Announcement of Requirements and Registration for DEBUT 2024

Announcement of Requirements and Registration for the 2024 Design by Biomedical Undergraduate Teams (DEBUT) Challenge

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH

National Institute of Biomedical Imaging and Bioengineering

Authority: 15 U.S.C. 3719

Date of Announcement: January 27, 2024

DESCRIPTION

Subject of the Challenge

The NIBIB DEBUT Challenge solicits design projects that develop innovative solutions to unmet health and clinical problems. Areas of interest for the biomedical engineering projects include, but are not limited to: diagnostics, therapeutics, technologies for underserved populations or low-resource settings, point-of-care systems, precision medicine, preventive medicine, technologies to aid individuals with disabilities, prevention, diagnosis, treatment, and care of diseases and illnesses such as cancer or HIV/AIDS. In addition to prizes where there is no restriction on the healthcare technology being developed, five categorical prizes will be awarded on:

HIV/AIDS prevention and care, with funds from the NIH Office of AIDS Research (OAR),
Healthcare technologies for underrepresented populations and/or for low-resource settings, with funds from the National Institute on Minority Health and Health Disparities (NIMHD),
Technologies for cancer prevention, diagnosis or treatment, with funds from the National Cancer Institute (NCI),
Rehabilitative and assistive technologies for the functional and healthcare needs of people with physical disabilities, with funds from the National Center for Medical Rehabilitation Research at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and
Technologies to empower nurses in community settings, with funds from the National Institute of Nursing Research (NINR).
Technologies to address problems faced by people with kidney diseases, their families, nephrologists, and other care providers, with funds from the National institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Undergraduate student teams participating in capstone design projects are especially encouraged to enter the Challenge.

To support and expand the DEBUT Challenge, the NIBIB has joined forces with VentureWell, a not-for-profit leader in funding, training, coaching and early investment that brings student innovations to market. This public-private partnership on DEBUT allows student teams to compete for prizes offered by both NIBIB and VentureWell by submitting one application. Student Teams entering the Challenge will have the option to have their entries also considered for prizes offered by VentureWell. VentureWell prizes will be selected and awarded by VentureWell following a separate judging process. The rules for the VentureWell prizes and the additional submission components that are required to compete for them can be found at: https://venturewell.org/students/debut/guidelines.

Partners:

NIH Office of AIDS Research (OAR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Cancer Institute (NCI)
National Center for Medical Rehabilitation Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Nursing Research (NINR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
VentureWell

Dates:

Challenge Launch: January 17, 2024
Submission Period: January 17, 2024 to May 31, 2024, 11:59 PM EDT.
Judging Period: June 7, 2024 to August 19, 2024
Winners announced: August 26, 2024
Award ceremony: October 2024, Biomedical Engineering Society Conference, Baltimore, Maryland

Statutory Authority to Conduct the Challenge:

NIBIB is conducting this Challenge under the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010, as amended [15 U.S.C. § 3719].

The general purpose of NIBIB is the conduct and support of research, training, the dissemination of health information, and other programs with respect to biomedical imaging, biomedical engineering, and associated technologies and modalities with biomedical applications. In line with these authorities, by challenging undergraduate students to identify unmet clinical needs and develop innovative solutions for them, NIBIB targets the education of biomedical engineers who have the background, skills, and confidence to make outstanding contributions to biomedical technologies. Engaging undergraduate students to work in teams to design, build and debug solutions to real-world problems/needs in healthcare not only prepares them to function effectively in their future work environment, but also yields novel, innovative biomedical tools that can transform healthcare.

PRIZES

Amount of the Prize:

The 1st (“The Steve H. Krosnick Prize”), 2nd, and 3rd place prizes will be $20,000, $15,000, and $10,000, respectively. Up to five honorable mentions will be selected to receive $1,000 each. Above prizes have no restriction on the topic of the healthcare technology solution being proposed. In addition, five categorical prizes will be offered:

The HIV/AIDS Prize for $15,000 awarded to the most meritorious entry developing engineering-based/technological solutions to current HIV/AIDS prevention and/or health care needs.
The Healthcare Technologies for Low Resource Settings Prize for $15,000, awarded to the most meritorious entry developing technology solutions to meet the healthcare needs of underrepresented populations or to advance healthcare in low-resource settings. (Low resources settings are limited to settings located in the United States, U.S. territories or possessions.)
Technologies for Cancer Prevention, Diagnosis or Treatment Prize for $15,000, awarded to the most meritorious entry developing technology solutions that address unmet needs in the prevention, detection and treatment of cancer, to reduce incidence of cancer or improve survival and quality of life for cancer patients; or enhance the performance, cost-effectiveness, applicability, availability or accessibility of existing cancer-related technologies.
The Rehabilitative and Assistive Technologies Prize for $15,000, awarded to the most meritorious entry developing technology solutions that address the functional and healthcare needs of people with physical disabilities.
The Technologies to Empower Nurses in Community Settings Prize for $15,000, awarded to the most meritorious entry to address problems faced by nurses in community settings where they engage in prevention, treatment, and care; such as schools and workplaces, homes and long-term care facilities, justice settings, or other settings throughout the community.
The Kidney Technology Development Prize for $15,000, awarded to the most meritorious entry to develop ground-breaking solutions to problems faced by people with kidney diseases, their families, nephrologists, and other care providers.

In addition to monetary prizes:

All NIH prize winners (including honorable mentions and non-U.S. citizen members of winning teams) will have the chance to partake in a self-paced, online commercialization course with didactic content, including embedded videos, covering the following concepts necessary to commercialize healthcare solutions: unmet need, value proposition, interviewing, proof-of-concept testing, regulatory, reimbursement, and milestone-driven go-to-market strategy.
Of the winning teams that complete the online course, up to 3 teams will be offered, at NIBIB’s discretion, the chance to participate in a second phase of commercialization training, d3Ci--Young Innovators. These teams will be selected based on the team’s completion of the online course, quality of the completed coursework and exercises, and effective participation in office hours, as evaluated by NIH staff. In d3Ci--Young Innovators, each team will engage in further exercises to commercialize their project, with the assistance of an assigned project manager, leading up to a final presentation to a group of four business advisors that will provide feedback.
In addition, NIBIB will consider offering additional in-kind support to DEBUT prize winners, which may include an invitation to tour the NIH campus. However, such additional in-kind support is not guaranteed and will only be provided at the discretion of NIBIB.

For each winning team, contributions of all team members will be recognized in announcements, plaques or certificates, and the monetary prize will be distributed equally among the cash-prize-eligible Student Team members, i.e., undergraduate students who are either citizens or permanent residents of the United States. Each cash-prize-eligible member of the winning Student Teams must provide his/her bank information to enable electronic transfer of funds.

Winning Student Teams will be honored at the DEBUT Award Ceremony during the 2023 Annual Meeting of the Biomedical Engineering Society (BMES) in Seattle, Washington in October 2023. Updated information on the BMES annual meeting can be found at https://www.bmes.org/annualmeeting. NIBIB will not provide financial support for winning Student Teams or Honorable Mention awardees to attend the award ceremony. However, they are welcome and encouraged to attend the award ceremony or designate a representative to attend on their behalf.

NIBIB will award up to a total of $125,000 to the Challenge winner(s). VentureWell has indicated its intent to also award up to $20,000 to the Challenge winner(s). If VentureWell fails to pay any portion of the monetary prize it has indicated it intends to pay, NIH/NIBIB does not have the legal authority to pay the amount on their behalf. For more information, please contact VentureWell.

Award Approving Official:

The NIBIB Award Approving Official will be Bruce J. Tromberg, Ph.D., Director of NIBIB.

Payment of the Prize:

Prizes may be subject to Federal income taxes. Prize winners will be responsible for any applicable local, state, and federal taxes and reporting that may be required under tax laws. Monetary prizes awarded under this Challenge will be paid by electronic funds transfer by a third-party vendor under contract with NIH/HIBIB; prizes will not be paid directly by NIH/NIBIB. The Team Captain of each Student Team winning an NIH prize, including Honorable Mentions, will be contacted by NIH Staff to provide them with registration/participation information for the optional commercialization training.

Prizes offered by VentureWell will be paid directly by them.

NIH reserves the right, in its sole discretion, to (a) cancel, suspend, or modify the Challenge, or any part of it, for any reason, and/or (b) not award any prizes if no entries are deemed worthy.

