I had the pleasure of interviewing MaryEllen Reider, co-founder of Yarlap®, an American company that designs an FDA-cleared AI device for pelvic floor muscle tone. The AI technology in the Yarlap® provides women a way to regain pelvic floor muscle control without narcotics, surgery, or skill in performing pelvic floor Kegel exercises with fantastic results. AutoKegel® is the registered mark of the technology and the AI is so effective that patients can relax or perform other tasks during their pelvic floor work out.
Thank you so much for doing this with us! What is your “backstory”?
Yarlap® patents are for patient security and safety, and the focus of our AI technology is to provide the maximum benefit to the patient and to re-enforce the woman’s relationship with their licensed health care professional.
Clinical studies indicate that even with guidance from a healthcare professional a majority of women do not perform pelvic floor exercises correctly. To be effective an exercise must be performed correctly. Yarlap® does it right for you. Yarlap® with AutoKegel® AI technology sends a precise impulse to work the muscles comfortably, safely, and correctly.
AutoKegel® technology reinforces the positive patient-doctor relationship. Hospitals, physicians, physical therapists, ATC’s, sex therapists and independent pharmacies can order Yarlap® for their patients through Performance Health.
Can you share the funniest or most interesting story that happened to you since you began leading your company.
For us, it’s the enthusiasm women have for the AI technology. The Yarlap® is FDA-cleared to treat incontinence, and we get wonderful calls from women who have regained control.
But we are truly surprised how excited our customers are when they share how much their newly found control improves their sexual performance and sexual expression through improved muscle control.
Women of all ages, even as young as 81 call to share their enthusiasm. It is amazing that a woman of any age can wakeup or go to bed anticipating the adventures ahead after using the Yarlap®.
What do you think makes your company stand out? Can you share a story?
Efficacy, safety, and security happen by design. The AI in the Yarlap® is the high point of pelvic floor muscle stimulations therapy research and development.
For medical equipment especially, it is a false narrative to think simply copying extant technology is going to be effective or safe. In fact, simply copying technology without understanding it or naïve enthusiasm for its use can lead to an inadequate assessment of risk, undesirable misadventure by third parties, and serious adverse potential outcomes for the patient. Here are two examples:
1. A patient’s personal data must be private. Wireless transmission of data poses an obvious problem — you have to think about who has access to the data. For example, it is not just who has access to your codes — simply by scanning the applications on your phone, the data collector knows a lot about you. Even adult toys (not regulated by the FDA) have been discovered transmitting data without the user’s knowledge (Cite: Hern, A. “Vibrator maker ordered to pay out C$4m for tracking users’ sexual activity.” The Guardian. March 14, 2017).
2. Have you considered the risk associated with the power to transmit data? Lithium batteries are powerful and lightweight, so they are very common for use in wireless devices and toys. If a lithium battery fails it produces intense heat (the technical term is called “Thermal-run-away”). A lithium battery inserted or near sensitive tissue can pose a serious risk (Cite: Australian Government: Australian Transport Safety Bureau, “Battery explosion mid-flight prompts passenger warning.” 2 August 2017).
At Yarlap®, we think carefully about AI risk and we focus on the patient having wonderful outcomes.
Are you working on any new or exciting projects now?
Yes, clinical trials for Yarlap® are underway at a leading research institution in the USA regarding sexual performance and expression. Additional AI patents are underway for amazing outcomes related to muscle control and fine motor skills.
What advice would you give to other CEOs or founders to help their employees to thrive?
Medical device design is not a stage nor a venue in which to equivocate. Follow FDA guidance.
None of us are able to achieve success without some help along the way. Is there a particular person who you are grateful towards who helped get you to where you are?
In medical device AI design, I am always impressed how wonderful contributions to success can come from the most interesting and diverse fields of expertise / research and concepts from wonderful people you may never meet in person. The power is in the connection of ideas as well as people.
How have you used your success to bring goodness to the world?
There are a number of ways the AI we have developed is making the world better.
In an eco-economic sense over 40 million American women have some form of urinary control issue. That’s a lot of expensive pads and adult diapers being thrown into landfills across the nation. The average American woman will spend over $800 annually on these disposables.
