In this MassChallenge talk, former med‑tech founder, reviewer, and consultant Stacy Chin shares the practical playbook she uses to help startups win NIH SBIR/STTR awards and other federal non‑dilutive funding. She opens with her own experience—spinning out a medical‑device startup that secured Phase I and II NIH grants and raised $1.5 M—then describes how she has leveraged that background to consult for founders, securing over $40 M in non‑dilutive awards across sectors. Chin walks the audience through the NIH review workflow (study sections, percentile scores, reviewer comments), emphasizing that scores below 25–30 are competitive and that resubmissions should be paired with proactive engagement of program officers. She explains the strategic choice between SBIR and STTR based on resource gaps, partnership needs, and the proportion of work outsourced to academic or clinical collaborators. Eligibility nuances are covered, including U.S. citizenship/green‑card requirements for the PI, handling foreign partners, and paperwork considerations. Budget mechanics are detailed: Phase I caps ($300‑$600 k), Phase II caps ($2‑$2.5 M), the role of budget waivers, and the “just‑in‑time” stage where reviewers assess budget reasonableness. Chin then outlines how to craft a focused one‑page Specific Aims draft, narrow the problem scope, and define three concrete 12‑month experiments with clear go/no‑go metrics. She describes the Fast‑Track (combined Phase I/II) pathway, its documentation requirements, and the critical need for a quantitative go/no‑go metric. Finally, she broadens the view to larger federal opportunities (ARPA‑H, DOE contracts, CDMRP) and stresses that strong relationships with program officers and a clear narrative are often the make‑or‑break factor for winning these larger awards.
Chapters
Thank you so much for having me today here at MassChallenge. It's always been a pleasure coming back here and just meeting new founders. So I started in the space over 10 years ago during grad school. I was doing my PhD and I was fortunate to spin out a startup where it was a medical device coding company. And we got Phase I and Phase II funding from the NIH. And we were also funded by a couple of other grants from Massachusetts. And from that startup, we raised over $1.5 million of funding. And that really catapulted us from just prototyping and benchtop testing all the way to human trial and IRB study. During my time there, I also was a reviewer for Anna Each. I also was at Techstars for a while to help 10 companies from the AFORS DOD SBIR program to help them get non-diluted funding. And then as I was going along my journey, I found there were a lot of other founders looking for help to get these non-diluted funding, whether it's through SBIR and STTR grants or even the larger FOAs going for like the $2, $3, $25 million grants. And so I started working with founders through my own consulting firm, and today I've helped to secure over $40 million of non-diluted funding across all sectors. I also help clients tap into the larger federal contracts like the DOE builds, infrastructure structures, ARPA-Es, ARPA-Hs, CDMRPs. Under due diligence, when you submit an application, it goes to different study sections, and study sections is going to advise the agency whether or not to fund it. They read through everything independently, and then they give you a score, and then they get together and only talk about the top 50 percentile of the applications. When the review process is done, everything is scored by percentile. So you want the lower the score, the more competitive it is. Usually if it's below 30 or even 25 or below, that means you have a very strong application. And you see your score in eRA Commons, wait about 5 to 7 days, and then you'll see a PDF file that has all the reviewer comments. And they're going to go through things like significance and investigator approach, environment, give you like the pros and cons of everything. And so clients expect a 10% shot of getting these applications the first time around. You were lucky to get a Phase 1 award. Getting a Phase 2 goes jumps up to like even 30 or 40%. I also recommend if the score wasn't well, you want to go in for resubmission to engage with the NIH program officer. This is a step that a lot of people miss, and not just for the SBIR program, for— but especially if you want to go for the larger non-dilute funding opportunities. Engaging with the agency will give you a leg up compared to those that do not. And I've had program officers that would sit with my clients for an hour and a half just to go through the specific aims and telling them exactly what they want to have. Not saying that's going to happen all the time, but they will help to champion you if they like your idea. And so there has been times where a startup didn't get a good competitive score, but because the program officer was so enthusiastic of their idea, it got funded. And so having those relationships early on is gonna be very, very critical and can even give you a boost in funding. I don't engage with you to help