Here are some answers to Frequently Asked Questions regarding the preparation of Commercialization Assistance Program Pilot Project grant applications.
1. General Submission
When will I know if I have been funded?
You will receive a decision letter 4-5 weeks after the application deadline. Included in the decision letter will be feedback from the reviewers with which can help you decide to re-submit if your project is not chosen. Some find this information extremely valuable for their product development even if they are not selected to move forward.
If our project is chosen, how does distribution of funds work?
If your project is chosen for a grant, you will first have a kickoff meeting with our team (by phone) to have an assessment of where you are with your product. We will work with you to make decisions on where and how our resources will best suit your commercialization goals and we will develop a plan of meaningful milestones and deliverables to move the product forward. This plan may include changes to the budget you submitted with your application. Once your assistance plan is finalized, TREAT will issue a check for your award amount.
How is my information protected?
We understand the importance of maintaining confidentiality and disclosing conflict of interest, as both relate to the development and eventual commercial success of your device. TREAT implements a process for disclosing conflict of interest and maintaining confidentiality for potential and active clients. It is not our intention to disclose your ideas to entities that may be competitive to your business or compromise that success in any way. When you submit an abstract, we consider the information provided to be non-confidential. When your application is submitted for consideration, this information is considered confidential to any of our reviewers or staff who view it. TREAT acknowledges that the submission of an application does not grant TREAT any rights to the work and the work and any accompanying intellectual property is owned by the applicant. For more information see our Terms and Conditions.
2. Need and Affected Population
In the reference section should I include formal citations?
TREAT reviewers use references to gauge the amount of research and work done up until this point. Any combination of secondary research (papers, articles, etc.) and primary research (interviews, focus groups, studies, etc.) will help the reviewers gauge the innovator’s understanding of the need for the technology. Reviewers are trying to understand how the innovator learned that there was a problem; conversations with stakeholders may indeed be powerful in conveying this point.
3. Technology Solution
What technical specs and requirements is this referring to in the question: “List and discuss technical specifications and requirements for your technology”?
We are interested in both the engineering and manufacturing guidelines; however, we are looking for a summary, not an extensive detailing, especially given that there is a 200-word limit. We use this question to gauge an applicant’s familiarity with what constitutes a specification or requirement and if they can explain the rationale behind why they chose these particular requirements. This section also helps the reviewers better understand the technology.
If you want to provide some more detail you can upload reference material with an overview of the system, features, user requirements, how it’s made, etc. as you see fit to communicate the device concept. Keep in mind that the reviewers are looking at commercialization potential and just want a clear picture of the state of development; they will not be analyzing details of your technology. Conceptual drawings or pictures can be very helpful here.
4. Competition and Market Hurdles
What is the difference between the Market Validation and Device Need sections?
In the abstract you were asked to fill out a section called Market Analysis. In this section the innovator should have laid out the potential market size for the new technology and the segment of the market that the new technology could feasibly capture. In the Market Validation section, we ask the innovator and team to update TREAT on any steps taken to validate the market size identified in the abstract. Validation here means research conducted on market trends or interviews/conversations with key stakeholders and/or potential customers. (This work may have been done prior to writing the abstract and may have been partially addressed in that submission).
The Device Need, on the other hand, has to do with WHY those customers would want the new technology. This would include how the other methods that customers currently use to solve their problems are insufficient and how the new technology will overcome the challenges that customers address. While Market Validation has to do with the market size and the potential for success of a new technology, the Device Need comes straight from customers’ wants and needs.
How specific do I need to be with the competition I list? What if there is no device similar to mine?
The competition and market validation is very important not just to TREAT, but also in the greater scheme of commercialization. Attempting to bring a device to a saturated market, no matter how innovative, will make commercial success difficult.
We use this section to gauge how much the innovator has assessed the potential market for the product and how customers currently solve the problem you are addressing. Even if the product is completely different from anything else on the market, the innovator must demonstrate an understanding of alternative solutions and workarounds already on the market, how customers utilize them and how they will present a barrier for new technologies entering the market.
5. Commercialization Goals and Challenges
I have laid out the three Key Challenges to address but my team does not have the expertise to carry out the Approach; what should I write?
