AUDIO Epi 4. Engineer Reveals SECRETS to Turning Research into REAL-WORLD Impact!

In this IPZO facto Podcast episode, we dive deep into the strategic mindset behind engineering innovation and the grant-winning tactics that bring research to life. Whether you're an early-career researcher, startup founder, or innovation leader in STEM, this conversation unlocks practical insights on how to:
✅ The journey of an engineering expert from academia to industry and back again.
✅ How an engineering expert strategizes research grants that move ideas off the page
✅ How to navigate current environment for strategic advantage and concept of "lottery tickets".
✅ Turn technical expertise into real-world impact
✅ Navigate the grant application maze with precision
✅ Build innovation strategies that funders actually want to support
✅ Align research with funding priorities without compromising bold ideas

🚨Calling all #startups. Don't miss September Deadline for grant submission! 
🎞️Watch the video, full podcast episode on #YouTube, and see the show notes for more information. 

🎧 Featuring real-world experience and advice from a top expert at the intersection of engineering, innovation, and funding strategy, this episode is packed with value for those looking to scale ideas through smart grants and strategic execution.

In this discussion, discover the speaker's insights on moving between academia and industry, offering valuable career advice. Learn how they navigated challenges and the motivation behind starting their own business, highlighting the importance of theory and practice. Gain insights into finding fulfillment in your professional journey.

📣 Subscribe and Listen to the IPZO Podcast here to get notified when released. https://www.youtube.com/@INNOPATHWAYZ?sub_confirmation=1
Share to support our mission: empowering innovators to build a better future, faster.

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#engineeringinnovation #medicaldevice #meditech #grantwriting #sbir #startup 
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➡️ Connect with us!
InnoPathwayZ (IPZ) https://www.linkedin.com/company/innopathwayz-llc/
Zina Manji, Founder & Principal, Regulatory Strategist, InnoPathwayZ https://www.linkedin.com/in/zina-manji/

Contact Kate on LinkedIn at dyadengineering https://www.linkedin.com/in/dyadengineering/
Dyad website https://www.dyadengineering.com/

🌟 This episode is brought to you by ExtendHealth Consultants Inc.
https://www.extendhealthconsultants.com
Email us: LearnMore@ExtendHealthConsultants.com
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🎙️SHOW NOTES
👓 READ Kate's Article https://www.mddionline.com/rd/the-end-of-free-money-navigating-the-deep-unruly-waters-of-federal-funding

Link to the main award announcements for the current SBIR program:
https://grants.nih.gov/grants/guide/pa-files/PA-24-245.html

List of Program Managers for the Different NIH agencies to connect with if you have a grant idea:
https://seed.nih.gov/aboutseed/contact-us/hhs-small-business-program-managers

Because with healthcare Innovation, there is No Way But Forward!

Transcript

I think you describe it as going from engineering to academia and back again. Academia, and they would say, oh, you're too much in the industry. We want to do more research. We want to do early stage science. 


And I'd go into industry and I'd keep asking all these questions. Like, why do we do it this way? Why does it cost this much? Why couldn't we do this a different way? And they said, we don't have time to do the research. 


Starting my own business was a way for me to do the things I really love. A dichotomy, it's theory and practice. You're at the interface of both of those aspects. I mean, this is actually a real conflict. 


A business person going, I only have a million dollars and we have to get revenue on a million dollars. You have to stop doing science and push that product out. And so the part of why I call my consulting firm, Dyad, is because you have these conflicting personalities, cultures, societies, that when you're working in innovation, you need to get those two sides to work together. 


That it's gonna make their great engineering not make it to market. It's a challenge. Something I see with a lot of startups, you have to be very brutal with what is the absolute cheapest, easiest, least failable thing to go for. 


Gene learning, you know, watch my budget with 16 different buttons and everything. And it's gonna cost $200,000. Your budget is $5. Tell me how you will change this product based on the budget. And if you only have one option, your startup's gone. 


When I talk about grants, okay, you have to come up with a very crafted project that the project clearly build your product towards a commercial device. This is a part of the key success factor. You go back and forth because how you do the engineering work can vastly change how much it costs. 


The grants, they're not as sure when. What it is, is it's additional lottery tickets. Well, honestly, the ideal startup has extremely senior people. And so this is why, in addition to doing my own work with Dyad, where, okay, if you just need a senior engineer, I've come in, I've been partnering with Extend Health and different partnerships on to fill the need for those startups. 


The reason is that the people who should have been in the room, work in the room. Innovation Research Loan, SBIR. It's a minimum of six months to get it in hand. Now, if you tell a startup, you're going to wait and do nothing for six months. 


They're going to tell you, we can't do that. Like we're supposed to have a product. So an article I wrote about a lot of my companies, I encourage them, I'm saying submit now. Other things you need to know right now. 


Valid strategy as a startup. This current episode will be released in June of 2025. Put out that public service message that the next submission timing is September. The next SBIR is very likely they will be renewed. 


It'll be in January, but it's going to be on a different award. And we don't know what is going to change about highly recommend aiming for September. Have the pieces assembled together to give yourself time to do it. 


Because even just getting onboarded into the government systems, you have to register your company. And sometimes that can easily take anywhere from four to eight weeks to get quotes from service providers. 


That's a minimum, another four to eight weeks. If you call them up now, it's one of the best times to be able to talk to them about what they're thinking of. funding come September, the number of local trade journals that if you connect with me on LinkedIn, I'll post about it, article generally about broad strategic topics about the industry. 


This episode is brought to you by Extend Health Consultants, expertise when and how you need it. Hello, welcome to the next episode of ipso facto podcast. I'm your host, Zina Manji, and I am thrilled today to be talking with Dr. 


Kate Stevenson. Kate, I met recently within the past year, and she is a phenomenal person with very unique and diverse expertise. And I think you're really going to enjoy our conversation. We will be talking about supporting life science products in a very unique way that you may not have heard before from an engineering standpoint. 


So Kate will be talking about engineering strategies for life science products and how engineering strategies are critical for successful grant writing. And you can understand in the current environment and also generally grants are the way that we start to research and bring products forward. 


I think you're really going to enjoy this episode and get a lot of unique learnings. I'm so happy, Kate, to have you on this episode to share that expertise. So thank you for joining. Kate, introduce yourself to this audience and talk about what inspired you and what you love doing with your current roles. 


All right. Well, my name is Kate Stevenson. I live in the middle of Silicon Valley, California. So I've been in the startup environment since about 1997. So I've seen a lot of new products, new companies come and go. 


And I am fundamentally, in my heart, an engineer. So did an undergraduate degree in engineering. First time going to college for most of my family. Went out, got a job, discovered things that discovered about medical devices, the life science industry, realized that, hey, maybe I'd like to learn more about working on those kinds of projects. 


Did a quick fly-by degree. Never thought I'd go back to school. Got my dream job out of grad school, which was working for a design firm that did nothing but medical devices. And seven years passed, two kids, a house mortgage. 


2012 came around and I suddenly realized I wanted to learn more about where technology came from. I wanted to understand why some of the devices I was working on would ultimately fail, meaning we would do great job engineering them, but they wouldn't get to the market. 


And so that's how I ended up going back for a PhD. I actually never thought I would have these letters at the end of my name, but I found out I am a super nerd. I love going back and looking through books. 


about information, learning how things work, and using that knowledge to create new solutions for some of the problems that we have. And so where I am right now is I have actually been running my own consulting practice for about six years now. 


That's what diet engineering is. I've joined up with another group of consultants called Extend Health that you'll hear about more later. And I'm also what is technically a fractional CTO of a small startup company in women's health. 


Wow, Kate, that's a lot of activity there. And I think very unique, inspiring for people to hear. You started on a very typical standard way of going into, I'm going to be an engineer. And now what you describe you're doing is far from your original, I'm going to be an engineer, but where you're really bringing that into supporting products for life sciences. 


And you also have the academia aspect looped in because you do teach as well. So I think you describe it as going from engineering to academia and back again. It's more like you just kind of keep hopping back and forth across the line until it blurs a little bit. 


It's kind of an uncomfortable space to be. Part of the reason I had to start my own business is I would apply for jobs in academia and they would say, oh, you're too much in the industry. We want to do more research. 


We want to do early stage science. And I go into industry and I keep asking all these questions like, why do we do it this way? Why does it cost this much? Why couldn't we do this a different way? And they said, we don't have time to do the research. 


And so really starting my own business was a way for me to do the things I really love, which means using my knowledge and ways to help companies to create those new devices, teaching students. I was a first generation college student and I learned to really appreciate having a good teacher to explain things to me. 


