This Surgical Innovation Solves a 50-Year-Old Problem | Ep. 98 [Will Crawford]

What if one of the biggest opportunities to improve surgical safety and efficiency is not a complex implant or robotic platform, but a smarter solution to a problem hiding in plain sight on the operating room floor? Welcome to Industry Ignited. I'm Dr. Leanne Aguilar, and today I'm joined by Will Crawford, CEO and co-founder of Smart Step Surgical, a medtech startup focused on improving ergonomics, safety, and workflow in the operating room with its innovative surgistep platform.

Will, welcome to the show. Thank you for having me. Now, I know your career began in spine implants and surgical sales before you stepped into entrepreneurship. What did those years in the operating room teach you about unmet needs in surgical environments?

Yeah, you know, the operating room, there are many inefficiencies. I think any healthcare professional will tell you that. Over the years, you start to see all these problems that are just everyday life. You know, these HCPs become conditioned to it because the problems they deal with, they're important and urgent.

So it's easy for them to overlook the friction points that may cause inefficiencies or workflow issues just because patient care is so dramatically important. So yeah, seeing these pain points and wanting to provide another solution. Right. Okay.

So just being there, you saw the like the problems, the inefficiencies like firsthand. And then that really compelled you to want to do something about it, is what I'm I'm hearing. Yeah, absolutely. As an industry representative, you're always finding yourself trying to add value, looking for ways to improve either a workflow or a custom instrument, or even sometimes combining two systems from different vendors.

You know, as a distributor, that was one of the value ads. So you're always finding your trying to find a way to help improve the outcome. Yeah, that makes sense. So you spent over a decade working across major spine companies and distributorships.

At what point did you realize you wanted to move from selling products to creating one yourself? Yeah, as I just mentioned, so you're always tinkering with little custom instruments between the manufacturer and the surgeon trying to improve that specific instrument or system. Um, and you kind of get a little frustrated dealing with some of the bureaucracy of the large companies because there's so many stakeholders and so many uh steps that need to get approved to bring that instrument to market.

So I always thought it'd be really fun to do it on my own with a small company or a small team and uh just increase the speed and efficiency of bringing that idea to market. And I know Smart Step Surgical began with an idea you and your co-founder initially thought you might patent and sell. What changed your mindset from licensing an idea to building a company around it? Yeah, I guess I have to relay a quick funny story first.

So my co-founder, Dr. Jennifer Kwan, she's a pediatric neurosurgeon in Toronto. And so we used to work together a lot in the operating room, and she's about five foot one. So routinely she's on stacked step stools, and I, as an industry representative in the room, would always move these step stools around for her.

So one day I was on my hands and knees stacking her step stools, and she leaned over and said, I just wish I had one that went up and down. And jokingly, yeah, I said, Hey, we should start a company, we should do that. So that joke kind of turned into where we are now. But um, to answer your question, you know, we thought that if we just filed a patent, had a cool PowerPoint and this idea, and with Dr.

Kwan being a practicing physician, we would have credibility to go to a company, they would buy the idea or license it, and we would get to see this thing come into the real world. But after talking to a few of the larger companies, we realized that organic development is tough for them. You know, they are big, they're extremely successful because of their ability to scale. You know, they have infrastructure, they have trained sales force, they have marketing teams, they have attorneys, you know, they are built to take something and just put it on steroids to grow it uh globally.

They do not like organic product development, and I can't say that for every large med tech player, but this was the feedback we got. They showed us a Gantt chart compared to ours, and they said, well, what you're gonna do in six to eight months, it would probably take us three to four years and cost a whole lot more. So they generally like to see companies commercialize it, bring it to market, show traction, and then they'll purchase that company later on down the road when everything's proven and then they'll scale it.

Right. Which is I smart, I guess, on their their end. It's more difficult and challenging for the entrepreneur because uh you know they're putting all the risk back in your your hands. But for them, I guess it does make sense.

And also, I guess they have a point though. I mean, it is easier for for you to be agile and and do things quickly with a big organization. It it takes a lot longer typically for them to make something happen when it comes to new new innovation and putting teams together and getting approvals, etc. So I I do see their point and and it's less risky, but but interesting.

Okay. So, Will, you made the decision then to hand over your distributorship and go all in on this venture. What gave you the conviction to take that leap? Yeah, I would have to say it's twofold before we made that conviction.

