DEBUT Guidelines

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) and VentureWell have come together to support and expand DEBUT, a competition that recognizes undergraduate excellence in biomedical design and innovation. DEBUT challenges teams of students in undergraduate biomedical education to solve real world problems in healthcare. Prizes of up to $20,000 will be awarded, with a total prize purse of $160,000. Strong DEBUT submissions will demonstrate a mastery of analytical and design skills and capabilities; the ability to manage the product development process; the ability to work effectively in teams; and technical communication skills. Submissions will be judged on the following criteria:

• Significance of the problem being addressed
• Impact of proposed solution on potential users and clinical care
• Innovative design
• Working prototype

Additional prizes will be awarded to entries that also demonstrate:

• Market potential and economic feasibility
• Patentability

In addition, five honorable mentions will be awarded with cash prizes.

The deadline for submission is May 31, 2024. Winners will be announced on August 26, 2024.

Winning teams will be honored at an award ceremony during the Annual Meeting of the Biomedical Engineering Society in October 2024.

All applications must be submitted online. We strongly recommend that you read these guidelines in full before applying.

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In past years, undergraduate student teams have applied separately to NIBIB’s DEBUT challenge and to VentureWell’s BMEStart competition. In 2016, the two organizations formed a public/private partnership called the DEBUT Challenge, allowing student teams to submit one application and giving teams more chances to win a prize in recognition of their technology solution.

NIBIB’s goals, specifically, are 1) to provide undergraduate students valuable experiences such as working in teams, identifying unmet clinical needs, and designing, building and debugging solutions for such open-ended problems; 2) to generate novel, innovative tools to improve healthcare, consistent with NIBIB’s purpose to support research, training, the dissemination of health information, and other programs with respect to biomedical imaging and engineering and associated technologies and modalities with biomedical applications; and 3) to highlight and acknowledge the contributions of biomedical engineering to advancing healthcare.

VentureWell’s goals for the competition are to challenge undergraduates to learn, practice, and demonstrate their technical, creative, and innovative capabilities by addressing a real clinical need and documenting the promise of 1) technical, economic and regulatory feasibility; 2) technological innovation; and 3) potential for commercialization of the solution described.

Strong DEBUT submissions will define a healthcare problem and demonstrate the development of a device, product, or technology designed to solve it. Examples include but are not limited to: surgical devices, home health care devices, diagnostic, therapeutic, and preventative applications, rehabilitative and assistive technologies, technologies for underserved populations and low-resource settings, point-of-care systems, precision medicine, or other innovations that will have a substantial impact on clinical care and patient outcomes.

DEBUT is open to undergraduate students only. Students enrolled in senior biomedical engineering capstone design courses are especially encouraged to apply to DEBUT. Multidisciplinary teams are also encouraged to apply and may include undergraduate students from diverse fields such as business, nursing, physical therapy, life sciences, physical sciences, or other related disciplines. Inter-institutional collaborations are also encouraged; in these cases we require a faculty advisor from each institution.

For applications 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.

See full eligibility requirements for each sponsor under rules of participation for NIBIB and VentureWell prizes.

Team members have rights to all intellectual property, subject to the rules of their home institutions, unless assigned to others in exchange for support, sponsorship, or funding. Teams will be encouraged to retain a significant and motivating interest in their project results.

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Eleven DEBUT prizes (plus honorable mentions) will be awarded. Prize categories and amounts are listed below.

NIBIB-sponsored prizes include:

First prize: The Steven H. Krosnick Prize: $20,000

Second prize: $15,000

Third prize: $10,000

HIV/AIDS Prize: $15,000, awarded with funds from the NIH Office of AIDS Research to the most meritorious entry developing engineering-based/technological solutions to current HIV/AIDS prevention and/or health care problems.

Healthcare Technologies for Low-Resource Settings Prize: $15,000, awarded with funds from the National Institute of Minority and Health Disparities 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 with funds from the National Cancer Institute 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.

Rehabilitative and Assistive Technologies Prize for $15,000, awarded with funds from the National Center for Medical Rehabilitation Research at the Eunice Kennedy Shriver National Institute of Child Health and Human Development to the most meritorious entry developing technology solutions that address the functional and healthcare needs of people with physical disabilities.

Technologies to Empower Nurses in Community Settings Prize for $15,000, awarded with funds from the National Institute of Nursing Research 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.

New! Kidney Technology Development Prize for $15,000, awarded with funds from the National Institute of Diabetes and Digestive and Kidney Diseases 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.

Additionally, five Honorable Mentions will be awarded with prizes of $1,000 each.

All NIH prize winners will be offered commercialization training. See Amount of the Prize section below.

