(Pain x Frustration) + (Technology x Innovation) = Modii Health
Applying to college was an incredibly stressful time for me and after a while, I started having severe pain in my gut. My dad’s a physician, so he got me in to see a great gastroenterologist in the area. It turns out, that what was causing the pain, was early-onset ulcerative colitis. I have prescribed a combination of drugs to ease my symptoms. But several months into my first year in college the drugs just seemed to stop working and I had an especially intense flare. It was heartbreaking, but I had to leave school and return home.
Two weeks later, the dull pain in my leg worsened. The pain became so excruciating that my dad rushed me to the ER. Turns out, I’d developed deep vein thrombosis – a potentially life-threatening blood clot in my leg – all because my body was so inflamed. I was absolutely terrified. I was wracked with pain from an unknown disease that seemed able to strike anywhere in my body, practically without warning.
A blood thinner and powerful steroids helped dissolve the clot but an inflammation from the ulcerative colitis spread intense pain to my neck, shoulders, and back. I was miserable. It was time to see a pain specialist. I assumed that my dad could get me an appointment right away – but the soonest the specialist could see me was 6 weeks away. My pain was so overwhelming I honestly didn’t know if I could hold out that long.
So, I became my own science project and queried my old friend, “Dr. Google.” I was willing to try practically anything to ease the pain. I gave up sugar, gluten, dairy, alcohol, and meat. I did 45 minutes of stretching exercises every day, tried CBD creams, and applied heat and ice packs. By the time I finally got in to see the pain doctor, I’d come up with a self-care plan that actually worked. Better yet, it didn’t involve steroids, injections, narcotic pain meds, or even having to see a doctor at all.
It dawned on me that no one should have to wait weeks for pain relief. People in pain should have rapid, no-nonsense access to treatments that are safe, work well, are affordable, and don’t require waiting for an appointment with a doctor – or even having to the house. My dad, the doctor, completely agreed. And so did lots of other folks. That’s why Modii Health was born. Our goal is to relieve pain and frustration by delivering a high-tech, personalized solution you can use in the comfort of your own home. Since pain is subjective in nature, I understood that one size does NOT fit all. Although, the opioid epidemic likes to paint that picture. I thought with all my engineering, design, and health knowledge, that we could do better as a society to help those in pain. Therefore, during my last year of college, I set out to start Modii Health with David Goodman MD and Joseph Heanue Ph.D. and grow it into something that could one day help people live a happier, more fulfilled life!
Step 1: Proof of Concept
The bread and butter of Modii Health is quite simple; To create a sensor-driven, wearable device, that combines the therapeutic effects of over-the-counter, non-invasive, and non-addictive treatment modalities, and have them controlled by an ios app. Seems simple enough. But in the world of medical investors, they need to see three things: Data, Data, and more Data that supports your claim. So I set out to do just this.
One of our Co-Founders, Joseph Heaue, has a successful Biomedical consulting firm Triple Ring Technologies. The three Co-Founders agreed that a proof of concept would be needed in order to raise a seed round of funding, so Triple Ring Technologies put in $100,000, and David Goodman and I put in $50,000 for a proof of concept study, using friends and family.
The objective of the study was to determine if we combined two OTC pain treatment modalities together, such as electric stimulation (TENS) and topical medicated patches (Lidocaine, Icy Hot, Voltaren Gel), would that result in a greater reduction of pain, that if we were to use the two modalities separately. This is what we needed to find out.
I designed a week-long study, that would test the pain-relieving effects of TENS, TENS + CBD, TENS + Diclofenac, and TENS + CBD + Diclofenac. We did it this way because we wanted to understand how these different combinations of modalities affect people with chronic pain and determine if one combination works better than the other and for what reason. With the help of Triple Ring Technologies and David Goodman’s medical staff, we successfully created our customized, off-the-shelf patches using customized die cutters. Three friends and family members volunteered to participate in the study. The study lasted 1 week which tested all 4 configurations listed above. The study members had to fill out a survey sheet every day before and after taking the test, to report on their pain level before treatment and after treatment. The data was stored on google docs and then analyzed after the study.
The results of the study showed a significant reduction in pain using TENS + Medication in contrast to using TENS only. In addition to this study, we also surveyed 30 of Dr. Goodman’s patients in order to get a better understanding of how people with chronic pain live their lives.
