NIH/NCI 454 – Software to Evaluate Artificial Intelligence/Machine Learning Medical Devices in Oncology Settings
Fast-Track proposals will NOT be accepted.
Direct-to-Phase II proposals will NOT be accepted.
Number of anticipated awards: 3-5
Budget (total costs, per award):
Phase I: up to $400,000 for up to 12 months
Phase II: up to $2,000,000 for up to 2 years
Proposals that exceed the budget or project duration listed above may not be funded.
There is an unmet need to develop software tools for evaluating the safety and effectiveness of cancer-related devices that use artificial intelligence and machine learning (AI/ML) algorithms. The development of such software tools to evaluate real-world performance in oncology settings will facilitate bringing medical devices to market faster, monitoring devices during post-market surveillance, and assessing rapidly developing updates to AI/ML algorithms. Importantly, these tools have the potential to promote trust and transparency among users, which is critical for the adoption of new devices that use AI/ML algorithms in clinical practice. Such software tools may be considered for qualification by the FDA Medical Device Development Tools (MDDT) Program.
FDA’s mission is to protect and promote public health. One of the ways it does this is by helping to speed up innovations that help provide methods to demonstrate safety, effectiveness, or performance of medical devices to encourage streamlined medical device development for patients. The FDA MDDT Program is a mechanism for FDA to qualify tools that companies can use in the development and evaluation of medical devices subject to regulatory decision-making by the Center for Devices and Radiological Health (CDRH). More information about the MDDT Program can be found here.
FDA’s MDDT Program collaboration with the NCI SBIR Development Center can help incentivize the small business community to develop and qualify innovative tools for oncology-related regulatory decision-making. These tools can be sold to industry or academia developing new medical devices that would benefit from using the MDDT in product development and evidence generation for a regulatory submission, thus stimulating and supporting translation of innovative devices to the clinic. Given these similar areas of interest, FDA CDRH and NCI SBIR have developed this joint contract topic to support innovation across our overlapping communities. Potential products that could be MDDTs developed under this topic include software tools for evaluating and monitoring existing AI/ML devices used for patient triage, diagnostic imaging, and radiation treatment planning as well as supporting the development of new devices used for diagnostics and therapeutics; for example, to support the evaluation of devices used to support the oncological workflow by helping the user confirm the absence or presence of cancerous lesions, including evaluation, quantification, follow-up, and documentation of any such lesions.
The goal of this contract topic is to stimulate the participation of small businesses in the FDA's MDDT Program to develop and qualify software tools for evaluating and monitoring AI/ML devices in oncology settings. A MDDT can be a method, material, or measurement used to assess the safety, effectiveness, or performance of a medical device. MDDTs can accelerate the device development process by providing developers with qualified tools that do not need to be re-evaluated within each regulatory submission, thus streamlining device development and FDA regulatory decision-making.
The project scope should include a demonstration that the software tool has a reasonable ability to evaluate device safety, effectiveness, and/or performance in a real-world setting. For example, FDA has qualified a modeling software instrument as a MDDT. The software predicts the interactions of medical devices (i.e., medical implants) with the electromagnetic fields in the magnetic resonance imaging environment. The software was validated against actual physical testing of medical device implants. The summary of evidence and qualification for this tool and all other qualified MDDTs can be found here.
Offerors are expected to follow the above requirements and conform to the two phases of the MDDT process. Please note that the MDDT process phases are separate from the SBIR phases.
Proposal Phase: The goal is to determine if the tool is suitable for qualification consideration through the MDDT Program by submitting a Qualification Plan that includes a proposed MDDT description, context of use, an appropriate plan for collecting evidence to support qualification of the tool for the defined context of use, and qualification criteria to describe how the tool is expected to perform. The result of this phase is a FDA determination on whether to advance the tool to the qualification phase.
Qualification Phase: The goal is to determine whether, for the specific context of use, the tool can be qualified based on evidence and justifications provided supporting that the tool operates within the proposed qualification criteria. The data collected according to the Qualification Plan is submitted as the Full Qualification Package and reviewed by FDA for a qualification decision.
During the NCI Phase I contract time period, companies will engage with the FDA in the proposal phase and develop their Qualification Plan for the proposed MDDT. By the end of the Phase I contract, companies will submit their Qualification Plan to the FDA, and the subsequent FDA review will determine if the tool is accepted into the MDDT Program. During the NCI Phase II contract time period, companies will complete activities in the qualification phase.
