ActivArmor™ With Diana Hall, Dr. Kevin Kaplan And Eric Miller
27th August 2020 • Business Leaders Podcast • Bob Roark
00:00:00
00:49:37
Shownotes
The industry leader for custom-made 3D-printed casts and splints in the United States, ActivArmor™ empowers patients with the freedom to be able to maintain their active lifestyles. Now, they begin producing custom-fit, low-cost reusable face masks that achieve a 98.9% to 99.9% bacterial filtration efficiency (BFE) test score. On today’s show, Bob Roark chats with Diana Hall, the President and Founder of ActivArmor™, orthopedic surgeon Dr. Kevin Kaplan, and critical care flight nurse and paramedic Eric Miller about the face masks. Dr. Kaplan and Eric share their experiences wearing the face mask, while Diana explains how they’ve added the product line using their existing technology. They also dive into the company’s cast and its benefits for athletes and regular patients.
You were talking about an interest in the hearing-impaired school and potential uses of those masks for the instructors at the school. Could you talk a little bit about your thoughts there?
I was approached by somebody when I was wearing the mask and he says, “I am a teacher for the hearing impaired. Where did you get that mask?” I told them about ActivArmor and he said, “Do you think we can get some of those masks?” I said, “The custom ones, you want to be using them all the time. There's a price point on those, but they also make some other ones that are probably more affordable for what you're looking for staff.” As soon as there are materials ready again, I'm going to buy some and have them try it out and see if that works. Being able to see and read the lips is an important aspect of the hearing-impaired community, not just the sign language.
This is a little bit backward, but we got everybody together, which you guys can imagine might be a tad challenging with everybody's efforts in the community. Diana, if you would, going backward, the mask came along later in the product cycle for you guys. Can you tell me a little bit about how the demand for the product was either requested or developed?
Our regulatory expert at the Robert Fischell Medical Device Institute called knowing that we are the experts in 3D body imaging and custom-fitted exoskeletons, meaning that we do 3D body imaging and we do custom designs for medical devices that fit your body map perfectly. The real issue that they were having with the FDA face mask was fitting because the filtration is only as good as the seal. Air is going to take the path of least resistance and try to go around the mask and avoid the filters if it can. In a traditional face mask, whether they're N95 or any that has filtration rate, the air that circumvents the filters is going to have potentially those viral particulates in it and then get in.
The point of it was the fitting. They called me saying, “We know that you guys do exoskeletons and that fitting is your thing. We wanted to see if you could figure out a way that we could make custom-fitted masks that would fit perfectly,” because everybody's face is shaped differently. We have different sizes and different cheeks. When I started doing an analysis of the facial features, there are many different dimensions as far as how far out your chin, nose and cheeks stick, how far out they come vertically and horizontally in all three dimensions. It takes a 3D body image scan to get that perfect fit. That's what Eric was talking about with his mask. Dr. Kaplan also wears one. Everybody's features are different. When you do start doing that facial analysis, you see how important the custom fit is to your face. You can't get something off the shelf and expect it to fit perfectly to your face. That's why they called us and asked me to design something that would be able to seal perfectly those particulates out.
Shifting gears a little bit, Dr. Kaplan, you're a user of the mask as well in your practice. What's been your experience as far as ease of use, changing filters and how your patients react to seeing you in the mask?
The number one thing is protection, protecting ourselves and our patients. In using or seeing other types of masks and people wear other types of masks, a lot of times you'll see people do the exact thing that you shouldn't be doing when you're wearing a mask and trying to prevent yourself from touching your face. People will adjust their masks or pull the mask down. Their hands are all over their face. The one thing that's appealed to me from the ActivArmor mask is the custom fit and the customer feel. It's designed specifically to my face. Even the ones that are moldable, it fits your face well. There are a few times that I’ll have to adjust the mask on my face. Patients enjoy being able to see my mouth and my lips when I'm talking. I had a number of patients that are hard of hearing compliment me on being able to look at my face and be able to still read my lips.
