms and assays work well in a setting with abundant resources and highly trained personnel.  When these same platforms are used in a resource limited setting, they are underutilized, perform poorly or do not enable effective quality result return.

Sample Collection & Specimen Processing: many test results are wrong or inconclusive due to the fact that the specimen was collected in insufficient quantities or decayed prior to analysis by the intended centralized lab.

Transportation & Distribution of Samples: transportation of stabilized specimens can extend the reach of many centralized laboratory services.  Currently, sample transportation in many developing world settings is unavailable, high cost, uncoordinated or otherwise ineffective.

Figure 1. The Tiered, Integrated Laboratory Network;

 

The Challenge

Our challenge is to make technological and process improvements in all the areas mentioned above, while at the same time paying attention to balancing the cost trade-offs. Because financing for healthcare in the developing world is limited, for any new technology to scale, it must demonstrate cost savings and increased efficiency to the system overall. To balance the cost trade-offs and efficiently manage services, interconnected and coordinated systems from specimen collection, local testing, sample transportation, centralized testing and return of results must be in place.

• Seek novel ways to implement interconnected laboratory networks that will efficiently track patients, specimens and data to and from various types of settings, ensuring quality diagnostic services are provided and can inform treatment and care decisions.
• Adapt selective centralized laboratory instrument platforms and assays that improve ease of use or robustness in developing world settings.
• Improve specimen collection methods through new materials that can stabilize or purify specimens, thereby improving the quality of the testing.
• Optimize transportation networks, and leverage distribution capabilities from other local services to improve sample transport logistics, timelines, and cost.

What we are looking for:

• Technical innovations that have a measurable improvement in an integrated laboratory network, starting from sample collection, transportation, laboratory testing (local or centralized) to return of the results
• Innovations should improve any of the performance metrics below:
  • turn-around time (from specimen collection to return of result),
  • laboratory instrument capacity utilization rate,
  • percentage of quality results generated,
  • percentage of quality results returned to patient or
  • cost per quality result returned.

Early stage feasibility studies are encouraged, but the investigator needs to state explicitly which performance metrics the solution improves and how the improvements will be quantitatively measured.

Options to be considered include:

• Improved reagents for centralized lab tests enabling greater robustness to developing world conditions, improving percentage of quality results generated.
• Improved usability of existing laboratory processes, such as an integrated sample processing device, improving the laboratory instrument capacity utilization.
• Technology that can stabilize specimens during collection and transportation, improving the quality of the results generated.
• Technology that can improve ease of specimen collection such as simpler blood or plasma collection systems, improving quality of results generated.
• Novel methods of improving the transportation network such as digital trackers or apps that improve sample transportation, reducing turn-around times.

To be considered for funding, proposals must clearly describe how the proposed innovation would work within and improve existing laboratory networks. Examples include:

• Estimates of current wastage that could be improved;
• Description of how the technology could improve a component of the entire system;
• Description of how the improvement could eventually be demonstrated using the following metrics:
  • turn-around time (from specimen collection to return of result),
  • laboratory instrument capacity utilization rate,
  • percentage of quality results generated,
  • percentage of quality results returned, or
  • cost per quality result returned.

We will not consider funding for:

• Projects that only involve implementation of existing technologies will not be considered. For example, many countries have yet to implement laboratory information management systems. Because systems already exist, their implementation, while important, is not considered an innovation.
• Point of care diagnostics instruments can be important to develop but this call for proposals is aimed at improving the centralized laboratory system. For this reason, we will not support new point of care diagnostics instruments.
• New diagnostic laboratory instrumentation will not be considered for this proposal since there are already many instruments developed for centralized lab settings that can currently be leveraged. For that reason, new diagnostics instruments will not be considered for support.
• Innovations that cannot demonstrate impact on efficiency will not be considered.