While not a comprehensive list, several examples of technologies considered responsive to this solicitation include software tools capable of:
- Estimating and reporting the robustness of AI/ML to variation in data acquisition, demographic, or other factors.
- Analyzing AI/ML-based computer-aided triage (CADt).
- Analyzing AI/ML-based computer-aided acquisition and optimization (CADa/o).
- Evaluating specific imaging performance claims and image reconstruction AI/ML-based algorithms in the clinical setting.
- Monitoring AI/ML device performance in the real-world setting over time and for devices that continuously learn from new training data.
- Acquiring data or developing data acquisition methods to support AI/ML evaluation and device comparisons.
Activities that would not be considered responsive to this solicitation include software tools that are not helpful for regulatory decision-making, software that is applicable only to one manufacturer’s device, software that is only applicable to FDA Drug Development Tools (DDT) Program, and other software tools considered to be a medical device.
Phase I Activities and Deliverables:
- Develop a working prototype of the software tool that meets the criteria defined by the FDA MDDT program.
- Prepare a MDDT Qualification Plan using the MDDT Qualification Plan Submission Template which outlines specific information necessary to submit a MDDT Qualification Plan. For additional details review Qualification of Medical Device Development Tools - Guidance for Industry, Tool Developers, and Food and Drug Administration Staff.
- Demonstrate the suitability of the software tool for use in regulatory decision-making (e.g., demonstrate how the tool supports the safety, effectiveness, or performance of the medical device).
- Submit a complete Qualification Plan to the FDA’s MDDT Program. It should include description of the MDDT, context of use, and a detailed plan to collect evidence based on the context of use for qualification of the tool. Use the MDDT Qualification Plan Template for this submission.
- Specify the quantitative technical and commercially relevant milestones that will be used to evaluate the success of the software tool.
- Conduct a pilot usability study of the prototype software tool.
- Develop a strategy/plan which includes a timeline for when you expect to submit a Full Qualification Package for a MDDT.
Phase II Activities and Deliverables:
- Test integration of the tool into the particular clinical workflow applicable to the specific medical device(s) that will be monitored.
- Design and conduct a validation study using the tool in a real-world monitoring setting.
- Develop user support documentation to support all applicable potential users of the tool. Provide a report documenting user support resources, including but not limited to, links to online resources and copies of electronic or paper user support resources as appropriate.
- Prepare a Full MDDT Qualification Package which includes specific requirements and activities with respect to the proposed MDDT.
- Submit a Full Qualification Package to the FDA’s MDDT Program including the data collected according to the FDAaccepted Qualification Plan. Use the MDDT Qualification Package Template for this submission.
- Engage with FDA to determine if your product is a regulated device or MDDT. If warranted, provide sufficient data to submit a regulatory application to obtain approval for clinical application.
Frequently Asked Questions:
1. Who are the potential customers for a MDDT?
MDDTs can be used by other developers, researchers, small businesses, and other industry and research groups who are working to develop medical devices in the same space as the MDDT technology. These tools will facilitate the regulatory decision-making process and expedite the development of new technologies, benefiting both FDA and companies with technologies under FDA review.
2. Will FDA or NCI purchase the MDDT?
Offerors must identify the eventual customers for their tool. NCI and the FDA are not potential customers for this product. These tools can be licensed or sold to medical device manufacturers developing new medical devices that would benefit from using the MDDT in product development and evidence generation for a regulatory submission, thus stimulating and supporting translation of innovative devices to patient care.
3. Are there examples of MDDTs?
Yes, the MDDT page (Medical Device Development Tools (MDDT) | FDA) lists all qualified MDDTs.
4. What happens if my tool is not qualified as an MDDT?
You must submit your qualification plan to the FDA by the end of the Phase I contract. CDRH will review Full Qualification Packages submitted at the end of the Phase II contract and make a qualification decision regarding the tool’s acceptance as a FDA-qualified MDDT. If awarded, companies are highly encouraged to engage the MDDT Program via email (MDDT@fda.hhs.gov) early on and prior to development of their Qualification Plan for the MDDT Program.
Receipt date: November 4, 2022, 5:00 p.m. Eastern Daylight Time
Apply for this topic on the Contract Proposal Submission (eCPS) website.