TechTalk: Medical Device Startup Pioneers AI-Powered Solutions for Skin-Related Diseases

Sanna Gaspard: 

Thank you for the opportunity, Fritz. I'm happy to be here and share my vision for our company and the lifesaving work that we're doing. 

Fritz Spencer: 

Wonderful. Can you briefly explain Rubitection's mission to our audience? 

Sanna Gaspard: 

So what we're really trying to do is really improve access to care, reliability of care, and also care management around skin health, focused on chronic wounds as well as focused on chronic dermatological conditions. So think of things like diabetic foot ulcers, bed sores, venous leg ulcers, psoriasis, eczema, rosacea, eventually skin cancer. Our vision is just to have a tool that anyone can use anywhere to measure their skin objectively, share that with the physician, and get a data-driven care plan and be able to track those incremental changes over time. Because at the end of the day, everybody has skin and at some point you're going to have some kind of potential chronic problem that involves inflammation, where currently it's monitored visually and we are providing an AI driven optical solution to do objective measurements and develop those associated care plans. 

Fritz Spencer: 

Given the early-stage pressure, detection and management can be extremely crucial in preventing more serious health issues. What specific health challenge or challenges are you guys aiming to solve? 

Sanna Gaspard: 

Again, specifically chronic wounds. So think of burns, people in the military who may get traumatic burns or who are in an accident who may get traumatic burns, people with limited mobility who use a wheelchair, which would be veterans. Anyone with spinal cord injury, anyone who ends up in a hospital ICU who's at risk for a skin breakdown for developing a severe bed sore that can end up being deadly, diabetics who suffer from neuropathy, who can develop diabetic foot ulcers. For all those patients, early assessment and diagnostics can help save a limb, can help reduce the risk of infection as well as help save their life. On the dermatology side, what we are doing is more supporting care management. So when we have a patient who may have psoriasis or eczema, it's usually obvious where that's located. So what we can be used as then is a companion device to their Rx prescription to evaluate how well it's working, how well it's progressing over time, and help identify some of the triggers for the flame up of their condition. 

Fritz Spencer: 

And you mentioned briefly in your intro that you guys are utilizing several different technologies scanning, AI. Can you tell me more about your diagnostic technology and kind of maybe what sets you apart? 

Sanna Gaspard: 

Yeah, what sets us apart as a few things high level is that we've designed a solution that's easy to use, that's cost-effective, and it can be used with minimal training. The core of that technology is really the combination of several things. So we have a multi-sensor sensing handheld device that allows you to take various measurements of the skin, including optical measurements to evaluate things like temperature, how stiff the skin is, and then we also couple that with some computer vision so we can capture images and assess that to derive additional features from the skin. Then we have proprietary data analytics that we then use to support the development of that care plan. With that you can do remote monitoring, bedside care, and just expedite patient specific care plans and effective management of the team that supports that patient at a more reduced cost. 

Fritz Spencer: 

Okay, very interesting. So a combination of both a physical product as well as a platform that you utilize to provide A to Z care for your patients. 

Sanna Gaspard: 

Yeah. So we have a device and a software combination. So the device allows you to get the data, think of it like a Fitbit. The Fitbit collects all the data, but the Fitbit software is where you can see all the analytics, get the recommendations, connect with your friends or family, things like that. So we're thinking of it like that for use at home and in the hospital where anyone can use it. We use a device and then use the app to follow the trend of the skin, to connect with a physician to share the data, to get the care management analytics. 

Fritz Spencer: 

What's next for you guys? What's your next big milestone in your entrepreneur journey? 

Sanna Gaspard: 

So our next big milestone is the goal of really launching the products on the market. So we have one or two phases, we have the pass through to get that, and we're trying to raise the funding to do that. But the first step is building out additional prototypes, getting additional patient data. We already have a prototype, but just to get more to expedite the second phase, which will be the FDA compliant product development process and manufacturing and sales process. So right now we are trying to close out our seed round, for phase one. We have about a million left, so I'm doing all of the JPM and Miami trips to connect with investors who are interested. Once we close that out, we'll probably focus on that phase one milestones for the rest of the year and then start raising for the phase two milestone, which will be product launch sometime towards the end of this year or early next year. 

Fritz Spencer: 

And speaking of raising money, I believe you're familiar with Wefunder. Can you tell our listeners a little bit more about that platform and what's been your experience with that? 

Sanna Gaspard: 

So Wefunder is a crowdfunding platform which helps democratize access to investing. So oftentimes people will see a company that's become super successful and they think, "Oh, I wish I could have had a chance to invest in that early before it took off." Well, Wefunder is a platform like that that allows anybody to find those companies that they're on the platform and invest in them to be an early investor in the company as it grows. And because it's for non-accredited investors, which means anyone who's making less than $200,000, it allows anyone to put in whatever amount they can to at least get them into investing and help them support a company or missions or visions that they are interested in. And as part of our fundraising strategy, we are also utilizing Wefunder to help bring in more women and minorities as part of our investment strategy as well and to allow it to be accessible for anyone just for this particular round. It'll be difficult for us to do that in the next round because we'll be raising a significantly larger sum of money, but we did want it to give that opportunity to our community essentially to be a part of our success early on. 