On a personal level, I was working a lot. I didn't see my family very much. I had toddlers, two toddlers, a beautiful, loving wife, Morgan Crawford, but I didn't see them very much at all. I was always up before they were up, and I got home when they were in bed, and I would usually stay up and work on admin.

So on a personal level, I knew there needed to be a change. And then on the business side, once we finished our second usability study, where we had prototypes and HCPs give formal responses to the prototypes that we had. We knew that we had something that was potentially commercially viable and we had reduced the risk enough to accept friends and family investment. And I knew that I couldn't keep the distributorship going, work full-time on a startup, and maintain my marriage.

So something had to give. And uh, once we had you know enough validation from the lab, we knew that at least two of those things were in play, and that was our ultimate conviction to move forward and a focus full-time on smart step surgical. Right. Yeah, it's no joke starting a company, right?

And I know a lot, a lot's involved, a lot more than people realize sometimes. And yeah, at some point it's like, okay, something's gotta go. I get that. So for those outside the surgical world, paint the picture for us.

What is the real problem with stacked step stools in today's operating room? And why has it gone unaddressed for so long? Yeah. Um, so if you can picture yourself in a surgical setting, there's usually one patient, hopefully only one patient, which means one operating table.

And those operating tables are pretty fancy. You know, they're expensive, they adjust in every direction, but there can only be one table height. And depending on where you are, whether it's a teaching institution or a community hospital, it may vary. But typically you have anywhere from two to six people sterile, scrubbed in, operating.

Um, and they could be different heights. You know, there could be a Dr. Jennifer Kwan at five foot one, and another Dr. Smith at, you know, six foot seven.

And the shorter person is usually on these step stools. And they're typically there, there are multiple sizes, but the most common in the ORs are 12 by 17 inch footprint, usually five inches tall. And so you're stacking these things vertically in five-inch increments, and sometimes you're stacking them side by side to accommodate more room for foot pedals that operate different equipment in the operating room. And I think the reason why it's just gone on, you know, 50 plus years is kind of the point I made earlier.

These they have bigger problems to worry about, these smaller friction workflow ergonomic inefficiencies, they're able to overlook because their problems are so big and so urgent. Um, so they just kind of become conditioned, they figure out workarounds and they just deal with what they're given. Right. And other than just height difference and stuff, what is the need for these step stools for you know the operating room doctors and and nurses?

And I mean, what you know are we dealing with here? What is there a risk involved? Is how they currently, you know, they were before your innovation. Yeah.

So because they're five-inch increments, I guess one point is every time you increase the height, it's you know, a half of almost a half a foot difference in height. So if your ideal ergonomic height is maybe two to three inches, you're compromising by shrugging your shoulders or you're getting too tall and then you're hunching over. So the ideal ergonomic standing height is to have the operating table about at the level where your forearms would be parallel with the floor. So your elbows are 90 degrees, they're slightly convergent.

Um, you're not hunching over. Hopefully, your back is straight, you're close to the table, so your belly button needs to be as close to the table as possible. So if you have to use step stools to make this adjustment, you actually can't do it yourself as a sterile team member. You have to wait for a non-sterile team member because anything below, I think it's mid-thigh is considered non-sterile.

So that usually means a circulating nurse or an industry representative like myself will come over and pick up these stainless steel step stools, put them in place, and they get really close to the sterile field. So their head sometimes maybe brush up against that sterile drape. Hopefully it doesn't, but it's uh possible. And then they're stacking them.

And sometimes hospitals that have been open for close to 100 years, 50 years, they'll accumulate step stools from different manufacturers. So there are countless images, and anecdotally I've seen it, where you have mixed match step stools that really don't configure and really aren't designed to be stacked, but they're doing it because it's the only thing available. And there are scenarios where whether it's a resident or a surgeon, you know, they've felt fallen off these step stools or tripped on, or or even a nurse maybe didn't see it there when they were moving around to the other side and you know they tripped over a step stool.

And one last point to make is with the foot pedals, every time that foot pedal accidentally gets dislodged and hits the floor, it's underneath the operating table. They have to stop what they're doing, wait for the circulator to come over, crawl underneath the patient, put the pedal back on the step, and then they can begin operating again. And in the operating room, minutes matter. You know, they always talk about surgical time.

It's really expensive. It's in the hundreds of dollars per minute. Not only is it the surgeon extremely frustrated having to stop in a critical moment, but also from a cost standpoint, it it means a lot. Yeah.

