In this instructional video, SBIR consultant and reviewer Stacy Chin outlines the five most frequent reviewer criticisms encountered in rejected NIH and NSF SBIR proposals and provides concrete strategies for addressing each when resubmitting. She begins by framing the importance of reviewer feedback as a tool for strengthening R&D alignment with commercial goals, then walks through each critique: (1) insufficient market need – advise narrowing the target market, quantifying affected individuals, and presenting TAM/SAM/SOM figures; (2) unclear design specifications – recommend a clear, three‑part description of the innovation, its unique value proposition, and customer benefits, supported by bullet‑pointed features and visual schematics; (3) ambiguous research roles – suggest detailing each senior personnel’s responsibilities in biosketches, adding role summaries in the technical narrative, and providing letters of collaboration for external CROs or consultants; (4) missing regulatory pathway – explain the need for a concise regulatory strategy paragraph (Phase I) or a full regulatory section (Phase II/Direct‑to‑Phase II), and recommend engaging a regulatory expert; (5) absent gender breakdown in animal or clinical studies – advise stating the gender ratio, updating all relevant documents, and providing a justification. Throughout, Chin emphasizes rewriting the relevant sections, using quantitative data, visuals, and concise one‑page summary statements to persuade reviewers. The video concludes with a call to action to like, subscribe, and watch Part 2 for the remaining five critiques, and directs viewers to her website for templates and further resources.
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In this video, I'm gonna go over the top reviewer critiques that I've seen all the time in rejected NIH and NSF SBIR applications. And as an SBIR consultant and also a reviewer for these agencies, I'm gonna break down for you how you should respond to these reviewer critiques so that you can turn around your rejected SBIR application to an awarded one. Hey guys, welcome back to the channel. I'm Stacy Chin from KeepYourEquity.co, and our mission is to help startup founders just like you secure non-dilutive grant funding so that you can bring your innovative ideas to the commercial market. This video is a one part in a two-part series where I'll break down the first 5 reviewer critiques in this video, and then the remaining 5 will come in our video next week. So make sure to hit the like and subscribe and the notification bell so you won't miss out in the next video. So after you hit the submit button on your NIH or NSF SBIR, you have to wait a very long time, until you realize whether or not you got that application awarded. And usually with that comes with a long list of reviewer critiques describing the strengths and weaknesses of your application. Reviewers can critique anything from your proposed research strategy, the innovation itself, the team, you as the PI, or even the significance of the problem you want to solve. Anything is fair game. Sometimes the reviewers' critiques can be a bit harsh, but you don't want to take them personally because regardless of what they say, these critiques, good or bad, can actually help strengthen your R&D approach to be better aligned with your commercial goals. So in the unfortunate situation where your SBIR application was rejected, you do have a chance to resubmit your application after substantial revisions has been made, and you don't want to miss this chance. Typically, when you resubmit your application, you have a chance to respond to the reviewer's critique in a one-page summary for your NIH or NSF SBIR application, and you can use the summary to inform the reviewers what changes you've made in your application. And after critiquing dozens and dozens of SBIR applications myself and advising startups how to strengthen their resubmission, there's quite a few repetitive reviewers' critiques that I've seen, that I've come across many different times. So if you watch until the end of this video, I'm going to share the first 5 out of the top 10 critiques that I've seen all the time for the past 10 years within rejected NIH and NSF SBIR applications. And I'm also going to walk you through how you should respond to them to improve your chances of award when you're ready to resubmit your NIH or NSF SBIR. So hopefully with these tips, if you're submitting an application for the first time, this is a way for you to avoid those reviewer critiques. Or if you're resubmitting your application, hopefully these tips will help you brainstorm ways that you can improve your resubmitted application. But before I jump into it, please like and subscribe to this channel and comment below so that you can learn more ways of how to secure non-dilutive funding for you and your startup so that you can keep all your equity within your fundraising journey. It helps the channel channel a lot, and I greatly appreciate your support. And with that, let's dive right in. Critique number 1: the market need is not large enough. So when presenting a problem in your SBIR application, you must describe the market need. Reviewers want to know that there's a big enough problem that warrants a better solution. So if you came across this reviewer critique in your first application, you either didn't describe the market well, or not many people are actually impacted by this problem. Usually it's due to the first reason. So when addressing this reviewer's critique in your resubmitted application, you'll likely have to just completely rewrite the entire section, and you want to do so in the main technical document, the commercialization plan if you have one, or both. And to strengthen your market discussion, there are a couple of things you can do