About Cody Simmons
Cody is a bioengineer and entrepreneur that has spent his whole career dedicated to bringing new health technologies to physicians and patients. Prior to his tenure with DermaSensor, Cody led commercial efforts for a Silicon Valley medical device screening startup and also held business development and commercial strategy roles at Genentech. Cody joined DermaSensor in May 2016 as co-founder and CEO. He has led the company through raising 15 million in financing extensive product development efforts, multiple clinical studies and most recently, successful regulatory clearances that now allow for the product to be sold commercially. He is an excellent leader in health care, taken really the advantage of the advances in digital health to help primary caregivers as well as patients maximize their health.
Equipping Frontline Providers in The Fight Against Skin Cancer with Cody Simmons, CEO of DermaSensor was automatically transcribed by Sonix with the latest audio-to-text algorithms. This transcript may contain errors. Sonix is the best audio automated transcription service in 2020. Our automated transcription algorithms works with many of the popular audio file formats.
Saul Marquez:
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Saul Marquez:
Welcome back to the Outcomes Rocket, Saul Marquez here, and today I have the privilege of hosting Cody Simmons. He is a bioengineer and entrepreneur that has spent his whole career dedicated to bringing new health technologies to physicians and patients. Prior to his tenure with DermaSensor, Cody led commercial efforts for a Silicon Valley medical device screening startup and also held business development and commercial strategy roles at Genentech. Cody joined DermaSensor in May 2016 as co-founder and CEO. He has led the company through raising 15 million in financing extensive product development efforts, multiple clinical studies, and most recently, successful regulatory clearances that now allow for the product to be sold commercially. He is an excellent leader in health care, taken really the advantage of the advances in digital health to help primary caregivers, as well as patients, maximize their health. Cody, I’m really excited to have you on the podcast to learn more about what you guys are up to and more about you. Thanks for joining us.
Cody Simmons:
I appreciate that. And the excitement is shared. Thanks for having me today. And like I said, very excited to be speaking with you and to have our work featured on your podcast.
Saul Marquez:
Absolutely, Cody. Now, DermaSensor is just fascinating, evaluating skin cancer in a much simpler way. I want to learn more about this, as the listeners do, too. But before we dive into that, I’d love to know more about what inspires your work in health care.
Cody Simmons:
Sure. Well, I think first and foremost, helping patients is really my inspiration for working in health care. Hands down. I think that everyone faces at least some challenges and frustrations with their job and their day to day work. And I think our company and me personally no exception that otherwise it would be called work. But at the end of the day, knowing that if you’re able to overcome those challenges in your startup and your product is successful, knowing that success will benefit hundreds or thousands of patients, that is incredibly motivating for me. And I’d say in line with that, I think for entrepreneurs, the common expressions that we’re supposed to address unmet needs. And as you’ve seen obviously from from from all your work in the podcast. Unfortunately, there is no shortage of unmet needs in health care, and many of them are very large ones that fixing what not only greatly benefit people’s health, but depending on the solution. Also, oftentimes, I think, has the potential to save the health system money. And of course, patients ultimately pay for all health care, whether it’s directly or through their employer for private insurance or through paying taxes that go to Medicare or Medicaid, et cetera.
Saul Marquez:
For sure. Yeah. And, you know, we’re experiencing so much change. And, you know, the epidemic has accelerated that change in digital medicine and telemedicine, remote care. What you guys are doing is fascinating. And skin cancer is a huge problem. A lot of it goes unaddressed, undiscovered. It’s way too late. And so tell us a little bit about what you guys are doing to add value to the health care ecosystem.
Cody Simmons:
Sure. Sure. And yet it really is a big problem. And to be clear, our product is not yet approved by the FDA for use in the US. But as you mentioned, it is available in certain areas abroad. So we just announced that DermaSensor’s had to receive CE mark for sale in Europe, as well as regulatory clearances in Australia and New Zealand. So for the US. Yeah. So that’s been an exciting milestone for us. And in the US we hope to be approved next year and then after that to start adding value to the health care system in a couple of main ways to just address your question. So our company’s mission is to improve patients’ access to effective skin cancer checks. As you noted, skin cancer is very common. It’s actually the most common cancer in the United States. And melanoma is the number one cancer killer of young women. Fortunately, effective. Effectively, all skin cancer can be successfully treated if it’s detected early enough. Unfortunately, the average wait time in the US for a dermatologist appointment is one to two months. And because of that and other cost and access issues, the majority of Americans report having never been checked for skin cancer. And only a small fraction of Americans do so annually, which is a recommendation for many of us. So our main objective is to fulfill our mission of improving patients’ access to effective skin cancer checks is to really empower America’s hundreds of thousands of front line providers, primary care providers like family physicians, internists, clinicians at retail health clinics to more effectively catch skin cancer. Studies show that primary care providers, they’re not dermatologists and that they only correctly decide to refer biopsy a malignant lesion as little as 54% of the time, the melanoma, five-year survival rates go from well under 50 percent for stage four melanoma to the high 90s for stage one melanoma. So far to help detect melanoma earlier helps his primary care providers, which by definition their front line providers right. So they see patients often in early. That would be huge. So detecting melanoma earlier, if this tool helps with that, would be a huge benefit for patients’ survival. And also treatment costs for late-stage melanoma can be over a million dollars, whereas stage one melanoma treatment typically just costs a few thousand dollars.