Wow. That does does sound yeah, daunting and and impractical. So I see how Surgistep is such a practical and but meaningful innovation. Tell us more about what makes it different from the status quo and how how does it improve ergonomic safety and workflow in the OR?

So you mentioned other problems, but yeah, how does it solve those problems? Yeah. Surge step is a motorized step stool. So it's battery powered by a lithium-ion battery.

It has a push-button foot actuator, so it's user-driven. So the buttons will actuate the step. It expands from five inches up to almost 13 inches. It has spring-loaded wheels.

So when it's non-weight bearing, so if the surgeon or tech or whoever the user is steps off and they need to move the step out of the way rather than wait for a circulator to come over and lift it up, um, they're able to just kick it. It rolls when it's non-weight bearing, kind of easy as a skateboard. And then as soon as they place weight, you know, about a 15-pound axial load back down, it'll compress down onto rubber feet and it's completely secure. And then it also has some accessories.

So we have different options for standing surface. You know, we use a really high quality platinum-cured silicone rubber mat, so it's anti-slip, and then we have a design that increases thickness and softness with a low durometer, so it's anti-slip and anti-fatigue, so it helps support you know, long cases where they're standing for 10 plus hours. It helps their back feel better and reduces fatigue. And then we also have modular pedal platforms to not only increase the platform space to accommodate the foot pedals so you're not needing to stack side by side, but it also has containment features to keep those foot pedals from getting kicked off accidentally, and then with some cord trap features as well.

All right. So it's solving a lot of problems all in one, I'm hearing. So that's really cool. So when you stand on it, it basically locks into place.

But then when you remove weight, then it's you can roll it around, is what I'm hearing. Yeah, surprisingly enough, since this has been out in the real world, people almost get more excited about that feature than the fact that it goes up and down. Right. I know.

Because typically, yeah, rolling platforms, you're having to lock them into place, you know, with the little locks on the wheels or something like that. But this sounds a lot more convenient to just stand on it and it it secures in place. So yeah, that is cool. Right.

Now, one thing that stands out is that your your product was also designed by listening closely to clinicians. How did surgeon, nurse, and tech feedback shape the final design? Yeah, so we um, like I said, we did two usability studies, one formative, one summative. And one of the earlier usability format settings, we had various users in that group.

I think about 10 or 12 people came through. And that included nurses, techs, different surgeons from different specialties, industry representatives. But one user in particular was going up and down and he was liking the height and the footprint, but he said, I have a problem. I can't use this in the OR.

We said, Why? He goes, I'm a trauma surgeon and I take a bunch of x-ray shots. And every time that CR, they call it a CRM machine, every time the C arm comes in and out, I need to move these steps out of the way because the base of the C arm is really large. And I can't kick this thing.

Your original prototype looked like almost a suitcase luggage where it had rear wheels, telescoping handle, and the idea was a circulator would come over, grab the handle, kind of lift it up on the rear wheel, rear wheels, and then move it out of the way. He said, I just I can't kick this thing, it's too heavy, and I'm not gonna wait for the circulator every time I have to take a CRM shot. And so that borne the idea of the spring-loaded ball detent wheels. Um, so the next round of prototypes, we included that.

And then we had to play with the tension and you know the clearance and also adjusted the heights. That was one. And then the other one that was obvious was the foot pedal containment. You know, after not even in the usability studies, but years in the OR, I was always chasing the foot pedals.

Right, right. Yeah. I probably can't use the name, but she would test the circulators. If the bipolar pedal didn't have eye tape, you know, just basically it's like a high-grade scotch tape, to keep the pedal on the corner of her step, she wouldn't trust that person because that was one of her MOs.

You know, SOP was right, you know, you need to tape this thing down. So after always taping down that pedal, I said there's gotta be another way. Right, right. Because if you're taping it down and then someone else comes in, they're a different height and they need adjusting it, then you're gonna have to untape it, secure it again.

Actually, that's a great you pointed that out. Especially at teaching institutions, it's pretty common to switch sides. So whatever setup you have in that current moment, interop, if the primary surgeon needs to move over to the other side, everything has to change as far as their foot configuration. So the steps need to be picked up, moved over, the pedals need to be swapped underneath the table, and then all has to be done by someone else that's you know not sterile.

Right, yeah. So it's not only inconvenient, but it also introduces uh um sterility, I guess, problems. Is that how you say that word? So okay, yeah.

Interesting. So you're solving a problem that affects not just surgeons, but the entire surgical team. How important was it for you to create something that improves collaboration across the whole operating team? Yeah, so as an industry representative, you always found yourself in the room, wanting to be part of the team, wanting to be cohesive, like I said, always wanting to add value.