you with ARPA-H if you not have made contact with a program officer. So depending on some of these agencies, ARPA-H is adopting a DARPA-based review application where the funding decision is really your relationship with the program officer and their funding decider. And so there are no study sections. If you want to tap into the larger non-dilutive funding pots, having that insider connection is going to be sometimes the make it or break it for a lot of these applications. So they're just looking for competitive applications. Usually when the reviewers get the applications, We get new applications and resubmissions. We kind of treat those as kind of the same, the same thing. If we get a resubmission that didn't get all their critiques addressed or it wasn't a strong application, carries a weight as well. So as a reviewer, when you get a resubmission, I don't have access to your first application. I have access to your past reviewer comments. And you also include a one-page introduction to rebuttal the reviewer's critiques from your past application. So when I review a resubmission, that's the only two differences compared to what I would review as a new application. Usually when I try to take an NIH application and I try to adapt it to an NSF application, the goals of the NSF is a little bit different than NIH. Instead of being more heavy health-focused, for the NSF they're more research-breaking, groundbreaking. So I like to try and tap into what the technology innovation there and hone in on the broader impacts of how this can contribute to like the knowledge of that space in addition to your commercialization effort. Do I have an opinion on SBIR and STTR debate? SBIR is Small Business Innovation Research and STTR is Small Business Technology Transfer. Both programs encourage businesses to pursue R&D efforts in support of commercializing new technology innovations. However, sometimes as a small business, you might not have all the resources to have everything you need to complete an application. So for example, if you're doing a small molecular therapeutic and you need a clinical research lab, you might not have that in-house. Or if you want to do a cancer therapeutic and you need a big lab, sometimes you might find yourself partnering with an academic institution or a research hospital to either carry some studies out. Sometimes a lot of the work and efforts will have to lean on to your academic partner. And so at— in those moments, maybe an STTR makes sense. So usually when I try to debate whether an SBIR or an STTR is a better route for the startup, I like to think about what are my goals to make sure I have a strong competitive applications. Do I have all the resources to carry that out? If not, do I have to lean academic partner, I might need to lean on their clinical or research expertise and the resources. If so, how much? If more than one-third of your work efforts are going to be dedicated to your subcontractor or that research partner, I would recommend going for an STTR. And sometimes, you know, you just need to do that, and then that's totally okay. However, the pot of money for an STTR is much smaller compared to an SBIR, but the reviewer is also getting less STTR applications versus SBIR. And so it's kind of a, or a risk they get to weigh out whether or not that makes sense for you. And also with a research university or a hospital, a lot of that funding is going to be taken up by their overhead. I do have clients that are also overseas as well. If you want to go for an SBIR and STTR application, because these applications are meant to spur the US economy, you know, create jobs here, they would like to fund either permanent residents or green card holders. Or US citizens as the PI or main contact for these applications, and the majority of the ownership to be US-based. I have had instances where you can subcontract or partner with a foreign entity, and in those cases we have to give a couple more paperwork, but usually they're going to follow up and ask you, you know, is there US-based alternative that we can consider? However, if for example, if you have a startup and you're a non-US company, but you have a lot of key assets that you can't really find anywhere else, whether it's expertise or like technology that you're developing, I can argue that's a strong justification. You know, we have partner as the US company with your company as the foreign entity in order to carry these out. Now, as a PI of an application, I did have a foreign entity partnership and it's just they had a lot of questions to make sure, you know, where's the IP? Why do you need this partnership? And we argue we don't have a manufacturing facility in the States to carry that out. I would also encourage trying for an R01, which is more heavy academic base, and the foreign entity can be a prime for that. But we do recommend partnering with US entities. Again, if you go for an SBIR Phase I application, you can get anywhere from $300,000 all the way to $500,000 with a budget waiver through the NIH. Phase II can go up to $2 or $2.5 million