Saul Marquez:
It’s a big difference. And so the challenges, I guess, on the one hand, shortage of dermatologists, because one in two months I mean, I just like I just wrote as we were talking one, two months, exclamation mark, underline for an appointment and it just seems way too long. And why should anybody have to wait that long? There’s got to be better ways to do it. And then the problem that we also run into, it’s the geographical differences right. you have your urban care centers, then you have your rural care centers where potentially there is not even a dermatologist.
Cody Simmons:
You’re exactly right. And that one to two months is an average nationally. There’s much better access in certain urban areas like I am here in Miami, in New York. But there are lots of examples in rural areas. I forget the specific regions and wait times, but that is as high as four to six months.
Saul Marquez:
And we need an answer. We need an answer for these gaps in care. The access is certainly something that I see could improve with what you guys are building there. Now, talk to us a little bit about what makes you different than what’s available today.
Cody Simmons:
Sure. Yeah. And before I jump into that, quick addition to your point there. Part of the access issue is that there’s a lot of unnecessary referrals and biopsies, Right. And so certainly one way to detect skin cancer earlier would be any patient asked about a mole to a provider or provider notices anything that even just catches their eyes and they don’t necessarily suspicious-looking. They just refer the patient to a dermatologist or they biopsy the lesion. Well, you know, practically speaking, like you’re saying, with the wait times and access issues and cost with dermatologists referring, every single patient isn’t practical nor, as Bob said, from a cost and a morbidity standpoint. So in addition to helping providers detect more skin cancer by having a higher sensitivity to skin cancer, we also hope to help providers decrease unnecessary referrals and biopsies as primary care providers are currently, according to literature, referring or in 30 to 50 moles for every one melanoma detected. So kind of a hit rate in a sense of two to three percent. So we think we could potentially help with that.
Saul Marquez:
It’s basically overutilization, Right. Unnecessary overutilization.
Cody Simmons:
Exactly. And especially when dermatologists are overwhelmed in terms of wait times they need a lot of those visits are dermatologists will be the first one to tell you that they often say this to me and team members, let’s be with them, that PCP’s they’re not dermatologists. So often when they’re at all concerned, they refer to us, which can be good. But a lot of those referrals didn’t need to come to see us. And so it ends up taking a lot of our time to just reassure patients that, you know, a lesion that’s clearly benign in our eyes is actually fine and then we send them away. That, by definition, takes up an appointment that could have been used for a patient to be there. And that’s why we think part of it in terms of just practically helping PCP’s, that our skin is having a very quick and easy to use the tool. And that’s what we’ve spent a lot of time developing, what was originally a 30-pound microwave sized device that we spent a lot of time and money on. Now miniaturizing a key design primer was that it just takes about 20 seconds to evaluate a lesion and that it’s also accessible from the ease of use in a price standpoint for PCP’s. So following FDA approval, we hope to get widespread adoption of our product and that that this will result in PCP’s catching more skin cancer and a decrease in unnecessary referrals and biopsies of which will benefit patients.
Saul Marquez:
That’s a key differentiator. And so, considering the technology itself, what would you say or even the company, the process that you guys do, what makes you guys different than what’s out there?
Cody Simmons:
Sure, sure. Well, actually, it’s a surprisingly easy answer because there’s no automated skin cancer detection tool available in the US for use by primary care providers. So we expect to be the first-ever device that is available for this use by these kinds of health care providers, there’s various other tools I don’t want to kind of go outside of my lane here, but for automated fungus assessment for certain diabetic-related diseases. And I think that there’s a few dozen sorts of FDA cleared or approved tools that use machine learning. And then often it’s non-invasive modalities. But none of them are for skin cancer for primary care providers.
