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Responding to the TOP 10 MOST COMMON Reviewer Critiques on REJECTED NIH and NSF SBIRs

When you submit an SBIR application to the NIH or NSF, you will receive 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, your team, and even the significance of the problem you want to solve. It is all fair game.


Sometimes the reviewer critiques may be a bit harsh, but don’t take them personally, because regardless of how they said it, these critiques, good and bad, can help strengthen your R&D efforts to be better aligned with your commercial goals.


In the unfortunate situation that your SBIR application was rejected, you have a chance to resubmit your application after substantial revisions have been made. Don’t miss this chance! You should also prepare a 1-page summary to respond to the reviewer’s critiques and inform them of the changes made in the application.


After critiquing dozens and dozens of SBIR applications as a reviewer, myself, and also advising start-ups on how to strengthen their proposals for resubmission, there are quite a few repetitive reviewers' critiques that I’ve come across. If you watch until the end of this video, I’m going to share the first 5 of the top 10 most common reviewer critiques I’ve seen in the past 10 years from rejected NIH and NSF SBIR applications. And, I’m going to walk you through how I’ve addressed them in resubmitted applications.


Hopefully, with these tips, you can avoid some of these critiques if you are pursuing an SBIR for the first time. Or, if you are resubmitting an SBIR application, then I hope you find these tips helpful to brainstorm ways you can strengthen your application.


Alright – here we go!


1. The Market Need Is Not Large Enough.


When presenting the problem in your SBIR, you must describe the market need. Reviewers want to know that there is a big enough problem that warrants a better solution. So if you come across this critique in your first application, you either:

  • Didn’t describe the market well, or

  • Not many people are affected by this problem

Usually, it is due to the first reason.


When addressing this reviewer’s critique in your resubmission, you will likely have to re-write that entire section in your main technical narrative, commercialization plan, or both. To strengthen your market discussion, there are a couple of things you can do to convince reviewers there is a large enough market for your innovation.


Define Your Target Market


First, define your targeted market. In other words, who will benefit from your proposed innovation? This helps you to start framing what are the key pain points in this market and helps set the narrative of how your innovation will solve a problem. So when identifying a market, it is important to be specific. For example, if you are developing brand-new cancer therapies, your market won’t be all cancer patients. This is way too broad! You’ll likely narrow the market to lung cancer, as an example, so that you can be better aligned with the scope of your SBIR efforts.


Market Size


Once you identify the market, you are not done just yet! Next, mention how large the market is. In other words, how many people are impacted by this problem? Going back to our lung cancer example, you can say, “According to the American Cancer Society, there were over 238,000 new cases of lung cancer reported in 2023 across the US.” That’s a HUGE market! Using quantitative metrics and statistics to describe your market emphasizes how many people are impacted by this problem.


Market Revenue


Finally, you will want to describe how much money is in this market. In other words, what are the total available market (TAM), the served available market (SAM), and the serviceable obtainable market (SOM)? Describing the TAM, SAM, and SOM are excellent ways to represent metrics that define the customer and revenue opportunities within a particular market.


So, when discussing the market need in your resubmitted SBIR application, make sure to mention the targeted market, quantify how many people are affected by the market, and then note the revenue opportunities within your TAM, SAM, and SOM. By doing so, you should have a very strong discussion that would hopefully motivate the reviewers that there is a need for your innovation! It is also a good idea to prepare a couple of sentences in your 1-page summary that outlines the numbers in your TAM, SAM, and SOM, as well.


2. The Design Specs Of The Innovation Are Unclear.


This is another common reviewer critique that is likely to occur for the same reason - the PI may not have described the innovation well. But surprisingly, this critique comes around quite often. The PI, who is usually also the inventor of the innovation, must think about every single detail of the innovation all day long. And because of that, the PI knows all of the details and intricacies of the innovation very well. But perhaps – maybe too well…


For that reason, it becomes difficult for the PI or inventor to pitch the innovation to someone who has no idea what it is. Pitching an idea to someone brand new is challenging! I’ve experienced this when speaking to many scientists, engineers, and clinicians trying to describe their innovation to me for the first time. These same struggles also occur when describing the innovation on paper in an SBIR application.


