In today’s episode of the Global Medical Device Podcast Jon Speer welcomes Sara Naab to the show.
Sara is the co-founder and director of quality and marketing for Sandstone Diagnostics.
Sara shares with us insights into what it has been like going from idea, to raising funding, to being name one of the 40 most innovative life sciences companies in the Bay Area.
Pretty impressive and interesting stuff.
Highlights of this episode:
It all started in the summer of 2012. The company makes consumer wellness products to help people better understand their health.
They provide over the counter results of tests to patients and physicians.
Sara begins the discussion with the company’s first product, Trak. Trak is an app that will help men monitor their sperm count and helps them learn how to improve their fertility.
Medical devices are expensive for a reason. Getting started is hard. Money will always be a challenge. That is her opening advice to startups.
At the beginning of Sandstone, Sara was pregnant. Her first suggestion to her co-founder (her husband) was a pregnancy test. This suggestion lead to the idea to create a sperm counter.
After researching the topic, they learned about a void in the market that was not being addressed. Not too surprisingly, sperm testing is a very delicate and private subject for most men.
Turns out sperm count is a sign of good health and being able to monitor it is very empowering to the patient. A number of factors can affect sperm count such as diet, stress, and even weight gain.
Sara says humor is actually very important when handling patients and being non-judgmental is key to helping men talk and think about their health.
Trak is a mini centrifuge that will take a sperm sample from a patient and spin it so the cells can be analyzed. Then the app is used to track the progress. The service is in the trial stage right now.
Manufacturing, investors, and regulations are among the obstacles Sara lists as the biggest challenges.
The design control, risk management and production are some of the positives Sandstone has going for them.
Sara thinks the importance of education has played into their success and the quality of their team.
She advises other medtech startups to consider the customer and remember who you are helping.
Announcer: Welcome to the Global Medical Device podcast where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the worlds leading medical device experts and companies.
Jon Speer: Hello, it's Jon Speer, co-founder of Greenlight.guru and the VP of Quality and Regulatory. Today we have an exciting episode of The Global Medical Device podcast. With me, I have Sara Naab. Sara is one of the co-founders and she's also the marketing and quality director for Sandstone Diagnostics. Sara, give everybody a big hello and let everyone know what you've been up to and a little bit about yourself and a little bit about Sandstone Diagnostics.
Sara Naab: Sure, so Sandstone started in June/July of 2012 and we are a medical device company making consumer wellness products, really focusing on giving consumers improved information about their health. So we focus primarily on developing diagnostics that can be delivered to consumers over the counter or through their physician, and giving people good feedback about their health. And we accompany these diagnostics with apps and information that will help them to better understand the health conditions connected. So our very first device is Track, and Track is an over-the-counter test for male fertility, so it will measure basically semen parameters, the first of which will be sperm concentration. And will provide men with feedback about their fertility and how to improve their fertility, and our app will give them kinda customized personalized feedback on how to improve it. So, that's what we're up to.
Jon Speer: Okay, that... Well, I'm... Yeah. It's just a little bit. You guys have been pretty busy. I've got a few things I wanna throw your way today. But before we get into some of those specific details, I know our audiences, they're very hungry to learn, from fellow entrepreneurs and the device startups. But before we get into that, I want you to think real hard about one tip. I like to give everybody kind of a little bit of a tidbit at the beginning of our podcast. But one tip, one thing, that you could share with a medical device startup that they need to know as they start their venture.
Sara Naab: It's gonna be harder than you think it is. [laughter] So just be ready for it to be harder.
Jon Speer: You thought it was gonna be easy. Is that what you're trying to tell me?
Sara Naab: No, you think it's gonna be hard and it's gonna be freaking harder still. [chuckle]
Jon Speer: So you've been at this for a few years, so the fact that you've persevered this long, I mean I'm sure you found a big pile of money somewhere to make this all happen, right?