RULES

Eligibility Rules for Participating in the Challenge:

To be eligible to win a prize under this Challenge, an individual must be a member of a “Student Team” as described below, and each individual of a “Student Team”:
- Must be an undergraduate student enrolled full-time in an undergraduate curriculum in a U.S. college or university during at least one full semester (or quarter if the institution is on a quarter system) of the 2022-2023 academic year;
- Must form or join a “Student Team” with at least two and not more than seven other individuals for the purpose of developing an entry for submission to this Challenge. (Therefore, Student Teams must include between three and eight individuals.) Each student on the Student Team must satisfy all the requirements for competing in this Challenge. Interdisciplinary teams including students from different departments/colleges are welcome and encouraged to enter the challenge. For submissions from institutions that have a biomedical engineering or bioengineering department, at least one student on the team must be majoring in biomedical engineering or bioengineering. The requirement of at least one biomedical engineering or bioengineering major is waived for student teams from institutions without a formal biomedical engineering or bioengineering department;
- Shall be a citizen or permanent resident of the United States. Non-U.S. citizen or non-U.S. permanent-resident students who are studying in the United States are eligible to be part of the competing Student Teams. However, they will not receive a monetary prize if they are part of a winning Student Team. See Prize section above for the distribution of prizes. As acknowledgement of their participation; however, the names of non-U.S. citizen or non-U.S. permanent-resident students who are part of winning Student Teams will be listed among the winning team members when results are announced and at the award ceremony. Additionally, these students will be eligible to participate in both the online course and the d3Ci--Young Innovators components of the commercialization training offered to winning teams;
- Must be a member of only one Student Team;
- Must be 13 years of age or older. Individuals who are younger than 18 must have their parent or legal guardian complete the Parental Consent Form;
- Shall have agreed to be registered by the Team Captain (selected by the Student Team) to participate in the Challenge under the rules promulgated by the NIH as published in this announcement;
- Shall have complied with all the requirements set forth in this announcement;
- May not be a Federal entity or federal employee acting within the scope of their employment;
- May not be a Federal employee of the Department of Health and Human Services (HHS), or any other component of HHS, acting in their personal capacity;
- Who is employed by a Federal agency or entity other than HHS (or any component of HHS), should consult with an agency Ethics Official to determine whether the federal ethics rules will limit or prohibit the acceptance of a prize under this (DEBUT) Challenge;
- May not be a judge of the Challenge, or any other party involved with the design, production, execution, or distribution of the Challenge or the immediate family of such a party (i.e., spouse, parent, step-parent, child, or step-child); and
- Must acknowledge understanding and acceptance of the DEBUT Challenge rules by signing the NIBIB DEBUT Challenge Certification Form. Each entry must include one NIBIB DEBUT Challenge Certification Form, completed with each Student Team member's information and signed and dated by each individual member of the Student Team. Entries that do not provide a complete Certification Form will be disqualified from the Challenge.
Each Student Team must appoint a “Team Captain” to carry out all correspondence regarding the Student Team’s entry. The Team Captain must be a citizen or permanent resident of the United States.
Each entry into this Challenge must have been conceived, designed, and implemented by the Student Team without any significant contribution from other individuals.
Entries that have been submitted to the DEBUT Challenge in prior years may be submitted again, by the same team, only if they have not won any prizes in the past.
Students or student teams who have won DEBUT prizes in the past may enter the Challenge again with a different entry, but not the one that won a prize in a previous DEBUT Challenge.
Federal grantees may not use Federal funds to develop their Challenge submissions or to fund efforts in support of their Challenge submissions.
Federal contractors may not use Federal funds from a contract to develop their Challenge submissions or to fund efforts in support of their Challenge submission.
Submissions must not infringe upon any copyright or any other rights of any third party.
By participating in this Challenge, each individual agrees to assume any and all risks and waive claims against the Federal government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from participation in this Challenge, whether the injury, death, damage, or loss arises through negligence or otherwise.
Based on the subject matter of the Challenge, the type of work that it will possibly require, as well as an analysis of the likelihood of any claims for death, bodily injury, property damage, or loss potentially resulting from Challenge participation, no individual participating in the Challenge is required to obtain liability insurance or demonstrate financial responsibility in order to participate in this Challenge.
By participating in this Challenge, each individual agrees to indemnify the Federal government against third party claims for damages arising from or related to Challenge activities.
An individual shall not be deemed ineligible because the individual used Federal facilities or consulted with Federal employees during the Challenge if the facilities and employees are made available to all individuals participating in the Challenge on an equitable basis.
By participating in this Challenge, each individual grants to NIBIB an irrevocable, paid-up, royalty-free, nonexclusive worldwide license to post, link to, share, and display publicly the entry on the Web, newsletters or pamphlets, and other information products. It is the responsibility of the individuals on the Student Team to obtain any rights necessary to use, disclose, or reproduce any intellectual property owned by third parties and incorporated in the entry for all anticipated uses of the entry.
Each individual agrees to follow all applicable federal, state, and local laws, regulations, and policies.
Each individual participating in this Challenge must comply with all terms and conditions of these rules, and participation in this Challenge constitutes each such participant’s full and unconditional agreement to abide by these rules. Winning is contingent upon fulfilling all requirements herein.