To address this reviewer’s critique in your resubmission, you will very likely have to re-write this entire section in the technical narrative, commercialization plan, or both. When describing your innovation, you will want to break down the idea by hitting these three key points.


Describe The Innovation


First, describe what the innovation is, whether it is a technology, a therapeutic, a device, or a software platform, and make sure this is clear. Then in that same sentence, mention how it works and what its purpose is. For example, a first strong 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 A, B, C.”


Innovation Value


Second, inform the reviewers why they should care about your innovation by stating its value proposition. In other words, how does it stand out compared to competitive solutions and what makes your innovation unique?


Customer Pain Points


Finally, describe how your customers would benefit from the innovation. Which pain points does it solve?


By pitching your innovation this way, you’ll capture the reviewer’s attention so that they are eager to learn more. Then, you are ready to dive deeper into the details of the innovation. To do so, tell them about the top 3-5 unique features of your innovation to hammer home why it is designed so different compared to other competitive technologies. I like to break down each key feature in a bullet point list that is followed by a short description that explains the importance of that feature.


Figures & Visuals


Some reviewers may digest information more easily using visuals and pictures rather than reading text. For that reason, include a colorful figure, schematic, or flowchart that summarizes how the innovation works with labels that point out each key feature. Providing these visuals can add so much value to your SBIR proposal since they are a great tool to help reviewers understand your innovation in a different way. Plus, this also helps to break up the monotony of the boring white and black text on paper.


If you follow all of these key points in your SBIR resubmission, I’m sure reviewers would have a much better understanding of the design specs of your innovation to improve your chances of getting awarded.


3. The Delegated Research Roles And Responsibilities Are Unclear.


Reviewers must evaluate whether the PI will have access to the appropriate resources and expertise to carry out their proposed SBIR efforts if funded. For that reason, the PI needs to identify who is performing which experiment within their proposed research efforts.


If your SBIR application requires many different skill sets and expertise, understanding who is doing what can be confusing if the PI doesn’t explain this well. And this can be especially true in a Phase II application since these start-up teams are usually bigger and they also must work with other outside parties to commercialize the innovation.


If you come across this critique in your first SBIR application, here is how to address it.


Detailed Roles & Responsibilities


First, you as the PI must figure out if you have all the expertise on your team to carry out your proposed research efforts. If so, make sure to include a line in each of your key personnel’s bio-sketch that explicitly states their roles and responsibilities. You can also include this summary in the technical narrative after each proposed experiment.


Hiring Third Parties


Early-stage start-ups with limited resources may choose to hire outside consultants, contract research organizations (CROs), or other third parties if they get funded. If so, make sure to identify who these parties are, as well as their roles and responsibilities in your resubmitted application. It is also a good idea to get a letter of collaboration from these parties that outlines what they are going to do along with their background expertise that describes why they are a great fit.


If you are looking for examples and templates to draft letters of collaboration, check out keepyourequity.co.


4. The Regulatory Pathway Is Not Discussed.


If you are developing an innovation in the medical or healthcare space, very likely you will need to obtain regulatory clearance from the US Federal Drug and Administration or FDA. For that reason, discussing your regulatory pathway is critical in your SBIR application because this impacts your commercialization strategy. Your innovation must undergo a series of very strict and standardized testing to confirm that it is effective and safe before engaging with humans.


There are many different regulatory pathways to consider depending if your innovation is a therapeutic, medical device, diagnostic, or software platform. For that reason, a lot of work must go into developing a feasible regulatory pathway to de-risk these hurdles so that you can bring your innovation to market.


In the case you received this critique in your Phase I SBIR application, make sure to prepare a paragraph that summarizes your proposed regulatory pathway both in your 1-page summary and in your technical narrative.


Now, if you got this critique in your Phase II SBIR application, you may have to prepare an entire section on how you plan to go about your regulatory pathway in much more detail.


Hiring a Regulatory Expert


Because Phase II is focused on commercialization, reviewers want to make sure you as the PI have a rigorous plan in place so that you can obtain regulatory clearance. At this stage, onboarding a regulatory expert to help guide you through is strongly recommended. Having a regulatory expert on your team would not only improve your chances of an SBIR award but it would also help you to bring your innovation to market.