Sara Naab: A big pile is relative, Bob. [laughter] It's enough to do what we gotta do for each moment. I think the reality is medical devices are expensive for a reason, there's a lot that goes into making them, and a lot of surrounding infrastructure, organizational structure that needs to support them. And so I think as a startup you're always having to do things leaner than what really would be ideal, and so finding ways to do that with the money that you have in hand. When you're first starting out, that's prototyping, and then when you're now starting to get to clinical, that's more scaling type stuff. But the reality is medical devices are physical products and the startup world is really... Most of the advice is tailored to software, which is a lot easier to do lean. Although, as you know, not still... It's still a challenge to do it lean, but when you have a hardware piece, you're dealing with things like manufacturing, and that's much more costly. And time. There's a lot more time.
Jon Speer: Sure, tell me if I ask too many personal questions or if I cross a line, I'm sure you'll set me straight. Of course...
Sara Naab: We're in the business of sperm so, it gets personal all the time. [chuckle]
Jon Speer: Well I just... You're a co-founder. And I can understand why, I guess a male, it seems like more of a male problem, the product that... The problem that your product solves. And I guess I'm curious how did... Who lured you into this venture and how did you really get kinda hooked into this?
Sara Naab: So that's kind of a funny story. So our main inventor is my husband and I was actually pregnant at the time when we started the company, and it was the platform was very flexible. So it's a platform that could do a lot of different kinds of tests, primarily different types of cell counts and amino acids. And so I said, "For investors, let's do a pregnancy test. Because that's the most common amino acid done. I'm pregnant, you're not. We could do it. It would be proof. It would be easy to do." And so, it got him thinking about our own journey to conception. And I had some issues. So we were brainstorming a little bit about that. And he said, "Hey what about a sperm counter?" And I thought, "Oh my God, you're ridiculous. Like this is the most ridiculous thing I've ever heard." Right? But then when I started to research it, lo and behold, male fertility is a very big problem, it's very not talked about, and it really is a good product to bring to consumers who are really struggling with this. And so, we started into the venture of counting sperm.
Jon Speer: Yeah.
Sara Naab: And I learned a lot about it, and I'm actually deeply now very, very passionate about getting the information out to consumers and helping people on this journey. Because it's a... It's a big thing.
Jon Speer: Because it's a real problem. It's not like you just went looking for some sort of cool technology and trying to find some sort of clinical need to force it into. This is a real clinical problem.
Sara Naab: It really is. And I think it's a private matter that people want to know about and they wanna know about it on their own terms. So one, clinical testing is... They don't do it very often, because you have to go in, you have to do it, the test isn't that great. You're having to count sperm on a microscope, manually, in most cases. And so the actual state of the art of sperm counting is rather archaic. And...
Jon Speer: I just have a picture of a person under a microscope. Counting one, two. You know? I mean it's...
Sara Naab: It is exactly that. And it's an issue in the clinical trial, which is a whole other thing. But people are counting sperm and eye sight actually matters, right? How good someone's eyes are looking under that microscope really will determine your sperm count. So that's a thing. But the other thing is that sperm counts are not static, it's a parameter of your health that's fluctuating based on how good you're taking care of yourself. And so, if you're kind of the average guy, and you start to get stressed out at work, start eating less healthy, and stop exercising, your sperm count's gonna drop. And that's a reflection of your health. And so, empowerment here is saying, "Look you can do things to improve this." And you're gonna wanna monitor that. Cause if you're trying to lose weight and you don't have a scale, how are you gonna know if your progress is going, right? So it's the same thing. If you're trying to have a baby and you're trying to improve your fertility, then you need that feedback to know if what you're doing is helping or not.
Jon Speer: Yeah, I can imagine from a macho male point of view, that admitting that you may have a low sperm count may not be the most masculine sounding thing that I could admit. So I can imagine that it is a secret private matter. But it's interesting to me how... Just over the past, I guess we've known each other now for just, what about nine months or so? Give or take. And it's interesting, I've had a chance to talk with you and Greg and many others from your team. You guys are having a great time.
Sara Naab: Oh yeah, we are.
Jon Speer: I mean, I'm just looking at the... You own the domain name dontcookyourballs.com.
Sara Naab: Yeah. And we certainly do, we have a lot of fun. This is a condition for which I think it takes a little bit of... There's a need there to create safety. And for a lot of men humor is a safe place. Right? It's a way to brush it off, but then be serious again. And so, giving that little room of humor can build trust and it can make the conversation approachable. So that's one thing, but then as a team, we're... We count sperm every day, so we have to have fun. [chuckle] We have to have fun with it.