From that standpoint, it's been a tremendous benefit. I see a large volume of patients during the day and being able to wear something that's comfortable that allows me to see patients throughout the day without having to adjust my mask has been certainly helpful. A lot of the physicians in my practice are using this mask. Even the athletic trainers at our stadium for the Jaguars have been using this mask. The ease of changing the filters makes this also helpful. I can wash my mask down. I can wipe it down. I can take the filters out. They easily pop in and pop out. That's also helpful. A lot of the cloth masks, if you use them over and over again, you start to get a little bit of fraying of the cloth material. In the throwaway cloth masks, those aren't protecting you like this type of mask is. From a comfort, protection and patient communication, this mask has checked those boxes for me on a daily basis.
For you on the protocol with the filters, what do you typically observe on filter rotation?
Diana can probably speak to this better than I can, but if you look at how long a virus lasts on a surface, roughly around five days is to my knowledge, where if you're exposed to a virus, technically if you take those filters out, put them in a bag and you can leave them there and not use them for that period of time, then you can go ahead and switch those out. I’ve bought several filter replacements and swapped those out over a period of a week.
Diana, do you have anything to add?
That's the FDA guidance. He's exactly right. The thing is that you don't get a lot of wear and tear on that.
For you, Diana, you guys were able to take in and use your existing technology from the casts to go to the masks. What allowed you to be able to add this product line so quickly?
Our expertise was the 3D body imaging, so we can create a 3D body map of any body part and then use our CAD design and our 3D printing to manufacture custom products that are fitted to your exact body map. That can propagate from casts and splints to face masks or any other exoskeleton that you want to use for medical protective products that you might need that's custom-fitted.
What's the typical turnaround if you order either the custom scan mask or the one that you're working on now?
It's based on demand and the custom fit mask are hand designed, hand manufactured. We 3D print the molds and then we form to them. If we don't have a huge backlog, it can be anywhere from 1 to 3 weeks. We started out at four weeks because we had thousands of orders coming in, but now it's reduced down. We're down to a week. As far as the standard sized ones, those ones we have on inventory. Those ones ship quickly. They're about a week.
[bctt tweet="An improperly worn mask is going to allow the air to go in the path of least resistance." via="no"]
Diana, when it comes into that, where are you seeing the predominant type of industries that are using your masks?
We have a lot of service industry people and healthcare. We have a lot of nurses and doctors that are using them, as well as people who are in hotels and customer service and food handling and those kinds of industries because they need that communication. We also have a lot of teachers. We have a lot of first responders, so people like Eric, fire, police, sheriffs’ departments, EMTs, those kinds where they need good communication and they need that custom fit for safety.
Eric, in your experience in working with the Guard, do you think that there's a demand or that the Guard is going to start looking at these masks across their platform?
I would encourage Diana to look at some grants and some other federal funding because there are some interesting possibilities, especially pilots. I'm on an aircrew in the back of an aircraft where we've got microphones that can be custom fit to people's faces. It's military. FEMA would be another great market as well. Anybody that's in the DOD, this is a hot issue.
Circling back to the face fit, Dr. Kaplan, I can remember in the military, we used to put on the chemical gear and the first thing you do is stick it on your face. You'd have to put your hands over the filter ends and suck it in to take and get the seal. Do you think that there's a recognition of that issue with the standard N95 masks that they don't have a good seal?
I do. An improperly worn mask is going to allow the air to go in the path of least resistance. In seeing patients, I have to wear goggles in addition to a mask. If I were to put on a regular mask, I don't wear reading glasses, but the goggles, they fog up. You know the air is getting in and out. Hot air is going up. With the ActivArmor mask, I haven't had that problem at all. Face protection in general is important, but the properly fitted face mask is much safer and can protect you and protect other people from getting this virus that we're all worried about. It’s much more effective, the better the seal.
For anybody that served in the military that went through a tear gas tent wearing a gas mask, you absolutely know upfront whether you have it sealed properly or not. If you don't, you get to enjoy the tear gas. You have tangible notice that it's not working well. The problem that you guys face, if it's not fitting well, you don't know. What are you seeing from the professional coaches at the Jaguars? When they're using the mask, what's their experience and commentary?
Our head athletic trainer piloted it with the other athletic trainers at the stadium right now. They've enjoyed the same type of custom fit. The reason why it's important for them as well, some of the players that are able to be at the facility are the ones that are rehabilitating from either surgeries that have performance injuries. They're working close quarters with these players. Protection is a must, and being able to communicate is a must as well. They've used this. We were discussing it in terms of our players. Several of our players have trialed this as well, in addition to a lot of the front office. Our coaches are older than our players. They're concerned about this virus. We're going to be getting them masks as well. For the coaches trying to communicate to their players, whether it's in meetings or on the sideline or in practices, communication is paramount. This is going to be a helpful part to our organization as we try to get back on the field.