So if you are resubmitting a Phase II application, make sure to provide a very detailed explanation of your regulatory pathway both in the 1-page summary, the technical narrative, and especially in the commercialization plan.


5. The PI Does Not Mention the Gender Breakdown in The Animal Study Or Human Clinical Trial.


Whenever you propose to do 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 diseases and cancers impact males and females differently. Therefore, your intervention or treatment outcomes may vary depending on your targeted population.


For instance, if you are developing a new therapeutic or patient monitoring platform for breast cancer patients, ultimately your recruitment pool should mostly be females since less than 1% of all breast cancers diagnosed in the US are men. In your SBIR application, reviewers are looking for this gender ratio to evaluate whether your proposed protocol is designed well to reflect the targeted population impacted by that disease or cancer.


In case you forgot this in your first SBIR submission, make sure to mention this ratio in the 1-page reviewer critique summary. Also, update the main technical narrative and any ancillary Human Subjects documentation to include this breakdown. Finally, you should also provide a rationale or justification as to why the gender ratio breakdown is appropriate for your study.


6. There Is No Discussion as To How The Company Plans To Protect Its Intellectual Property Or IP.


If start-ups are developing a new innovation, then securing your IP is critical to prevent competitors from taking your idea. Start-ups should seek legal counsel to help them develop an IP strategy. A common practice is to file patents which are usually done if you are developing a physical product or therapeutic. Companies developing software or platform-based innovations may prefer to secure IP through trade secrets instead. You can also protect your assets by filing trademarks as well.


In your SBIR application, reviewers are looking at your IP strategy because it plays a significant role in your commercialization pathway. Federal agencies are not going to fund start-ups that don’t have protected IP! So that means you as the PI must include a discussion of your IP strategy in your SBIR application.


And this should be mentioned in both Phase I and II, but ESPECIALLY Phase II. When I help start-ups draft this section, I’d like to mention their IP council since this shows reviewers they have identified a party who will guide them on their IP strategy throughout their developments.


To address this reviewer’s critique in your resubmission, mention whether you have filed patents or plans to file IP in the 1-page summary and the main technical narrative. You’ll also want to mention the status of those patents, whether they are provisional, granted, or PCT.


Now if you are applying for a Phase II application, you’ll want to include a more rigorous IP strategy in your commercialization plan. Here, PIs should mention how they plan to expand their IP portfolio by filing additional patent applications and whether they plan to conduct a freedom of analysis to verify their innovation can be sold without infringing another party’s IP rights.


7. There Is No Clear Plan for Commercialization.


Since the purpose of the SBIR program is to commercialize new innovations and technologies, PIs must explain how their R&D efforts in Phase I and Phase II are aligned with their go-to-market goals. Federal agencies want to fund start-ups that will make lots of money because this will grow the US economy and create more jobs!


So if there is no clear plan for commercialization in your SBIR application, reviewers will call you out on it and you will have to address this major weakness in your resubmission. This is a common reviewer critique I’ve come across many times, especially from PIs coming from academia.


Because many start-ups pursuing SBIR funding are in the very early stages of development, it can be challenging to propose a commercialization strategy especially since there are so many different go-to-market strategies, business models, and ways to generate revenue.


From my experience as a strategy consultant and reviewer, I found presenting one clear, straightforward pathway is the best way to go for these SBIR applications. If you mention different ways to commercialize your innovation or say “if this pathway doesn’t work out then we might try these 3 different ones,” it does not give reviewers the confidence that you know how to bring your innovation or market or have the proper resources and mentors to guide you on that strategy.


Also, if you present a very complicated commercialization strategy that reviewers can’t follow, this also won’t look good for your application. Just keep it simple!


If your first SBIR submission lacked this discussion, make sure to include a strong and clear commercialization pathway in your resubmission. Again, this should be noted in the 1-page summary, the main technical narrative, and, especially, in the commercialization plan for a Phase II application.


Here, you’ll want to present a commercialization plan that makes the most sense for you and your start-up. To do so, you can research other similar start-ups and learn how they went about their go-to-market strategy.

8. There Are No Quantitative Metrics for Success.


This is one of the biggest mistakes I see start-ups make all the time.


