We believe in incredible people with amazing visions.
That was the foundation for our 12 candidates for the 2017 Amber Grant: Mom Made Peeks, ScriptoPro, Levity Products, Gabby Bows, aLoo, Yoga2Sleep, STEMed Academy, Mama Joy Foods, Pepper, Farm.Field.Sea, Omiga and WiGo Trips.
Congratulations to each and every one of you.
After careful and lengthy deliberation, we’ve come to a conclusion on the 2017 Amber Grant recipient ($2,500).
Congratulations to Sarah Olson, Founder of Levity Products. Please take a few minutes to read about Sarah’s impassioned motivation and mission.
WN: You earned a Qualification Grant back in January. Remind everyone of your backstory and mission with Levity Products.
Sarah: My middle son, Levi (5), was born with Spina Bifida. In his five years, he has had 15 surgeries! In 2016, he had 9 of them. It was a brutal year for all of us. Levi endured a lot of pain and infections from the device that had to be used to drain his bladder after every one of his surgeries. We ended up having to spend 60 nights total in the hospital that year, and the majority of it was due to the complication from the device he was forced to use.
By the beginning of April, he had already underwent 6 surgeries/procedures. He was so worn out and I couldn’t take it anymore. To watch my son in that amount of pain was maddening. I felt so helpless, as I would hold him screaming in pain. I was desperate to do something to help him.
By July, his 7th surgery was scheduled and I made an appointment with his Urologist to discuss what was going to happen. I remember sitting in that appointment and asking the doctor, “What else is there? We can’t use that device again. I can’t do it. I can’t watch him suffer like we have. It feels so inhumane! Please tell me there is something else we can use.” I will never forget the words he said next.
He said, “Sarah, there is nothing else. This is all there is to drain the bladder while Levi heals.” Then he jokingly said as he walked out the door, “if you want something different, you’re going to have to invent it.” In that moment, a light bulb went off. I couldn’t watch my son in pain anymore, so I thought, “well, I guess momma is going to invent something then.”
I have zero medical background and zero engineering skills. I was just a momma on a mission to help my baby. I had less than two months to come up with a device that could help him. One day I was thinking and praying about what to do and it hit me like a bolt from heaven. I had the idea. I asked a friend if he would help me bring my idea to life by helping me draw out dimensions to create a CAD for a 3D printer to print a prototype. We got it done in a matter of days and a couple weeks later, we had a prototype printed. I took it to Levi’s Urologist and said, “do you remember telling me that if I wanted something different that I would need to invent something?” He laughed and said yes. Then I pulled out my prototype and said, “So I invented something. Will you try it?”
He looked at me with a blank stare and said, “Sarah! You know I was joking right?” I replied, “I know you were, but I wasn’t. Will you please try it.” He tried it right there in the office and it worked. IT WORKED! He told me he would use it under one condition…I had to file for a patent, and then he would use it on Levi for his surgery that was 29 days away.
I scrambled and worked hard with another friend of mine to prepare and file a patent. 3 days before Levi went in for surgery, we successfully filed for our first provisional patent. What a rush of emotion. We completed what we set out to do and now we would put my device to the test on my own child. I remember waiting in the waiting room while Levi was in surgery, praying that it would work. I was praying that my device would do its job and help my son. Levi’s Urologist came out after surgery to update us on how everything went and the first words out of his mouth were, “IT’S WORKING!!” What took Levi 2 1/2 weeks to heal from in January of that year with the existing device now took Levi 1 observation night in the hospital. He went home and healed beautifully with my invention.
My original goal was to help my son, but my goal has changed. Now I’m on a mission to help children all over the globe feel relief from pain and infection and have a chance to live more independently. I’m a momma on a mission to help other mommas who feel as helpless as I did.
WN: What progress have you made since January?
Sarah: The device is being put through a New Product Development Process for medical devices frame work known as “Stage Gate” to make sure that the prototype I designed will be in compliance with the medical device industry requirements. This Stage Gate NPD frame work is a process comprised of well defined stages. Each stage has a specific purpose within the process. The stages we have completed in this last year are:
a) Conceptualization and Prototyping
b) Market segment Feasibility Study
c) IP protection and branding strategy
d) Raw Material Integration Process
e) Manufacturing Integration
f) Biocompatibility Testing in animals
We are now beginning:
g) Clinical Validation through a Phase II Clinical Trials in Humans
h) Commercialization Process split in 3 stages: i) Pre-Launch ii) Launch iii) Post-Launch
We have come a LONG way. We refuse to cut corners and are dedicated to creating a legitimate medical device recognized internationally as a device that has the potential to change the way children are treated in Urology.
WN: We know the Amber Grant funds will go towards clinical trials. How long do you anticipate that period taking?
Sarah: There are lots of variables to the length of time it can take. We expect anywhere between 1-2 years if we continue to stay on track and move forward the way we have been. Again, we are extremely dedicated to doing exactly what it takes to make the device safe and effective for kids. It’s a process, but a process we are very careful to complete well.
WN: How do you plan to monetize your device?
Sarah: We are in conversations with several straight catheters manufactures to execute a strategic alliance where we can speed up the market penetration process. My goal is to get the LECS to market as quickly as possible so that it can start helping kids the way it has helped my son.
WN: How is Levi?
Sarah: He is doing well. He will always have physical battles, but what matters most is that he’s mentally tough. He can’t control his body, but we teach him that he is able to control his mind and his attitude towards his condition. Let me tell you, Spina Bifida does not slow him down often. He lives with an incredible amount of pain a lot of the time, but you may never know it. He fights hard to turn his pain into power. He desperately wants to be just like any other 5 year old boy. He’s my hero.
WN: Is there anything else you’d like to add?
Sarah: What I’ve accomplished could not have been possible without the incredible talent and genius of the team of people that I work with. They are incredibly gifted and have a heart for the mission of this project. They have an intense focus on giving back and making a difference on this planet with the talents they’ve been given and knowledge they’ve acquired from successfully taking other devices to market. People frequently comment on what I’ve done in inventing the LECS (Levi External Catheter Stabilizer), but I will whole heartedly admit that the main thing I focused on was surrounding myself with people that are far better than me. I’ve worked very hard to become what I’ve had to become to lead a project like this, but I’m grateful for a team that makes me look as good as they do. The entire Levity team deserves an enormous amount of credit for what has been accomplished. As a team, we will complete this mission and give hope to those who suffer as Levi did.