Saul Marquez:
So that’s a niche to find.
Cody Simmons:
Yeah, and we think it’s not too much of a niche, unfortunately, in terms of how come it was skin cancer is the most common type of skin cancer. We just think it’s challenging from a clinical from a product, from a regulatory standpoint, challenging. And so no products have ever been approved in the US for this before. So really, that’s a question of how are you different or better than what’s available today? Really, the comparison today is just how does it compare to visit a dermatologist is the only option. And we’ve talked about the challenges of that and whether it’s in person or using teledermatology. And again, we’re not trying to replace a dermatologist visit in any sense. We’re just trying to help primary care physicians better assess skin and decide should a patient go see a dermatologist or not. And we hope that that’ll ultimately be beneficial because of the relevant clinical and also health care access considerations that we’ve been speaking about. And so, yeah, basically go to a dermatologist or just leaving everything status quo with the current care paradigms and performance levels that primary care providers have now and the gross number of over referrals and also often skin cancer that is evaluated by a primary care provider. But they decide that it’s not concerning and decide not to biopsy or for oftentimes when it actually is malignant.
Saul Marquez:
Yeah, that’s pretty cool. And so being the first to market is, is when the opportunity does come to fruition. And I feel like we’ll open up some opportunities for you guys. I’m sure it hasn’t all been straightforward. ‘s things that we do here is to learn as entrepreneurs and leaders in health care. So can you talk to us about one of your biggest setbacks and what you learned from that setback?
Cody Simmons:
I, unfortunately, there’s one that clearly jumps to mind here. And I’ll be frank, we’re hoping to be an exception to the saying that hardware is hard, but we most certainly were not. Our first design approach to miniaturize. I think I mentioned the original 30-pound microbicide device was to use a discrete wavelength light source instead of broadband light for us to get a bit technical here. But we ended up encountering significant cost, product, cost of goods, and also performance issues with that approach. So we basically shelved a year of work on that and essentially started from scratch with redesigning a device that used a miniaturized broadband lamp or light source and that ended up taking about two years to fully complete instead of the original target, our hope of nine months. So kind of a couple of significant delays first and just the sort of technical approach we took and ended up kind of going in another direction. So lost about a year or so there and then the direction we did set on, which we’ve ultimately been very happy with, but ran into significant delays on that as well. So I’d say key learnings were really to never underestimate the challenges of product development and to expect for there to be setbacks, not just with the known unknowns. Right. Where there are X and Y we know we’re gonna have to work through. It can be challenging, but also to expect setbacks from many unknown unknowns and just assume that those are going to be all kinds of things that come up that you have to deal with and work through, that you have you know, you have no idea that they’re potentially going to be problem areas. You’re not even thinking of them as a potential problem matter. And so I think that that was a big one. And on a related note, to kind of the product and hardware, it’s hard also to be as diligent as your company, reasonably, Can be, with development partners you pick in terms of their capabilities and track record, and also to make sure your sort of payment terms and agreement with them and both companies incentives are well aligned on both sides. I think that’s stuff and something. And looking back that we learned the hard way, certain they were going to incorporate in our work moving forward and hope, hope that simple suggestion there can perhaps help other entrepreneurs and folks in the industry that are developing their products and bring them to market and to patients faster.
Saul Marquez:
Some great learnings are coded. Thank you for sharing that. And so to go from a 30-pound machine to something that is. I mean, this thing is hand-held, right?
Cody Simmons:
Yeah, it’s just over a pound now and we did the type of technology. So this field of spectroscopy, it’s called elastic scattering spectroscopy to type the optical spectroscopy was originally invented by Key, our key collaborator, Professor Irving Biju at the Los Alamos Research Institute. And he’s been a professor now for, I think, 20 plus years at Boston University. So his group’s been kind of key collaborators of ours, was kind of sponsored research agreement, a licensing agreement with some issued patents. And he’s a key one of our scientific advisory board members. And so it’s interesting, it’s actually the first time that this technology has come to market in a medical product. So that’s something that us having worked on this for a decade and about three decades now, are very excited about. But, yes, certainly to your point that it started with a 30-pound large spectral spectrometer and corresponding equipment. Now that it’s handheld, you can really it’s basically the size of a thick smartphone, touch screen, and point and click take 20 seconds to evaluate a mole and you’ll need one hand operated. We’re really happy with the path we went down to get there, but it took 10 years and about ten million dollars in product and clinical development. So was not an easy, quick effort.
Saul Marquez:
How long did you say it took?