VentureWell-sponsored prizes include:

Venture prize: $15,000

Design Excellence prize: $5,000

These prizes are made possible with support from The Lemelson Foundation, in partnership with IEEE EMBS, the Biomedical Engineering Society (BMES), and the Council of Chairs of Bioengineering and Biomedical Engineering Programs.

Applying teams must indicate which prizes they wish to be considered for as part of the application process. Teams may choose to be considered for NIBIB prizes only, VentureWell prizes only, or all prizes. The rules for participation for each sponsor’s prizes are outlined below. It is each team’s responsibility to check and abide by the rules of any and all prizes for which they wish to be considered.

Each winning team will be awarded one prize only. For NIBIB-funded prizes, contributions of all team members will be recognized in announcements, plaques or certificates, and the monetary prize will be distributed equally among the prize-eligible Student Team members, i.e., undergraduate students who are either citizens or permanent residents of the United States. Each prize-eligible member of the winning Student Teams must provide his/her bank information to enable electronic transfer of funds (requested upon notification of winning status). VentureWell-funded prizes are awarded to the winning team’s university to be distributed at the discretion of the Faculty Advisor.

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(1) 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”:

a) Must be an undergraduate student enrolled full-time in an undergraduate curriculum during at least one full semester (or quarter if the institution is on a quarter system) of the 2023-2024 academic year;

b) 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;

c) 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 below 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 dC3i—Young Innovators components of the commercialization training offered to winning teams;

d) Must be a member of only one Student Team;

e) 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;

f) 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;

g) Shall have complied with all the requirements set forth in this announcement;

h) May not be a Federal entity or federal employee acting within the scope of their employment;

i) 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;

j) 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;

k) 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

l) 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.

(2) 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. Correspondence by other members of the Student Team or by faculty sponsors will not be considered to be official correspondence on behalf of the Student Team.

(3) Each entry into this Challenge must have been conceived, designed, and implemented by the Student Team without any significant contribution from other individuals.

(4) 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.

(5) 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.

(6) Federal grantees may not use Federal funds to develop their Challenge submissions or to fund efforts in support of their Challenge submissions.

(7) 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.

(8) Submissions must not infringe upon any copyright or any other rights of any third party.

(9) 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.

(10) 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.

(11) 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.

(12) 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.

(13) 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.

(14) Each individual agrees to follow all applicable federal, state, and local laws, regulations, and policies.

(15) 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.

Registration Process and Submission Requirements for Participants

(1) 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 http://venturewell.org/students/debut/guidelines.

(2) Each entry must comply with Section 508 standards that require federal agencies’ electronic and information technology be accessible to people with disabilities, http://www.section508.gov/.

(3) Each entry must be submitted as a single pdf file including the following 4 components:

a) The NIBIB DEBUT Challenge Certification Form, 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.

b) 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:

i) Abstract

ii) 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. 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. Teams are encouraged to visit https://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 https://www.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.

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

iv) Documentation of the design, providing sufficient detail

v) 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.

vi) A link to a 3-minute video describing the project is required. The video must include background and the problem addressed, the conceptual design and how it solves the problem addressed. Functional prototypes should be displayed in the video to demonstrate their 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, title page 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 application and may consider the optional material at their discretion.

c) 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 2023-2024 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.

d) 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.

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. 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, six categorical prizes will be offered:

1. 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 problems; and
2. 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.)
3. 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.
4. 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.
5. 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 setting 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.
6. New! 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, dC3i—Young Innovator. 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 dC3i—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 prize-eligible Student Team members, i.e., students who are either citizens or permanent residents of the United States. Each 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 NIBIB DEBUT Award Ceremony during the 2024 Annual Meeting of the Biomedical Engineering Society (BMES) in Baltimore, Maryland, in October 2024. Updated information on the BMES annual meeting can be found at https://www.bmes.org/annualmeeting. Neither NIBIB nor VentureWell will 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 $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/NIBIB; 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 VentureWell.

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.

Judging Criteria

Basis Upon Which 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 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?

Additional Information: For more information visit the National Institute of Biomedical Imaging and Bioengineering (NIBIB) website.

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VentureWell sponsors the Venture prize ($15,000) and the Design Excellence prize ($5,000). As stated in the Introduction section of these guidelines, in order to be considered for VentureWell prizes teams must also meet the following criteria:

• Consist of all undergraduate students
• Include at least one biomedical engineering or bioengineering student.
• Be working on a product that 1) solves a clinical problem; 2) features a novel and practical solution; 3) includes a description of potential intellectual property and how it could be protected; and 4) shows market potential.
• Submit a complete application package, as described in the “preparing your application” section of these guidelines.