And I'm also doing a lot of writing right now. So whether it's for industry journals, or I even have a book in the works right now, based on the type of information that's And I found a lot of my clients really need to help. 


That's wonderful, Kate. And I think really meaningful and useful. Because as you say, these are things you're talking about or you're not going to learn in a course at any typical university, right? These are like in the field learnings you're bringing forward. 


And what has failed and how do you succeed? I mean, you've got real life experience that you're bringing into your teaching as well. Yeah, and they appreciate that. I mean, one thing you don't realize when you're a college student is that none of your teachers have actually worked in the industry. 


They've studied it. They've researched it. But working as a professor or even a lecturer, your entire career path looks very, very different from any of the paths their students are going to be. So in some ways, you get taught the knowledge, but you don't get taught how to do the job that you want if you go out in there. 


If you want to go into becoming a teacher yourself, your professor is a great contact. But however, if you want to go into a specific industry and maybe start a company or go into investment or go into public service, that's where you've got to go outside and find ways to connect with those types of people. 


So do you think there's a dichotomy, it's theory and practice, it's theory versus application and you're at the interface of both of those aspects. Yeah, I mean, this is actually a real conflict that I feel in real time, often in meetings because sometimes I'll have a founder of a startup who they may be a professor, they may be a researcher, someone who's literally spent the last 15 years of their career focusing on the science and they've hired an engineer or a business person or an MBA to try and commercialize their technology. 


And the personalities in the room can be so completely different. You have the professor who never stops trying to do better science, add the next thing, publish the next paper and you have the business person going, I only have a million dollars and we have to get revenue on a million dollars. 


You have to stop doing science and push that product out. And so that's part of why I call my consulting firm, Diad is because you have these conflicting personalities, cultures, societies that when you're working in innovation, you need to get those two sides to work together. 


Yeah, absolutely. And being a regulatory strategist for my end, I can totally understand what you're saying where I'm trying to ask for the data and the data's not there, but I'm not always understanding the deep aspects of why it cannot be provided. 


And you're actually saying that that is the dichotomy that's actually happening. Well, I realize even in regulatory, I mean, if you take a traditional scientist on a research funded grant in an academic institution and try to explain the specific type of data that you know you have to get because that's what the FDA wants. 


And that may be very different from what all the academic journals or the current practice may. And so even you you have your own very specialized context that you're aware of your job is to get the FDA reviewers to approve a device. 


So they need to see a very specific type of data. And most likely that was based on the device that came before that's the closest to yours, not what was done in science, what they're used to doing what their equipment is. 


So it's a very interesting case and I've had to explain that to founders as well. Sometimes regulatory doesn't always make sense. You are literally talking to human beings who have a different way of seeing the world and a different set of values and ways of making judgments from what you may see in a scientist or in a business person. 


Yeah, and I think this is a challenge definitely that occurs. I remember having conversations with medical affairs leads and saying, but this is this is what we do. I say. in practice, yes. However, the product is not, we can't claim the product for just that. 


Now, we're not getting into off-label use, but there is scientific data and clinical data that might be available, but it hasn't been included in the product, specific product that we're talking about. 


So, you really have to develop that full package that supports mechanism of action, which engineering is a huge part of that to understand, you know, all of the aspects of how does a product do what it's supposed to do and what are the risks and harm reduction aspects that you can bring in for controls and risk management, but also the clinical aspect. 


How can you produce the product or design the product in a certain way that you're actually going to have the clinical benefit you're looking for, especially in the conditions of use. So, that's the other aspect, right? 


Is you have to also look at the conditions of use that you're considering for the product and what you want to commercialize, the context in which you want to commercialize. So, yeah, that is really interesting space, Kate. 


And you're right, you do come up with dichotomies and a really great explanation of your company brand name. I think that's really clever. One thing I love to do with first-time founders or students or people entering the space is take them to a major trade show in our space. 


Because most first-time founders, when you're just getting introduced and all you see is the little vial of drug, all you see is the small little device and you think it's so simple. Why does it take so long? 


Why does it take so much money? Why does it take so much effort and so much people? I can do this faster. I can do this quicker. And I walked into a trade show with 1,500 booths and every booth represents a company that provides a service. 


or product that is key and absolutely vital to getting their medical device to market. And it's like a light goes on because they realize all of this is needed. Everything from the sterilization to the clinical studies to the documentation, to the software for the documentation, to all of these different moving pieces that support our current expectations of healthcare and health products. 


And so that's something that I love doing in my teaching. I love doing in my consulting is finding ways to communicate the scale and depth of what it takes to do what we do safely and effectively. You know, you're absolutely right, Kate. 


And I think that's extremely insightful because it's very hard to understand and absorb when someone's telling you a bunch of things. And when you're reading a bunch of requirements, and you're trying to figure out, okay, well, you know, what does that mean? 


And often there is a perception of the expert that's telling you these things or advising you their experiences. Well, you know, you're a little risk averse. I don't think we need to do all of that because, you know, I'm an expert in what I'm trying to create here as a founder. 


And yeah, I don't know that's where that was then, this is now, we can do a lot more innovative things without thinking about how do you have to bring the proof of that, right? There's that evidence generation there. 


There isn't a natural acceptance that, hey, you've got something new, and therefore, you know, the healthcare system, the regulatory system will just naturally apply it, right? There are standards that need to be created and methodologies that give assurance that for any follow-on products, you know, these methods and such and into post-market will result in reliable and safe use as intended. 


I want to just double down a little bit on how you transitioned from being an engineer and how you entered into the healthcare space. What was that introduction for you? When I went away to college in undergrad at 18, I honestly picked Stanford University because I really didn't know what I wanted to do. 


I was one of the first of my family to go to college. And going to college is where for the first time you start interacting with doctors, lawyers, business people, professions of all kinds that I'd only ever seen in movies or on TV. 


And so understanding what that actually was, that was a real job you could go do, was in some ways, it was almost like this massive feast in front of me of like, there's all these amazing, fascinating things to learn. 


And so I honestly didn't declare my major until... of my junior year because I was having too much fun learning all of this different cool stuff. And for a while in my sophomore year, I was actually pre-med. 


I was seriously considering medicine because I love the idea of doing surgery. I love the body. I love the mechanics of how it moved and all the different parts of it and how you could fix and repair it. 


And I took the pre-med, I took a quarter pre-med courses at Stanford and I did really well. I loved the material, but every one of those classes was so miserable. And in the meantime, I'd go back to my dorm and I'd run into the eight or 10 engineers who were busy building something in the hallway of the dorm. 


And they'd have power tools and two by fours out. They'd be building giant subwoofers like if to like fill up their dorm room or they'd be taken apart a toaster oven or, and honestly, most of the time, half the time, they would start asking me for tools because my dad was a machine as he was a technician. 


I grew up building stuff in my garage growing up. And so I actually took seven toolboxes with me to college. Now, I was also scared to death of math, which is probably why I held off doing engineering so long. 


But I love to make things, and I love to figure out how to take things apart and build new things. And so there was this combination of like, hey, you can take apart and build things as a surgeon, and you can take apart and build things as an engineer, but the engineer, you'll probably get to play more and experiment a little more. 


And the lifestyle difference was very, very different. And it's something that even is true today. When they talk about lifestyles, engineers, if you're not working at a startup, you've actually got one of the top life quality lifestyle balance anywhere of any profession. 


It's like one of the top five. And so I realized, look, the stuff I love to do is in this major that even though it scares me, I'm going to go do this anyway. And so that's how I got into it. But the fascination with medical was always there. 


I got my first job at a startup out of undergrad, and this was around 2000, middle of dot-com bust. I graduated in the middle of a horrible economy. I have a lot of sympathy for everyone who's graduating right now. 


And I remember applying to 40 different jobs and no one even called me back. Like here it is, I'm a Stanford engineering major. Everyone's told me how smart and amazing I am, and I cannot get a job. And so what I did is I ended up having a friend who had a startup here, and it was in telecom. 


Like we were building this little optics object, and they said, hey, I heard you like to build stuff, and we've got something really tiny that we need to make. And I said, well, I built primarily doll houses. 


Like I worked on really teeny tiny stuff growing up. Ever since I was like about six years old, I got my first X-Acto knife kit, and I was building microscopic things. And they said, that's great. We have a tiny microscopic project. 


We just need somebody with really good hands. And that's honestly how I got my first job. Wow. And what I loved about the first job is, but it also introduced me to startups and the idea of building from nothing. 


I think I would have a very different career path if I'd gone to work for a major corporation. But the whole idea of build something, figure out, did it work? Did it not? Build something different. And I did the classic Silicon Valley thing. 


