255-A New Product from an Old Technology for Laryngectomy Patients with Meryl Kaufman

Episode

255

A New Product from an Old Technology for Laryngectomy Patients with Meryl Kaufman

“We looked back instead of looking forward to solve a simple problem.”

Can an abandoned technology from the 1970s become a meaningful new product for today’s laryngectomy patients? In this episode, Steven and Noah speak with Meryl Kaufman, a speech-language pathologist and founder of Georgia Speech and Swallowing, about her long journey to modernize a pneumatic voice device for people who have undergone removal of the larynx. Meryl explains common approaches to post-laryngectomy speech, including the electrolarynx and tracheoesophageal puncture voice prosthesis, and why cost, anatomy, access to specialists, maintenance, or surgery can limit available options for some people. Drawing on more than 30 years of clinical experience, she revisited an older breath-powered concept that uses a reed and oral tube to create a sound source without batteries or implantation. The interview follows the invention from clinical need and an obsolete reference device through reverse engineering, proof-of-concept testing, patent prosecution, licensing, and partnership with CranioRehab. Noah describes the “product archaeology” involved in studying reeds, wind instruments, airflow, materials, and geometry. The broader product-development lesson is powerful: innovation does not always require the newest technology. Sometimes the best path begins with a proven idea, deep user expertise, a clearly defined access problem, and the patience to update an old solution for modern users and manufacturing.

Core Topics for this episode:

(possibly) Obscure pop culture references you might hear during this episode of Product Genius include Pete Holmes; Pet Rock; TOMS; Stretch Armstrong; Evel Knievel; James Bond; Ice Pirates; Darth Vader; Spaceballs; Rick Moranis

Key Takeaways Include:

Start With Deep User Expertise

Revisit Proven Old Technology

Choose a Mission-Aligned Partner

Listen here:

Episode Blog

Product Archaeology: Turning Old Technology Into a New Voice Option

Innovation is often described as a race toward more electronics, software, connectivity, and artificial intelligence. But a better product does not always require newer technology. Sometimes an older solution disappeared because manufacturing knowledge was lost, the market changed, or the product no longer fit modern clinical practice—not because the underlying principle stopped working.

Meryl Kaufman’s journey offers a compelling example. A speech-language pathologist specializing in head and neck cancer rehabilitation, she identified a persistent access problem for people who had undergone laryngectomy surgery. Her response was to revisit a pneumatic voice technology from the 1970s and redesign the concept for present-day users.

Begin With the Clinical Need

A total laryngectomy removes the larynx and changes the way a person breathes and produces speech. Rehabilitation options vary based on individual anatomy, treatment history, access to trained clinicians, personal preference, resources, and medical suitability.

An electrolarynx can provide an accessible electronic sound source, but some users may dislike its robotic quality or the need to hold and power a device. A tracheoesophageal puncture and voice prosthesis can support more natural-sounding speech for suitable patients, but it involves a clinical procedure, maintenance, follow-up care, and ongoing access to specialized services.

Meryl was not attempting to declare one method universally superior. She wanted another option—one designed around low cost, simple operation, broad access, and independence from batteries or implanted components.

This is an important product-development discipline: define the unmet need without pretending that every user has the same needs.

Look Back Before Inventing From Scratch

Through decades of clinical work, Meryl remembered an older pneumatic speech device. Exhaled air powered a reed, which generated vibration and sound. An oral adapter carried that sound into the mouth, where the tongue, lips, and palate shaped it into speech.

The concept had precedent, but the old product was no longer readily available in the United States and did not integrate well with contemporary anatomy, surgical practices, accessories, materials, or manufacturing expectations.

That created an unusual opportunity. The team did not need to invent the physical principle from nothing. It needed to understand why the earlier device worked, identify what no longer fit, and translate the useful principle into a modern product architecture.

Reverse Engineering Can Become Archaeology

Noah describes the work as a form of product archaeology. The reference device existed, but the people and manufacturing knowledge behind it were no longer accessible. The team explored related mechanisms—from wind instruments to duck calls—to understand how airflow could drive a reed at the rates and pressures available through breathing.

The development questions were deceptively small:

What reed geometry responds reliably to the available airflow?
How should the vibration and sound travel through the oral tube?
Which materials balance sound, comfort, hygiene, cost, and manufacturability?
How should the product connect with modern stoma accessories?
Can the design remain simple enough to support broad access?

Each question required focused prototypes and tests. This is where deep domain expertise and engineering complement one another: the clinician understands the user and care environment; the engineer turns those requirements into physical experiments and manufacturable geometry.

Solve the Whole Access Problem

A medical or medical-adjacent product does not succeed merely because the mechanism functions. Reimbursement, coding, regulatory classification, training, distribution, cleaning, support, and clinical adoption can determine whether users ever receive it.

Meryl recognized those layers early. The product had to work, remain affordable, fit current patient needs, and find a realistic path through the healthcare system. That broader definition of the problem shaped the choice to favor a simple pneumatic approach over rapidly changing, more expensive electronic concepts.