Whenever you propose an R&D strategy, you should inform reviewers of the checkpoints that confirm you have completed that experiment successfully. This shows the reviewer you have a clear idea of the metrics to evaluate whether your innovation has commercial potential.


Quantitative Metrics


To describe what success looks like, you’ll want to use quantitative metrics that can be measured and calculated using data. What do I mean by this? In your SBIR application, you don’t want to say “our goal is to prove our innovation is better than the current standard.” What does “better” even mean? It is your job to define what “better” is by using metrics like speed, weight, performance, efficiency, toxicity, and costs. Also, you’ll want to state the anticipated amount of improvement in your deliverable. Some examples of strong quantitative metrics are:

  • Our battery will have 25% improved efficiency while costing 50% less in production than the current standard, or

  • Our drug delivery system will deliver therapeutics to the tissue site at 2X concentration over a 24-hour period compared to the state-of-art alternative.

Describing your outcomes for success this way strengthens your R&D strategy. And, most importantly, will give reviewers the confidence that you know exactly how to go about your technical objectives.


To address this reviewer’s critique in your resubmission, make sure to include these metrics at the end of each experiment in the main technical narrative. Including a simple bullet point list that clearly states your anticipated quantitative metrics is all you will need!


9. The Proposed Technology Is Not Innovative.


I’ve actually come across a lot of start-ups that don’t describe the technology of their innovation well. This makes it challenging for SBIR reviewers to understand the innovations’ value proposition and competitive advantage in the market. When I see this reviewer critique on rejected applications, most of the time this is solely due to poor positioning of the argument. It could likely be a misunderstanding or the PI did not pitch the innovation well.


In your resubmitted application, there are a couple of strategies you can take to convince reviewers that your technology is innovative:

  • Explain the competitive landscape. Identify the top 3-5 competitors, explain how they solve the problem, mention their downfalls, and then emphasize how your innovation is an improvement.

  • State the unique value proposition and list the innovative features. In my SBIR proposals, I like to dedicate a full hearty paragraph that explains why the technology is innovative. In fact, the first sentence starts off with, “This technology is innovative because (fill in the blank).” You can also state, “There is no one in the market that is solving this problem by doing A, B, C.” Afterward, mention the technology’s innovative features in a bullet point list.

  • Addressing the gap in the market. Explain why none of your competitors is addressing the gap in the market in the same way that you are doing so.

  • Describe how your innovation will solve your customer’s pain points more effectively. Here, you can mention why your customer is frustrated with all of the other solutions in the market. Then explain your innovation will overcome those hurdles and save the day.

To address this reviewer’s critique in your resubmission, scrap your original discussion on the innovation since the key points did not come across well in your first application. You will want to restructure that entire section according to the outline that I’ve discussed. You should also add a couple of sentences in your 1-page summary that explicitly states why your innovation is innovative.


By giving your resubmission a huge facelift, hopefully, you can convince the reviewers you have a ground-breaking innovation that is worth funding the second time around.


10. The Proposed Timeline Is Overly Ambitious.


I’ve seen this critique quite often and I’ve also been guilty of giving out this critique too. I’ve reviewed SBIR Phase I applications proposing to develop a new therapeutic, conduct benchtop testing, perform animal studies, do all the necessary safety testing, and then eventually test it in humans…. all within 12 months. Whoa! For that to happen, you either must be godly or need a miracle!


The reality in the research world is that everything will take much longer than expected. If you propose to do too much in a short time period, this tells reviewers you don’t have a good sense of your timeline, and that’s a major concern!


From my experience, it is much more effective to propose a well-thought-out R&D strategy for 2-3 critical experiments that will get you reliable results. You don’t want to cast a wide net and propose many experiments in such a short timeframe.


To address this reviewer’s critique in your resubmission, there are a couple of things you can do. One way is to max out the timeline if you did not propose the full 12 months for Phase I or 24 months in Phase II.


If you’ve already done so in your first submission, then you have to cut back on what you originally proposed. To do so, identify which experiments or objectives you can eliminate but still give you what you need to support your end goals. And this can be a hard decision so take the time to re-strategy and speak to advisors or mentors who can help optimize your R&D plan.


If you adjust your timeline, make sure this update is reflected in your budget and budget justification.

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