Cody Simmons:
Well, the company was formed in 2009 and our first kind of early validation study on the large 30-pound device started in 2011. And obviously, there is product development work leading up to that. So, yeah, our product and clinical development work started pretty much exactly 10 years ago, in 2010.
Saul Marquez:
It’s a long road, but you guys have made some significant progress. So major kudos to you. And obviously, with some of the comments you made, you know, it’s difficult, but you guys learn a lot of lessons and hardware is hard.
Cody Simmons:
And we were not we were hoping to be the exception to the well, I don’t know if it’s a rule per se, but it’s certainly common saying we’re open to the exception. But that was not the case.
Saul Marquez:
Yeah, well, I appreciate you sharing the learnings, Cody, and the winds. What are you most excited about today?
Cody Simmons:
I’d say I’m most excited about kind of building on the discussion we just had a minute ago about our tool and this technology finally being available for real-world use by clinicians abroad for now, as we talked about, to help them better assess their patients for skin cancer. We’ve spent over 10 years, pretty much exactly 10 years, like I mentioned, 10 years and over 10 million dollars on product and clinical development. So it’s very exciting to now finally have our product available for use by for sale and for use by providers and those countries I mentioned. And so, yeah, that’s a very exciting thing for me and I think for the company. Also, DermaSensor is the world’s first point and click tool available for primary care providers for skin cancer. So we’re excited about that. Just in kind of being a first globally. We spoke earlier about it’s kind of first any kind of skin cancer tool in the US for primary care providers. Also, it’s, as I mentioned, the first medical product in the world that uses this type of optical spectroscopy. So the company and the inventor of this field of spectroscopy sort of individual, very excited about that.
Saul Marquez:
And who knows what other opportunities might be ahead for this optical spectroscopy. So fascinating work. Lots to build upon and certainly exciting for the people that are not receiving the care that could potentially be receiving the care, the right. care moving forward.
Cody Simmons:
Yeah, knowing that. Actually so I’m glad you mentioned that because there are dozens of peer-reviewed publications on the use of elastic scatter and spectroscopy and assessing malignant tissue. Only a few of them are on the skin. Obviously, some of our work included among that. But there’s a lot so a lot out there for other cancer types. I know Professor Bija and his group of you have done tons of work on Colon. I think also there’s been a few studies and papers on esophageal cancer. So certainly this type of technology, a lot of long development cycles, it’s in the scheme of things, a couple of decades old and being invented. It’s relatively new, but I think we really benefit from the optical non-invasive nature paired with the very recent developments, I would say, in machine learning, just kind of having a new kind of non-invasive optical modality that is able to benefit from the very recent advances in machine learning. I think we certainly were fortunate that both of those trends kind of noninvasive assessment and monitoring and whatnot as well as machine learning, have both become such important parts of kind of health care tools. Products and is a big focus for health technologies moving forward, because obviously that those are key aspects of our products,
Saul Marquez:
Some great call-outs there Cody. So, man, I mean, congrats to you guys. Certainly rooting for the release or the approval and release here in the US. But in the meantime, you know, the commercialization abroad. And so with that in mind, what call to action or what thoughts would you like to leave us with? And then the best place that listeners could get in touch with you and the Derma Sensor team.
Cody Simmons:
Sure. Well, at the end of the day, you know, in terms of closing thoughts, right at the end of the day, anyone at any time is literally able to see skin cancer. So effectively detecting and treating it through health care boils down to health care access or even could be considered a public health issue. So it’s all about for us. It’s all about improving access to effective skin cancer checks. And we think a quick, easy to use low-cost tool that, of course, has high clinical performance, has the potential to be a game-changer for skin cancer detection and care. And I’d say Saul for your listeners, if they think that their company could be a good partner to work with us and showing what a big impact our tool can have on health care and or in getting the dermo sensor device in the hands of thousands of primary care providers, please do reach out to me directly on LinkedIn or like you said, get in touch to touch with the company, generally using contact@dermasensor.com.
Saul Marquez:
We’ll certainly appreciate the insights you’ve provided here. And listeners take Cody up on the invitation to explore this idea and spreading the idea to primary care providers beyond and helping them deliver care that we all deserve. And so Cody, we just want to give you a big thanks. And again, folks, a reminder that the company website is dermasensor.com or go to outcomesrocket.health and type in dermasensor for the entire show notes and transcript and links on ways to get in touch with Cody in the show notes so. So. Thanks again, man. Really appreciate the time you’ve spent with us today.
Cody Simmons:
Thanks so much. So I really appreciate your time to. It was great speaking with you.
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