Inventors in healthcare should map every stakeholder: patient, caregiver, clinician, facility, payer, distributor, regulator, and manufacturer. A design that ignores any critical stakeholder may never reach the person it was intended to help.

Patents Are Milestones, Not the Finish Line

The project moved through provisional and nonprovisional patent filings, an initial rejection, further examination, and ultimately an issued U.S. patent. That achievement protected the work, but it did not manufacture, distribute, support, or reimburse the device.

Meryl then sought a licensing partner with relevant speech-pathology experience and a mission aligned with access. The relationship with CranioRehab allowed a clinician-inventor to remain engaged while a commercialization partner addressed development, production, marketing, distribution, and reimbursement strategy.

The lesson is broader than licensing: inventors should know which role they are best equipped to play and find partners for the rest.

Patient Expertise Can Matter More Than Speed

The project took years, including delays during 2020. That timeline was frustrating, but it also protected the original goal. Meryl did not simply accept the first available partner. She watched how a potential licensee developed, reconnected at professional conferences, and looked for evidence of mission and capability alignment.

Moving slowly is not automatically virtuous, but healthcare products often require patience. The objective is not delay; it is steady risk reduction while preserving safety, clinical relevance, affordability, and trust.

When Old Technology Is the Better Technology

An older technology may deserve reconsideration when it offers:

A proven physical principle
Lower component and tooling complexity
Independence from batteries, networks, or software
Easier use in low-resource settings
A clearer route to affordability
Durability and serviceability
Compatibility with modern materials and manufacturing

Not every obsolete product should return. The key is to separate a discarded implementation from a still-useful principle.

Product Genius Take

Innovation is not synonymous with adding technology. Start with the user’s unmet need, study every existing and historical approach, and choose the simplest principle capable of delivering meaningful value. Meryl Kaufman’s story shows how clinical expertise, product archaeology, careful prototyping, intellectual property, and the right commercialization partner can give an old idea a new purpose. Decisions about post-laryngectomy communication remain individual clinical matters and should be made with qualified care professionals.

Or, read the full transcript here:

Steven Julian

So picture this. You've got 30 years of clinical work behind you. You are trying to solve a medical problem in your community. You found what you think is a great solution from an old technology. So what do you do? You get your team together. You introduce yourself to Noah McNeely, and he does a little archaeological engineering and helps you come up with a great new product from an old technology. Next on Product Genius.

Meryl Kaufman

Do you want to be a successful inventor entrepreneur? Struggling to get your product from idea to market? Well, you've come to the right place. Welcome to Product Genius, the down-to-earth podcast that explores important topics about inventing and launching new products. Noah McNeely is your trusted guide. With more than 20 years of product launch experience, he's here to help you on your journey to become a product genius. Let's get started. Here's your slightly annoying co-host, Steven Julian.

Steven Julian

Hey, that's my line. Yes, it is your slightly annoying co-host, just like she said. See, that's why I'm slightly annoying. It's me, Steven Julian. Welcome back, I have to say, to the greatest podcast about product development and getting your products to. market and having a little bit of fun and not taking yourself too seriously. All that known as Product Genius. I am seated next to... Jody Smith, the intrepid producer, I am seated across from the genius that brings all the other geniuses to the table, Noah McNeely. Noah!

Noah McNeely

Happy New Year.

Steven Julian

Happy New Year. You know, Pete Holmes says, I say that as long as I can throughout the year, because no matter what point it is in the year, it's a new year based on this date.

Noah McNeely

Why don't we say it every episode?

Steven Julian

We should. Well, I have my little schticks that I do. You know, that's my line. That's a shout out to my son, the massive wrestling fan. And so, you know, that can be your schtick. You can say Happy New Year.

Noah McNeely

I have this doctor specialist I see once a year. And every time I see him, he goes through the whole list of holidays. And it's just amusing.

Steven Julian

Of the entire year?

Noah McNeely

Of the entire year. Holy cow. Happy New Year, Happy Valentine's Day, yada, yada, yada, all the way up through.

Steven Julian

There's a show somewhere where we're not going to get. anything accomplished, but we're going to talk about the creation of days. Hey, it's National Donut Day. Hey, it's Sibling Day. You know, who is behind this cabal of wasting our time?

Noah McNeely

National Useless Day.

Steven Julian

Exactly. Exactly. I think there's maybe one, there should be one day on the calendar. It's nothing today. So that would be what, agnostic day? I don't know. So, hey, we've got a guest. We do. Someone you've worked with in the past that is just about ready to launch a product.

Noah McNeely

Yeah, one of my favorite clients. And I've actually, she'll have to help me remember, but I feel like I've known her for eight, nine years, something like that. I almost said six, seven.

Steven Julian

I can't wait to ask her.

Noah McNeely

But I didn't want to say six, seven, because I think it is eight or nine years.