Do you think you'll see the linemen and everybody else wearing these masks during practice with the airflow restriction a little challenging?
That could be a challenge. The NFL is trying to work through what they're going to be doing when we practice. We have a long way to go and the NFL is working through that process now. How often are we going to be tested? How are we going to keep our social distance? How are we going to travel? There are many things at play that I don't think they have that set in stone in terms of what guys are going to be wearing. Football is a contact sport. They're very close to each other, especially if you think about getting tackled and having a pile of guys. If one person has it, how close are you going to be? There's a lot that's going to go into that decision. I don't know where we are with what they're going to wear or if they're going to wear anything while playing.
I can imagine trying to call an audible with crowd noise and who knows how well that would transmit, but I can remember trying to run with a gas mask on. That wasn't much fun just from the airflow restriction. Shifting gears a little bit, Diana, is there anything about the masks that we missed? Maybe talk about on the custom masks versus the non-custom masks or the different price point masks. Talk about the procedure to either get scanned or get their face fitted for one of their sites. What does that process look like?
If you want a custom mask, there are two options. One, if you look at our website, we have some clinics that are scanning clinics like at Jacksonville Orthopedic Institute, and they are providing facial scans to people who want to get custom-fitted facial masks as well and at our providing clinics that also provide ActivArmor. In addition, anyone anywhere can get one of those iPad snap on, which is a structure sensor. It costs around $500 for the whole packet. You snap it onto your iPad or your iPhone and then you do a scan and send it to us and we will make you a custom-fitted mask. As far as the standard sizes, you saw the mask that Eric had. His is a custom one. We have the small narrow, and it fits me. The seal, I had these tested and 5 out of 7 have the fit passed, the standard ones, on 98% of adults. There are templates on our website. If you pick the standard mask, you go there, print out the templates, then try one on. You see which one fits you the best. You can order a standard size mask if you like. Those are much less expensive.
Is there anything that's been missing from what we've talked about? They're badass looking. When I'm walking through the hospital, people are always staring at me. I wear them in the store or wherever I go. I'm always wearing this thing and I’ve got several of them. I’ve got one in the ICU. One I keep for my flight and I’ve got one in my car. I’ve got a spare. Everywhere you go, everybody stares at you. You hear people as they walk by, “Cool mask,” or “Did you see that mask? Where'd you get that mask?” All the time, you get comments. They're badass all the way around.
There is that factor. Diana, do you have the one from your daughter at hand?
She painted hers like a stormtrooper. It’s a custom one. It doesn't fit me because her face is a different shape than mine. You can see how the custom ones are perfectly fitted, whereas the standard ones stick out more on the front. It's a little bit different. These ones are lower profile and they fit specifically to your face and then standard ones are a little bit different. These ones, I know people like the feel of them around the perimeter and their lower profile. It depends on which one you think you need.
Eric, Dr. Kaplan, there are things that I noticed in the pictures that you see of the healthcare workers that have had their mask on for hours and they look like they've been beaten. There are marks on their faces and bruises and stuff. For you guys, when you have an extended period of time where you're wearing the masks, do you have much in the way of that going on?
I don't have any of that going on. I take the mask off and my face looks like it did before I put the mask on. It's not these big marks around the face. They're adjustable. Being that it's so custom, you need a little bit of a pull, but it's not like you're trying to hogtie it when you put it on. My strap below isn't that tight. The one behind keeps it on and it seals so perfectly. The thing that's nice about it too is that it's smooth. It's plastic. It doesn't leave marks and doesn't have an edge to it. It seals across the bridge of your nose and then around your chin. There isn't a pressure point. There...