Jon Speer: There was one story, I didn't ask for the details. And don't mishear me. I'm not asking for the details now. But you mentioned something about you... To prepare for the clinical study, you needed a bunch of people to volunteer sperm samples, and you were just... I think you were on the phone with, maybe it was Tiffany that day. The two of you were in the background just giggling like little girls when we talked about it. But, I can imagine that the humor that you guys inject into this makes it a lot more... If I'm a male that has this sort of issue that your product helps address and helps me solve and mitigate and fix. I can imagine seeing your humor, your light side, makes it very disarming and makes it a lot more approachable for me to come up and say, "Hey Sara, I've got a problem. I'll give you a sperm sample if you need one." Right?
Sara Naab: Yeah, yeah. I think so. I have found that it's been this delicate mix of humor and then nonjudgmental. Like it's okay and I'm safe and this is okay, and I care about this, and I care about your health, and I care about you as a human being. And I think that is a culture that's... It's pervasive in our organization, so all of our staff just have really embraced both the absurdness that we talk about testicles every single day at work, and there's just... We have all the words for balls that we use, and just on going... Right? They write themselves, the jokes. But then there's also this point of, "This is a man's health and this is... It's essential to his man-ness." And a respect for that, and a respect that no one else takes it seriously, no one else is out there advocating for men, men don't go to doctors, men don't get treatment. And so what we're doing is really quite revolutionary in that we are providing a tool for men to talk and think about their health, which is not being done.
Jon Speer: Right. And I don't know a ton about your product. You and I have an opportunity to share a little bit. You were sharing some images with me a little bit earlier. And of course you can go to sandstonediagnostics.com. All spelled out, no hyphens or anything like that. Or dontcookyourballs.com. That's probably the one that's easier to remember, but to say a little bit more about your product. But it's a... It's an over the... Correct me where I'm wrong, but it's an over the counter product that a man can use, eventually in the privacy of his own home, once you get through some of your trials and other tests. Is that correct?
Sara Naab: Yeah, so it's basically like a little mini centrifuge, which is kind of interesting, it makes it a little bit of a gadget. You can... Basically a man will be able to add a semen sample to a little disposable and that will load onto the centrifuge, it'll spin it, and basically the spinning motion is gonna isolate the sperm cells and visually you'll be able to read it out like a thermometer. The height of this white column that'll appear, will be the number, it'll correlate with the number of sperm cells. And so that's what we're taking through trials right now and the goal eventually is to develop additional tests that we'd be able to add on to that. So being able to see how well the sperm swim, or measure the volume of the semen which is also something that men are fairly interested in, and also contributes to the fertility too. So those are additional things, but step by step. The FDA is not the easiest body to work with. But step by step we're gonna work on bringing those things out to people.
Jon Speer: Right, right. And it's all because you found that pile of money once upon a time. [laughter] Yeah, so you've been at this for a while, I know some of it's been baptism by fire, some of it's been easier. Well, I speculate there have been some things that have been a little bit easier than maybe... And a whole heck of a lot of things, as you said from the beginning, been a lot harder and maybe take a lot longer than you thought. Now, let's get into a couple of details. And of course, share what you're willing and able to do so, but today what would you say has been your single biggest challenge? Has it been something to do with the product design, has it been something to do with manufacturing, is it more about the quality system and regulations or is there something else that comes to mind?
Sara Naab: Well, it was a tough question and I've been thinking about this and I think it's kind of hand in hand. I think the regulatory... First of all, thanks to you, quality systems is not on the list. Quality systems is relatively straight forward. And I think that was one thing that was surprisingly easier than I had anticipated. I was expecting it to be kind of a bear. I think the harder things have been manufacturing and regulatory and dealing with investors a little bit. Because we're scurrying a line here. The classic medical device is very straightforward. You're selling to doctors or you're selling to hospitals, or whatever. There's known models, there's known things. When you're talking about a consumer product, that gets a little bit more like, "Okay, this is a consumer thing, you have to have consumer marketing", etcetera. And the investors who invest in consumer are afraid of FDA, and investors that are investing in FDA regulated products are not very friendly or used to dealing with consumers. So I think that's been a challenge for us in terms of how do we present ourselves to the investor community.