Steven Julian

That's another show.

Noah McNeely

My 12-year-old would go nuts with the 60s.

Steven Julian

You know what cracks me up? Nobody knows where it came from or what it means, which I'm like, so why are we talking about it? And we're talking about it on this show. Exactly. So there's agnostic as well. Anyway, we have Meryl Kaufman. here. She is the founder of Georgia Speech and Swallowing. Meryl, welcome to Product Genius.

Meryl Kaufman

Thank you. I'm excited to be here. Thanks for inviting me.

Steven Julian

Absolutely. So Georgia Speech and Swallowing. Your company is focused on advocacy, outreach, education, and product development for individuals who've undergone laryngectomy surgery, which is removal of the voice box and the larynx. So you are in the midst of... A of launching a new product that's taken a few years, apparently, somewhere between six and eight or longer. So let me get out of your way and just give us a little bit of the backstory or what it is and what you're in the middle of developing and about to bring to market.

Meryl Kaufman

Awesome. Happy to do that. And yes, Noah, it's been just a little more than the six, seven, eight years now since I've known you. We met in 2018. I am a speech-language pathologist. I have specialized in head and neck cancer care and treatment and advocacy for over 30 years. I've done that mostly through academic medical centers. I still provide patient care. It is my passion and my love, and it's a privilege to be able to. work in that world. Laryngestomy specifically has been my focus, which is the removal of the voice box because typically it's cancer sometimes.

Other reasons may lead to that, but usually it's because of cancer in the voice box. And the surgery laryngectomy basically removes your ability to produce voice. And in doing so, it separates your upper airway from your breathing. So basically, you breathe through a stoma in your neck and you swallow in and out of your mouth. And in order to speak in the natural way, you have to somehow get air and sound into your mouth so that your lips and tongue and palate can then turn that into words for speech.

Steven Julian

You with me? Yep. I'm with you. Keep going.

Meryl Kaufman

Okay. So if you remove the voice box, you no longer have a sound source and you no longer have a way to get that sound into your mouth for speech because you're breathing through a stoma or a hole in the front of your neck. Okay. Now, there's a lot of negative connotation for people who've had laryngectomies. I'm sure we've all seen those scary commercials on TV with like, don't smoke or. this is going to happen to you, which really isn't fair. You know, a lot of most, it's never a patient's fault.

Plenty of people smoke and don't get laryngectomies or larynx cancer. And plenty of people who have laryngectomies never smoked a day in their life. People do have the surgery. People do go on and live full lives. I've worked with CEOs and teachers and realtors and newlyweds. You can live a full life as a laryngecomy, but you do have to learn a new way to speak. And that's what I've had the privilege to do for all these years.

Steven Julian

So before we talk specifically about the product, let me just ask, before you started really developing this product, What were some of the main ways that people would learn to speak without a voice box?

Meryl Kaufman

Yes, that is a great question because that's what led me to create this device. So really what people are most familiar with are two main ways to communicate. One is with something called an electrolarynx, which you've probably all heard that kind of robotic, electrosounding voice that people sometimes hold something to their neck and they say, one, two, three, four, five, and they sound like a robot. That's called an electrolarynx. The way that works is it produces an external vibration that makes a sound and then you couple it to your neck or your cheek so that sound goes into your mouth and then your lips and tongue turn that into speech.

It's very easy to learn. It's very inexpensive. It's typically the first way of communicating after you have a laryngectomy. But in general, people don't love it. It calls a lot of attention to itself. It sounds very robotic. You have to use a hand to use it. So it's not ideal, but it's perfect for some people. And for some people, it's enough. There are some Medicare limitations. You can only have one every five years and blah, blah, blah. There's always things like that that get in the way. That's kind of the ground level entry point for speech after laryngectomy.

The kind of other end of that, the gold standard, the thing that people really like the most, that achieves the most natural sounding voice is something called a tracheoesophageal voice prosthesis. But the short term for that is a TEP. And what? that is, is that's a surgically implanted little device that goes. Into the wall between the breathing tube and the swallowing tube and lets air from your breathing tube into your swelling tube or esophagus then vibrates your throat to make a sound like a burp basically and brings that sound into your mouth so you can use it for speech, which is great.

It sounds very natural. You can eventually get to a place where you can even do it hands-free where you don't have to cover your stoma with your hand. But it's not for everybody. And one of the reasons it's not for everybody is because access to care is limited. Financial resources can be limited. Surgical reconstructions or prior treatment may limit it. Your anatomy. There are lots of things that make it unattainable for some.

Noah McNeely

So that's a much more expensive and limited type of solution. Is that correct?

Meryl Kaufman

It is. It is. And it takes a lot of personal responsibility to take care of it. They have to be changed every so often. They leak, which can cause problem swallowing, coughing, choking when you swallow, which can lead to aspiration. They have to be. properly maintained. But the biggest barrier, or one of the biggest barriers, is the Medicare reimbursement structure is such that it's really unsustainable for medical facilities to provide it long-term because of the way that Medicare is set up. Which is how I got on my journey.