Our AI empowers these women, but the goodness is more than stopping the leaks. An important dimension our AI technology is learning.
Learning to hold and release using our AI technology can bring pleasure to intimate relationships as well as continence. Yarlap® results are concordant with clinical data and that is very exciting. As one of our loyal followers reports, “Happy mommy, is happy daddy is happy family.”
Can you share the top five ways that technology is changing the experience of going to the doctor.
AI has changed medicine significantly. AI devices can be highly effective whether simple, like Yarlap®, or extremely complex like Watson® (I have a friend at Watson). Our top five ways technology is changing the experience of going to see the doctor is based on our expertise:
#1. AI technology can strengthen the patient–doctor relationship. As many as 70% of the women who visit a healthcare professional to treat their urinary incontinence never return for a second visit. Data suggest this is because patients may not have adequate control to perform pelvic floor muscle exercise, known as Kegels, or the experience is so intensely personal that professional instruction is not clearly understood. AutoKegel® technology enables the patient to follow the physician’s instructions comfortably, safely and effectively in the privacy of her home — even for patients with severer muscle control loss. Patients experience results so they return to advance their care. FDA guidance is very clear on devices supporting the physician patient relationship.
#2. AI technology can grant the patient-physician’s wish to treat the cause, not the symptom. Stress, Urge and mixed incontinence are not diseases. They are indications of an underling problem. Pelvic floor muscles hold our organs in their natural position. When the muscles lose their tone, organs shift, putting pressure/ stress on our bladder. The extra stress on our bladder causes some women to leak when we sneeze or cough. When muscles contract abruptly, it can create a sudden urge. Stress and urge together are known as mixed incontinence. Improved muscle tone treats the urge and the stress, causing the leaks.
#3 AI Technology can liken nature’s solution(s). When we exercise, our mind sends a mild electrical impulse to our muscles through our nervous system telling muscles when to contract and when to relax (work/rest). The AI in Yarlap® with AutoKegel® sends precise instructions to the muscles using a mild impulse to work-rest the pelvic floor muscles correctly, comfortably, safely and conveniently. It’s much like in nature but there is no minimum muscle control necessary to start, there is no need to concentrate on the routine, and there is no guessing as to what are the proper muscles to contract or for how long; with AI it is pre-set.
#4 AI Technology can teach nature’s solution(s). Patient report they can learn to Kegel on their own, because with AutoKegel® they understand how the exercise feels as the Yarlap® builds tone. With feeling and tone, patients report they can establish control. The results not only treat incontinence but improved muscle control often heightens a woman’s ability for sexual satisfaction in a way that the most dedicated Kegel practitioner could only dream about. Yarlap® is a super-duper Kegel machine because it not only treats the cause, it teaches the solution and can help us improve our quality of life!
#5. AI can maximize use of patients’ and physicians’ time. AI makes it possible for the correct muscle re-education protocol directed by the healthcare professional to fit the patient’s lifestyle schedule. Physicians seek effective solutions for their patients that consider patient lifestyle (e.g., what really works for the patient to get results). AI technology can be used to fit a solution with the patient’s schedule and lifestyle and therein AI broadens the usability of medical technology significantly. Yarlap® AI has been used by patients to make the following activities more productive; watching television, working in the office, telephoning, fixing dinner, vacuuming, airline passenger travel, concerts, conference lectures, etc.
Can you please give us your favorite “Life Lesson Quote”?
“Whatever the problem, be part of the solution. Don’t just sit around raising questions and pointing out obstacles” — Tina Fey
You read statistics about women’s incontinence and think “why is this NOT talked about everywhere? It’s so common and our pelvic wellness is so much a part of our relationships!” Instead of pointing out all the factors and what women could do, we decided to become part of the solution with Yarlap®.
Is there a person in the world, or in the US whom you would love to have a private breakfast or lunch with, and why?
Kathy Lee Gifford and Hoda Kotb on NBC’s Today Show. They’re a team, so I put them together as my answer because they can bring humor and empathy to whatever they talk about (with a glass of wine). They’re so into what they do, it’s contagious — I hope I come off that way about women’s pelvic floor health.
I think if I had lunch with them, we could have a great talk about incontinence and women’s pelvic floor health.
Originally published at medium.com