I remember like riding home on my bike at 3am in the morning because we had an investor meeting the next day while I was planning my wedding. And I went through all of that. But sometimes about the middle of that, and of course, eventually the company went under. 


I also experienced my first Silicon Valley layoff. What happens when the startup doesn't take off? My manager actually left to take a job at a medical device company. And he was like, yeah, I want to go. 


It's like, wait, you're a mechanical engineer. What are you doing working in medical devices? You can design medical devices. And I thought, wow, that's amazing. And so. when I lost that first job I thought I think I want to go into medical devices and that's when I went back to my master's and the whole reason I just did what I call a fly by master's I went in four quarters I actually wrote my application I don't want to do a PhD I just want to work on medical devices you know get some courses and go out and get the job dream job I want and that's exactly what I did I four quarters I got out I signed up with a design firm and I worked there for the next seven years and I worked on about 16 different devices cardiac catheters knee implants aneurysm stents pacemakers and I absolutely loved the work but at some point I realized I'm doing the same thing there's about the eighth catheter I worked on the eighth tube I designed and I'm going where's the pediatric devices where's the devices for pregnant women where's like literally there's all these different conditions in the world and why is my design company doing catheters pacemakers and diabetes monitors and I realized you know this was one of the big questions that made me go like hey like I work with special needs kids like I actually worked with a sports program for about 20 years working with children on autism spectrum cerebral palsy and I realized a lot of their parents and their families had very specific medical needs that were completely unmet because there were no devices designed for them and so I had all these big questions and I actually had this moment where I was like driving down to highway 280 I was coming back from my job I was thinking about picking up my kid I just had a new I had like about six month old and a four year old and I'm thinking about like you know for me to solve this question I would need to come up with all these detailed questions I would need to come with a thesis I would need to do all this formal research and literally I felt like the glare hit the windshield and like the lights lights just went on I go like oh my gosh that is a PhD and I'm going like I am a mother with two small children a mortgage and I told my husband I'd never go back to school after the masters and I was absolutely terrified and I walked into our condo my husband's like bouncing our baby on his knee and I said honey what would you think if I went back for PhD and he kind of stopped and went you know that's not a bad idea and five years later I was graduating with a PhD and I got to spend a lot of time getting all the context for the engineering that I was doing the engineering so I learned about business models I learned more about regulatory pathway I learned about patents and IP going looking back over those seven years ago like there were definite times where I had the client in the meeting who just refused to go with a solution that was obvious and it never occurred to me at the time that that was because it was on a patent of their competitors aha this is this kind of stuff that you don't get told or no there's a regulatory barrier to using that technology or no we have a limited fund We can't send the engineering team down to go talk to the doctors because that would be this many thousands of dollars. 


You don't necessarily think about money as an engineer. And that was one of the biggest things I went back to when I did the PhD, is I got asked to write up a business plan for a medical device startup. 


And the first thing I realized is how expensive I was. Literally 50% of the cost of most startups with you raise a million dollars, half of that is going to salary. And a lot of times it's hiring that really senior level engineering talent that is the biggest cost. 


You'll have a business person going, hey, I've got some money, I'll go in on equity. You have a doctor saying, hey, this is a side gig for me. I'll go in on equity. And like, we've got to scrape enough money to hire an engineer to actually build and make the thing. 


Right. And which is sobering when I'm thinking about all those devices that I said, why don't they exist? And I was like, I'm part of the problem. Interesting. And so there were a lot of things I learned doing the PhD. 


I also learned about how to do research, how to do formal citations, science, how to build a thesis, how to write a lot and how to ask a lot of really good questions. But it gave me a lot of insight that I thought over the last six years of my consulting of I still put on the engineering hat. 


I walk in the room and I see the engineers I used to be. And they've got great engineering and they don't realize everything else that's going on in the room that is going to make their great engineering not make it to market. 


That is fascinating. Kate, really fascinating. So when you went into the PhD program is that that's when you learned more about medical devices specifically in terms of the business plan and all the other aspects that we've done that was part of the programming Was that also coming from your past experience linked into the program as well? 


So I came in with very deep practical experience. I probably knew more than anyone else in the room how to sit down to work bench, what the plastics were, the types of components, the metals you needed, the sterilization. 


But if you wanted me to just draw out a five step, these are the five steps you need to do to take an idea to a commercial device, I couldn't do that. Got it. It's kind of sobering when you think about it, that I'm designing products that fundamentally I didn't know 80% of the picture about. 


So when startups are looking for engineers, right? What you're bringing forward for me is it's not having that title, I'm an engineer, is actually, but do you have the experience and the knowledge base to design and to really interrogate questions that leads to a purposeful design? 


that can actually serve a business plan as well and be done and designed and produced in an effective, efficient manner towards a targeted intended use that then feeds into the story and the narrative for regulators to understand the piece by piece design build to give them assurance of how has this product come together to therefore produce the intended use. 


It's a challenge. Something I see with a lot of startups is startups will buy what they can afford in the terms of engineering talent. So I see a lot of very early graduates. They find somebody who had a really good senior capstone project and say, okay, you're, we're going to and they've hired this 22 year old engineer to actually do the actual engineering and it's cost effective, but they don't realize all the knowledge that's not there because they are not engineers themselves. 


Right. And they don't realize like, and even as a young engineer, you know, like I'm a mechanical engineer. So I love watches. I love mechanisms. I love industrial engines and heavy construction equipment because they are complex and beautifully elegantly designed, but that's not what you need in a medical device. 


Medical device, you have to be very brutal with what is the absolute cheapest, easiest, least failable thing to go for. And so sometimes you're going to like, yes, we can create a Bluetooth enabled AI machine learning, you know, watch my budget with 16 different buttons and everything, and it's going to cost $200,000. 


Your budget is $5. What can you actually do? And so for me, and sometimes you don't even know your budget is $5. Oftentimes a founder will come to me and say, okay, well, we might be able to get it for 1000, we might get it for 50, we might get it for five. 


Tell me how you will change this product based on the budget. And so that's really the skills you need to come in with as a founding engineer at a startup, is to be able to as you are crafting the path forward, to come up with not with just one product, but literally 20 or 30 with each one of those has a dozen different potential design options. 


So when you're working with a very junior engineer, they may know one or one, two or three ways of doing something. Senior engineers very quickly, you need to know 40 or 50 or 60 different ways to do something. 


Because by the time you go through the regulatory pathway, the IP constraints, the business constraints, the requests from the market, the clinical challenges and all those different elements, eventually, that's going to knock away 95% of your options. 


And if you only have one option, your startup's gone. Yeah. Right. So this is really interesting. And if you talk about engineering and elegant engineering, the human body is a great example of that, right? 


There are mixed ideas about that. Some people will say as a self-healing, regenerating mechanism with a lifespan of about 30 years, it operates great. Self-reproducing, you know, it's, you know, you expect it to go beyond those 30 years or to engage in activities it wasn't designed for, you start having a lot of problems. 


You know, like anything that involves walking or moderate pace running, we're very, very good at. Anything that involves repetitive loads with our arms and shoulders, if you look at the way the ligaments and the joints are set up, they're actually horribly designed. 


They're designed for dexterity and reach, not strength. So if you wonder why people's backs and shoulders are so torn up all the time, it's because we're doing things that a lot of times our bodies are fundamentally mechanically not optimized to do. 


Really interesting. So as we talk about longevity and quality of life, these are real things to consider on, you know, how are we overstretching ourselves beyond what we're designed to do, but what's a way to kind of build that appropriate strength and, you know, span of movement? 


You know, I think about even the fact that we wear high heels. So I actually spent the first two years of my PhD studying biomechanics and understanding what happens when you move your heel up more than an inch and a half off the ground. 


The way it misaligns your knees and your hips and all those different things, like it scared the heck out of me. And so I don't wear heels over two inches anymore because it throws everything out of whack. 


The stresses, the force, the range of movement, motion, are not what we were designed for. And so you start getting breakdowns and wear patterns that you wouldn't typically see otherwise. And so, as we're thinking about longevity, there is a certain amount of don't do things the body wasn't intended to. 


But there is also a lot of thought of how can we in some ways circumvent and go around some of our body's natural mechanisms. For example, we use wearables, tracking. So we stick things on skin, and our skin has this amazing ability to constantly slough off skin cells and create new skin. 


Well, if you want to wear a wearable for more than two weeks, how do you get around that? Because the skin that you want to stick to naturally should disappear after a week or two, it gets sloughed off. 


And so you're thinking about like, oh, you're going to have a you're going to stick this to your skin for a month. It's like you're not going to have the same skin in a month. And so it's actually These are some of these interesting challenges when we're getting into medical device that there are fundamental aspects of how our bodies work and function. 