if whether or not you have a budget waiver. Fast-track, you can do both. If you want to go tap into non-dilutive funding outside of the $3 million, $5 million, $25 million, these are federal contracts, and a lot of the ways to capture their dollars is to also partner with different institutions and people within the ecosystem in order to make sure you have a strong, you know, narrative on paper. If the budget cap for an SBIR Phase 1 application is about $300,000-$600,000, we can ask the NIH for even more money. I had clients receive up to like even $500,000 for a Phase 1 SBIR application, and that can be done something called a budget waiver. And so the budget waiver is kind of a waiver saying, hey, the NIH is looking for applications or topics to fund innovations in this space. And there's a PDF online, you just type in NIH budget waivers, and depending on the agencies, they'll tell you all the topics they're looking to really fund and kind of put more money in those research areas. And you can talk to your program officer, which, and ask them, "Hey, does my technology innovation, my specific aims, qualify for a budget waiver?" Whether an SBIR application gets awarded is the rigor of their approach, the significance, and whether it's a good proposal. The reviewers are not allowed to discuss the budget. They get— the reviewers can say whether or not the budget is reasonable for the allowable proposed R&D efforts. And so if the study review section recommends this proposal to get funded by the agency, that's when they might get into more of the budget. That's when you enter something called a just-in-time or the due diligence stage. So usually when I start a project with a client, I like to talk about their proposal aims, their short and long-term goals, and then we prepare a one-page specific aims draft. I have a video somewhere that walks you through how to go about that. Once you have a nice draft draft, doesn't have to be perfect, then we can go and talk to the program officer saying, hey, I have an idea, I'd love to go for the April 5th NIH deadline, which is next, I would love your input, please can we jump on a call? Say very little, listen, listen, listen, and then if they're enthusiastic about their application and the one-page specific aims draft, you can ask them and say, do you think this qualifies for a budget waiver? Make sure you do your homework beforehand and check out the budget waivers and make it easy for you which topic that they're interested in. As a reviewer, I have written a critique saying, "This is overly ambitious. You cannot complete this in a time frame." When I prepare an SBIR application, I like to think of a funnel of I had this huge idea that I want to solve, right? And then saying I'm going to solve cancer in my SBIR application is not realistic. Let's kind of narrow that scope in. Maybe I can focus on lung cancer, right? But lung cancer is still pretty big. So how can we niche down the focus in terms of core problems that my innovation wants to solve and really hone in on that, on that narrative? Don't ever try to broaden out your scope too much because it just doesn't seem like it's— we're not focused. Once you kind of narrow down the key problem within that bigger problem that you want to solve, next question I like to ask my clients is, if you have $300,000 and 12 months to develop and validate your proof of concept, what are the 3 biggest experiments that you want to do? Kind of helps me to frame— I'm time-bound by 12 months. I only have $300K, but I not only need to make something, but I need to prove it works better than what's out there. Say I'm going to give you $300K tomorrow. I want to know exactly What is the experiment? What are you going to do? How are you going to do it? What data are you measuring? How do you know if it's successful? What potential problems and solutions you're going to encounter and how do you mitigate those? I want to know every little nitty-gritty detail might happen to complete that aim. The Fast-Track process. So the Fast-Track, if you guys don't know, is a Phase I plus Phase II combined and accelerated pathway. So instead of just getting Phase I and then do your stuff and then you apply to Phase II, you can apply to something called a Fast Track. It requires a 12-page research strategy, a 12-page commercialization plan, and then all the other supporting documents. The competitive nature to get a Fast Track approved is going to be very similar to a Phase I. However, I don't recommend going for a Fast Track if we haven't thought out the commercialization strategy. So Phase I is all about proof of concept, prototyping, benchtop testing. If you want to do a Fast Track application, I'm also interested in understanding what's the next step look like? Addition to your Fast-Track application is something called a go or no-go metric, and the reviewers are strictly looking for that. The go/no-go metrics have to be a quantitative metric that would tell you, "I have been successful in a Phase I application," and it's the green light to say, "I'm ready for a Phase II."