Steven Julian

There you go. So I have a feeling you're, so you kind of talked about the, forgive the, well, you kind of talked from one end of the spectrum to the other. The electro larynx is relatively ubiquitous, kind of low cost, and then you have this gold standard TEP. So Georgia speech and swallowing, one of the reasons it was. Found it or started or one of the things that came out of it is you started this journey to develop this product. Tell us where it fits on that spectrum and what it is.

Meryl Kaufman

Perfect. So, yes, I started the journey because as an advocate for many, many years through a nonprofit that I helped found, the Headnet Cancer Alliance, I was able to advocate to try to change the limitations that are keeping patients and clinics from sustaining TEP without sustaining too many losses and to help meet patients. The. end result of that is that I went all the way to Washington, D.C. with a team of advocates and stakeholders, patients, doctors, the national organizations that support us. We went to the Department of Health and Human Services.

We met with the Medicare and Medicaid people, and we gave them all the information that they needed to adjust the rate of reimbursement to make this accessible to all. And we failed miserably. Nothing changed. We gave it the best possible effort we could. And basically they said, well, not much we could do.

Steven Julian

All right. So before you continue, let's all in the studio and all of our loyal listeners, let's all pause for a moment because we're all in shock that the government. Of any party, I'm not picking a party, actually was ineffective, inefficient, did not listen to common sense, did not listen to experts.

Noah McNeely

Usually those solutions are rolled out immediately.

Steven Julian

Yeah, I'm shocked, Meryl, that they didn't, you know. So anyway, okay. So thankfully, that's not the end of the story.

Meryl Kaufman

Optimist that thought that I could change the world.

Steven Julian

You can, just not through the U.S. government. Anyway, I apologize. Continue. Yes.

Meryl Kaufman

No, that's. okay. So after failing miserably on that front, I decided I left my clinical job. I was in a position where I have all this experience and all this knowledge and all these resources and relationships through 30 years of doing this. I decided, let me see if I can do something better. Having been in the field for so long, I remembered that there's this old technology from the 70s that was developed called a pneumatic device. And there were some really proficient users that I had met through the years that used this device.

And basically, it's like a musical instrument. It has an external reed that you can couple to your stoma, which is that hole in the neck. And as you exhale, it vibrates. That read to produce a sound. and then you can take this oral adapter basically like a little straw that goes into your mouth and takes that air and sound from your stoma to your mouth to produce a more natural sounding voice. that's not as electronic as the electro larynx because it's powered by your air and a read within the device.

Wow. So I did not invent that. That is. old technology. It's not available in the United States. There are a few countries that have something similar, but it wasn't up to today's. anatomy, surgical procedures, stoma, stoma accessories. All the things that patients use now as compared to the 70s didn't really interface. So what I did is I took that old technology and that old concept and I updated it to meet the needs of the today's laryngectomy with the goal of creating a low-cost, low-tech, easily accessed to everybody worldwide device that can be used in addition to an electrolarynx or TEP or instead of an electrolarynx or TEP.

Steven Julian

So, Noah, I'm going to bring you in at this point, and I'm going to say, at what point did you, where was Meryl at in her journey when she met you?

Noah McNeely

Wow. You know, eight years ago, I'm getting, I turned 51. My memory's not quite what it used to be.

Steven Julian

Listen, you brought her on the show, so you better figure it out.

Noah McNeely

Okay, I'll do my best. So, yeah, she'll fill in what I leave out. But as I recall, and there are a lot of things that I found really interesting about Meryl and her project when we met. And, you know, we can cover that at some point today as well. But as I recall, she had this really old device. And Meryl, was it called? A Tokyo device or something like that?

Meryl Kaufman

Exactly. Yeah.

Noah McNeely

Okay. So this thing, and she came in and the story, as best I remember, is like, hey, there's this old thing. It worked great. Nobody knows how to make it now. And we can't figure it out. Nobody can figure out the, you know, how we even made it work, which actually turned into. a big part of what we did was trying to figure that out. I'm not sure we ever really, really got to the final physics of it, but we came to some other solutions. So she came in and she's like.

This is where I'm at. And I want to make something that will help as many people as possible, which, you know, A, that was a gold star for her. I was like, I'll definitely work on this. And I think that she, early on, she identified all the different layers of the problem here. You know, A, it's got to. work. B, it's got to be inexpensive to get in the hands of as many people as possible. C, it's got to be something people. And then D is kind of the one that's overlooked is you've got this government problem of, you know, it's will Medicare cover it?

How do you get Medicare to cover it? You know, how do you get all these obstacles to work around? So it was all these sort of problems rolled into one. And that may not have all been on the first time we met, but that's, you know, my memories kind of pulled some things together.

Meryl Kaufman

Yeah, that's pretty close.