The
Patient Workflow
Raw Materials
Patch Configurations
Friends + Family Study Results
Step 2: Patent Market Research Study
After we received positive results from the usability study, we wanted to further understand the demographic and type of person suffering from chronic pain. Therefore, using 17 patients from Dr. Goodman’s clinic, we asked them a series of questions pertaining to their experience with chronic pain. This was to further understand a micro-sample of the larger chronic pain market, and further understand, if there is a there, there for a business.
Step 3: Professional Market Research Study
After the completion of the 17 patient surveys, we thought it would be a good idea to get some non-biased data, using an outside resource. We hired Epidemiologist, Barbara Wexler, to conduct a 30-person study, inquiring about their lives with chronic pain and initial reactions to the idea of the Modii Health system. “We’re planning to offer an online pain clinic with personalized, simple-to-use treatments. It would include clinician consultations, access to personalized therapeutic devices and topical medications, and monitoring to see how our patients are doing. Treatments improve over time as they adjust to each patient. “The results were better than expected.
Seed Round Funding
After the completion of the friends/family usability study and the two market studies, it was time to raise a seed round and start building some prototypes. We ended up presenting and partnering with an early-stage VC firm, General Inception, in which we received a $400,000 seed round to complete 4 objectives.
Intellectual Property
5 Prototypes
Original IOS app
Smart Sensor
As the Co-Founder and operating officer, it was my job to make sure that we delivered all these tasks in under 4 months. We partnered with Triple Ring Technologies to help complete the Prototypes and Smart sensor, we partnered with an app development firm called Folio 3 to help complete the IOS App and I was in charge of completing the IRB and writing/submitting our patent.
Systems And Methods For Multi-Modal Personalized Topical Pain Relief
I wrote and submitted this patent while still in my senior year of college as a provisional patent, and worked with a law firm, Carr and Ferrell, to submit it as a full-scale utility patent. When writing the patent, I wanted to cover all bases and potential innovations that the company and device could go. This includes multiple modalities such as heat, TENS, cold therapy, vibration therapy, medication dispensing, advanced sensor monitoring, and AI analysis. All the illustrations were completed by myself, using Illustrator. This was one of the most enjoyable moments is when the application showed up on google patents.
Here is the link: https://patents.google.com/patent/US20220087891A1/en?assignee=Modii+Health&oq=Modii+Health
Abstract
Taking an individualistic approach to the treatment of chronic pain may soon be the norm of modern-day medicine. The potential to control the type of medication, in addition to external stimulus including, but not limited to electrical, thermal, cold, or ultrasonic, presents itself in a new “toolbox.” The present invention relates to the management of chronic pain through non-opioid, multi-modal compounded transdermal applications, whose properties are enhanced externally, by electrical, thermal, or mechanical energy. More specifically, the present invention encapsulates the customization of personal health, in analyzing, applying, and contributing to the betterment of the patient'’ well-being, adapting to the patient's preference, and biological requirements, and regulating for various environments based on the individual's specific body part
Claims (20)
What is claimed is:
1. A multi-modal personalized pain management system comprising:a sensor subsystem within a single assembly;a skin stimulator subsystem within the single assembly;a drug delivery subsystem within the single assembly;a control subsystem within the single assembly; and user interface subsystem.
2. The multi-modal personalized pain management system of claim 1, further comprising: the single assembly configured to be attached or worn in a vicinity where pain relief is desired.
3. The multi-modal personalized pain management system of claim 1, further comprising: the user interface subsystem including software with instructions executed by a processor and configured to operate as part of the system or a separate computing device.
4. The multi-modal personalized pain management system of claim 1, wherein the sensor subsystem includes any of an oximeter, a pulse oximeter, a thermometer, an infrared radiation sensor, a colorimeter, a blood flow sensor, a pH sensor, a galvanic skin response sensor, an imbedded accelerometer, a biochemical sensor, an infrared radiation sensor, a colorimeter, a biochemical sensor, or a combination thereof.
5. The multi-modal personalized pain management system of claim 1, further comprising the skin stimulator subsystem including an electrical stimulation portion, a thermal stimulation portion, a mechanical stimulation portion or any combination of an electrical portion, and a thermal portion, or a combination of an electrical portion and a mechanical portion, or a combination of a thermal portion and a mechanical portion, or a combination of an electrical portion, a thermal portion, and a mechanical portion.
6. The multi-modal personalized pain management system of claim 5, wherein the electrical stimulation portion induces a current flow to a tissue.
7. The multi-modal personalized pain management system of claim 5, wherein the thermal stimulation portion induces a temperature rise or fall in a tissue.
8. The multi-modal personalized pain management system of claim 5, wherein the mechanical stimulation portion applies a force to a tissue.