JUDGING CRITERIA

Basis Upon Which a Winner Will be Selected:

Entries will be judged by a panel of NIH staff. This panel may take into consideration the preliminary technical assessment provided by external subject matter experts in the field. The final winner selections will be approved by the Director of NIBIB.

The winning entries will be judged based on the following criteria:

Significance of the problem addressed— Does the entry address an important problem or a critical barrier to progress in clinical care or research?
Impact on potential users and clinical care—How likely is it that the entry will exert a sustained, powerful influence on the problem and medical field addressed?
Innovative design (creativity and originality of concept)—Does the entry utilize novel theoretical concepts, approaches or methodologies, or instrumentation?
Working prototype that implements the design concept and produces targeted results—Has evidence been provided (in the form of results, graphs, photographs, films, etc.) that a working prototype has been achieved?

Each team will receive an Ideation and a Prototype Score. The Ideation Score will be based on the significance, impact, and innovative design criteria weighed equally. The Prototype Score will be based on the significance, impact, innovative design criteria, and working prototype criteria, weighed equally. The team's final score will be the higher of the two. Prizes will be selected based on the final scores.

HOW TO ENTER

Registration Process and Submission Requirements:

Each Student Team may submit only one entry into this Challenge through the Team Captain. The Team Captain will register at https://venturewell.org/debut/ and follow the links and instructions to certify that the entry meets all the Challenge rules and submit the Student Team’s entry on behalf of the Student Team. At this time, teams will have the option to indicate that they wish to have their entries considered also for prizes sponsored by VentureWell. For a description of these prizes and rules of participation, see https://venturewell.org/students/debut/guidelines.
Each entry must comply with Section 508 standards that require federal agencies’ electronic and information technology be accessible to people with disabilities, https://www.section508.gov/.
Each entry must be submitted as a single pdf file including the following 4 components:
i.    The NIBIB DEBUT Challenge Certification Form (downloadable from https://www.nibib.nih.gov/sites/default/files/2022-12/NIBIB-DEBUT-Certification-Form-2023.pdf) completed with project title and team member information, printed names, indication of U.S. citizenship or permanent residency, dates, and signatures of each individual member of the Student Team.
ii.   Project Narrative (not to exceed 6 pages using Arial font and a font size of at least 11 points) that includes the following 6 sections:

            1.) Abstract

            2.) Description of clinical need or problem, including background and current methods available. When
                 the submitted entry is part of a bigger/ongoing project, the specific components designed and
               implemented by the competing Student Team must be clarified and distinguished from those
                 accomplished by others (e.g., other students, advisor, collaborators).

                 Teams wishing to be considered for the HIV/AIDS Prize should indicate this in this section and
                 discuss how their project advances or develops technology for HIV/AIDS prevention and/or care.
                 These teams are encouraged to visit https://www.oar.nih.gov/ and study the OAR research areas
                 and priorities.

                 Teams wishing to be considered for the Healthcare Technologies for Low-Resource Settings Prize
                 should indicate so in this section and discuss how their technology advances healthcare for
                 underrepresented populations or meets healthcare needs in low resource settings. These teams
                 are encouraged to visit www.nimhd.nih.gov and study the NIMHD Minority Health and Health
                 Disparities Research Framework
                 (https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html) to explore
                 factors contributing to health disparities.

                 Teams wishing to be considered for the Technologies for Cancer Prevention, Diagnosis or
                 Treatment Prize should indicate so in this section and discuss how their technology advances the
                 prevention, detection or treatment of cancer, to reduce incidence of cancer or improve survival and
                 quality of life for cancer patients. These teams are encouraged to visit both cancer.gov to learn
                 about NCI’s overall mission and areas of engagement, as well as the Annual Plan
                 (https://www.cancer.gov/research/annual-plan) to see some specific areas that are highlighted
                 there.