Steven Julian

Oh, hey, you got a gold star for Merrill on your memory.

Meryl Kaufman

I think he nailed it. Yeah, he nailed it for sure.

Steven Julian

What are some of the things to this point? as we're recording this? And as of right now, the product is still not officially on the market, although it's getting very close. And depending on when people listen to this, we're going to give you contact information so people can see if and when it has gotten to market by the time they're listening to this. This process. that you've gone through, and I guess the first question I would ask, at the time when you're talking to Noah, you know, seven, eight years ago, are you thinking, oh, by, you know, it'll only take, this will be ready in a couple years, or were you, given that you've had 30 years of clinical practice and being around the medical community, it might be, I know this is going to take a while.

Is it kind of gone? Mostly the way you thought? Has it gone completely different than the way you thought? Talk a little bit about your experience in this journey of finding this old tech or reinventing it and trying to bring it to market.

Meryl Kaufman

Yes. It's taken a long time. A lot of that is because I'm a clinician, not a business person. And I came into this. You know, trying to solve a problem to help people. I didn't come into this to make millions of dollars or to grow a giant business or, you know, I really wanted to bring something to the table that solved a problem and could, you know, change the landscape a little bit. And so, you know, I had a lot to learn from there. Noah really helped me. When I came to Noah, I had...

So I found Noah after I hired a patent attorney, Brad Chowalke, who was fantastic. And he helped guide me through the provisional patent application process. And he informed me that I was going to need an engineer to help me get a prototype and get some CAD designs and drawings for this patent application. And he directed me to Noah, thank goodness. And I met with Noah and had the conversation. he just explained and said, hey, this is what I'm trying to do. And this is where I want to go. And both Noah and Brad were just so incredibly supportive and patient with me and my lack of understanding of the whole process and how things work.

And, you know, they gave me things to read and videos to watch and books. So they really helped me kind of hone in on some of those business skills that I just don't have as a clinician. So that was really one of the main limitations. A passion project is one thing, but to make it come to life is. another. And I am proud to say that I was able to file the provisional patent in 2018. We filed the formal patent in 2019. I defended it to the examiner's board after they originally denied it, which what I understand is they almost deny everything.

So I had an opportunity to defend it. In kind of mid-21 and was awarded a U.S. patent at the end of 2021. And then I signed a licensing agreement about a year ago. So, you know, made it happen. It took a little while. Some of that was complicated by the fact. That 2020 happens in the middle of all of that.

Steven Julian

Right, right, right. Yep. And that affected everybody's timing on everything. So we can factor that into the equation. Absolutely. Yeah.

Meryl Kaufman

Yeah. And so after 2020, so I had some NDAs, I had some conversations, you know, I was talking to different distributors and people and trying to figure out, okay, how do I take this to the next step? Once I had my kind of rudimentary prototype and the plan. But 2020, definitely, you know, people were being more cautious with where they were putting money. I was being more. cautious. Everything just kind of slowed down a little bit. And then, you know, I am a clinician and my passion is taking care of people.

So I kind of put it aside and thought to myself. I will know when the right partner shows up. I will know. I will trust my instincts. I'm going to go to my professional conferences. I'm going to talk to people. I'm going to utilize all these relationships that I've developed over the last 30 years, and I'm just going to follow the lead. And that led me to Rob Christensen. He has a company called Cranio Rehab out of Colorado where he... He develops products and works with small companies like myself within the field of speech pathology and creates products, kind of adjacent type products.

And I had a conversation with him at a professional meeting and he liked what I had to say and I liked his company and I liked what he was offering. I just wasn't sure he was far along enough for me at that point and I wasn't sure I was far along enough for him. So we kind of just exchanged information and let it. pass. And then about a year later, I saw some of what he was publishing. I got a newsletter in the mail. I saw him at a different conference, and I was really excited about the direction his company was going.

So we had another conversation, and I told him what I was doing, and he really liked it, and he felt like the right partner for me in that the mission was to do something for people. I was able to stay attached to it and engaged with it. And really, it feels like a true partnership. I like that. So that's how I got to where I am. Yeah.

Steven Julian

I like that.

Meryl Kaufman

Yeah.

Steven Julian

So I feel like before the government comes and takes me away, I need to also make a note at this point in time, at this point in the show, that we should also have another moment of pause because even though they rejected it the first time. Hats off and a tip of the cap to the U.S. Patent Office for having a process that Meryl could go through and actually see a result at the end of the tunnel and allow her to. go through. Right, Noah? Yeah.

Noah McNeely

And hats off to, you know, she mentioned Brad Trewonky, who I know from college. He and I met freshman year at Georgia Tech, as I recall. And that's another story. He remembered me years later, which was fantastic. But hats off to Brad and people. I can know how to navigate that because, you know, if you try to navigate that on your own, it's just it's very hit or miss.