Sara Naab: On the nuts and bolts side, I think the combination of the regulatory, just the bars that the FDA has thrown at us and some of the things that they want to see, I think have been more challenging than we anticipated, and more challenging than a lot of our predicates have had to do. So that's been a thing, a mountain to climb. And manufacturing, I think every business has to deal with figuring out with what exactly are the critical things. And I think that's just an ongoing process. In your prototypes it's one set of issues, and then when you're starting to scale, that's a whole other set of issues. And so yeah, I think both of those have been our biggest challenges.
Jon Speer: Well, it's been a real pleasure and I've enjoyed the opportunity to get to know you and others from the Sandstone team over the past several months. It's clear that you all have a can-do attitude. You all seem for the most part, I'm sure there are days, maybe I'm catching you on good moments, but for the most part you all seemed to get along or get along well enough to realize you're all in this together, you have a common cause. And when you all work together that you can accomplish some pretty significant things. I know when you and I first started talking you mentioned that from a design control, quality system, risk management standpoint, that across the board the team was relatively green, but I haven't seen that. So what is your trick, what is really making things easier from a design control, a quality system, risk management, regulatory standpoint? Because it may be tough according to what you're saying, but I'm not seeing that. So give every one out there your secret sauce.
Sara Naab: Secret sauce is...
Jon Speer: Green waffles? Is it green waffles?
Sara Naab: Tackle every problem with everything you have when it comes. I think one thing that's really been incredible for us is we, from the get go have said, "Okay we have to be lean." And we focused on being leans from the very beginning. And what can we do right now with the resources that we have right now? And we've also kind of adopted a lot of the learnings from the software industry, so we're an agile team. We do scrum. We've had to adapt it because manufacturing time frames are not two week sprints. Manufacturing time frames are a couple months. So we have had to use traditional tools like ganting and trying to figure out what our critical path is, and all those things to keep timeline on track. But we've really been laser focused and saying, "Okay, if this is our critical timeline then we need to attack this problem in this sprint."
Sara Naab: And really focus our team around that. We've also really put a premium on learning within our organization and so everyone in our team is fairly green, fairly young, but we've said, "Okay we're gonna learn this and we're gonna figure out what we need to know." And we've had a flexible team for that. So we've been able to take our marketing staff and have them help in the lab. Our lab staff has come and help on some of our consumer stuff and gone to trade shows. And because of that we have a lot of learning that happens, and so a lot more understanding about the condition. In terms of the technical teams, what does the consumer need? And that gives them more feedback about what can we do to make the product better? And then the marketing team understanding the technical challenges. And I think these are things that are fairly unique in our organization.
Jon Speer: I mean, like I said, I look forward to continuing to work with you and the Sandstone team. I know you're just on the very cusp of some super exciting things that are happening. I wanna thank you for your willingness to participate with me on the Global Medical Device podcast today. And any parting words before we move on to... You probably have three more clinical studies to wrap up this afternoon and a couple of new risk assessments to do yet today. So any parting words for our audience?
Sara Naab: I would say my last parting words would be, know your customer and love your customer. The thing that you're gonna put your whole heart into making and your whole energy, you need to have a reason to do it, and the better you can understand the needs of your customer, the better the product you're gonna make, and the more inspiration and perseverance you're gonna have, because you're gonna understand exactly what problem you're solving.
Jon Speer: That's really, really well said. Speaking of knowing your customer, Sara, did you hear that greenlight.guru has a new feature and it's called Risk Management?
Sara Naab: I'm so excited.
Jon Speer: Risk is something that's been a long time coming. So, it just came out today. I look forward to you having a chance to play around with it when the time is right, and chatting about that. But again, thank you for participating in this podcast, and I look forward to hearing more about the adventures of Sandstone and Sara and all your colleagues there. Again, visit Sara Naab. You can find her on LinkedIn. She has this wonderful picture of her riding a giant sperm. Yes, you heard me correct, she is riding a giant sperm. And you can check out Sandstone Diagnostics a couple places. The easiest URL to remember, ever, is dontcookyourballs.com, you can go to sandstonediagnostics.com as well. My name's John Speer and I am the founder of Greenlight.guru and you've been listening to the Global Medical Device Podcast.
About The Global Medical Device Podcast:
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.