VentureWell-sponsored prizes are awarded to each winning team’s department, to be allocated at the discretion of the Faculty Advisor. Prizes are not awarded to individuals or ventures.

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NIBIB and VentureWell claim no rights to intellectual property. Team members will have the rights to all intellectual property, subject to the rules of their home institutions, unless assigned to others in exchange for support, sponsorship, or funding. NIBIB and VentureWell take no financial or ownership interest in the projects entered into this challenge. However, by checking off the box to be considered for a sponsor’s prizes, your team grants to that sponsor (NIBIB and/or VentureWell), an irrevocable, paid-up, royalty-free, nonexclusive worldwide license to post, link to, share, and display publicly the challenge entry (application) on the Web, newsletters or pamphlets, and other information products.

Please read and understand your institution’s Intellectual Property policy before submitting an application. Teams are advised to address intellectual property filings prior to submission.

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All applications must be submitted online by a “Team Captain.” If your team wants to compete for NIBIB prizes, the Team Captain must be a US citizen or permanent resident; if you want to compete for VentureWell prizes only, anyone on the team can be the Team Captain. To start and submit an application, click here. You may start, save, stop, and return to your online proposal at any time before submitting.

Please read the “Preparing your application: required and optional components” section to make sure you correctly prepare the necessary components.

All applications must be submitted by 11:59 pm Eastern Time on the day of the deadline unless otherwise indicated.

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As part of the online application process, you will be prompted to upload the following components into your submission:

Required application components

Applications not containing all of these components will be considered incomplete and ineligible.

1. A single PDF file containing:

• • NIBIB DEBUT Challenge Certification Form *(you can omit this form if you do not wish to be considered for NIBIB prizes)
  • DEBUT Parental Consent Form *for any students under the age of 18 (you can omit this form if you do not wish to be considered for NIBIB prizes)
  • Project narrative (see below for details)
  • Faculty letter(s)

We strongly encourage the following naming convention for this PDF: “YourTeamName_YourUniversity_DEBUT”.

2. A link to a 3-minute video describing your project and demonstrating you have achieved a working prototype (see below for details).

Optional Application Components

You may choose to include the following additional material to aid the judges’ evaluation of your project. However, the judges will mainly review the required components of your application and may consider the optional material at their discretion. Optional supporting documents combined together in a single PDF (up to three total) include:

• Support letters from stakeholders (patients, healthcare providers, industry, etc.)
• Supporting articles, reports, etc. that present background information for your project
• Optional videos and/or web links up to three links can be included (websites, video links, articles, etc.).

We strongly encourage the following naming convention for this PDF: “YourTeamName_YourUniversity_DEBUT_Appendices”.

Detailed instructions for preparing the required application components
Please prepare the following required documents, combined together in a single PDF in the following order:

(1) DEBUT Certification Form
Click here to download the NIBIB DEBUT Challenge Certification Form*. Please fill out the requested information about the project and for each team member. Note that the form needs to be signed by all team members; leave yourself enough time to obtain all signatures. If you wish to compete for VentureWell prizes only (Design and/or Venture), you may omit this form.

(2) Parental/Legal Guardian Consent Form (for any team member under 18 years of age)
For any/all team members under 18 years of age, the Parent/Legal Guardian Consent Form must be completed and included after the Certification Form. Click here to download the DEBUT Parental Consent Form*. If you wish to compete for VentureWell prizes only (Design and/or Venture), you may omit this form.

(3) Project Narrative Description and Guidelines
The narrative must adhere to the page limits specified below (using Arial and a font size of at least 11 points). Please include any images referenced in your narrative in the body of the narrative, NOT as appendices. Recommended lengths for each section are included as a guide, but the total narrative must abide by the appropriate page limit below:

• • Teams wishing to be considered for NIBIB prizes only: address sections 1-5 in your narrative description. Page limit: 6 pages.
  • Teams wishing to be considered for VentureWell prizes (alone or in addition to the NIBIB-prizes): address all sections. Page limit: 10 pages.

The project narrative/description includes the following sections:

1. Abstract (no more than 250 words). Brief description of the problem and addressed and the solution achieved.
2. Description of the problem (1/2 page). What is the problem you have solved? What is the clinical problem or the health and/or market need that you addressed? Teams wishing to be considered for category-specific prizes should indicate so in this section and discuss how their project addresses unmet needs in prevention, detection, care, cost-effectiveness, access, etc.
3. Project objective statement (1/2 page). How has your team addressed the problem? What is innovative about your approach? How does your final design solve the problem? What were the specs for your device? Note: If your entry is part of a bigger project that was started by others (other students, advisor, etc.), please clarify your specific contribution, i.e., what your team has accomplished vs. what progress had been made by others prior to your involvement.
4. Documentation of the design (1 ½ pages). Provide sufficient detail and highlight innovative aspects of your design.
5. Documentation of the prototype of the final design (1 ½ pages) 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.
6. Results of a patent search and/or search for prior art, assessment and patentability(1 page). Two excellent resources for this search are http://www.uspto.gov/, and your institution’s technology transfer office. Regarding marketplace competition, what is currently being used to solve the problem and/or what are the anticipated alternate methods that could be in competition with you in the future?
7. Anticipated regulatory pathway (510(k) vs. PMA, etc.) (1/2 page). Consider researching how the FDA has treated analogous devices.
8. Reimbursement (1/2 page). Do you expect your device to be reimbursable by Medicare/Medicaid? Why or why not?
9. Estimated manufacturing costs (1 page). Provide detailed per unit cost breakdown, including volume discount, for components, final assembly, quality assurance, etc.
10. Potential market and impact (1 page). Define the potential market size, selling price, and distribution channels. Who would your customers be (i.e., who will be purchasing the product) and who would the end users be (i.e., who would be using the product). If possible, quantify the number of potential users and the potential impact the product could have (# of people who would benefit from use, etc.)

(4) Letter of Support From Faculty Member
A letter of support is required from the Faculty Sponsor from the Biomedical Engineering, Bioengineering, or similar department of the institution in which the student team members are enrolled. This letter must be written on departmental letterhead and verify the following:

• That the entry was achieved by the named Student Team. The letter must describe 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 a competing Student Team must be clarified and distinguished from those accomplished by others.
• That each member of the team was enrolled full-time in an undergraduate curriculum during at least one semester or quarter of the current academic year.
• In cases where students from multiple institutions work on a project as a multi-institutional team, we require a Faculty Sponsor letter from each institution.
• 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.

(5) Required Video

A link to a brief video (up to 3 minutes) describing the project is required, whether a prototype was achieved or not. The video should:

• Provide a brief introduction and background about the healthcare problem or unmet need that you chose to address, focusing on the technical aspects of your device;
• Describe the concept that your solution is based on, emphasizing its innovative aspects;
• Demonstrate that the prototype works and achieves its aims;
• Make a compelling case that your device will have a significant impact on the problem you chose to address.

The content and the quality of the video are both important. Make sure that the audio is free from background noise and the volume is high enough throughout the video to be easily heard. If you have multiple speakers, make sure they can all be heard comfortably at the same volume level. Refrain from using background music that overpowers the narration. The device you present in the video must match the description in your written application and must not be an earlier version. The video is your chance to impress and engage the reviewers and to make them want to read the details of your application carefully. In addition, the video may be used for PR purposes by the sponsor for whose prizes you wish to be considered, and will be a lasting summary of your design accomplishment. Videos should not contain proprietary information about the innovation. It is the team’s responsibility to ensure the video is appropriate for public use.

You will submit the link to this video (via YouTube or a similar web-accessible site) on the online form to submit your final application.

Instructions for Preparing the Optional Application Components

Optional Appendices
Additional supporting materials may be included with your submission and must be uploaded as one merged PDF. The following naming convention should be used for this PDF: “YourTeamName_YourUniversity_DEBUT_Appendices”. You will upload this file during the online application submission if you choose to include optional material.

Appendices may include:

• Up to 3 additional letter(s) of support: one letter of support from a faculty sponsor is required (see above), but additional letter(s) of support are also encouraged. Effective letters of support will demonstrate the strength of the work accomplished. They can be from individuals who may benefit from your device, such as clinicians who may use it in their practice, patients who may use your device, or industry representatives that can highlight the market need for your innovation.
• A summary of prior art
• Literature review
• Supporting articles, reports, etc., that present background information for your project
• Any data collected as part of testing your technology
• Any other relevant supporting materials

Note: Sheer volume of material is not an asset. The judges will mainly review the required components of your application and may consider the optional material at their discretion.

Optional Videos
Up to three optional links to videos and/or websites up to three links may be included. These links can refer to online articles, videos and/or other relevant online data.

Proposal Review Process and Notification

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

NIBIB prizes 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?

VentureWell prizes are reviewed by external panels of reviewers made up of individuals from academia, industry, nonprofits & NGOs, and venture capital with experience in the technology areas and in the commercialization of early stage innovations.

In addition to the four criteria above, VentureWell prizes will take into consideration:

• Market potential and economic feasibility
• Patentability

The winners will be announced on the VentureWell and NIBIB websites, in direct emails and social media on August 26, 2024.

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If you have any questions about the Challenge or application process, please contact us at grants@venturewell.org.

Contact info@nibib.nih.gov or (301) 451-4792 with questions specifically related to NIBIB prizes.

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