Steven Julian

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Meryl Kaufman

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Steven Julian

That's GetOpu.com. And Noah, I want to ask you, kind of coming back to the conversations you had with Meryl and the help that you offered her at the... A critical part of this journey of hers. On this show, we've talked a lot about how you help entrepreneurs and inventors, and you've talked a lot about being an inventor and developing a product. And the thing. that I find fascinating in this case study that you've brought to us and this guest you brought is here's an old technology. To try and kind of reverse engineer or recreate in today's world.

What were some of the things that excited you as you were looking through this? Well, knowing that very little excites you because your heart rate stays at 45 most of the time.

Noah McNeely

I wish I was that healthy. I'm not quite that healthy. I think if my heart rate dropped to 45, I'd die. So, well, the first thing, frankly, that interested me and excited me about the project was Meryl and her approach. Because, and she touched on some of this herself, that she has a lot of the things that are kind of check marks I look for when I see people have a good chance of succeeding. And number one, she wasn't inventing something just to make money. You know, there are a lot of people I run into.

That's their goal. It's like, I want to invent something so I can become rich. It's like, that's okay. That's not really how it works.

Steven Julian

The Pet Rock. Go repeat it.

Noah McNeely

Yeah. And then of course she has passion for it. I mean, she wants, her goal here is not to have a product on the market. I mean, it is, but her goal here is to help a lot of people that she runs into every day in her, you know, in her practice that need that sort of help. And she's got deep expertise in the area that she's developing a product in. She's, you know, sometimes I run into. Hey, I'm a nurse, but I invented a plumbing product. Okay. It might be a great plumbing product, but tell me about your expertise there.

But Merrill hit all those things really well. But I'm sorry, go ahead.

Steven Julian

No, go ahead. Finish, finish.

Noah McNeely

But I think you started the question around old technology becoming something new. So I was excited about that because, A, it showed that people had attacked this problem in the past, meaning it's a real problem. Been around clearly for 50 years, well, forever. It's not going anywhere. There's a need for it. And there's some reason, I was also kind of intrigued by what she told me. It's like, hey, they used to make this. thing and everybody that knew how to make it is dead or whatever, because nobody knows how to make it anymore.

So I was like, okay, that is one of the most interesting stories I've ever heard. I want to be part of finding a way to bring this into the modern era.

Steven Julian

So what part did you play? What were you able to do? Are you able to share that or is that proprietary or what? I feel like you're teasing us here, Noah. Come on, give us the goods.

Noah McNeely

Oh, well, again, Meryl can probably fill in stuff because, you know, I work on a million projects, so some of it runs together. But we went through a lot of exploration of how do we recreate some of what was going on with this old device. And we looked at everything from like wind instruments and how they work to duck calls and how they work. All sorts of different, we had all these prototypes of trying to get this little reed to vibrate just the right way when you pass air. You know, your throat, as you inhale, exhale, the air passes in and out at a. certain rate and range of rates.

And how do you get that just right vibration with that? And then you have the tube that goes up to your mouth. How do you transfer that vibration up there? What materials? It was just a whole bunch of little challenges to attack.

Steven Julian

So, Meryl, let me ask some specific questions about this product, this pneumatic product. When it hits the market and will be working, does it require surgery for someone who's had a laryngectomy to get this put in?

Meryl Kaufman

That's a great question, and the answer is no. It does not require surgery. It doesn't require a plug or a battery. Just very rudimentary, easy to use, easy to learn, easy to access.

Steven Julian

Compared to the pricing of from one end, the Electrolarynx to the TEP, where is this in terms of price of getting started and also upkeep over time? What are the goals?

Meryl Kaufman

The goal is to price it below an Electrolarynx. Wow. Yes. Now, I say that in full transparency. I have a partner in my licensing deal who has taken this from me, the clinician, to a place where he is creating, developing, marketing, distributing, and using. all of his resources to bring it to market. So he will guide us on pricing and he will guide us. He's going to navigate. You know, insurance and codes and all of these things. And so all of that is going to come into the cost. You know, I have a pie in the sky, you know, unrealistic expectation because I'm a clinician who's just excited about a product to bring to my patients.

He's the realist who understands, you know, the obstacles that are going to get us there. The reason I partnered with him is because he understands that the goal is low cost, easy to access for all, which is a win for us.

Noah McNeely

And I think that fundamentally, you know, your product, just the materials used, the way it's constructed, and et cetera, it should intrinsically be less costly than the others over time. Now, it may not start that way because, like you said, you got to pay for all that regulatory and everything else. that he's, you know, that whenever you launch a medical or medical-adjacent product, there's a lot of costs that goes into that that you're going to have to recoup. But over time, it seems to me that this will get... This will attack your goal of making this universally available.

Steven Julian

And I would assume your partner is also, and you've got some background in this as well, but your partner in the licensing and working through that, you talked about coding, getting it coded so that insurance may reimburse if not part, then all of it. And again, to the insurance companies, if it goes in even in the same ballpark, let alone less, Then an electrolarynx, then that's a win-win for insurance as well as the patient to be able to have this as a second option to the, you know, what we've seen on commercials and movies all the time.

