Proposal Content

This section provides an outline of the content that would typically be included in a successful proposal.  Each section has a short description with links for additional information where available and examples.  
 

Introduction
In the introduction identify the disease state, describe current treatments, and other information that demonstrates how clinical care will be improved. | Introduction Example  |

Clinical Need
A 'Statement of Clinical Need’ is the expression of a problem requiring a solution. Statements should relate to the application of Health Technologies in the clinic or community, and might cover subjects such as weaknesses in current treatments, difficulties in the use of devices or clinical instrumentation, or gaps in the range of available treatments. | Clinical Need Example  |

Proposed Solution
Outline the outcomes that will result from successful research. Specifically demonstrate how the clinical need will be satisfied. Describe the eventual product and how it will be used in a clinical setting. | Proposed Solution Example  |

Background/Previous Research
Summarize what previous research has already been conducted and the results from that research. Describe the status of the current technology and how new research will contribute to the current pool of knowledge. 

Specific Aims
Provide a brief description of the overall project objectives and then state the specific aims in terms of measurable, time-phased objectives. Make sure your specific aims build toward accomplishing the project objectives. 

Design Methods
Describe the proposed design of the study and why that design was chosen. Justify the methodology choice explaining its merits versus alternative methodologies. To the greatest extent possible, the reviewer should see your decision as one that was based on scientific merit rather than on the basis of convenience or simplicity. 

Data Collection
State how the data be collected, who will collect the data and what procedures will be used. Identify data collection instruments and processes, and provide descriptions of their domains of information collected. 

Data Analysis/Evaluation
Describe what statistical procedures and methods will be used to analyze the data for each hypothesis you are testing. A strong analytical plan should go beyond simple statistics but need not be excessively complex. Reviewers especially like to see multivariate analyses that control for the effects of extraneous variables or conditions. 

Limitations and Barriers
Discuss the limitations of the proposed study and alternative methodologies for carrying out the proposed research plan. Describe the key limitations of your study, recognizing that all research has limitations, and how these concerns potentially effect the validity of your results.

Describe the Product
Describe the purposes of your device/technology and how these fit into point-of-care technology. Briefly discuss how your product will be used by the target users, what information will be collected from this device and how this data will be used to improve patient care.  | Product Example  |

Identify Users and Use Location
Describe who will be the primary users of your device/technology such as emergency room physicians, nurses, EMTs or other point-of-care health professionals and where your device will be used including an emergency room, an ambulance, or other point of care locations.  | Users Example  |

Calculating Market Size
Calculate the projected market size for your device in dollar sales. Revenues can be achieved from two sources: the sale of the device and the annual cost of disposables. In this section, show your estimate of the number of devices needed in the US market, the estimated price of each device and the total device revenues. Similarly, discuss the estimated number of disposables per device, the cost of those disposables summed to total an annual disposable revenues. Briefly explain whether this product will replace existing competitive products or will be a new device for the clinician. | Additional Information  |  Calculating Market Size Example |

Competitive Benchmarking
Identify other products that provide a similar function as the proposed device/technology. In this section, briefly describe the companies competing in the market where your product will be introduced, the estimated size of those companies and their share of the market. Discuss how your device/technology creates better value than your competitor's products. | Competitive Benchmarking Example  |

Market Entry Strategy
Describe options for introducing your device/technology to the target market. Identify the most likely approach for market entry including licensing your technology to another firm, selling it to an existing firm, or starting your own company.

In this section detail how your device/technology will fulfill FDA requirements for new medical equipment. Show the projected regulatory steps for your device and how you expect to complete those requirements. | Additional Information  | Market Entry Strategy Example |

Establishing IP Ownership
Identify if any intellectual property has been created to date and who "owns" that intellectual property. State any rights, restrictions and/or royalties to which the IP owner is entitled. In addition, discuss who will own the rights to the intellectual property created from this funded research. | Additional Information  |

Protecting Intellectual Property
Describe intellectual property legal filings at the time of the proposal submission. Also, describe the intellectual property protection steps you anticipate taking to further protect rights to the technology you currently have or will be creating with this grant. | Additional Information  | 

In addition to identifying the resources that are available to the project applicant, this section should clearly identify any resources that may be needed from the Center to facilitate the success of the project. The applicant is strongly encouraged to identify resource limitations that could impact the success of the project and work with their project advocate (Center contact) to develop a resource utilization plan that will support the successful completion of the proposed project. | Additional Information  |

Applicants may request up to $100,000 in direct costs per year for up to two years under this program. Facilities and Administrative (F&A) costs will be paid at the full, negotiated rate. Applicants should provide a budget justification that details the direct cost budget items requested. These are 2-year projects but continued funding is dependent upon meeting agreed upon milestones. The applicant determines the milestone time-line. | Additional Information  |
 

Brief career summaries, or biosketches, are required for all key personnel proposed on your project. (Key personnel are defined as those who contribute to the scientific development or execution of the project, whether or not salary funds are requested.) Biosketches should emphasize the following points: (1) research skills and experiences, (2) management or supervision experience (especially regarding key roles played on major projects or studies), and (3) publications or paper presentations. Focus on the individual's experiences relevant to the work he or she will do on your project. It is not necessary to include every publication bearing the individual's name. A list of relevant, selected publications will suffice. In some cases, including relevant paper presentations can be useful, too. | Click Here for NIH Guidelines  |

A brief time-line should be constructed to summarize project milestones.  Show the start and projected end point of work on the objectives described in the specific aims section of the research description.  If possible, also show on the time-line a relationship between resources spent and objectives reached.