We sweat, we exude oils. We do all this stuff. We have body hair that when you have this nice ideal idea in your head and go like, oh, I'm gonna put this on a person's body and just track them for a month. 


They're going like, your body is not gonna support that. And so you have to work around it. Yeah, really, really interesting. And so talking about working around that, that also comes into evidence generation, right? 


And I get answering hypothesis on what you're designing. So how did you get into, I mean, you said one aspect of the PhD program was you were writing like crazy, right? And the design aspects, all of those things, you were learning those skills and going deep on those skills too, to do that, to ask the questions, to answer the questions and product design and presenting that in a way that leads to a viable product, 


right? And so when you bring, so that's one type of writing. Yeah, the other type of writing is that clinical presentation or what we typically think of a clinical presentation in terms of grant writing. 


And part of grant writing is coming to overarching summary of what you're intending to do and what the purpose is. And so how did you get into that aspect of life science product innovation? Well, let me talk about the writing a little bit because one thing you'll realize is getting into life science products, you'll find yourself doing all kinds of writing. 


And so if you get you graduate, you know high school and you're used to your high school English class you're used to writing the 500 word essay and But realizing as an engineer in medical device even before I went for the PhD I did an intense amount of technical documentation whether it's writing up reports writing up protocols writing up Standards of how the technicians were going to assemble the products and there's a very certain Format and language and tone that you use for that kind of writing Then there's the kind of writing that you do when you're publishing a scientific paper And again, 


even that kind of tone depends on what field you're publishing in Some of my research covered everything from education to engineering to medical technology and clinical journals And I had to really look up and say like okay. 


How do they present these documents? I have a client right now that they want to do peer-reviewed publications for their medical device and They have an amazing manuscript that talks in detail about the medical device and going, this is a great white paper for a design firm, but this is not a paper that is going to be clinically published, scientific, peer-reviewed, clinical journals. 


And so it's really understanding your audience is very critical. This is something that I feel sometimes a little insecure as an engineer, but you really have to have a certain level of empathy and understanding your audience, which engineers are not known for. 


When you write something, it's not just for you. A lot of times when I write something, I'm never the audience. Unless I'm writing it on a sticky note, I'm not the end audience. And so whether it's writing a grant, whether it's crafting a pitch deck for an investor, whether it's applying to be an accelerator, an incubator, or applying to a nonprofit for it, all of these, you really have to understand who that person is on the other side. 


A great observation when I was drafting my PhD thesis, I realized that ultimately there's only three or four people I know for sure are going to read this. And that's my PhD thesis committee. And one of the best pieces of advice I got was the thesis committee was also my defense committee when I presented it, is don't make professors feel stupid. 


So when you are writing, use the words they know. Use the phrasing they're comfortable with. Use the templates they are familiar with. Don't make them have to think too hard. And when we got in a medical device, same thing is true. 


You don't design a medical device that makes the surgeon feel stupid. Brilliant, smart people do not like to work or engage with things that make them not feel not smart. Very same thing with grants. 


Your grant is going in front of a program director. If you're going for a federal one, very likely they have a PhD in a STEM science, either science, clinical, engineering background. They have literally looked at hundreds, if not thousands of proposals. 


If your proposal doesn't look very similar to something they've already seen before. If they have to... to dig through it to find the information they need. Already, they're going to be going, okay, they don't like their job, they hate their job, they want to get rid of your application as soon as possible. 


So just like the thesis, when I did my thesis, I actually looked up the last 20 theseses that were produced out of my department. I got an Excel spreadsheet, I figured out exactly how many pages they were, what all the sections were, how long each section was, and I had literally, I had a table of exactly how many pages I need to write and of what for my thesis before I ever started writing it. 


Same thing with a grant. Grant submissions look very different depending on who you're going to for money. So whether you're going for the NIH, National Institutes of Health, they have a particular template versus NSF, National Science Foundation. 


They have a slightly different template, slightly different review process. They're both big money federal grants. They both may have similar types of grants. That's when we're talking about SBIRs, R01s, R44s. 


or career development grants, they may have this similar mechanism, but they have their own flavor and way of reading it and very different types of humans in the room who are doing the reading. And so when I talk about grants or writing of any kind, I really have to think about humans in the room. 


Now, I also wanna talk about a different thing about grants, which is before you even get to the writing, people talk about grant writing, but it's more, the writing is just one part of it. You have to actually come up with a project to write about. 


Yes. So this is where some of the strategy comes in. You don't just write an amazing piece of about an experiment you wanna do, and they go, here's $2.5 million. Okay, you have to come up with a very crafted project that the project has to be compelling and contributing to the state of science and clearly build your product towards a commercial device. 


Hmm. That is really on point, Kate, and a lot is jelling for me as I hear you state that, because absolutely, I think maybe you would consider this as a part of a key success factor that you actually have a project in place. 


You're not writing a grant against an idea. Oh, I have an idea. Let me write a grant and see if I can get money for it. You actually have something thought out on a project structure behind it to actually give the grant submission reviewer some evidence that this is something that you're actually committed to, and it's in play. 


And now this is what you need the grant for towards this purpose against this project strategy. And I guess this is part of the, you know, if you're talking about chicken and egg, this seems to be a very clear thing you should start with, right, before you actually go in. 


do you actually come across who start with the idea but don't actually have the project? So I come across people at many different stages when they reach out to me and they say, hey, I want to write a grant. 


Sometimes they may have already written a dozen grants and they're literally looking for someone to actually do the writing. They need someone to actually submit the document. Some of them literally they may have a previous investor and the investor is saying, hey, we want some more non-dilutive funding. 


Go look into grants. Sometimes you're a college student, like you literally just got out. No one's going to fund you because like literally you just got your, you may not, you may have even dropped out of college. 


We don't know. And they're like, you have no evidence, no background, no funding, and you just want someone to give you the first check so you can go out and do that. And so I meet all these types of people and even zooming back from the grants, you have to think about going back to what I learned the PhD, like engineering costs money. 


creating stuff, making things is expensive. And you have to have a plan for all the money piece, not just the engineering work you want to do. But they go back and forth, because how you do the engineering work can vastly change how much it costs. 


Yeah, that's right. And it can change your clinical design, you know, and what what parameters you you are going against. Yeah. So when I talk about a startup that talked about I want grants, one of the first things I'll say, well, what is overall funding strategy, because grants will not pay for everything. 


That's the ideal is I got to come in, I'm going to go direct to phase two, get two and a half million dollars, and that's going to get me through my FDA submission. And they're like, Okay, what do you have? 


It's like, well, I have this 3d printed part. And they don't realize, most likely, you're going to need minimum 3 million, more likely closer to 10 million, you're not going to get it all at once. People are chunks that start with usually about friends and family, it's $10,000, $20,000, maybe even just $1,000. 


Then you're going to go, Okay, maybe I get a small grant, it's $50,000. And then you go with that small bit that a little bit of a couple of awards, I got an incubator, I want to pitch contest. Now I have some evidence that I can take on a phase one, SBIR, which is a quarter million dollars, $250,000. 


And then if you land that, that's when seed investors start thinking about, okay, maybe we'll give you a million dollars. At the same time, you're doing your phase two grant application, which is a two and a half million dollars. 


And then about that time, you go, okay, maybe we can do a Series A, which is a five to $10 million raise. So something happens in series. And the grants, they're not as sure when just like raising investment money is what it is, is it's additional lottery tickets. 


Now, it may be a very small lottery, you know, it may be that there's only 20 people going after the same bucket of money. But you realize the more lottery tickets you have, it is going to increase your odds. 


So any startup, they're going to be looking friends and family, they're going to be looking at venture capital, they're going to be looking at what's called family offices or non-profits. If you have a medical technology that's working in pediatrics or a rare disease, a lot of those are funded by very specific groups. 


There's federal, there's state programs. If you work in a state that's using life sciences like the state of Texas, a lot of life science support where they are actively trying to get startups to come to their state and launch new businesses in their state for economic reasons, not just long-term life science benefits. 


And so, and then you also even have business loans and maybe that you're mature enough and you're close enough to market, you want to take out a certain amount of debt because giving away a chunk of your company is no longer a good prospect for you. 


So all these pieces and because uncertainty happens. You know, every startup, I've been a plenty of startups that did not make it. I had a couple of startups that made it, but sort of made it, didn't make it that well. 


My husband had a company, had a startup that went all the way to an IPO. And so you can't exactly choose what path you're gonna say. You can't say, I'm gonna do all grants, I'm gonna do all investors, I'm gonna self fund completely. 