9. The multi-modal personalized pain management system of claim 1, further comprising the control subsystem configured to cause a time-varying force.
10. The multi-modal personalized pain management system of claim 1, further comprising any of a reciprocating electric motor, a rotating electric motor coupled to an eccentric weight, a piston driven by an external fluid such as air or water, a piezoelectric transducer, or any other means of applying a time-varying force.
11. The multi-modal personalized pain management system of claim 1, the drug delivery subsystem comprising any of a drug dispensing mechanism, a drug dispensing control mechanism, a drug supply, a drug patch, a drug dispensing solid, a flat structure with a port and a channel, a trapped volume or any combination thereof.
12. The multi-modal personalized pain management system of claim 1, the drug delivery subsystem configured to dispense two or more types of drugs.
13. The multi-modal personalized pain management system of claim 1, the control subsystem configured to receive user inputs or sensed signals and to provide control over the skin stimulator subsystem or the drug delivery subsystem.
14. The multi-modal personalized pain management system of claim 1, further comprising the system communicating over any of an Internet network, a radio frequency, near-field communication, optical communication, acoustic communication, or any other communication means capable of receiving sensed signals and transmitting control signals, or a combination thereof.
15. The multi-modal personalized pain management system of claim 1, further comprising the user interface subsystem configured to provide information on functioning of the system and to provide information from a user on their preferences or perceptions as to the functioning of the system.
16. A method for multi-modal personalized pain management, the method comprising:receiving sensing input by a control subsystem in an assembly;receiving user input from a user interface by the control subsystem in the assembly; and generating a control signal by the control subsystem to control a skin stimulator subsystem in the assembly and a drug delivery subsystem in the assembly.
17. The method for multi-modal personalized pain management of claim 16, the method further comprising:attaching the assembly in vicinity of where pain relief is desired.18. The method for multi-modal personalized pain management of claim 16, the method further comprising:measuring by an infrared radiation sensor a combination of a temperature of skin and a temperature of a tissue beneath the skin.
19. The method for multi-modal personalized pain management of claim 16, the method further comprising:measuring by a colorimeter any combination of skin color, tissue color beneath skin or color of a dye.
20. The method for multi-modal personalized pain management of claim 16, the method further comprising:sensing by a biochemical sensor a substance exuded from skin, including any of water, sodium, potassium, oil, sebum, proteins including defensins, metabolic products including lactic acid, oxides of nitrogen, or a combination thereof.
“Looks Like” / “Works Like” Prototypes
Since $400,000 wasn’t enough money to make a fully functional prototype, we decided to make two prototypes. One prototype was called the “works like” and the other was called the “looks like.” The works like prototype was a fully functional stimulation unit, controlled by an IOS app that had a smart sensor attachment. The looks like prototype is a visual representation of what our generation 2 device will look like. I worked and oversaw the work at Triple Ring, to make sure that everything looked good and ran smoothly. We got the models done and working in under 3 months.
Works Like Prototype:
The works like prototype was a converted stimulation unit from a previous Triple Ring Technology project. And the stimulation waveform used on our device is one that has been proven to help reduce chronic pain and recover muscles. I worked closely with the design team to make sure it worked and looked like a professional, friendly, and trustworthy device.
As you can see, the two holes are where wire leads would go and the button on top is the power button. The IOS app would connect to this stimulation box and would be able to control the about of stimulation and intensity desired.
Looks Like Protoype + Smart Sensor
The looks like prototype is what generation 2 would look like. It consists of a battery, a smart sensor, and a medicated patch all in one convenient package. The smart sensor was actually operational and connected to the IOS app as well. The smart patch was able to sense heart rate, heart rate variability, skin temperature, motion, and sleep.
Looks Like - Patch Configurations
Below are different renderings myself, and another designer worked on to represent how different patch configurations could form to different parts of the body.
Lower Back
Knee
Leg
Neck
Looks Like - Charger Configurations
Modii Health IOS App
We worked with a third-party app developer, Folio3, to help build a working IOS app, capable of controlling the stim box and having the smart sensor data uploaded to it. This app would be the patient portal, where they would be able to control their stimulation level, order more supplies, contact a doctor (if needed) or access our community of users.
Here is a link to the wire frame: https://xd.adobe.com/view/f8c1e4b2-bbdf-417c-b336-2cc1f2aa90e0-ad92/screen/a7151dff-c679-4352-b056-9ea3aa9d216c
Wire Frame
Final IOS App