And that wasn't always just for the surgeon. A lot of times you're helping the circulator run and find something in the sterile core, or you're unplugging they used to use headlights that plugged into a light box. Now they use headlights that are battery powered, but you would unplug the headlights when they switch around to the other side of the table or move the step stools so you could see the pain points for the circulators because they have other obligations as well. They're not there just to move non-sterile items around the OR.

They also need to chart, they need to get the next patient ready. Um, you know, they have other obligations. So they're busy. Uh they're running around all the time.

So we used to joke that we, as representatives, were the uh repulator. You know, we were the extension of the circulator. But there's always ways to improve that workflow that helped the whole team. Right, yeah.

And now you're in the exciting early commercialization phase with products deployed and trials underway at major institutions. What have those early trials taught you about market demand and product adoption? Yes, um, it's been a ton of fun, I have to say. You know, 30-step, it's a different product.

You know, it's definitely not, you know, another commoditized screw like I was starting to get used to. But when you bring this in the OR, there's a lot of puns. People who think it's a scale because it has numbers and a little screen, um, they don't want to stand on it, or or they think it's a printer. You know, outside of the yeah, outside of the cuts and the jokes.

Um, it's been a ton of fun. The position of a surgical tech, you know, they love it because they're always moving around on the back table, um, moving instruments from one table to the sterile field, and having something that they can mobilize and move that fits their needs and not wait for someone else has been really cool to um introduce and get feedback. And then, of course, as you would assume, anytime there's something new, there's always great feedback on how to improve it or what to remove or what to add.

So we've done quite a bit of changes um even since we started these early trials to keep improving the product. Um it's actually countless. We we've made quite a few changes since that first day that we stepped in on our first trial, just over a year ago. Yeah.

Um and hospitals themselves are complex systems, and getting approved as a vendor can be a challenge in itself. What have been the biggest hurdles in moving from prototype to real hospital use? Yeah, so working with these large healthcare systems is tough. You can have one healthcare system that will approve you as a vendor and approve a trial or even just purchase the products in a matter of weeks.

And then you could have another system that takes almost 11 months over a year to approve you as a vendor before even doing a trial, and they're both requesting the same information. So you wonder, you know, why is this process so different from company A and B? So it's pretty ambiguous. Uh, it's kind of frustrating, to be honest.

It's almost like it's designed to be that way to slow down new technology intake. So that's that. But even after you get approved as a vendor, a lot of times you need to go through some kind of T's and C's on making sure the evaluation is approved by the legal system. And then we offer up to a month free trial.

And then even after the trial, if you have consensus that they want to buy a certain amount, it still takes a couple months to get to the point where you have a purchase order and then you could ship the product. So if you add all that up, it could be well over a year sales cycle. And I should have known, you know, I have experience in this, but I just didn't appreciate it because as an implant vendor, you know, you're used to things that are consumables and you have ongoing business, and then the capital sales cycle was always just kind of running in parallel.

So didn't fully appreciate what that meant as if this was our only thing. So it's been uh challenging. So now you're on the other side and can see everything that's involved and and how the length of the sales cycle. And so I guess that's challenging to balance between staying lean, not running out of money, and continuing to innovate, and especially in this commercialization process.

How are you navigating growth while bootstrapping and building organically? I've had to learn the hard way to really stick to budgets. We have a lot of ideas that we want to pursue, whether they're organic between Dr. Kwan and I, or ideas that have come to us from uh peers.

The pipeline's pretty full and it's really exciting. But as I mentioned earlier, product development's really expensive and ambiguous and timelines slip. So we've had to be very intentional about shelving a lot of these fun, exciting ideas, even if they're half baked, and just be diligent about every dollar that goes out our spend is going to achieving revenue right now. And then with revenue, we'll start refunding product development.

So we are continuing to improve and build out the accessories, as some I've already mentioned, but some of the kind of new products that would be a standalone, they're on hold until we catch up on revenue. Yeah, that makes sense. So, how many products do you currently have available? So we have three formal SKUs.

So we have Surgy Step, and then we have Surgy Step Endurance, which is the anti-fatigue mat, and then we have Surgy Step Pedal Assist, which are the accessory uh pedal wings that contain the pedals. And then there's about another three products that we really want to pursue. But like I said, the cost of tooling and molding, we're on hold right now. But we really think it'll be a fun kind of value add, especially for the team, more of like a workflow solution.

