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.
Oncology data science and analytics is a burgeoning area of machine learning (ML) and artificial intelligence (AI) technologies that have fueled unprecedented levels of interest across the industrial and academic sectors. The past few years have witnessed many startups and large companies focusing on ML/AI technologies with the aim of reducing complexities in clinical workflow or increasing accuracy in detection, diagnosis, and treatment of cancer. To that end large, well-characterized datasets with the best available ground truth/reference standard and relevant metadata are essential for developing machine-based applications in cancer. While tremendous amounts of data are generated through clinical practice, significant gaps remain to leveraging the data for device development and evaluation, including: 1) generation/acquisition of patient outcome data; 2) truthing of images by clinicians; 3) correlation of combined imaging, comprehensive clinical, and genomic data in common repositories for developers; 4) extraction of information from unstructured electronic health records (EHR) data; and 5) availability of infrequent, but clinically relevant, variants. The goal of this topic is to promote and support an unmet need for the development of large, well-curated, and statistically robust datasets that can be used for the evaluation of cancer medical devices subjected to regulation by Center for Devices and Radiological Health (CDRH). Such datasets may be used in scientific research, to develop new devices as a measure of device performance, and have a regulatory use appropriate for the FDA Medical Device Development Tool program. A tool eligible for consideration by the MDDT Program is one that reduces the regulatory burden of industry and the FDA.
FDA’s mission is to protect and promote public health by helping to speed innovations that make medical products safer and effective for the public. To qualify a dataset as an MDDT, the FDA evaluates the dataset and concurs with the available supporting evidence that the dataset produces scientifically plausible measurements and works as intended within the specified context of use. More information about the FDA’s 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 device technologies that would benefit from using the MDDT in their 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 stimulate and support innovation across our overlapping communities.
The goal of this contract topic is to stimulate the participation of small businesses in the FDA's MDDT program to develop and demonstrate the utility of qualified datasets as MDDTs to assess medical devices subject to regulation by CDRH. An MDDT can be a method, material, or measurement used to assess the effectiveness, safety, or performance of a medical device. The functionalities of such medical devices run the gamut in the cancer care continuum including prevention, detection, diagnosis, treatment planning etc. Datatypes of interest cover a broad range of data produced by those devices, and include, but are not limited to, imaging (radiology and pathology), cancer genomics, proteomics, structured data extracted from unstructured EHR, and treatment outcome data. In order to achieve the goal of developing datasets as MDDTs for a specified context of use, each dataset may have the following technical characteristics:
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 MDDT is suitable for qualification consideration through the MDDT Program by submitting a Qualification Plan that includes MDDT description, context of use, and an appropriate plan for collecting evidence to support qualification of the tool for the defined context of use. The FDA makes a decision on whether to advance the tool to the qualification phase.
Qualification Phase: The goal is to determine whether, for a specific context of use, the tool is qualified based on the evidence and justifications provided. The data collected according to the Qualification Plan is submitted as the Full Qualification Package and reviewed by FDA for qualification decision.
During the NCI Phase I contract time period, companies will engage with FDA in the proposal phase and develop their Qualification Plan for the MDDT. By the end of the Phase I contract, companies will submit their Qualification Plan to FDA, and 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.
Examples of technologies considered responsive to this solicitation include, cancer diagnostics (e.g., laboratory in vitro, imaging in vivo) and therapeutics (e.g., chemo, radiation, surgery, and immunotherapy).
Activities that would not be responsive under this announcement include datasets solely for the purpose of algorithm training and acquired without proper statistical considerations, or datasets that are applicable to assessing performance of only a single manufacturer’s device design.
1. Who are the potential customers for an MDDT?
MDDTs can be used by other developers, researchers, small businesses, and other industry and research groups who are working to develop technologies 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.
3. Are there examples of MDDTs?
Yes, the MDDT page (https://www.fda.gov/medical-devices/science-and-research-medical-devices...) lists some examples of MDDTs. There are no examples in the biomarker or the dataset spaces, which is one reason that the FDA and NCI are interested in supporting offerors working in these areas.
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 an FDA-qualified MDDT. This risk is mitigated by a company developing their Qualification Plan in accordance with CDRH feedback prior to submitting their final Qualification Plan to FDA. If awarded, companies are highly encouraged to engage FDA early on when developing their Qualification Plan for the MDDT Program.
Receipt date: October 28, 2021, 5:00 p.m. Eastern Daylight Time
Apply for this topic on the Contract Proposal Submission (eCPS) website.
Inquiries: Cherie Wells (email@example.com)