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Watch the episode here:
[embed]https://youtu.be/D1uoZyaf3ls[/embed]ActivArmor™ With Diana Hall, Dr. Kevin Kaplan And Eric Miller
We have three guests on the show. We have Diana Hall. She's the President and COO of ActivArmor. We have Dr. Kevin Kaplan. He is an orthopedic surgeon with the Jacksonville Orthopedic Institute and Head Team Physician for the Jacksonville Jaguars. We have Eric Miller. He's a critical care flight nurse and paramedic and a Major in the Wyoming Air National Guard. We're going to be talking about ActivArmor, both their casts and their face masks. Eric, tell me a little bit about the face masks and why they're useful and attractive for you to use in your business. I work on the helicopter, and also work in an ICU. One of the big complaints, if you talk to any healthcare worker about masks, and if you have to wear these things, every time you breathe or exhale, your glasses are fogging up. The ActivArmor mask, I got a 3D scan of my face. This thing fits directly on my face and I don't get that fog in my glasses. I can tell you, if you're in a helicopter, you can't have that happening. It's a safety issue. Being in an ICU, after twelve-hour shifts, it's irritating. The other great thing is the ability to be able to see facial expressions and stuff, especially with patients. It's already scary enough. In this, you can see if you're smiling. If they have trouble hearing, they can see your lips. They're a fantastic tool and the fact that they're N95s, which is great for the situation with the COVID. I use mine all the time. Eric, you said that you were out flying and that you got your sound boom to work with the mask on. That's another big issue for me. I can put my visor down. It works like it goes over my nose and then putting the microphone to the side, I was able to still communicate within the cabin with the other crew members and discuss the patient. It was fantastic.You were talking about an interest in the hearing-impaired school and potential uses of those masks for the instructors at the school. Could you talk a little bit about your thoughts there?
I was approached by somebody when I was wearing the mask and he says, “I am a teacher for the hearing impaired. Where did you get that mask?” I told them about ActivArmor and he said, “Do you think we can get some of those masks?” I said, “The custom ones, you want to be using them all the time. There's a price point on those, but they also make some other ones that are probably more affordable for what you're looking for staff.” As soon as there are materials ready again, I'm going to buy some and have them try it out and see if that works. Being able to see and read the lips is an important aspect of the hearing-impaired community, not just the sign language.
This is a little bit backward, but we got everybody together, which you guys can imagine might be a tad challenging with everybody's efforts in the community. Diana, if you would, going backward, the mask came along later in the product cycle for you guys. Can you tell me a little bit about how the demand for the product was either requested or developed?
Our regulatory expert at the Robert Fischell Medical Device Institute called knowing that we are the experts in 3D body imaging and custom-fitted exoskeletons, meaning that we do 3D body imaging and we do custom designs for medical devices that fit your body map perfectly. The real issue that they were having with the FDA face mask was fitting because the filtration is only as good as the seal. Air is going to take the path of least resistance and try to go around the mask and avoid the filters if it can. In a traditional face mask, whether they're N95 or any that has filtration rate, the air that circumvents the filters is going to have potentially those viral particulates in it and then get in.
The point of it was the fitting. They called me saying, “We know that you guys do exoskeletons and that fitting is your thing. We wanted to see if you could figure out a way that we could make custom-fitted masks that would fit perfectly,” because everybody's face is shaped differently. We have different sizes and different cheeks. When I started doing an analysis of the facial features, there are many different dimensions as far as how far out your chin, nose and cheeks stick, how far out they come vertically and horizontally in all three dimensions. It takes a 3D body image scan to get that perfect fit. That's what Eric was talking about with his mask. Dr. Kaplan also wears one. Everybody's features are different. When you do start doing that facial analysis, you see how important the custom fit is to your face. You can't get something off the shelf and expect it to fit perfectly to your face. That's why they called us and asked me to design something that would be able to seal perfectly those particulates out.
Shifting gears a little bit, Dr. Kaplan, you're a user of the mask as well in your practice. What's been your experience as far as ease of use, changing filters and how your patients react to seeing you in the mask?
The number one thing is protection, protecting ourselves and our patients. In using or seeing other types of masks and people wear other types of masks, a lot of times you'll see people do the exact thing that you shouldn't be doing when you're wearing a mask and trying to prevent yourself from touching your face. People will adjust their masks or pull the mask down. Their hands are all over their face. The one thing that's appealed to me from the ActivArmor mask is the custom fit and the customer feel. It's designed specifically to my face. Even the ones that are moldable, it fits your face well. There are a few times that I’ll have to adjust the mask on my face. Patients enjoy being able to see my mouth and my lips when I'm talking. I had a number of patients that are hard of hearing compliment me on being able to look at my face and be able to still read my lips.