And, you know, so to have something that's more natural sounding, I guess, would be the way to. That's correct. Yeah. Okay.

Meryl Kaufman

Yeah, that's exactly right. And accessible. So, you know, there are all these missions that go to other countries, you know, Project Smile, where they go and work with people who've had cleft palates, you know, other kind of medical missions. But I've been invited to go on to those and I've never been able. to participate. because what am I going to bring? You know, I can't bring a surgical device and I can't bring a $500 electro larynx, you know, so that needs a battery or a plug. Like, how do I do, how do I help?

Bring people what they need if I don't have a product to bring to them. So, you know, hopefully I read, you know, when I was starting this business, one of the books that I read was the Social Entrepreneurship, the Tom Inventor, who did a lot of that, you know, buy one, give one kind of entrepreneurship, which also weighed into my mind. Like, how do we do this in a way that is not purely just about reimbursement and money and how much we charge it, but what impact we can have? And yeah, so all of that comes into play.

Steven Julian

All right. So we've come to the time for the payoff for our listeners because so one of the things I just want to state one thing, one of the things I find fascinating is as we hurtle forward and always looking for the next new technology, I think it's fascinating that you. found an old technology that is Perfectly suited for what you're trying to accomplish, which is more access to good or better care than what people currently have with newer technology. I think it's fascinating. I think the fact that you're willing to navigate the wipeout level obstacle course of Medicare and health insurance and the current way that people who practice medicine versus paying for that practice of medicine, it just, man.

Noah McNeely

Well, again, she's looking at all the facets of the problem. Correct. Not just make it work better, make it universally usable or easy to use, but also the whole government. And cost side of this, that's a big chunk of the problem here.

Meryl Kaufman

It absolutely is.

Steven Julian

And Meryl, if we had five more hours, I'm sure we'd maybe tackle 20% of that part of the topic, right? So, yeah, but you've painted a wonderful picture. I think all that's left to do is there are people listening who probably know someone who's gone through cancer of the head and neck and maybe had a laryngectomy or have one coming up. How can people keep track of this product that, by the way, I know the name. is not yet to be determined. I just want to confirm, you're not naming it the McNeely or the Noah, correct?

Noah McNeely

Please don't.

Meryl Kaufman

You know, I thought about it, but it just didn't seem to stick. Yeah, that wasn't going to be it. That was Noah not here because, you know, the point that you made about going back to older technology, when I came to Noah, I had... Several ideas. This being one of them. I also had a Bluetooth device. I had other kinds of higher tech things that I wanted to go with. And Noah really kind of steered me in that direction. And like, let's focus on this because. Technology is changing so rapidly and something that we, you know, it's taken us six years or eight years, whatever, to get here.

You know, eight years ago, the technology was different than it is right now. And it's hard to keep up. There are a lot of inventors out there in the field right now with AI and voice banking and all of these really interesting and exciting new ways to approach this. But it's all changing so rapidly. It's all very expensive to achieve. And. so, yeah, that is. You hit the nail on the head when you highlighted the fact that we looked back instead of looking forward to solve a simple problem.

Noah McNeely

Yeah, well, there comes a point where a wheel is a wheelie. You stick with what works, right? You don't want an AI wheel. We don't? Well, why would you? And your point about AI tech and others changing so quickly. I mean, if you're writing an AI tool right now, it's going to be obsolete by the time you publish it. Right.

Steven Julian

All right. So we've mentioned AI and we've mentioned 6.7. I better stop this show before something really get off the rails. Yeah. So tell everybody how they can keep up. Yeah. Yeah.

Meryl Kaufman

Yes. Let's go back to where we were. Okay. So Cranio Rehab is the company that I'm working with and they have a website, craniorehab.com, I believe. Let me confirm that.

Steven Julian

Is it C-R-A-N-I-A? C-R-A-N-I-A?

Meryl Kaufman

Cranio like head. C-R-A-N-I-O. Cranio rehab. There you go. And he attends all of the big professional conferences. We attended together in November in Washington, D.C. It was the first time I attended my professional organization, which is the American. Speech, Language, and Hearing Association, which has a conference every year that about 16,000 people attend. And I attended instead of a presenter or an attendee as a vendor, I was with him at his table and we kind of did a soft launch. Hey, look, what's coming to get? a sense of people's input, the excitement, where we need to be.

We're going to be attending more conferences for people in our field who practice with this population. There's also a lot of support groups online that we're posting to and staying connected with so that we can reach the end users. But yeah, if you follow Cranial Rehab, you can reach out to me directly as well through my company, which is Georgia Speech and Swallowing. My email is... That's mcoffman, K-A-U-F-M-A-N, at gaspeechandswallowing.com. And I am happy to share updates.

