THE SHEIKH ZAYED PRIZE FOR PEDIATRIC DEVICE INNOVATION | 2015

October 23, 2015 | The Knight Conference Center at THE NEWSEUM, WASHINGTON,DC

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General Guidelines

 

Eligibility

The Sheikh Zayed Institute for Pediatric Surgical Innovation is seeking proposals from inventors who have medical device concepts for use with pediatric patients. Proposals should address a significant, yet unmet need within the pediatric population with a device idea that lends itself to commercialization.

 

The FDA defines a medical device as follows:

A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. Furthermore, a pediatric medical device is: Pediatric medical devices treat or diagnose diseases and conditions from birth through age 21. Some products are designed specifically for children, while others are borrowed from adult applications or produced for more general use. The proposal should be directed towards development of a commercializable product, not research of a scientific concept. Issues such as prototyping, manufacturing, marketing, and regulatory clearance will be paramount and should be addressed explicitly.

 

We enthusiastically welcome projects that are past the prototype phase.

 

Key Dates:

RFP Released – July 6, 2015

DEADLINE EXTENDED: Submission of Round 1 deadline – September 21, 2015 at 5pm EDT

The judges decide on the selection for Round 2 – September 28, 2015

Notification to Round 2 applicants – September 28, 2015

Awardees announced at the Award Ceremony on – October 23, 2015

Review Process and Scoring Criteria

The written proposal format is listed below and must be submitted by September 21, 2015 at 5pm EDT. A subset of submissions will be notified on September 28, 2015 to prepare a 10-minute presentation. Those notified must be prepared to travel to DC to present live at the Symposium. Scoring by the judges will be based on an assessment of the following factors:

1. clinical significance of the pediatric device

2. approach to product development

3. likelihood of being marketed successfully

4. project team, environment, and resources

5. potential for additional funding

 

This funding is intended to promote the commercialization of a medical device for pediatrics. The application should include a description of the long term funding strategy. The success of the seed grant program will be measured by advancement through the product development progress, generation of intellectual property, clinical trials progress, steps toward FDA approval, follow-on funding, and clinical impact. Awardees will be required to submit three quarterly progress reports and a final report. Investigators that do not submit this report will be at risk of losing continued funding support. Applicants must be up to date with, or able to obtain Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) approval for work proposed, if applicable. Any additional relevant certifications (FWA numbers, CITI certifications, etc.) must be made available upon request.

 

Submission and Questions

> Applications should be submitted as a single PDF document through the online system. CLICK HERE TO SUBMIT

 

> Please submit by September 21, 2015 at 5pm EDT. Late submissions will not be accepted.

> Questions about this RFP may be directed to innovationinstitute@childrensnational.org.

 

Proposal Format

Proposal page limit: 5 pages total (includes 2 pages for references and budget | 5 page total does not include cover page).

 

Font size: 11 Arial, Margin: 0.5 inches

 

Applications should include:

Cover page with the following information (1 page that is not included in the 5 page limit) :

Title of project

Applicant name(s), title(s), email address(es)

Company, institution, or school and department

Notification email address

Requested budget (Must not exceed $50,000. Please note that indirect costs are not allowed)

Abstract – a short executive summary that will be shared with the public (please do not include confidential information)

 

Description of proposed project following the outline provided below (3 pages maximum). The applications are generally for one year of funding.

Unmet need in pediatric care: Describe the clinical application/situation/condition that the project is to address. Estimates of the number of potential patients that would benefit and describes the intended patient population such as age range, weight, etc.

 

Product: Describe the pediatric medical device that will be developed with seed grant funding. As appropriate, provide detail on the prototype fabrication, materials, specifications, any software requirements, and method of manufacturing.

 

Significance: Describe the benefits the project will have on the technologies, treatments, services, or preventative interventions that relate to improvement in pediatric healthcare.

 

Approach/Milestones: Identify the current state of development of your device (concept, prototype, preclinical, clinical, manufacturing, marketing or commercial use) and describe your approach for moving it through the next few phases with seed grant funding for which you are applying. Provide an outlook describing potential sources of funding beyond the seed grant funding. Specify the current status of your intellectual property.

 

Product marketing plans: Describe your market analysis to date. Please include a description of potential competitors and/or competing technologies.

 

Project team, resources and environment: Describe your project team and the resources you will require to complete the work proposed. Briefly describe any relevant prior experience.

 

NOTE: Applicants will retain all intellectual property ownership in their submissions.

 

Budget & Budget Justification (1 page):

 

Provide an itemized budget for funds requested. Prototype production, data collection and analysis, clinical and pre-clinical studies, testing, manufacturing costs, cost of consultants, quality systems development, materials, and personnel support are eligible budget categories. The awards are for a maximum of $50,000 for one year. There will be two awards.

References (no page limit, but 1 page is recommended):

References and citations may be used in support of the description of the proposed project, but should be kept within the page limit.

Because this is a two-step selection process, applicants are encouraged to work on their 10-minute presentation should they be selected to present at the Symposium. The applicants should be ready to travel to DC for the competition or will not be considered.