Right. And how many hospitals are your products in so far in multiple states? Are you confined to the US right now? Or and what's your growth plan?

It's yeah, been really fun. So we're actually approved vendor and have surgery steps delivered. I should have this totally dialed in, but we're in New York, Florida, California, Texas, Montana, Utah, and then we have pending trials. Moving forward pretty soon and several other states, you know, Washington State, Nevada.

And then we are engaged with actually four different distributors and outside of the US, so Mexico, Canada, the UK, and Australia. So we're just kind of working out that engagement. But yeah, it's been really exciting. No, that is exciting.

So looking ahead, what milestones would signal that Smart Step Surgical has truly broken through, whether in adoption, profitability, or future product expansion? Being bootstrapped, obviously, profitability would be great. But I think the milestone that sticks out the most to me is if we can get away from going into existing ORs and swapping out existing instruments or equipment that the hospital already owns to getting trust and going into a healthcare system that's building a brand new operating room and have Surgy Step outfitted in each OR, I think that'll really be a huge milestone for us.

And that's a major goal right now. Right. Yeah, no, very exciting. And Will, you've described this journey as learning on the fly and figuring things out as you go.

What has entrepreneurship taught you about resilience, humility, and persistence? So it always takes way longer than you anticipate, and it costs way more than you planned. So just having to keep going, figure out a way whether you're raising capital or reducing costs, just the burn the boats mentality. You know, just know that you're in too deep and there's no turning back and you're doing the right thing.

And I think one other important point, at least that's helped me a lot, is just hearing other people's journeys, other entrepreneurs. There's so many resources out there, whether it's podcasts or books, but being able to relate to these individuals that have made it, you know, it's you realize that their journey wasn't seamless, that they went through a lot of trouble. So it helps to realize that this is just part of the path and you gotta fight through. Right.

How long has your journey been so far with this product development? Yeah, so uh I think from the joke I mentioned to now, I think that conversation started in late 2020 and we started in uh putting money into it in 2021. Okay. Yeah, it's been about five years.

Yeah, great. So for other founders entering the medical device world, what should they understand early about quality systems, regulatory realities, and the true cost of bringing a product to market? So for me personally, as a sales guy, I really underestimated quality systems. So I might just go after that one.

For sales and marketing, usually product complaints are kind of the obvious quality system that you're aware of, but I had no idea about the depth of what a QMS actually entails. All the SOPs, your risk management file, Dafema, the whole thing. So finding someone that can set that up for you and budgeting for that person, and then also making sure you find someone that has experience not only with a large device company where they can be extremely thorough, but also has experience with a startup because it is easy to overkill your QMS and create way too many belts and suspenders.

So having someone that has that perspective of both and keeping your QMS lean as well as your budget, because the more in-depth you have your QMS, the more work it's going to require. And if you're not doing it, someone else needs to, and you need to be able to pay that person. I think that's the biggest one. And then regulatory, you know, if you just have an advisor um that's able to direct you usually um just follow their advice.

Right. So did you lean on other entrepreneurs or you know, medical device uh you know, uh innovators in this process? Yeah, a ton. Always, I mean, I'm naturally kind of a sponge.

Um, you know, I definitely don't have I try to stay away from hubris, so I'm always asking questions, always getting feedback. And I have been really fortunate to have relationships with some medtech entrepreneurs that have done really well and you know they've given me a ton of advice and I always take it. Right. Yeah, it's like if you don't have to reinvent the wheel, then don't.

So finally, Will, as you look to the future, what is your bigger vision for smart step surgical and for improving the everyday experience of surgical teams? I'm really hoping that we can have surgy step as a new category, do a motorized step stool, become the new expectation and standard where if someone is in a healthcare setting and they see a traditional stackable step stool, that they scoff at it. When that happens, that will be a dream come true. That we've changed that expectation.

I love that. Yeah, so redefining yeah, that that niche and yeah, that that product category, really. Yeah. So, well, thank you for joining me.

How can listeners learn more about you and Smart Step Surgical? Yeah, so we have Smart Step Surgical basically on three platforms Instagram, we have a LinkedIn page, and our website. And it's all spelt out smart step surgical and surgy step, obviously, is the flagship product. Great.

And yeah, thank you again. And to our listeners, thank you for tuning in. And please subscribe and join us for the next episode of Industry Ignited. Until next time, stay bold, stay curious, and keep igniting industry.