Steven Julian

I love it. So cranio rehab, C-R-A-N-I-O rehab, and then mcoffman at georgiaspeechandswallowing.com. So, yeah, everybody listening, keep trying. And, you know, this is, I guess I didn't ask this question at the beginning. How big of a population is this at any one given time? How many laryngectomies are done? This is not a small population, but it's also not the most talked about, right? Is that fair to say?

Meryl Kaufman

Yes. Yes, it is a relatively small population. So head and neck cancer itself is like the sixth most common cancer in the United States, but that includes tongue, palate. You know, lip, thyroid, all of that. Larynx cancer, when you narrow that down within the category of head and neck cancer, is in the United States, it's about 3,000 to 5,000 laryngectomies per year, which may be about, you know, 40,000 living laryngectomies at a given time. Worldwide, there are about half a million to a million living laryngectomies at present. So it's definitely not a huge population.

It's communication. It's speech. It's voice. It's life. And so the impact that it can have on that population is just tremendous.

Steven Julian

Yeah. It's a great opportunity to do what we've done here, and that's communicate with each other through speech and to be able to do that universally around the world and not being tied down by cost or tech. As much as the other options that are available. I think that's fantastic. So, Meryl, thank you so much for sharing the story with us. Thank. you for letting us pick your brain about some things. And thank you for not calling this the Noah as it launches to the world. But thank you so much for being here.

And we look forward to hearing some updates and maybe talking about it on the show in the future. So thank you very much.

Meryl Kaufman

Thank you for having me.

Noah McNeely

Thank you, Meryl. Good to talk to you. Okay.

Meryl Kaufman

You too.

Steven Julian

So, Noah, that was, what a great guest. We've talked a lot. I say this almost every show, I'm sorry, but we've had so many conversations and we repeat subjects and stuff like that, but I can tell why this story kind of triggered something in you, like, yeah, we need to get Meryl on the show.

Noah McNeely

Yeah, so, you know, Meryl and I touch base every once in a while, and, you know, she'll have, over the years, she's had sort of nuances to add to the idea, and so it's always been fun to keep in touch with her. I'm really happy she's found a good partner to help her get this to the market. So I know that's been a long journey for her. and sounds like she's there. So that's fantastic.

Steven Julian

I know. I know you did not want to say this on the show.

Noah McNeely

There's a lot of things I don't want to say on the show.

Steven Julian

Oh, I know that. I know this.

Noah McNeely

There's a few things I do want to say and don't.

Steven Julian

Yeah. That's because you forget.

Noah McNeely

Well, that and then, you know.

Steven Julian

And your slightly annoying co-host won't shut up and let you talk. I know. I know you. You didn't want to say this on the show, but I, as your slightly annoying co-host and the person you trust to steer the show to slightly entertaining status, is going to bring it up. I know one of the reasons you loved this idea of finding an old tech is because you're a child of the 70s and the 80s, and you were like, If this was around in the 70s, of course it was better. I had my Stretch Armstrong.

I had my evil Knievel stunt cycle. And I get this old device and all these guys are dead. I'm going to find it. It's like a Bond movie.

Noah McNeely

Well, yeah. I mean, it's sort of, you. know, maybe someday there will be product archaeology that people will go back and, or would that be anthropology? I don't know what it is. Some sort of, you know, some sort of. A role where people go back and look at products that existed 100 years ago and say, hey, why doesn't this still exist today? How can it be revised? And is there a need for it? And I don't think we're going to bring the buggy whip back, but... There might be some other things out there that we would.

Steven Julian

Well, and I think also the other reason was you remembered that I think there was a character in Ice Pirates who had lost their voice box and they had this old tech. And so you were like, I remember that from Ice Pirates.

Noah McNeely

Well, there's that. And then, of course, Darth Vader. Of course.

Steven Julian

Yes, exactly.

Noah McNeely

Darth Vader was a much bigger part of my childhood than Stretch Armstrong was. Sadly, my stretch Armstrong did not survive. There is a limit to how far he stretches.

Steven Julian

And thankfully, Merrill is not developing a product of a Darth Vader helmet.

Noah McNeely

Yeah, that's... Maybe the dark helmet where.

Steven Julian

it just pops up in the front and Rick Moranis comes out.

Noah McNeely

I don't think that's what she was after.

Steven Julian

No, not at all. All right. I've officially gotten it off the rail, so it's time to go. Noah, thank you very much. I want to thank our guest, Merrill Kaufman of the Georgia Speech and Swallowing. If you want to bring your product to market, you need to go to Product Genius. Actually, you need to go to productquickstart.com. Fill out the form. Don't put, I have a great idea. Call me.

Noah McNeely

You know, the more you say that, the more people do that.

Steven Julian

Is it really?

Noah McNeely

I've gotten a lot of those lately.

Steven Julian

Then they're getting my emails where I tell people to do that. So for Jody Smith, the producer, for Noah McNeely, stop doing what I tell you not to do. It's Steven Julian. We'll catch you next time on Product Genius.