From that standpoint, it's been a tremendous benefit. I see a large volume of patients during the day and being able to wear something that's comfortable that allows me to see patients throughout the day without having to adjust my mask has been certainly helpful. A lot of the physicians in my practice are using this mask. Even the athletic trainers at our stadium for the Jaguars have been using this mask. The ease of changing the filters makes this also helpful. I can wash my mask down. I can wipe it down. I can take the filters out. They easily pop in and pop out. That's also helpful. A lot of the cloth masks, if you use them over and over again, you start to get a little bit of fraying of the cloth material. In the throwaway cloth masks, those aren't protecting you like this type of mask is. From a comfort, protection and patient communication, this mask has checked those boxes for me on a daily basis.
For you on the protocol with the filters, what do you typically observe on filter rotation?
Diana can probably speak to this better than I can, but if you look at how long a virus lasts on a surface, roughly around five days is to my knowledge, where if you're exposed to a virus, technically if you take those filters out, put them in a bag and you can leave them there and not use them for that period of time, then you can go ahead and switch those out. I’ve bought several filter replacements and swapped those out over a period of a week.
Diana, do you have anything to add?
That's the FDA guidance. He's exactly right. The thing is that you don't get a lot of wear and tear on that.
For you, Diana, you guys were able to take in and use your existing technology from the casts to go to the masks. What allowed you to be able to add this product line so quickly?
Our expertise was the 3D body imaging, so we can create a 3D body map of any body part and then use our CAD design and our 3D printing to manufacture custom products that are fitted to your exact body map. That can propagate from casts and splints to face masks or any other exoskeleton that you want to use for medical protective products that you might need that's custom-fitted.
What's the typical turnaround if you order either the custom scan mask or the one that you're working on now?
It's based on demand and the custom fit mask are hand designed, hand manufactured. We 3D print the molds and then we form to them. If we don't have a huge backlog, it can be anywhere from 1 to 3 weeks. We started out at four weeks because we had thousands of orders coming in, but now it's reduced down. We're down to a week. As far as the standard sized ones, those ones we have on inventory. Those ones ship quickly. They're about a week.
[bctt tweet="An improperly worn mask is going to allow the air to go in the path of least resistance." via="no"]
Diana, when it comes into that, where are you seeing the predominant type of industries that are using your masks?
We have a lot of service industry people and healthcare. We have a lot of nurses and doctors that are using them, as well as people who are in hotels and customer service and food handling and those kinds of industries because they need that communication. We also have a lot of teachers. We have a lot of first responders, so people like Eric, fire, police, sheriffs’ departments, EMTs, those kinds where they need good communication and they need that custom fit for safety.
Eric, in your experience in working with the Guard, do you think that there's a demand or that the Guard is going to start looking at these masks across their platform?
I would encourage Diana to look at some grants and some other federal funding because there are some interesting possibilities, especially pilots. I'm on an aircrew in the back of an aircraft where we've got microphones that can be custom fit to people's faces. It's military. FEMA would be another great market as well. Anybody that's in the DOD, this is a hot issue.
Circling back to the face fit, Dr. Kaplan, I can remember in the military, we used to put on the chemical gear and the first thing you do is stick it on your face. You'd have to put your hands over the filter ends and suck it in to take and get the seal. Do you think that there's a recognition of that issue with the standard N95 masks that they don't have a good seal?
I do. An improperly worn mask is going to allow the air to go in the path of least resistance. In seeing patients, I have to wear goggles in addition to a mask. If I were to put on a regular mask, I don't wear reading glasses, but the goggles, they fog up. You know the air is getting in and out. Hot air is going up. With the ActivArmor mask, I haven't had that problem at all. Face protection in general is important, but the properly fitted face mask is much safer and can protect you and protect other people from getting this virus that we're all worried about. It’s much more effective, the better the seal.
For anybody that served in the military that went through a tear gas tent wearing a gas mask, you absolutely know upfront whether you have it sealed properly or not. If you don't, you get to enjoy the tear gas. You have tangible notice that it's not working well. The problem that you guys face, if it's not fitting well, you don't know. What are you seeing from the professional coaches at the Jaguars? When they're using the mask, what's their experience and commentary?