Some can do that, it's a nice thing. But you have to prepare for all of them. And so what is the first thing going into grant writing is, okay, what else are you pursuing? Because there are certain things you can pay for with grants that investors don't like to pay for. 


And there are certain things that investors will pay for that grants won't. So big thing, CEO salary. A good investor knows that they need the full time attention of a competent CEO. So they will push the founders to give a CEO equity. 


They will give them enough of a salary that they're not split among six different companies to focus on building that one company. But an SBIR grant, they don't wanna see more than like 10% of a CEO salary on the grant. 


Because they say like, well, they're not doing engineering, they're not doing science, they're not doing technical development. And so when you look at the budgetary items of what's on a grant, they wanna see scientists, they wanna see lab specimens, they wanna see clinical trials or clinical studies, they don't wanna see a CEO salary. 


Got it. And so realizing, this is where you're gonna be playing back and forth. On the other hand though, your investors are gonna be really happy if you can land that two and a half million dollars to run all your clinical studies. 


Right, yeah, really insightful. And I think really good point about having a focused CEO because we do see that a lot, right? A lot of fractional roles and because of the uncertainty as well, right? So I think the more well-planned you have as a project Intention with the room to be agile enough to pivot as the data drives you that you need to pivot, but at the same time, as you say, it's, it's the scientists on board and clinicians on board who will be the interest of, 


of, of, of grant support where. You know, you're really going to get the assurance that you have deep expertise, that is part of that development. And that's what investors will also want to see. Yeah. 


But investors also want to see that you've got some sort of legitimacy, which you, you wrote it, you wrote an article recently, Kate. Now I'll share that in the show notes. Part of this activity that you get into grant writing, you're, you're, you supply that through your role with extend health consultants. 


Yes. So, you know, I realizing, you know, medical device. One of the things that I've told any early career person is it's a industry of sub specialties, whether you're in going into drugs, pharma, diagnostics, medical device, biologics, biotech, there are so many different niches and small portions of expertise you need to have. 


And I mentioned early on the challenge of having a very young engineer, where honestly, the ideal startup has extremely senior people in every single position. You know, you have a very senior operations person, senior clinical person, senior medical person, senior engineer, but no one can afford quarter million dollar salaries for six people at a very early stage. 


And so this is why, in addition to doing my own work with DIAD, where if okay, if you just need a senior engineer, I come in, I've been partnering with extend health, where there's individuals like yourself, where they cover regulatory, there's individuals like our other friends who are scientists, who are digital health experts, and who are more commercialization acquisition experts. 


It's very rarely do you get somebody with a deep corporate background on a startup team, who knows about the end game about being acquired, and what that looks like. And so what I love being part of extend health is it's a bench of, you know, I kind of think of it as like the Avengers, you know, I think I'm a nerd, okay, I'm like, or if I the engineer, you know, but sometimes Iron Man gets his own movie, 


other times you got to bring out the Avengers, because you've got to bring different partnerships on to fill the needs of those startups. And if people want to contact you, and work with the Avengers team that you mentioned, we're happy to say that this episode is brought to you by extend health consultants. 


And with that, it's expertise when and how you need it. And Kate did describe all the different expertise that's needed in grant writing, extend health is bringing this episode forward for you. And with that, please contact us there will include the contact information. 


One of the things I loved supporting and discovered that inspired my PhD was supporting those founders who were very much passion founders and passion founders come in, you may have one of the skills. 


You might have an MBA, you might be an MD, you may be an engineer, but very, or even I have met a few people in my life who were all three. That doesn't mean you can do all three jobs equally well into the level that you need to for a startup to succeed. 


In tech, consumer, you see a lot of single founders who go out. They hire a couple of consultants and suddenly they're like, okay, I just sold my company for $10 million. That doesn't happen in medical or if it does, it usually isn't a good thing. 


It realizes that the people who should have been in the room weren't in the room and the long-term prospects for safety and efficacy of that device, it's questionable. I won't go into too many, like I tell horror stories to some of my students. 


about devices that when they launched, they made a lot of money. People were very excited about them, but something was missed along the way and people got hurt. And so when I talked to startup founders, they want to change the world, they want to do good, but I also have to drive home, this is serious stuff. 


And you need to make sure you have the right people saying only telling you what you need to know to be able to do it right. Now, consequently, you also need that for a good, successful grant application. 


Okay, so the people reviewing applications, they're experts. So usually you have the program director who literally you think you have the most amazing cardiac wearable, he's seen 20 of those before breakfast. 


Yeah. So you really have to have the details that communicate, I know what needs to be done, I know what the important things are, and here's my plan to do it. And not only here's my plan to do it, here's letters of support from all those people I've listed in the plan. 


So I mentioned part of this is about planning the project. So usually grant funding, it takes you even for a small business innovation research loan, SBIR, it's a minimum six months to get it in hand. 


Now, if you tell a startup, you're gonna wait and do nothing for six months, they're gonna tell you we can't do that, like we're supposed to have a product. And so you have to think about, well, what can you do? 


So a lot of times we'll see like, okay, I am gonna work on the early prototype, but this is gonna be my commercial device, or I am working on this device, but I also wanna develop this device for a second indication. 


And so that's what's going in the grant. I mentioned like the master strategy is all about breaking it up into smaller bite-side chunks and getting funding for just that chunk. So if you're a successful grant application, means you need to think of a chunk that you don't need to do yet for six to nine months, but you can find all the resources and get them agree to be part of the grant application. 


And so a lot of times that can be very difficult. You can't... find an amazing engineer looking for a job right now and say, hey, give me your resume and then come back in nine months when I have money. 


Very likely they're all going to have another job, they're not going to be able to do it. So part of what I do with my grant people is like, okay, do you have a service provider? Do you have a engineering consultant? 


Do you have a regulatory expert? And then different parts of the grant have very different types of writing. I mentioned a commercialization plan. And the research plan is for the scientists. They are the ones who are going to check your math, they're going to check, did you do your citations? 


Do you have good literature? Did you show that you've built the case for your science? The commercialization plan, this is where when I do peer review, so I've been a peer reviewer for both the NIH and NSF, and what this means is if you submit your grant, it's first reviewed by the program then after that it's reviewed by three peer reviewers. 


This is the first three people who are going to look at your entire application and they're going to be mixed expertise. Generally there'll be some kind of either there be pharma to pharma, either there be in medical device, maybe they publish number of papers, 80% of them are professors at a university somewhere. 


They need to score your application high enough that it gets called in to the larger group to get reviewed. You need to score those three people have to score your application in the top 50%. So this is where you're getting into kind of the random chance and risk mitigation aspect of grant writing. 


So you have to assume like I've been in the room. Some of these are literally 80 year old professors emeritus. They set the entire field. If you go not enough detail, they will tear your application apart. 


But there's also dentists who know nothing about imaging physics. Okay. They use your, they may use an imaging technology heavily with patients. They know all about patient care. They know standard practice. 


They do not know about whatever the unique sensor physics are of your particular technology. So they won't get that. And so if you don't write it right, they may completely lose the clinical case and the value proposition to their profession. 


So you really have to figure out those first three. You've got to get a solid enough score to get into the top half. And then if you score in the top half, you go to group peer review. That's where those three original reviewers are going to present their thoughts on your, on your application to a room of about 20 to 30 reviewers. 


So if you can make it to the 20 or 30 reviewers, there's a much better chance that someone in the room is going to have the expertise in your particular area and they're going to be able to see the value of it. 


So you want to be able to get to the top half, but once you get to the top half, you need to score in that top 15 to 20% out of all of the applications in that pool. to look at getting a solid chance of getting funded. 


Now, even if you're reviewed very highly, you still have to follow a lot of the rules. There is some budgetary and some due diligence that's done after you get the peer review. But if you could score in the top 15 to 20% out of all the applications, you've got a really good chance of getting funded. 


So article I wrote about why we were submitting applications in April after all the horrible news and headlines and layoffs at the NIH and NSF. Like a lot of companies held off on doing grant submissions. 


A lot of my companies, I encourage them, I'm saying submit now. Because remember, they fund the top percentage, not the top set number. So if 500 applications come in, they score, they fund 50 to 100 of those. 


If 50 applications come in, they're gonna score five to 10 of those. The odds are. and they're gonna do the top of those, the best of those. So think about how much competition you may have. 500 applications, there may be at least 50 that are cardiac wearables, which means it's not just your application alone, it's how it's being compared and judged compared to all the other applications. 


So even just how novel you look, how unique you appear can vary drastically depending on just how many other applications are in the pool. So April was actually probably a really good time. Now, you go back, read the article, a few more details, there's a couple other things you need to know right now. 