                 Teams wishing to be considered for the Rehabilitative and Assistive Technologies Prize should
                 indicate so in this section and discuss how their technology advances the functional and healthcare
                 needs of people with physical disabilities. These teams are encouraged to visit
                 https://www.nichd.nih.gov/about/org/ncmrr to learn about the overall mission and areas of
                 engagement for NICHD’s National Center for Medical Rehabilitation Research (NCMRR).

                 Teams wishing to be considered for the Technologies to Empower Nurses in Community Settings
Prize should indicate so in this section and discuss how their technology will enable nurses to improve
patient care in community settings such as schools, workplaces, homes, long-term care facilities,
justice settings, or other settings throughout the community. Teams are encouraged to visit
https://www.ninr.nih.gov/ to learn more about NINR’s mission, and the Research Framework
(https://www.ninr.nih.gov/aboutninr/ninr-mission-and-strategic-plan/research-framework) to learn more
about NINR’s priorities and settings of interest.

Teams wishing to be considered for the Kidney Technology Development Prize should indicate so in this section and
discuss how their technology will address problems faced by people with kidney diseases, their families,
nephrologists, and other care providers. Teams are encouraged to visit https://www.niddk.nih.gov/ to learn more
about NIDDK’s mission, and the NIDDK Strategic Plan
(https://www.niddk.nih.gov/about-niddk/strategic-plans-reports)
to learn more about NIDDK’s research priorities and strategic vision.

            3.) Project objective statement, describing the approach to address the problem, including a
                  discussion of the innovative aspects

            4.) Documentation of the design, providing sufficient detail

            5.) Documentation of the prototype of the final design, with photographs, graphical representations,
or link to a video, as appropriate. Indicate if the design is functional and solves the problem. If so,
provide proof and discuss how the efficacy of the device was evaluated, including test results,
graphics obtained with the designed solution and comparison to existing device outputs.

                 Teams that did not achieve a prototype should indicate so here and state the reason for why a
prototype was not achieved. These teams will compete based on their Ideation Score only.

            6.) A link to a 3-minute video describing the project is required, whether a prototype was achieved or
                 not. The video must include background and the problem addressed, the conceptual design and
                 how it solves the problem addressed. Teams that have achieved a prototype must display it here
                 and if functional, demonstrate its successful operation. This link may be provided in this section and
                 will be requested separately during the online submission process.

                 The 6-page limit includes any graphics, but excludes the certification form, parental consent form,
                 and any references. Submissions exceeding 6 pages for the Project Narrative will not be accepted.

                 Optional supporting material: The following optional supporting material may be submitted as a
separate pdf file and will not count towards the 6-page limit: up to three support letters from
stakeholders (patients, healthcare providers, industry, etc.); up to three supporting articles, reports,
etc. that present background information for your project; and up to 3 links to videos and/or websites.
However, the judges will mainly review the required components of your submission and may consider
the optional material at their discretion.

iii. Sponsor letter, on department letterhead, from a faculty member from the Biomedical Engineering, Bioengineering
or similar department of the institution in which the Student Team members are enrolled, verifying: a) that the entry
was achieved by the named Student Team, b) that each member of the team was enrolled full-time in an undergraduate
curriculum during at least one semester or quarter of the academic year 2022-2023 and c) describing clearly any
contribution from the advisor or any other individual outside the Student Team (especially when the submitted entry is
part of a bigger/ongoing project, the specific components designed and implemented by the competing Student Team
must be clarified and distinguished from those accomplished by others). For submissions from institutions without a
formal biomedical engineering or bioengineering department, the sponsor letter may be provided by a faculty member
familiar with the student team and the conception, design, implementation, and testing of their project.

iv. A completed Parental Consent Form, downloadable from
     https://www.nibib.nih.gov/sites/default/files/Parental%20Consent%20Form.pdf,
     for each individual on the Student Team who is under the age of 18.

ADDITIONAL INFORMATION

Supplementary Information: For more information and to submit entries, visit https://www.nibib.nih.gov/training-careers/undergraduate-graduate/design-biomedical-undergraduate-teams-debut-challenge/ or https://venturewell.org/students/debut.

For Further Information Contact: info@nibib.nih.gov or (301) 451-4792.

January 17, 2024
Bruce J. Tromberg, Ph.D., Director, NIBIB