to better convince reviewers that there is a large enough market for your innovation. First, you'll want to identify the target market. In other words, who would benefit from your proposed innovation? And this helps you to start framing what are the key pain points in this market and this helps us set the narrative of how your innovation will solve that particular problem. So when identifying the market, it is important to be specific. For example, if you're developing a brand new cancer therapeutic, your market won't be all cancer patients because that is just way too broad. Instead, you'll likely want to narrow down your market to lung cancer patients, as an example, so that you can be better aligned to the scope of your SBIR efforts. So once you identify the market, you're not done just yet. Next, mention how large the market is. In other words, how many people are affected by this problem? Going back to our lung cancer example, you can say, according to the American Cancer Society, there are over 238,000 cases of lung cancer reported in 2023 across the US. That's a huge market. And using quantitative metrics and statistics, to describe the market emphasizes how many people are impacted by that particular problem. Finally, you'll want to describe how much money is in this market. In other words, what are your total available market, or TAM, the served available market, SAM, and the serviceable obtainable market, or SOM? TAM, SAM, SOM. And describing the TAM, SAM, SOM are excellent ways to present metrics that define the customer and revenue opportunities within that particular market. So when discussing the market need within your submitted SBIR application, make sure to mention the targeted market, quantify how many are affected by the problem, and then note the revenue opportunities within your TAM/SAM/SUM. And by doing so, you should have a very strong discussion that will hopefully motivate the reviewers so that they are convinced there is a need for your innovation. And it's also a good idea to prepare a couple of sentences on that one-page summary that outlines the numbers in your TAM/SAM/SUM. So don't forget to do that. Now the second reviewer critique is the design specs of your innovation are unclear. And this is another very common reviewer critique that I see all the time that likely occurs for the same reason. The PI just may not have described the innovation well enough. But surprisingly, this critique comes around quite often. Usually in the startup, the PI, who's also usually the inventor, must think about every single little detail of the innovation all day long, and because Because of that, the PI knows all the details and little intricacies of the technology very well, but perhaps maybe a little too well. And for that reason, sometimes it's very challenging for the PI to pitch the innovation to someone who has no idea what it is. And pitching an idea to someone brand new is challenging. In fact, I've experienced this when speaking to many scientists, engineers, and clinicians for the first time as they try to describe their innovation to me. And these same struggles also occur when describing the innovation on paper within SBIR applications. So to address this reviewer's critique in your resubmission, again, you'll very likely have to rewrite the entire section. Sorry. And this has to be done in the technical narrative, the Commercialization Plan, or sometimes both. And so when you describe the innovation in your resubmission, you'll want to break down your idea by hitting these 3 key points. First, describe your innovation. What is it? Is it a new technology, a therapeutic, a device, a software platform? Make sure this is clear. Then in that same sentence, mention how it works and what is its purpose. So for example, a strong first sentence when describing your innovation can be, "We are developing a proprietary software platform that leverages artificial intelligence and machine learning to identify and analyze biomarkers in blood samples to screen for ABC. Second, inform the reviewers why they should care about the innovation by stating its unique value proposition. In other words, how does it stand out compared to competitive products out there? What makes your innovation unique? Finally, describe how your customers would benefit from that innovation. What pain points does it solve? And by pitching your innovation in this manner, you'll capture the reviewer's attention, so that they are eager to learn more. Then you're ready to dive deeper into the details of the innovation. To do so, tell them about the top 5 to 3 different features of the innovation to hammer down why it is designed so differently compared to the other competitive technologies. So I like to break down each of these key features using a bullet point list that is then followed by a short description to describe the importance of that feature. Now, it's important to note that some reviewers might digest information easier through figures and visuals rather than boring black and white text. And so for that reason, you'll want to include schematics, photos, or flowcharts that summarizes how the innovation works with labels that points out each of these features very clearly. And providing these visuals can add so much value to your SBIR application since these serve as an excellent tool to help reviewers understand the innovation in a completely different way. Plus, this also helps to break up the monotony of the boring black and white text on paper. So if you follow all these key points in your resubmitted SBIR application, I'm guarantee that the reviewers would have a much better understanding of the design specs of your innovation so that you can improve your chances of getting awarded. Reviewer critique number 3: the delegated research roles and responsibilities