Join us as we chat with guest Emile Maamary, co-founder and CMO of Steadiwear, Inc., a company dedicated to stabilizing hand tremors through advanced assistive technology. An IMPACT Center training program alumni, his story is one of perseverance and ingenuity as he navigated the challenges of product development, regulatory hurdles, and market introduction to bring the Steadi Three device to users Worldwide today.
Host: Dr. Mary Goldberg, Co-Director of the IMPACT Center at the University of Pittsburgh
Co-Host: Dr. Michelle Zorrilla, Senior Research Scientist and Associate Director of Technology Translation, IMPACT Center at the University of Pittsburgh
Guest: Emilie Maamary, CMO of Steadiwear
Use the code "IETF" to get an additional $50 off the pre-order of the Steadiwear Three device, which is currently available at a 40% discount through the end of the year 2024.
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Transcript | PDF
Timestamps:
1:43 Steadiwear's Origin and Personal Inspiration
3:47 Challenges and Initial Steps
4:45 User Testing and Product Development
8:40 Navigating the FDA Process
16:53 Seeking Consultants and Mentors
18:37 Collaborations and Connections
21:40 Promotions and Final Thoughts
Mary Goldberg00:00
The IMPACT Center at the University of Pittsburgh, supported by the National Institute of Disability, Independent Living and Rehabilitation Research, proudly presents ImpacTech. Welcome to season four of the ImpacTech podcast. On today's episode, Steady Advisors for Steadiwear, we have the privilege of exploring the remarkable journey of an innovator who has transformed a vision into life changing technology. Our guest, Emile Maamary, is the co-founder and CMO of Steadiwear Inc, a company dedicated to stabilizing hand tremors through advanced assistive technology. Recorded remotely from my soundproof bedroom closet in Pittsburgh, PA this is your host. Dr. Mary Goldberg and
Michelle Zorrilla 00:51
your co-host, Dr. Michelle Zorrilla. Bienvenidos y welcome to our 26th episode of the ImpacTech podcast series as we chat with Emile, who happens to be IMPACT training program alumni, about Steadiwear. His story is one of perseverance and ingenuity as he navigated the challenges of product development, regulatory hurdles and market introduction to bring the Steadi-3 device to users worldwide. Today, we delve into Emile's aspiring career path, the unique technology behind Steadiwear and the profound impact his work is making in the lives of individuals with hand tremmors. Welcome Emile, And could you tell us a little bit about your background and what inspired you to start Steadiwear?
Emile Maamary01:43
Well, steady wear was started by Mark Elias and myself in 2015 it was driven by a personal experience from both of us having tremors in our families. You know, this personal experience, it drove our passion to address hand tremors, and we realized that tremors impact a lot of people globally, daily living activities like eating, drinking and writing were impeded. And so the goal was to create something that restores the independence of people with hand tremors. And we actually commercialized our first device in 2019 in terms of backgrounds. Mark is a structural engineer, and you know, that's that's why we are focused on earthquake design and our products. And my background is more of a business development role, so mark really handles the product while I handle the business. And we balance it out that way.
Michelle Zorrilla 02:34
That's always a nice balance to have that and the team coming together.
Emile Maamary02:38
Absolutely
Michelle Zorrilla 02:39
That's interesting with the whole earthquake background. And so this is a lot of times as people start to develop their own ideas, as far as its technologies, it does come from a personal story. And so yours seems to do the same. Was there a particular family member or something that you've just seen as you've come along the way?
Emile Maamary02:59
Yeah, both of us have grandmas with tremors, and as a matter of fact, everybody on our team has tremors in their families. One member of our of our team actually has tremors themselves. So it's been, it's been very important to us that we make sure that everybody that we work with can I understand and relate to the problem. It really drives the passion on a different level, and it helps us, you know, stay focused on the goal.
Michelle Zorrilla 03:28
So you have this super cool idea. And so what were the first steps that you and your team took, and you and Mark took to actually get the ball rolling? And were there any challenges in just getting this off the ground?
Emile Maamary03:43
Wow, many challenges, as I mentioned. You know, the personal connection. It really helped us understand that this was a real issue. We then interviewed many different stakeholders, involved, neurologists, occupational therapists, patients, and really understood how bad the problem was. You know, there, we found that there was a gap in between the continuum of care, which started off with a diagnosis, went on to medication, and from medication, it jumped immediately to surgery, and that that was not okay. There, there. There was a lot of room for an assistive device. You might have seen some other ones out there, but what we wanted to do is create a battery free device that provides unlimited usage and affordable price points.
Michelle Zorrilla 04:31
That's amazing. So how did you approach the user testing? Have you had a number of individuals, both family and then tapped into local centers that you might have worked with. And how did you get that use the feedback to refine the product as you were developing it?
