#StartupsEverywhere profile: Jean Anne Booth, Founder and CEO, UnaliWear
This profile is part of #StartupsEverywhere, an ongoing series highlighting startup leaders in ecosystems across the country. This interview has been edited for length, content, and clarity.
Innovating Technologies to Support Independent, Vulnerable Populations
Jean Anne Booth is a serial entrepreneur who came out of retirement when she and her mother realized an unmet need for technology to promote both safety and independence in aging populations. Based in Austin, Texas, Booth founded UnaliWear and developed the Kanega Watch to provide vulnerable individuals and their families better alternatives to live with the dignity and support they deserve. We spoke with Booth to learn more about her company, the prospects for funding medtech development, and her experience with the U.S. patent system.
Could you tell us about your background and how it led you to UnaliWear?
I'm an electrical engineer from the University of Texas at Austin. I worked in the semiconductor industry for many years, and as a serial entrepreneur launched a number of successful semiconductor startups—one of those sold to Texas Instruments and another sold to Apple. Then, funnily enough, I retired and was a dive master on a liveaboard scuba boat, which was amazing. But then my mom turned 80. As you age, there are some things that you kind of need, and I was worried about her safety and her independence. She and I talked about all the solutions on the market and she looked at me and she goes, “Don't you get that for me. I'm not wearing it.” That was what led us to create UnaliWear.
I had been enjoying retirement, but I saw such a compelling need to extend independence with dignity for our vulnerable populations and fill gaps in the current market. UnaliWear has a patented battery system for our watch band that means users never have to take the watch off to charge. So it's there to help 24/7. This is especially important, since the number one cause of injury or death among seniors is falling, most often in the bathroom at night. With other products, even if my mom had interest, they would have been charging overnight when she was most vulnerable.
Tell us about UnaliWear and the Kanega Watch. What is the work you are doing and how are you supporting safety and independence for vulnerable populations?
Unali is Cherokee for “friend,” and Kanega is Cherokee for “speak.” So we are the friend who speaks with you. In simplest terms, users can talk to the Kanega Watch and get help during emergencies. The watches have cellular,Wi-Fi, and GPS connectivity, and are Bluetooth enabled to connect with hearing aids and other telemedicine devices. They are specifically designed for independent but vulnerable populations that are not well-served by consumer electronics devices today. My mom was our senior user experience advisor, was responsible for working with focus groups to make sure we built the right product, and even picked “Fred Astaire” as the wake word. This is her legacy.
We also have artificial intelligence built into our solution—we use motion detection, voice recognition, and location—all to learn about the wearer’s lifestyle and what they tend to do. When something happens outside of the wearer’s normal activities, then we can make sure that they're okay. For example, we have automatic fall detection that is conditioned by our patented AI. This becomes really important, as I feel very strongly that devices like the Kanega Watch need to be connected to medical alarm operators. There is so much evidence that people who wear pendant-type medical alert devices won't press the button when they need help. Users do not want the embarrassment of having EMS or a fire truck rolling up with sirens blaring when all they need is for somebody to come over and help with something that could feel more minor. Even if it may not seem like a big deal, it's a big deal to our wearers. So we can rely on our tech to identify potential concerns. And instead of immediately connecting our wearers with emergency services, we connect to medical alarm call centers, which can either contact loved ones/caregivers or go directly to dispatch emergency services (bypassing 911) if needed.
Have you faced any unique challenges launching a medtech startup focused on the needs of vulnerable populations?
Under the Food and Drug Administration’s (FDA) definitions, our product is a Class II, Emergency Services, Statutory Exempt device. This means we have to follow the agency's regulations, but we do not need FDA’s permission to come to market. And that’s not an accident—I designed our solution so that it would not get hung up in the FDA processes. But that has created other challenges. For example, the number one investor question I get is: “How are you different from an Apple Watch? Can’t an Apple Watch do everything you can do?” The answer is no, they absolutely cannot. The Apple watch offers zero protection at night, as it is charging, and no non-emergency assistance, as it only connects to 911, not a medical monitoring center. Having said that, the Apple Watch has a heart rate monitor, which means it is already a Class II device. The FDA says that combining emergency services with any biometrics like a heart rate monitor makes the product a Class III device. Class III means that we would have to conduct full clinical trials and go through the Premarket Approval (PMA) process at the FDA. That would cost about $15 million, which is more money than I've raised for this company over the past eight years.
That reality is compounded by another problem. I call what we do ‘SilverTech.’ By my analysis, the entirety of venture capital funding available for SilverTech startups—if I add up every single fund—is $75 million. While I might like to add monitoring for some physiological biomarkers that are relatively easy to engineer into our solution and carry value for our vulnerable populations, I can't do it because it would suddenly cost an additional $15 million. I understand where the FDA is coming from and I support their mission, but I'm not sure what the answer is to giving people access to helpful technology.
How can the government better support medtech startups like UnaliWear, be it through better funding or otherwise?
Incentivizing private investment would go a long way. While the National Institutes of Health (NIH) is there to make grant funding available, I have the patience of a gnat and have never applied for a grant. It does not make sense to spend nine months applying—or even hiring a firm to write an application—only to get $200,000 when you’ve got a physical product to build. While that first government grant may be followed by another $1 million grant a year or so later, the company’s burn rate is over $2 million a year, so even that doesn’t help. It never occurred to me that it would be this difficult to raise money for SilverTech. I have raised over $100 million in venture capital for semiconductor companies. Yet it is an absolute slog to raise money for UnaliWear, where I’m doing more social good than anything else I’ve done before. In addition, there are other challenges with venture capital funding, because unless the deal flow analyst or the investor has experience with an aging loved one, they do not see the problem or the value of our solution. Incentivizing angel investment in SilverTech would help.
Another super important thing we need to do is to provide clear, uniform requirements around the privacy and security of a user’s health data. Right now if you are a consumer health device, the Health Insurance Portability and Accountability Act (HIPAA) does not apply. But if you have a consumer device connected to a health plan, then HIPAA applies. This means, by law, UnaliWear does not have to treat our user’s personal health information according to HIPAA security standards, but we do because security matters to us. I think we need to do a better job in the consumer health space to make sure everyone’s health data is secure. I am not usually in favor of adding more regulation, and I do not think the requirements for consumer health devices need to be as heavy as what is in HIPAA—but some clear, uniform requirements, perhaps around encryption, could help.
I understand that you’ve had some experience with the patent system. Could you tell us about that?
I had to stop publicizing positive news about UnaliWear because every time I did, we would get hit with a demand or lawsuit from a patent troll. It does not matter that we do not violate their patents—they still threaten to sue. The whole business model feels like legalized extortion. I firmly believe that non-practicing entities (NPEs) should not be allowed to sue. Patents should be there for the people who are doing something meaningful and implementing novel ideas. With NPEs, it is just a waste of time and investors' money. In one case, the NPE threatening to sue would not even send me the necessary tax paperwork and kept ignoring my calls and emails, so I had to prepare a hand-written 1099 to report a payment to the IRS. There are good things that I and my company could be doing in the world besides dealing with patent trolls.
What are your goals for UnaliWear going forward?
Our desire is to execute on our mission: to extend independence with dignity for millions of vulnerable people all over the world through the products we develop. There are very few SilverTech companies left, and I want to make sure we are meeting the real need that is out there to support these communities. In the US today, there are 54 million people above the age of 65—over one billion people above the age of 65 worldwide. UnaliWear is passionate and determined to deliver independence with dignity for millions of vulnerable people.
All of the information in this profile was accurate at the date and time of publication.
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