are unclear. Fortunately, this is a very easy one to address. When looking into SBIR applications, reviewers must evaluate whether the PI has access to all the necessary resources and expertise to carry out the proposed R&D efforts. And for that reason, the PI needs to identify who is performing what and where the experiments are going to be performed within their SBIR efforts. Now, if your SBIR application requires many different expertise and skill sets, then understanding who is doing what can be confusing, especially if the PI does not explain this well in their application. and this can be especially true within a Phase II application since usually these startup teams are much bigger, and usually they have to work with other outside parties to complete the proposed task in order to commercialize the innovation. So if you come across this critique in your SBIR application, this is how you want to address it. First, you as the PI must figure out if you have all the expertise on your team to carry out the proposed research efforts. If so, make sure to include a line item in each of the senior key personnel's biosketch that explicitly states their roles and responsibilities. You can also include the summary in the technical narrative after each proposed experiment. Early-stage STARFs with limited resources may choose to hire outside consultants or third parties, such as contract research organizations, or CROs, if they get funded. And if so, make sure to identify who these parties are, as well as their roles and responsibilities, in your resubmitted application. and it is also a good idea to get a letter of collaboration from these parties that outlines what they're going to do along with their background that describes why they are such a good fit. If you're looking for examples or templates of how to prepare these letters of the collaboration, check out keepyourequity.co. I'll leave a link in the description below. Reviewer critique number 4: the regulatory pathway is not discussed. So if you're developing an innovation in the medical or healthcare space, you'll very likely need to obtain regulatory clearance from the US Federal Drug Administration, or FDA. And for that reason, discussing your regulatory pathway is critical in your SBIR because this impacts your commercialization strategy. Your innovation must undergo a series of really strict and standardized testing to confirm that it is effective and safe before engaging with humans. And there are many different regulatory pathways to consider depending if your innovation is a therapeutic, a medical device, a diagnostic, or a software platform. And so for that reason, a lot of work must go into developing a feasible regulatory strategy to de-risk these hurdles so that you can bring your innovation to the commercial market. So in case you receive this critique in your Phase I SBIR application, make sure to prepare a paragraph that summarizes your proposed regulatory pathway, both in your one-page summary and in the technical narrative. Now, if you got this critique in your Phase II or Direct-to-Phase II SBIR application, you have to prepare an entire section to describe how you plan to go about your regulatory pathway in much more detail. Because Phase II is all focused on commercialization, reviewers want to make sure you as the PI have a rigorous plan in place to execute so that you can successfully obtain regulatory clearance. At this stage, onboarding a regulatory expert or consultant to guide you through your strategy is highly recommended. And having a regulatory expert on your team not only helps you to get an SBIR awarded, but it would also help you to better bring your innovation to the market. So if you're resubmitting your Phase II application, make sure to provide a very detailed explanation of your regulatory strategy in the one-page summary, the technical narrative, and in the commercialization plan. Reviewer critique number 5. The PI does not mention the gender breakdown in the animal study or in the clinical trial. Whenever you propose to conduct an animal study or a clinical trial, PIs should mention in their SBIR application the breakdown of genders they plan to recruit in these studies. And this is because different diseases impact males and females differently. Therefore, your intervention or therapeutic treatment outcomes may vary depending on your targeted population. So, for instance, if you're developing a new therapeutic or patient monitoring platform for breast cancer, ultimately your recruitment pool will most likely be females. And that's because less than 1% of all breast cancer patients in the US are diagnosed in men. So in your SBIR application, reviewers are looking for this gender breakdown to evaluate whether your proposed protocol is designed well to reflect the targeted population impacted by that disease or cancer. So in case you forgot to mention this in your first SBIR submission, make sure to mention this ratio in the one-page reviewer critique summary. Also, don't forget to update the main technical document and any ancillary human subjects documentation to include this breakdown. And finally, you should also include a rationale or justification as to why this gender-racial breakdown is appropriate for your study. And with that, thank you so much for watching until the end of this video. If you found these tips helpful, please like, like, subscribe, and comment below. And make sure to check out next week for part 2 of this series where I go over the last 5 top reviewer critiques that I see all the time in rejected NIH and NSF SBIR applications. And don't forget to visit our website at keepyourequity.co where you'll find more resources, advice, and templates to help you secure non-dilutive funding. Thanks for joining me today, and I'll see you very soon.