Emile Maamary04:50
Well, you know what developing the product it was, it was a real challenge for the first there was so many different things that we had. To account for. We wanted to make it lightweight and compact. We wanted to make a modular design. We wanted to integrate the magnet to mass damping system, and we wanted to do all three of those things in a seamless fashion to make the device look as elegant as possible. Of course, critical validation was required. We did actually run a single, blind sham control study for the study three device, we found that 80, 85% of users, they saw significant improvement across daily activities like eating, drinking and writing and partnerships. Wow, we have so many of them. We've we have distributors, we have neurology clinics, we have, you know, community partners like the International central tremor Foundation, obviously, distributors, manufacturers, you name it. We've, we've partnered with them in multiple different capacities. And those partnerships, they've really helped us, you know, reduce costs, enhance scalability, address the challenges, rate to production and adoption, and we're we're definitely on our way to scaling this product.
Michelle Zorrilla 06:11
So you're on your third iteration. Can you explain the unique technology behind that and how it differs from what's already on the market. I know you've mentioned, there's competition out there and that this is you wanted something that was battery free, right? But what really is that what makes you stand out from everybody else, and as you've gone through the iterations, how have they changed?
Emile Maamary06:36
Yeah, there's quite a few different things that make us stand out. On the first one, as you, as you mentioned, is the battery free components, which allows for unlimited usage unlike the majority of other products in the market. The other one is the fact that it's non intrusive. It's a class, one, low risk device, another. Another component is the affordability. Where we're we're much more affordable than the majority of the other products out there in this category. And last but not least, the thing we're most excited about is that we're demonstration friendly, so our devices can do not need any calibration, they do not need any any customization. So patients can really try the device with their physician, and if they like it, they could go ahead and buy it back from our website.
Michelle Zorrilla 07:23
And is that the model that you have adopted? I know you have different ways that you actually get the product out there.
Emile Maamary07:31
Yeah, that's a great question. So the Steady-one was more of like an alpha test. We tested it with a small population. We tested it through, through surveying different members of different organizations, we adopted around 500 users, garnered that feedback, and then we built the study two. The study two was launched amidst the peaks of COVID. So it wasn't exactly, you know, clinic clinically tested. It was more of a user tested approach, because most physicians weren't interested in launching a new technology or exploring something new at that time. So they were more focused on on their patients, and we decided to go with a B to C approach. So we went through the E commerce approach. We garnered around 2000 users over two years, and we took their feedback in, and then that's how we built the study three so we made a smaller, lighter, more effective device, and we launched that into the market last month for pre orders, and it will be ready for commercial, commercial adoption in April of next year.
Michelle Zorrilla 08:40
That is amazing, and it's so neat since you've participated in the training to see this. So Mary, would you like to ask a question? I know you've been quiet so far.
Mary Goldberg08:51
Sure, yeah, you so proudly mentioned that your product is a class one device, so I suppose that means and for all of our listeners that you've successfully navigated the FDA EA process in the US. Could you walk us through what that experience was like for you and your team?
Emile Maamary09:12
Nice, nice to hear your voice, Mary. We are actually a risk to orthotic device company, so it's a class one medical device. Our requirements from the FDA was to register our facility, have an agent in the US. We were exempt from the 510, K pre market approvals. You know, a class one, it doesn't undergo the same regulatory controls as a higher risk device, like a class two or class three. So I can't speak too much the regulatory hurdles or give much advice about that for the class two, class three devices, or any device you know any risk class, it's it's important to have a strong risk analysis completed. You also should be doing durability testing. And so what I would do is, I would strongly recommend to work with a regulatory consultant in the early stages, not only to get educated, but also to understand what really are the required. Requirements that should be done in order to, you know, complete this activity with the least amount of resources and time dedicated to it.
Mary Goldberg10:09
You talk about these topics with such ease, you're a real savant in terms of just pushing forward and getting to that next step and phase. So thinking about our listeners, and some of them just being budding entrepreneurs or students, for example, phrases that are common to you, like risk analysis or durability testing, may be new to them, also just the even. Where do I go to start the FDA process or learn more. So starting from the top, I guess you have a new device. Say it's an orthotic device, and in your case, you know that it's going to require some level of approval. How do you start this process?