In the Key Challenges the reviewers are looking to gauge if the innovator and their team understand the road ahead of them. They also use the Approach section to evaluate the team’s ability to problem solve. The Approach should be actionable steps towards solving or overcoming the Key Challenge listed. It is perfectly okay if your team does not have the expertise to complete the steps, simply state how this additional challenge would be overcome. This is not the place to list challenges you have already faced and explain how you overcame them.
Key Challenge: Refine the design through trials with appropriate patients
Approach: Obtain IRB for clinical trial. Hire expertise for designing trial through Boston University Biomedical Engineering. Recruit spinal cord injury patients through The Spinal Cord Center to participate in clinical trial. Conduct trials to learn which aspects of the design need improvements and which features to incorporate.
6. TREAT Support
For what purposes may TREAT funds may be used?
Budgeting requests should be for tasks and deliverables, which will be completed in the 6-9 month project period with TREAT and for a maximum of $25,000. Therefore, manufacturing costs for next year would not be appropriate. Below is a list of previously approved TREAT funding requests:
- Hiring consultants to supplement TREAT services
- Facilities & Overhead (8% maximum – see below)
- Journal publications
- Patent filing
- PI Salary
- Clinical studies and focus groups
- Paying for clinical study work
- Technology & Infrastructure
- Marketing collateral
- Tooling & Manufacturing
- FDA Registration Fees
How do we request salary support with the budget form?
Salary support requests should be in line with the anticipated percent effort for project related activities over the project period. For example, a software developer who will be contributing 20% effort to the TREAT-funded project over the next 6 months (project period) may request only that salary support.
‘Indirect costs for institutional overhead may be supported by TREAT funding to a maximum of 8% of direct costs’. Can you elaborate what this stipulation entails?
Some businesses, particularly universities, expect that a certain percentage of a grant will go toward non-grant overhead costs to cover rent, utilities etc. Most of our applicants do not request overhead because they need all the funds to cover project expenses. It is perfectly acceptable to leave this line blank. Requesting overhead will not affect the outcome of your application review.
I am working on the budget request and wanted to know what the budgeting period would be (start and duration).
TREAT project periods are generally nine-month engagements. For a start date, you can use one month after the application due date (it may not be exactly that but close enough for application purposes).
What services can I requested from TREAT?
Below is a list of typical activities that TREAT clients have undergone during a project with TREAT. Requested services might be the activities that are needed most immediately in product development, or areas where the team has less knowledge and would like to gain the skills to carry out.
Business Development Activities:
- Customer profiling and Value Proposition creation
- Market Sizing
- Preparation of Market Requirements
- Revision/Development of Pitch Materials (executive summary & pitch deck)
- Go to Market Strategy/repeatable sales process
- Business Model Development
- Team Gap Assessment
Product Evaluation Activities:
- Regulatory Strategy
- Reimbursement Strategy
- Introduction to Quality Management Systems
- Safety and Usability User Testing
- Protocol and research question development
- Focus Group/Interviewing for Concept Evaluation
- Assess IP landscape
- Concept Design and Iteration
- Preparation of Product Requirements
- Product Design & CAD Modeling
- Vendor selection for manufacturing
Do I need to ask for a certain number of in-kind hours?
You do not need to ask for a certain number of hours. If you receive an award there will be a kickoff meeting between you and TREAT staff to talk about your project and draw up an assistance plan that will give estimates of the number of hours allotted to the different in-kind services. Instead, be very specific about aspects of TREAT assistance that would provide the most value to commercialization of your product.
Should I upload CVs for all team members?
Be sure to upload CVs or resumes for all key team members. This may include advisers if they are integral to the success of the team. You do not need to use the NIH format.
8. Supplemental Documentation
How do we submit the additional documents? Should they all be stitched together in a single PDF or submitted separately?
Information for uploading supplementary documents is located on the application’s submission page. You don’t need to create a single PDF – in fact it is better to have them separate and with descriptive titles (i.e. ‘FDA Correspondence – Classification.pdf’).
9. Additional Questions
Can I create a new title or do I have to use the one on file?
If necessary, titles can be changed. Keep it short – titles should be a product name instead of a long, descriptive academic grant title.