Our head athletic trainer piloted it with the other athletic trainers at the stadium right now. They've enjoyed the same type of custom fit. The reason why it's important for them as well, some of the players that are able to be at the facility are the ones that are rehabilitating from either surgeries that have performance injuries. They're working close quarters with these players. Protection is a must, and being able to communicate is a must as well. They've used this. We were discussing it in terms of our players. Several of our players have trialed this as well, in addition to a lot of the front office. Our coaches are older than our players. They're concerned about this virus. We're going to be getting them masks as well. For the coaches trying to communicate to their players, whether it's in meetings or on the sideline or in practices, communication is paramount. This is going to be a helpful part to our organization as we try to get back on the field.
Do you think you'll see the linemen and everybody else wearing these masks during practice with the airflow restriction a little challenging?
That could be a challenge. The NFL is trying to work through what they're going to be doing when we practice. We have a long way to go and the NFL is working through that process now. How often are we going to be tested? How are we going to keep our social distance? How are we going to travel? There are many things at play that I don't think they have that set in stone in terms of what guys are going to be wearing. Football is a contact sport. They're very close to each other, especially if you think about getting tackled and having a pile of guys. If one person has it, how close are you going to be? There's a lot that's going to go into that decision. I don't know where we are with what they're going to wear or if they're going to wear anything while playing.
I can imagine trying to call an audible with crowd noise and who knows how well that would transmit, but I can remember trying to run with a gas mask on. That wasn't much fun just from the airflow restriction. Shifting gears a little bit, Diana, is there anything about the masks that we missed? Maybe talk about on the custom masks versus the non-custom masks or the different price point masks. Talk about the procedure to either get scanned or get their face fitted for one of their sites. What does that process look like?
If you want a custom mask, there are two options. One, if you look at our website, we have some clinics that are scanning clinics like at Jacksonville Orthopedic Institute, and they are providing facial scans to people who want to get custom-fitted facial masks as well and at our providing clinics that also provide ActivArmor. In addition, anyone anywhere can get one of those iPad snap on, which is a structure sensor. It costs around $500 for the whole packet. You snap it onto your iPad or your iPhone and then you do a scan and send it to us and we will make you a custom-fitted mask. As far as the standard sizes, you saw the mask that Eric had. His is a custom one. We have the small narrow, and it fits me. The seal, I had these tested and 5 out of 7 have the fit passed, the standard ones, on 98% of adults. There are templates on our website. If you pick the standard mask, you go there, print out the templates, then try one on. You see which one fits you the best. You can order a standard size mask if you like. Those are much less expensive.
Is there anything that's been missing from what we've talked about? They're badass looking. When I'm walking through the hospital, people are always staring at me. I wear them in the store or wherever I go. I'm always wearing this thing and I’ve got several of them. I’ve got one in the ICU. One I keep for my flight and I’ve got one in my car. I’ve got a spare. Everywhere you go, everybody stares at you. You hear people as they walk by, “Cool mask,” or “Did you see that mask? Where'd you get that mask?” All the time, you get comments. They're badass all the way around.
There is that factor. Diana, do you have the one from your daughter at hand?
She painted hers like a stormtrooper. It’s a custom one. It doesn't fit me because her face is a different shape than mine. You can see how the custom ones are perfectly fitted, whereas the standard ones stick out more on the front. It's a little bit different. These ones are lower profile and they fit specifically to your face and then standard ones are a little bit different. These ones, I know people like the feel of them around the perimeter and their lower profile. It depends on which one you think you need.
Eric, Dr. Kaplan, there are things that I noticed in the pictures that you see of the healthcare workers that have had their mask on for hours and they look like they've been beaten. There are marks on their faces and bruises and stuff. For you guys, when you have an extended period of time where you're wearing the masks, do you have much in the way of that going on?
I don't have any of that going on. I take the mask off and my face looks like it did before I put the mask on. It's not these big marks around the face. They're adjustable. Being that it's so custom, you need a little bit of a pull, but it's not like you're trying to hogtie it when you put it on. My strap below isn't that tight. The one behind keeps it on and it seals so perfectly. The thing that's nice about it too is that it's smooth. It's plastic. It doesn't leave marks and doesn't have an edge to it. It seals across the bridge of your nose and then around your chin. There isn't a pressure point. There...