So process is being slowed down. So we are potentially losing some of the employees who they run the whole machine. So the money is allocated. Sorry, just to interrupt you a bit, Kate. So when you're talking about possible changes, right? 


Or changes that are happening in reviewers that either will not be there or there might be other reviewers. To your point about writing to the audience, do you have to think about that in a different way? 


Not necessarily, I'd say the program directors, there's still gonna be a number of very experienced people who have looked at a lot of technology, primarily PhDs, because that's what's been hired by the NIH for review for a very long time. 


Right. And so even though you are an SBIR, you're asked a lot of questions about commercial regulatory pathways forward, there is still gonna be a very heavy focus on the research element of any grant you put in. 


Okay. But as far as the peer review process, it got slowed down. You may have heard that there were some peer review sessions that got canceled. Yeah. And so now they're doing what's called kind of an accelerated peer review, where maybe they just send it out to a small handful and there is no large group discussion. 


Because during the group discussions, we can do things like. a rescue. Like, hey, I saw an application that didn't make it into the top 50. And I think it just happened that those first three people didn't understand what the grant was talking about. 


I do, I think it's worth funding. So that happens in the group review. There's a lot of back and forth negotiation. I've changed my scores based on those conversations that I've had in a group review, because I read the grant one way, a different peer reviewer with different sets of expertise read at another. 


And I've scored it either higher or lower. So like, I'm not perfect. I'm not fallible. I have an hour or two to read 100 page documents. And you can do the best you can, but there's definitely is the safety nets are disappearing a little bit. 


So it's becoming even more critical to very quickly show your science, show your value, and supply the evidence to make it a no brainer for them. Because the time and effort is being spent on reviewing and not allowing potentially really good research go by that support that safety nets going away. 


Right, right. And so really important that you're planning your project and you're planning how you're approaching the grants, but also how what you're presenting in them very specifically. So I think a lot of insights you're bringing here, Kate, because not only do you support and write grants and do the research, have been involved with research as well. 


You've actually been one of those reviewers and in the grant allocation process. Yeah. And one of the other recommendations I would make is you need to commit some time to it if you're going to submit a grant. 


Very rarely will a first time sub submitter first time investigator land a grant with their first attempt without any help. That's that just doesn't happen. Now, you get a lot of times they'll get funded on the second attempt, because they get the feedback from the reviewers, they learn more about the process, and they start realizing they need to put the extra, the level of time and effort it takes during that response so oftentimes they'll get funded on the second one. 


And so when I talk about grant strategy. It's really trying to get all of that things you would have learned on a second attempt into your first attempt, and making sure that you're even applying to the right person. 


So, most people submitting grants don't realize is you can talk to the program directors. I call them a lot they're basically investors but they use federal public funds. And they have a very specific idea about what they do fund what they don't fund what they're looking to fund. 


They're the ones who a lot of times, the SBIR there's kind of a general SBIR, which is what most small businesses apply to, but sometimes there'll be additional special awards that are for very unique applications there's a bucket of money set aside for this indication in this population or for this technology, the program directors are the ones who wrote that award announcement. 


They have a very specific idea they started need and realize we need to put some money in this. But you may not get that. Now, their entire job is to provide a public good. They are there to try and find the research that is most needed, give it the funding, and give it what it needs to get it to the people to meet the medical need. 


And so a lot of times they are very supportive. If you talk to one and you are not a good fit for their program or their fund that they are managing, they will immediately send you to their colleagues. 


Going like, oh, we can't do clinical studies with this bucket of money because that's not what we intended it for. But here, I will send you to so-and-so, so-and-so, and so-and-so. Or, hey, this looks like it could have a very strong pediatric indication. 


We only do adults, or we only do older adults, and so for this one. And so they will give you a lot of that insight that even if you very carefully read the award, you may not be able to pick up. And you get the warm introduction and the third thing, they recognize your name. 


You were not, you said you can easily, they can't say, oh, I like this person, I'm going to give them money. But it's like, hey, this is an investigator who actually took the time to find out really what we were trying to do with this fund. 


What the ultimate goal and mission of what we're trying to do, not just fund this company. And so what you're, yeah, go ahead. No, so what you're highlighting here, Kate, is there's a broader strategy here. 


It's not supporting the, this one grant in and of itself. You're actually developing a relationship with the, with the programming and learning how to engage with it, not just this one time, but, you know, going further as well. 


And that can serve your company's growth and additional indications or different use cases that you might need to study. As you mentioned, you know, thinking six to nine months ahead. Yeah. And so this is something we talk about pipelines all the time. 


We talk about, you know, what are we clinical plans, regulatory plans, you need to have a grant strategy where SBIRs are submitted three times every year, January 5th, September 5th, and April 5th. And it's the same every single year. 


So you just plan, okay, what am I going to submit? You know, what can I submit? Even if you don't think you need it, come up with a project, submit it anyway. And not just the SBIRs, there's other funds, get to know grants.gov is the main site that you can go to and find all the different awards because they're constantly issuing new ones. 


You'll find several dozen new awards every single day. And it's somewhat sober when we talk about how much money is spent on research. But, you know, you start realizing how big the needs are. And so if you are, if you have a technology that you think has a very broad need that it can meet in the US population, using your technology, if you're a US based company, you really need to think about submitting every grant you possibly can. 


Now, that means you may need maybe not a full-time resource, but you need to find the right resources to do that or become very good at yourself. Now, I've met some grant writing resources who got that way because they won a grant themselves, and then they wrote a grant for a friend, and then they wrote a grant for another friend, and they found that the original business they were trying to fund with the grant was less profitable than just writing grants. 


Interesting. And even so, if you do one one grant, your odds of winning the next couple of grants go way up. So it is a valid strategy as a startup to just, every time you're thinking about a new project, R&D, new indication, write a grant for it. 


Instead of having to go get a loan, go after a, go get more investors to increase your capital or any of that, go after the grants. because realizing even small business, this is small in terms of the federal government. 


In some industries, small is any company under 500 people. One thing I've realized, especially in my industry, medical device, it's not so common in pharma. Medical device, probably 80 percent of the companies are under 50 people. 


A lot of small and medium-sized companies that you could be producing product for the last 20 years, go file a grant, expand your pipeline, go after a new indication. Because you have the resources and you just need the extra capital to hire the teams on to be able to do the work. 


And what you're saying is also, in being in practice with the grant writing and going through that review process, you're actually also experiencing the validation. Are you meeting a standard with a submission of the grant? 


And that just goes, it's feedback, right? It's feedback that you can continuously improve. And like you say, with those cycles, you're more likely to be more successful the more you're doing it. Yeah, and if you really want to make a long-term play at using what we call like non-dilutive funding from the federal government, I would recommend being a peer reviewer. 


So I've met on a number of panels where there's ex-startup founders or serial entrepreneurs who, yeah, they make a point of volunteering on a panel every other year just to be in the room, hear the discussion, understanding how the trends are and look around and see the questions people ask. 


And it takes your experience, especially if you've done a number of startups. I joined, I am probably one of the least academic academics in the room. I don't hold a professorship. I have actually been in industry. 


And so I ask a lot of, I ask all the commercialization questions that a lot of the professors in the room won't ask. And so if you believe that startups should be judged and evaluated by people who understand what it takes to commercialize a technology, not just do good science, I recommend volunteer. 


So that goes back to... we started this discussion with and what you were suggesting with founders and people who have not actually produced a product before is actually going to the trade shows and going to, you know, seeing how things are actually happening, right? 


Same with grant writing. It's that touch and feel really knowing and experiencing what's required and what's really happening, right? And I realize there's something that's come about. Um, so the founders of Googles were actually the same year at Stanford as my, as my husband. 


And it's been weird realizing that prior to me and my husband in college, like there was no Google. If you had to get to make a library, you'd go to shows, you'd talk to people, you'd talk to a professor. 


And since then I've met so many professionals that they think the only way to find or learn something is to ask a question in a browser. and I'm realizing there's so much out there like you can't ask questions about things you don't know. 


And so going to these occasions where you open yourself up to people of different backgrounds, different experiences, and say what do you know, what do you think about, and just have that curiosity. And I mean I find it an incredibly effective. 


Now I do both ways. I have my books, I have my databases, my websites, but I also have my networking events, my trade shows I go to, the classes that I take, and classes I teach. It's amazing about what you learn trying to actually voice what you think you know. 


So yes, I recommend if you're going to be you know in startups in the space launching companies, it's going to be a lot of learning journeys. And so diversifying your sources of where you learn and where you get that information I found is very you know it's very effective. 


So you you did mention of you know that things are changing in the current landscape with with Grant, at least in the administration of them, and maybe how many of them may be available. But I think you're also suggesting, and I'll have in the show notes your article so people can get more advice on how you're explaining the current environment and what to do. 