Emile Maamary10:58
Yeah, so we started off by communicating with our advisors. At the time, we were part of an accelerator program, and, sorry, an incubator program, and we reached out to them, saying, hey, you know, we have this medical device. How do we go about classifying it as a risk class? Because we didn't even know it was a class one device, right? So we were then referred to a medical device design agency or consultant agency. They they assessed the device. They took it through a couple different risk analysis programs. They made sure that, hey, it's not intrusive. There is no battery powered component to it. They also made sure that it wasn't something that was, you know, going to cause any risk to any other potential implant or anything like that. And then they classified in that in that category. Once they classified in that category, we identified what the timeline was going to be to get approved as a device in that category, which required us to work with a consultant to submit an application to the FDA. It took a couple of months. At the time, this was around seven years ago, so at the time, it only cost us around five $6,000 US with the consultant, then another five or $6,000 to register with the FDA, and we got it right for the first time. Fortunately, a lot of a lot of other entrepreneurs I know said, Hey, I don't want to spend that kind of money. I'm going to do it myself. And even as a class one, the application is not very straightforward, so it can quickly get complicated, and I would strongly recommend having a consultant near or somebody who has done this before, near and dear to you while you're going through this process, because it will save you a lot of time and money, and backtracking with the FDA is not a fun process, so if you get it right from The first time, you'll be better off.
Mary Goldberg13:02
Can you describe the components to the risk analysis that you mentioned before?
Emile Maamary13:09
Yeah, so what they did was they basically made sure that there weren't any electric components in the device. They made sure that none of the components in the device could cause any risk to any other potential implants or any other technologies. They made sure that the the what else they do there? They made sure that it was durable and would last a period of time. They made sure that the the materials we were using were somewhat of a good quality. And I think that's about it. Yeah, they obviously they understood. They want to learn more about the mechanism, too. And once they understood the mechanism, it was a little bit more straightforward.
Mary Goldberg13:57
And then durability testing was the other one, I assume that the test needs to either adhere to a standard, or if the standard doesn't exist yet, you have to come up with something potentially your own metric. So what is that process like, and what steps did study where go through specifically,
Emile Maamary14:17
Absolutely. So the durability testing was actually required for a durable medical equipment license, so that that's that's a different, different thing than the FDA registration, but I'll walk you through that process too. What we need to do is make sure that the device is durable enough to go through multiple years of use. So in our case, they put a stabilizer on a simulator, and they ran it for something like 20 million cycles, which sounds like a very lengthy period of time it's supposed to simulate. I think it was four years of usage, and after that, they identified the device is still functional, and they deemed it. Durable, and it was qualified as a device that could be a DME. We haven't gotten the DME yet for the study three device, but we will definitely be going down that road.
Mary Goldberg15:15
And the simulator, is it used for other devices as well, or was that something that you needed to develop specific to your product?
Emile Maamary15:24
We had to work with a group of mechanical engineers that we outsourced the durability testing to, but they were, they were a licensed organization, and they gave us a report which we submit. We will be submitting to the what is called the PDAC, the product data analytics committee, and once that's submitted, you have a couple of months to hear back from them if they approve it, they might actually want to do some additional testing. Every case is different, and once we submit that, we'll hear back from them whether or not our device is deemed durable. If not, then they want to take it for more testing themselves and run their own cycles for durability testing. It also helps if you work with a facility that's been ISO certified, or your company is ISO certified to there are different types of ISOs for different types of products. They're just international standard organization. That's what stands for, and so that's something to think about, too.
Mary Goldberg16:25
Sounds like you've had lots of on the job training from different types of professionals with different backgrounds and so on. So how do you seek a consultant or a mentor? And what kinds of qualities or skills experiences? Do you seek in such a person or an advisor?
Emile Maamary16:46
Yeah, that's a great question. You know, it really depends on what type of advisor you're looking for. Are you looking for somebody who's going to engage with you once a week, once a month, once a quarter or once a year? You really want to make sure that they are fully invested. There's different types of mentors for different stages of the company. The earlier stage mentors, they tend to be more more flexible. They tend to have the experience that you're looking for to really help you with whatever it may be. In our case, let's, let's take the example of commercialization. So if we were looking for medical device commercialization advisor, so we went after, you know, the largest companies in the world, Medtronic, Boston, scientific trying to identify some regional directors or some VP of sales that used to work there or still work there, that would be open to consulting our company. And we, we were fortunate enough, through a different accelerator program to be introduced to them for free, and it didn't cost us anything. So that tape was removed, and in some other cases, we reached out to them, you know, cold messaging on LinkedIn, and said, hey, it looks like your skill set might be helpful with our commercialization process, are you open to an introductory call? And most of the time, you'd be surprised for them to say, Yeah, I am open to an introductory call. I can't say that every single introductory call led to a closed contract, you know, with them joining us as mentors. And obviously, there are different stages of mentors. There are, you know, as I mentioned the beginning, you know, weekly, monthly, quarterly, you know, is it a one off mentorship opportunities? Are you more of an advisor? Are they going to take a stake in the company? If they take a stake in the company, does that mean that they're, they're not able to do any, any clinical work for you, for example. So different advisors have different requirements, I would say, so it's important in the case, in each case, to really identify what you want to do and deem if this person is worth your equity or not, because your equity is your biggest bargaining chip, and if you hand off too much of it in the beginning, you'll be left with not too much of it in the end.