Fritz Spencer: 

Super interesting. I love to hear about opening the doors to a much more diverse portfolio of investors as well as minorities and just smaller investors. And I know that being in health tech, the FDA can really be a make-or-break situation and especially when it comes to funding because it's so expensive to go through those application processes. Can you tell me maybe what was the easiest thing or something that surprised you about the application process or have you been through it before and you know what you're doing there? Tell me a little bit more about that FDA application process. 

Sanna Gaspard: 

So we're at the beginning of our FDA application process. I think for most people it seems very daunting, but since I have a background in biomedical engineering, I've been studying the FDA process since I was an undergrad, so I kind of know the general process granted that updates, but basically with a good consultant, you can navigate that process pretty effectively. And in the last five years, the FDA has become more consumer friendly. By consumer, I mean open to conversations, to giving feedback early on to help lower that barrier at the end when you're seeking approval. But for our solution specifically, we've already done the regulatory analysis. It showed that we are a Class I. So FDA has Class I, Class II, Class III. Class I is like the lowest risk. Class III is anything that has to be implantable that can kill you. Most medical devices are in a Class II, but we, because we're a decision support aid where we are providing data to help drive data-driven care plans, initially we are a Class I, so it's the lowest risk. It's about getting through the product development process using FDA manufacturers, developers and processes, including the quality management system to make sure that everything is being done to the right specificity for safety. And we submit to the FDA, it's kind of a self-certification process. It'd be a Class I 510(k), which is like lower risks options for getting through the FDA. 

Fritz Spencer: 

What is one piece of advice that you would give to a listener out there who's about to start it for the first time? 

Sanna Gaspard: 

For anyone doing it for the first time who's maybe never even studied the FDA and doesn't know what they've done, I would get a very good FDA consultant with a preference for someone who has previously worked at the FDA. You want to make sure that person who's worked at the FDA has worked in your sector. So if you're doing pharma or drugs that they've worked in the drug section, if you're doing radiology, that they've worked in the radiology section, if you're doing devices that they've worked in the device area because every area has different requirements. If you don't know where to start with finding a good FDA consultant, find other startups who are ahead of you, who've already gone through the process and ask them for recommendations. 

Fritz Spencer: 

Let's circle back to Rubitection. And to leave this off, I'd love to know what's one thing that you're most proud about? 

Sanna Gaspard: 

What I'm most proud about? I would say there's probably two things at the top. One that we were able to quickly secure our IP for our solutions, which really speaks to the innovation behind what we were doing. And second, that we took something that was theory at the time, this was my PhD research, something that was theory that we weren't sure would work, built a solution that would work, proved that there was a business around it, and then started the work to bring it to market. So it was like that whole process of having an idea and not knowing if it would work and then kind of seeing it to fruition. Now we are on the second part of that vision of launching it on the market and making it globally accessible. So once I've achieved that, that's going to be the next thing I'm the most proud of. 

Fritz Spencer: 

When you look up a framework for success, I feel like you just laid it out there exactly as you would read about it in textbooks. It sounds like the perfect step-by-step you guys have been following to kind of meet your goals, understand what's achievable, know the market, know your product, know how to push it and develop it. And that's super impressive. I love to hear that. 

Sanna Gaspard: 

Thank you. I think it's about knowing where you want to go from the beginning. Oftentimes, especially with engineers, you'll have people who develop solution and then try to fit it to a problem. But I knew early on that I wanted to translate my research. I didn't want it to just be a thesis. And so I was really looking for a problem where I could solve it with technology and where that technology would have either a significant US or global market. And believe it or not, skin is partially overlooked as in general, it works so well, but people take it for granted. And so there's not been a lot of good solutions for skin management, even on the cosmetic side, on the dermatology side or the wound care side. So we're really addressing this huge market, which is like a $36 billion market, which is largely untapped, and we think we have the best solution for that. So I'm really excited about what we're building and the opportunities ahead. 

Fritz Spencer: 

Well, it sounds like you guys have got a full handle on it, and I want to thank you so much for joining me today Dr. Gaspard is sharing about Rubitection. I can't wait to follow you guys' journey through the whole process. And a special thanks to our listeners for tuning into TechTalk, the entrepreneurs and innovators who turn to EisnerAmper for accounting, tax, and advisory solutions. Again, subscribe to EisnerAmper's podcast to listen to more TechTalk episodes or visit eisneramper.com for more tech news that you can use. 

^{Transcribed by Rev.com}