But basically you're saying just go at it because you mentioned the lottery scenario and you know some people might be pulling back. So this is an opportunity to just continue while submissions are still being accepted and the timing has not changed. 


And so you should just go ahead and submit. And it could be you're in a smaller pool of grants to be reviewed, but nonetheless you know continue to do so. Unless something changes and you know everyone's advised that the process has changed right now it is what it is and just keep going and the reason that we're broadcasting this podcast now this this current episode will be released in June of 2025 is to actually have put out that kind of public service message that you know keep going forward the next submission timing is is September and so it is critical to be deep into this now plan your project take the advantage leverage the opportunity it's also a learning opportunity basically be present and and put your submission in yeah and so this September for the small business grants is actually a very key date because it's the last date on the current award announcement so awards are renewed every two to three years And so if you go to grants.gov and you look up SBIR and you'll find what's called the omnibus, 


you'll see a series of dates that have gone back about two or three years now to where the original bucket of money was allocated. The rules were written up about how you can apply and get that money. 


The last date is this September, which means the next SBIR, very likely they will be renewed. It'll be in January, but it's going to be on a different award. And we don't know what is going to change about the submissions, about how they're going to be evaluated, and what types of awards may be funded with it. 


So from a risk mitigation standpoint, I would highly recommend aiming for September. And right now is a great time because I mentioned you've got to have a project and you've got to have the pieces assembled together to give yourself time to do it. 


Some people talk about wanting to write a grant two weeks before the grant deadline. That's not going to happen because even just getting onboarded into the government systems, you have to register your company. 


And sometimes that can easily take anywhere from four to eight weeks to get into the appropriate databases to them to confirm the status of your company, that you are in fact a company and to get the account to upload your grant submission. 


So that's the first one. And then by the time, if you want to work with partners, if you want to get letters of support, if you want to get experts to support your work, if you want to get quotes from service providers, that's a minimum another four to eight weeks. 


So right now, definitely if you are thinking about September, you need to start putting the works together. If nothing else, you can submit it early, submit what you have to a program director and get a chance to talk to them. 


It's another challenge. Program directors, you're not going to be able to meet with two weeks before the grant submission deadline because that's when everyone wants to talk to them. If you call them up now, it's one of the best times to be able to talk to them about what they're thinking of funding come September, because literally nothing's due for three months. 


Right. So they're, they're available to talk. Yes. So if you go to the grants.gov, you go to the award announcement, there is a link where it talks to about so there are about 17 different agencies, I'm talking just about NIH, National Institutes of Health, 17 of those agencies fund SBIRs. 


And if you go to the main award, there's a link to a table and it will tell you the email and phone number of the specific person, the name, email, phone number of the specific person associated with that agency. 


So if I have NIA, National Institutes of Aging, I click on that agency or I can just even Google NIA SBIR and look at program director, they will have a name, email and phone number that you can call them up, send them an email and say, Hey, I'd like to talk to you about a grant submission. 


And they'll go, okay. You do that two weeks before the grants submission deadline. And it was something bad, because they're like, why did you wait until two weeks to talk to me? So by doing so, you can get insight on what they're focused on, right? 


And perhaps some idea on how you can better position your grant. Yeah, remember, SBIRs are actually agency-specific. And so they'll want to know which of those, if you're doing an NIH, now there are additional agencies that actually fund SBIRs. 


Department of Defense does it, Environmental Protection Agency, NSF. There's actually a large number of agencies. So if you have a non-health-related technology, you can still do a lot of things with grants. 


I just focus primarily on health-related technologies, because that's what I know. But sometimes the person you call may say, oh, you may think that our agency would be interested in this technology. 


But I know this agency and this agency are actively looking for these types of projects. And they will say, here's my colleague. Go talk to them. Or sometimes there may be updates. It may be, OK, there's actually a subaward or a slightly different agreement. 


So it may not be an SBIR. Small businesses can actually apply to other grants besides small business. It just happens that that one is mandatory, that you have to be an independent business organization to get those funds. 


It's actually one of the reasons why it's one of the safest grants to go after right now. Something I've heard a lot through the whole various grant writing community is Project 2025, the whole document that was associated with this current administration, specifically talk about the SBIRs. 


And they talk about how great they are, because they support businesses. They are probably the most direct supporting of creating new jobs, new technologies, and new companies within the US. So if you are looking after going after grants that are associated traditionally with research institutions, major universities, that's a whole separate topic. 


What I'm talking about right now about applying for grants and going for them is just for small business focused grants. because it would be very counter to the current administration's promises to move funding that could be used to start new companies and start the economy. 


Right, amazing Kate. So really what we're highlighting here is the SBIR process and grant program that we suspect that it is something that is being supported and to focus on that, take this as an opportunity because it is something that is quite useful and there is a certain timeline associated with that. 


When you talk to the program directors, you get further insight onto how your project, where it fits best and so best to do that early. But you also mentioned Kate about another thing I think that people don't consider from a timing aspect, is actually that registration process, right, especially if it's your first time. 


That's, I think, probably unexpected or probably often unplanned for just the timing it takes to actually register and get in there. So if you plan on submitting in September, maybe you haven't kind of strategized how you're writing yet, would you suggest you still go ahead and register? 


So for the NIH process, yes, there's actually a multiple, there's a couple of websites you need to register for to be able to do the grant submission. And so I would recommend starting that process. The one thing you have to make sure is that you clearly know your entity identification number, that you, that you are a formal incorporated company to be able to apply for these types of grants, you've got to be minimum an LLC, 


if not a C Corp or S Corp. And you have to make sure that the principal investigator on that grant is actually an employee of the company at the time that you are awarded the grant. So this is a careful thing you need to be aware of. 


So a lot of times SBIR phase ones, that first quarter million dollars, that's the point at which a founder can actually get some income and be able to quit the day job. And now they realize that you're not going to quit the day job until you actually get the grant. 


And so it really has to be, okay, this is, you know, you're going to meet that requirement when they actually, before they submit them out, you're going to say, okay, I'm a formal employee now, you get to quit your job, you get the check. 


And so, but the registration you can do, and you can even download a lot of the templates and start putting the materials together. Because the big materials, the research strategy and the commercialization strategy, they are very formal templates. 


And there's a lot of, it's not very long, even if you're doing a direct to phase two, okay, phase one is just a six page document. And you have to tell the entire story of your product, your history, the science, what you plan to do, where you're going with it, why it's scientifically justified. 


in six pages, aerial font, 11 point, minimum, half inch. They've literally gotten it down to like, okay, this is how much space you actually have. And you're not allowed to use links. You're not allowed to put any additional information. 


And so you have to be very selective about what information goes in. I've been handed grant applications that were 40 pages long and I've been told I have to cut it. And you can't just cut it. You have to really fundamentally think about how to rewrite what's important and what's not. 


Again, going back to strategy. You need to make sure the chunks. So there are people who've wanted to fund a incredibly complex project that had four different stages and it was less, do we have enough money for those four stages? 


As providing enough detail and evidence for those four very different stages of the project was way more than what we could do in the pages. And so you were at risk not getting the grants because you were describing a project so complex. 


there was enough room to describe it. So in some ways we'll say actually go simpler. Okay, so you still get the same amount of money, but go with a simpler project. Give yourself more income, give yourself more budget for materials and supplies, bring in some extra consultants, but don't make it so complicated that a reviewer or a director can't very quickly scan through and understand what you're trying to do. 


Right, so I think that's a key point, right? And you experienced it as a reviewer yourself. There's a stack of applications you're going through and you really want to, as a submitter, be able to make the point clearly and simply, but also comprehensively so that it's understood what the grant is for and what's gone behind it, right? 


So I think that that's kind of a very key insight from being in the field is that if you've got something that's very complex and let's face it, as we get to more and more advanced technologies, right? 


And how they interface with integrate, let's say with the human body, it can be quite complex. Yeah, so I call it, don't kitchen sink your grant applications. They're like every, some days they say like, oh, especially if you're doing a direct to phase two or fast tracks, like, oh, that's two and a half, that's $3 million, we could do so much with that. 


Here's all the people I wanted to hire and the projects I wanted to study and all the experiments I was gonna do. And it's like, it's just a mess. There's no order, there's no overarching strategy. You've got to tell a really good story. 


And as much it should be is like, we're gonna do A, B and C, A feeds into B, B feeds into C, and out we get D, ta-da, done. And it should be that easy to scan it and understand that's what you're doing. 


