Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional)
Highlights
You have a unique opportunity to join a program designed specifically for small businesses like yours, focused on developing therapeutic and diagnostic devices for nervous or neuromuscular disorders. By applying for this program, you can receive funding for key activities, such as creating clinical prototypes and conducting safety tests. This financial support could be what you need to elevate your innovative ideas from concept to reality.
In addition to funding, you'll also gain access to expert advice from NIH consultants specializing in regulation, intellectual property, and commercialization. This guidance will help you navigate the complexities of health device development, ensuring you're not alone in this journey. Collaborating with contract research organizations for specialized tasks, such as large animal testing or quality assessment, further enriches the support available to you.
By participating in this program, you're investing in the future of your business while making strides in the medical field that can positively impact many lives. Don't miss out on this chance to advance your projects and enhance your business growth.
Financing Details
Type of Financing
You will receive funding through a cooperative agreement. This approach supports milestone-driven projects, meaning you’ll receive funding as you meet specific goals.
Repayment Terms and Fees
There are no repayment terms since this funding does not need to be paid back, making it a unique opportunity for your business. Additionally, there should be no hidden fees associated with this program.
Eligible and Ineligible Expenses
Funds can be used for a range of activities, including:
- Implementation of clinical prototype devices
- Non-clinical safety and effectiveness studies
- Design verification and validation efforts leading to submission for FDA or IRB applications.
However, these funds cannot be used for general business expenses or unrelated research. Ensure you focus on the specific activities allowed within your project to make the most of the funding.
Qualifications
- Business Type: Must be a Small Business Concern (SBC).
- Location: Available across the country.
- Employees: No minimum or maximum number of employees required.
- Company Revenue: No minimum or maximum revenue qualifications.
- Legal Structure: All legal structures are applicable.
- Profit Structure: All profit structures are applicable.
- Device Development: Must be involved in advancing therapeutic and diagnostic device development for nervous or neuromuscular disorders.
Disqualifications:
- No specified disqualifications were mentioned in the context.
Description
This program is designed to support small businesses like yours in developing new therapeutic and diagnostic devices for nervous or neuromuscular disorders. You can receive funding for various activities, such as creating clinical prototypes, conducting safety tests, and even gathering data for FDA submissions. This money can be used to advance your innovative ideas and move your projects from concept to reality.
With this funding, you will also have access to expert advice from NIH consultants who specialize in areas like regulation, intellectual property, and commercialization strategies. This means you won’t be alone in navigating the complex landscape of health device development. Additionally, you may collaborate with contract research organizations for specialized tasks, such as large animal testing or quality assessments, giving you a comprehensive support system.
The emphasis here is on creating a more effective device while getting guidance tailored to your needs. By participating, you are investing in the future of your business and making strides in the medical field that can benefit countless individuals.
Program Steps
Gather Required Documentation
Prepare the following documents for your application:- Business registration and ownership information
- Project proposal outlining your device development plans
- Budget plan detailing how you intend to use the funds
- Evidence of previous research or development efforts, if applicable
- Any relevant intellectual property documentation
Create a Project Proposal
Develop a clear project proposal that describes your innovative idea, the problem it solves, and how it fits within the program's focus on therapeutic and diagnostic devices for nervous or neuromuscular disorders.Budget Plan
Detail how you will allocate the funding. Include costs related to creating clinical prototypes, conducting safety tests, and any other necessary activities.Reach Out to NIH Consultants
Consider contacting NIH consultants early. Discuss your plans and seek their expert advice on regulation, intellectual property, and commercialization strategies.Submit Application
Review your documentation and submit your application through the program's website. Ensure everything is complete to avoid delays.Follow Up
After submission, keep an eye on your email for any communication from the program administrators. Be ready to provide additional information if requested.