Medical Device Innovator Grant Writing
Whether you're building a medical device in a university lab or a startup garage, you face a long journey to bring your product from prototype to patient. Along the way, you need funding to keep your research and development efforts moving. As a medical device innovator, you understand engineering and clinical science. However, you may not have experience navigating Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants from the National Institutes of Health (NIH).
Blue Haven Grant Consultants offers the expertise necessary to bridge complex technical specs and present them as a compelling business case. We can help with grant writing and other aspects of the funding process to help you secure the capital you need for prototyping, testing, and regulatory efforts.
Translating Engineering Into Clinical Value
NIH reviewers don't just fund interesting technology — they focus on clinical impact. Medical device developers tend to overfocus on specs while underfocusing on real-world patient support. We can help you take dense technical data and refine it to showcase clinical necessity. While we simplify the narrative, our team will maintain the technical accuracy your technology requires.
Navigating the Unique Hurdles of Device Commercialization
Bringing a medical device from idea to execution brings several challenges. Here's how we help you overcome them:
Regulatory expertise: We understand the regulatory standards for these grant applications and help articulate your compliance with them in your grant application to increase its appeal to reviewers.
Commercialization planning: While you focus on science and prototyping, we handle business tasks, such as market analysis and customer discovery, to showcase your device's potential in the grant proposal.
Administrative relief: Our team removes the distraction of registrations, budget justifications, and paperwork gathering so you can focus on research and development.
Phase I: Proof-of-Concept and Feasibility
SBIR/STTR has two funding phases. During the first, you use the funding to develop a proof of concept. We can help you secure the funding for this initial phase through the following steps:
Project evaluation: Determine whether your project is a good fit for this funding type. We start by learning about your project so we can adapt our approach to meet your needs and align your project with NIH goals.
Proposal preparation: Using our proprietary Significance-Innovation Analysis™, we break your project details into a format that most effectively appeals to NIH reviewers. We handle the entire application, including managing biosketches, finalizing the specific aims section, and submitting the application.
Proposal review: You will receive feedback from reviewers upon submission of your application. We review it with you and help develop a summary response if needed. Our team can also assist with just-in-time document submissions.
Project completion: Once your project is funded, we manage government reporting requirements, freeing you to focus on the prototype. Our support includes technology assessment and business analysis (TABA) and completing the Phase I report.
Phase II: Commercialization and Scale-Up
The technology development phase of SBIR/STTR funding provides additional financial support to develop the technology and prepare to bring your product to the commercial market. We can assist with various aspects of the renewal phase, including:
Phase I integration: We'll bring the findings of your Phase I final report into your Phase II grant application.
Commercialization plan: Our team can help you plan for market entry, scaling, and patient impact for your technology, then write a coherent strategy for NIH reviewers.
Letters of support: We gather these documents while focusing on emphasizing the commercial potential of your technology.
Specific aims and milestones: Work with us to develop more specific aims and milestones that build on the success of your Phase I project.
Application review and reporting: When you receive your impact score and summary statements, we can coordinate with NIH program officers and help generate report documentation.
If you have a mature device with significant data, you may be able to skip Phase I and proceed directly to Phase II. We can review your progress so far and determine whether this direct-to-Phase II strategy is a good fit for you. If so, our team will support you through every step of the process.
Offering Specialized Expertise and Lower Risks
Blue Haven Grant Consultants offers the link you need between technical expertise and grant funding applications. Our team includes scientists who understand your work and ensure the accuracy of your application. We also have grant writing experts who can help distill the science into a format that appeals to grant reviewers and meets all compliance requirements. This balance helps provide a more effective grant application process.
In addition to our expertise, we offer a Pay Upon Award™ process. This setup means that we charge no up-front costs for eligible clients. Instead, you only pay when you get results. You can preserve your limited funds while aligning with a partner that's invested in your success. With this structure, we only get paid if you do, so we work hard to ensure you receive funding.
Fund Your Medical Device
We bring together scientific knowledge with business strategy and SBIR/STTR grant expertise to enhance your funding applications. Schedule a consultation with our team to discuss the funding potential of your device.