If you start telling this elaborate story about the three legs, dog and the tavern on the beachfront and how you met your brother's sister's little cousin and I've got to reread it four times. I remember like going back to my PhD advice, don't make really smart people feel stupid or annoyed and having to think harder than they're ready to. 


Or have to graph out what you're actually saying. Yeah, sometimes you do use the space to put a diagram in or a very specific picture. Sometimes you don't put a picture or diagram in because it'll ask more questions that you can't answer in six pages. 


So again, what goes in, what goes out, it's not just, as soon as I talk to scientists, they have their scientist blinkers on and they're used to writing a journal publication, which unless you're being peer reviewed by people who don't have enough training to understand it, there's a whole thing in academia about making these papers as complicated. 


and the vocabulary as dense as possible, and yes, you have to use the right words, you have to be precise in your application, but you also need to be able to use it judiciously. Right. Similar there, I think, in regulatory writing, right? 


You don't want to make it too hard for the reviewer to follow your story. Oh, yeah. So a lot of flowery language and long paragraphs. It might sound very nice and be beautiful, but you lose the point buried in that very lovely sounding paragraph. 


So one of the classes, a workshop I actually teach, I call it design thinking for medical products. And one of the key points is sometimes in modern days we talk about the doctor as a user or the patient as a user. 


Those of us in industry realize that sometimes there are people in our industry who will spend a thousand times more time with that product than any of the patients. The technician assembling it on their workbench for five years, the reviewer who's reviewing the document for three months, the startup team that is working with it for six years, the patient may use it for 30 seconds. 


But we don't think about the needs of all those different people. So a question I'll ask the classmate is, have any of you ever met an FDA reviewer? What's their educational background? What's their work criteria? 


What's their lifestyle like? What is their, what are their values and what drives their decisions? And most of the students on the studio, like we don't know, it's kind of like when we were little kids and we thought our teachers never left the school, real people, they were the teachers, and they must live in the classroom and like, oh, an FDA reviewer is well, they review for the FDA. 


And thinking more deeply about, well, no, like what kind of literature are they used to reading? What arguments are convincing to them? What have they seen before with the other dozen devices? You know, so it's going back to that whole empathy and understanding your audience and realizing that even a grant submission, a regulatory submission, think of it as a product. 


You know, we have very detailed design specifications for drugs, for medical devices, for diagnostics. Who's the user? Under what conditions are they going to engage with it? How long will they engage with it? 


What kind of preferences do they have that we can include in the design? And when you think of it from that way, you're going to greatly increase your success, you know, whatever that is for whatever you're trying to write, whether it's a grant, whether it's a regulatory submission. 


Yeah, absolutely. And just one question I had for you, if you have something that's more complex, but you're focusing down on, OK, let's start with, you know, stage one, right? And what we want to get the grant for this kind of sinks in with what I like to do with regulatory strategy is you can stagger. 


the regulatory advice you get from FDA, for example, because you will go in and talk to FDA and get get their feedback. And the earlier, the better the earlier when you have something, so you can be go too early. 


So there's a strategy behind that. But if you plan it out, like you say, you plan the project and you're planning, okay, when are you going for seed funding support, right? You want to be able to say something at certain time points that you've had a discussion with FDA. 


This is part of what we discussed with FDA. You may not be able to state things in absolute terms, because of course it comes to the actual submission and ultimate approval by the agency. But you can say what stage you've been at and that you have engaged with the FDA and whatever critical feedback that you've understood from that and share that. 


And that can often really give investors more assurance to what you're presenting. But similarly with grant writing, you want to chunk it, you want to focus, but also while you are engaging with FDA in trying to figure out, because it does take time to get FDA meetings, oftentimes what I've discussed with teams is you want to plan out what assumptions are you making in terms of your product and how it will work, 


and especially in their early stages. So in order to understand your go, no, go milestones, because if certain assumptions are foundational to whether your hypothesis works, to whether that actually leads up to a product that can be produced, implemented as intended, what assumptions are you making that is going to go to that end? 


So you prioritize those assumptions you're making and test them and you have go, no, go time points. Could you then that to this grant strategy in a way that we're focusing on this high-level assumption here that we're making, that if we test this and we get the grant to do this, this will give us assurance to go to the next stage. 


And in that grant, you might not be able to have the room and space to talk about your entire idea of the full product design, like A goes to B, B goes to C, C goes to D. But you can outline it, I suppose, so that the reviewer has an understanding that there is a plan behind this, but we're starting at this stage, and this is what we want to learn from this stage. 


And this is our intent going forward, but it will be informed by this stage. Yeah. So the space you have to do that is a little different. So if you're just doing a phase one, literally it's like a three sentence, like What is your plan? 


How will you pivot? What will you change? In the commercialization plans I write, I actually have a very specific diagram I include that shows funding milestones, clinical milestones, regulatory milestones, different grant submissions, and we plot that out over the next couple of years. 


And that's something they love to see because like, okay, you've thought about all these pieces. You've locked them up. And so it demonstrates that it's just one more piece of evidence saying, yes, we know what we're doing. 


And then on the research strategy plan, they also, you have to include alternatives and potential risks. So usually you have your, you know, milestones A, B, and C. It's like, well, you know, we're going to recruit 100 patients in this clinical study. 


It's like, well, what if you can't recruit those? It's like, well, we will either change the indications or we will change, expand the exclusion criteria, or we will bring in a second party, like there's all these different things. 


But what they want to see is just demonstrate that, yes, we have a plan and we have a backup plan. Right, right. And that goes into your, you're, you're forming that relationship with the reviewers here in this process, because this will not be the first time you come. 


Yeah. And I mean, I mentioned before, like some of the differences between a young engineer and an older engineer is coming up with a dozen different ways to do something. And yeah, you have to think of like, sometimes as a founder, you go, this is what I'm going to do. 


Obviously, it's the best way. So that's what I'm doing instead of based on my current knowledge, our current risks. This is the path we are currently taking. If we get new information here, here, here, we will go in this direction, this direction or this direction is really the way you have to go with it. 


It's been wonderful talking with you today. I think a lot of insights, both from the field, like you say, you know, going from engineering to academia and back again, working on, you know, from all sides of putting life science products together. 


It's been absolutely amazing, so thank you for your time to date, Kate, and if the audience members want to reach out to you or talk to you further, what's the best way to contact you? Okay, so if you want to reach out to me, you have an idea. 


You are looking for some engineering strategy. You might be invested, looking for some due diligence. Best way to get a hold of me is on LinkedIn. I'm at Dyad Engineering, so look up Catherine Stevenson. 


You'll find about 50 of us, so it's D-Y-A-D, Engineering, E-N-G-I-N-E-E-R-I-N-G, and you'll find Kate Stevenson, and usually please follow me if you like. I try to post a lot of content about grants, about different accelerators and incubators, anything involving about technology innovation in the medical technology space, whether it's in drugs, pharma. 


I also do my best to try and support early professionals in the space, so whether you're graduating or not. whether you're looking for new interns or people to work with in the space, feel free to connect with me as well. 


And you also post articles as well. Can you talk a little bit about that? I do work with a number of local trade journals that if you connect with me on LinkedIn, I'll post about it usually every, hopefully every month I put out a new article generally about broad strategic topics about the industry, about things about education, workforce. 


There's a lot about the trades and tariffs right now, but I know a lot of students are graduating and the whole question about how to get your first job in the industry when biomedical engineering is a very popular major right now, but there's actually not a lot of jobs for biomedical engineer, but a lot of these students, they've never heard of regulatory experts. 


They've never heard about clinical engineers. They've all these other titles that again, you can't put them in a Google search engine because they don't know to ask about those types of professions. They know biomedical engineer. 


And if you look up how many current openings there are for that specific job title, there's not a lot. And so right now my article is all about thinking about where do you go from here? One, just the practicals of landing that first job. 


And two, how to think about all those different opportunities when you're one year out from school, five years out, 10 years. Obviously I've taken a lot of pivots in my career over the last 20, 25 years. 


I'm probably gonna continue. I learn more every day. And so how I make judgments about what I'll be doing a few years in the future is continuing to change. And so that's gonna be in MD and DI, which is medical device and diagnostic industry put out by Informa Markets. 


And then I also try to do regular blogging on dietengineering.com, my webpage. And if you would like me as a guest article or would like me to write additional content for your organization, please reach out to me as well. 


Fantastic, a lot of things you're doing, Kate and you're tapped in in many different areas. So we'll include all this information in the show notes so everyone can take advantage of that. And do also look at the most recent article on the grant submission and timing. 


And we'd be happy to help you should you need further support to reach out to Kate for all the needs you may want. So such a joy having this time with you, Kate. Thanks for the invitation. Great talking with you, Zina. 


Thanks, Zina.