Mary Goldberg19:05
You described nicely the pros and cons to having a clinical advisor, I guess, officially be on your team, relative to the, I suppose, contractual type of work that they would be able to do for you related to the testing and so on, what path Have you taken related to clinical collaborations? And do you have any advice for how to make those connections? If someone is kind of tinkering in their garage somewhere and unclear where to start.
Emile Maamary19:38
LinkedIn has been our best friend, really, we looked for, we looked for keywords like startup innovator, or especially when you're going after physicians who are really, really busy, and then you're going after sub specialties like movement disorders, so you're, you're really limiting yourself to not a large population of people. Who would be able to help you, and then you have to factor in that a lot of them are already working on research that can either be a content of interest with what you're working on, or make their load too heavy for them to take something new on. So we would send out, you know, 50 to 100 targeted messages on LinkedIn, and hope that you know five would respond, potentially three or two would schedule a call and one would close, and that's how we identified our lead medical advisor. Currently, the clinical clinical advisor that we were introduced to was introduced through the grapevine here in Toronto. He is an assistant professor at the University of Toronto, and he also ran our our first study. And we're still working with him. We're really excited to be, continue to be working with him, too.
Mary Goldberg21:03
So when they take that kind of position, what can they do and what can't they do?
Emile Maamary21:09
Well, obviously there are, there are loopholes to every scenario, but typically, if you're running a clinical trial for an organization, it wouldn't be. It would be very frowned upon if they were also investors in the organization, right? So that's a real conflict, right? Even, even if they really believe in the product, it's hard to convince them to throw out their credibility and invest in the company. There are other ways around it. I don't I we haven't yet navigated that space. We've been very transparent about people running our trials, not being investors in the company. It's safer that way, and we'll be focused on that moving forward.
Mary Goldberg21:59
Thank you so much.
Emile Maamary22:01
Of course, I'm happy to speak with anyone who is listening to this podcast. They can find me on LinkedIn as Emile Maamary, or type in Steadiwear with an I to find the company and connect with me. And I'm happy to chat.
Michelle Zorrilla 22:17
Thank you so much, Emile and we'll make sure to have all those details in the Episode Notes as well for both of them, and it's been a pleasure. It's great to see you growing and and I really wish study where all the best.
Emile Maamary22:31
Thank you so much. You know, if anybody listening to this podcast is interested in trying out our technology, or know somebody who's interested in trying out their technology, as I mentioned, you know, we offer a 30 day money back guarantee. Right now we're running a pre order campaign so the device is purchased, purchasable for 40% less than the MSRP, and if you use the code IETF, you'll get an additional $50 off. IETF stands for International central tremor foundation.
Mary Goldberg22:59
Is this a Black Friday or Cyber Monday special, or giving Tuesday. Maybe it falls into all of the above. How long is the promotion going?
Emile Maamary23:09
Yes, this specific promo will last until the beginning of January. As we get closer to the delivery date, the price will increase the earlier you commit to the product or commit to the to the company, the bigger the discount you'll get.
Michelle Zorrilla 23:27
Sounds like a plan. Hop on that if you're listening. If you need one. Know anybody who needs one, it's always worth a shot, because living with tremors can can make things difficult, and being able to do that self care, and can really give you a sense of self so thank you so much, Emile.
Emile Maamary23:46
It's my pleasure. Thank you.
Mary Goldberg23:47
Thanks so much, Emile, and to all of you for joining us for this first part of our conversation with Emile Maamary, co founder and CMO of Steadiwear, it's been incredible to hear about the early stages of study, where and the challenges of navigating product development and the FDA process.
Michelle Zorrilla 24:07
Be sure to tune in to part two, where we dive into the real world impact of the Steadi-3, the lessons Emile learned along the way and his advice for other innovators in the assistive technology space. Thanks for listening, and we'll see you next time on ImpacTech.
Mary Goldberg24:25
If you like ImpacTech, please review us on Apple podcasts or wherever you listen to podcasts. Thank you again for tuning in and continue to make an impact in whatever you do. A quick note from our sponsors, IMPACT initiatives are being developed under a grant from the National Institute on Disability, Independent Living and Rehabilitation Research. NIDILRR is a center within the administration of Community Living, Department of Health and Human Services. IMPACT initiatives do not necessarily represent the policy of NIDILRR, ACL, or HHS, and you should not assume endorsement by the federal government. And the same goes for the University of Pittsburgh. We would like to thank our ImpacTechguests and our production team led by Dr Michelle Zorrilla at the University of Pittsburgh Department of Rehabilitation Science and Technology.