What was it like to create and launch a medical product in the middle of a pandemic? Kyle Jansson and his startup team at RoddyMedical™ learned many lessons developing the medical device, the SecureMove-TLC®, which is a wearable, single-use medical device designed to secure and manage medical tubes, IV lines, and cords to improve patient safety.
We met Kyle Jansson at our Madison event last summer, and he will return to help teams build their prototypes in Milwaukee this year. Kyle is a mechanical engineer and the Director of the UW-Milwaukee Prototyping Center. The UWM Prototyping Center provides product development, prototype creation, and fabrication services for businesses, researchers, and entrepreneurs from the Greater Milwaukee Area and abroad. His team works on multiple projects a year for companies and individuals. “Our team of three people execute about 70 projects a year. We work on anything from consumer products to surgical tools to scientific instrumentation. We've worked with clients in all four USA time zones and have had products sent to five continents. Our typical project is between a week and a month long, so it's a quick turnaround.” Kyle and I spoke about one of his favorite projects and how closely it reminded him of his own Make48 challenge.
The SecureMove-TLC is the first product launched by RoddyMedical. RoddyMedical was founded by Lindsey Roddy, a critical care nurse who almost lost a patient in an ICU when a medical line carrying life support accidentally pulled out during standard care. The patient recovered, but Lindsey couldn’t forget about the incident. After being unable to find anything on the market that could have effectively prevented this problem, and hearing from other nurses this was not an isolated incident, Lindsey began to design something that would prevent this from ever happening again. Her journey soon led her to Kyle and a collaboration to develop a solution was created.
Lindsey initially reached out to Kyle regarding her idea to create a better device for organizing IV lines. However, they learned that the issue was the need for line securement during mobility, patient transport, and daily care. After twelve weeks of researching existing products and shadowing clinicians in the ICU, Kyle saw the struggle firsthand on how medical tubes plague medical professionals and patients and knew he had to do something to help. He was determined to create a product for patients and clinicians. Kyle received permission from UWM to join her in developing the product, which led to a four-year effort that was sidetracked by the pandemic.
From their initial meeting, fast forward almost two years in which Kyle’s nights and weekends had been dedicated to this product, then the pandemic hit. “Lindsey and her husband John (an ICU physician) called me on a Saturday night and John said ‘I won't have a clean N95 mask when I go to work on Wednesday, and I'm intubating COVID patients. What can we do?’ So my team at the UWM Prototyping Center and I cleared our schedules, I said goodbye to my family who supported me, I called the designers and engineers I knew, and we put our heads down and got to work. Our mission was to develop a reusable N95 mask for clinicians ASAP.”
The mask development team included RoddyMedical partners Lindsey, Pat, (who has previous experience in launching medical devices), and significant clinical support. They joined up with the UWM Prototyping Center’s Aaron and JD. Additionally, there were two freelance industrial designers (Lauren and Kent), and several other independent contractors and engineers and volunteers - all on a volunteer basis per the dire urgency of the situation and the task at hand. The mission was to create a couple of versions of high-fidelity N95 masks; one that could be quickly made anywhere with rapid prototyping and one that could be mass produced in parallel via injection molding. Their team quickly joined forces with the Milwaukee MaskForce led by HUSCO and many members of the Milwaukee community including universities, manufacturers, hospitals and others. “We received support from UWM and our clients to cease working on our projects. All of our clients said, ‘Go make masks! Our project deadlines are no longer significant’.”
The race was on! The development teams worked tirelessly around the clock attempting to create the masks. They researched regulatory requirements, evaluated filtration media and acceptable materials. They incorporated that information into the designs and prototyped masks rapidly. They received almost daily feedback from hospital teams regarding the masks ranging from clinicians to the CEO’s as to what was needed. It was a race to make anything as quickly as possible while maintaining the very high filtration standard that N95 masks required. “Everyday we’d iterate the design and make about three mask versions per day. Then we’d get feedback. Another round of masks would be created. More feedback.” After 27 straight days, the core design team had created two masks that were being made; the first was an injection molded mask that was being tooled up, the second was developed in parallel as a version any maker could produce with a 3D printer, and other common materials. They developed an airtight, conformable, comfortable high fidelity mask from FDA-approved materials with an FDA-approved ventilator filter. Like everyone, Kyle was beyond exhausted and very proud of the work his team put in. “I'd say there were about 100 people involved on the Milwaukee team dedicated to this. From filtration experts to injection molding experts to regulatory experts to engineers. On the molded mask, we went from the need, to steel tooling for injection-molded production in just three weeks, which is insane! Those were intense days, but we learned a lot on the way, quickly. The mask development didn’t stop there, but that’s another story.”
Looking back to RoddyMedical’s original mission, the mask project became a catalyst for the SecureMove-TLC product efforts. Kyle, Lindsey, and the RoddyMedical team used their experiences to move the SecureMove through the final stages of product development, regulatory, manufacturing, and other key milestones.
“We learned the medical product had function effectively, but provide a quantifiable value to the hospital system as a whole.” The team continued refining the design until Kyle had an A-HA moment on how it would finally work. “We were struggling for the breakthrough we needed, and then one day it clicked! The optimal shape came to me on a bike ride, as things always do when you're not thinking about things.” From there, it still took another year of optimization, but after 37 total design iterations, the SecureMove-TLC was ready to launch.
The SecureMove is FDA registered, comfortable for long wear time, and provides a level of securement and safety above any other product on the market. Competitive products are not designed for patient movement and therapy, do not protect the patient from hazardous line pulling and dislodgement, and are unable to secure and manage multiple size lines and cords. While current solutions fail between 4-9lbs of pull force on average, RoddyMedical’s patented tension mitigation technology in the SecureMove-TLC can absorb on average 80lbs of pull force, and often more to truly protect the patient.
“We were blessed with tons of feedback from the nurses and therapists on the front lines who were going to be using it to mold it into what it is. And since then, we've created a quality system and registered with the FDA. RoddyMedical raised a $600,000 seed round last year to kick off our manufacturing tooling, build up our initial inventory, and start our soft launch. Now, we are fundraising a similar amount to be able to increase our production capacity and scale into the market. So, we're actively pitching now to close this round.”
The SecureMove-TLC is currently manufactured in the Midwest, is FDA compliant, and is available for sale. The device has been evaluated on patients in multiple hospitals across the country, with significant positive feedback and testimonials. The SecureMove-TLC is the solution the team had always dreamed of.
If you have a project that needs some development, visit https://uwm.edu/prototyping/.
To learn more about the SecureMove-TLC, visit https://www.roddymedical.com for updates and listings of conferences and podcasts where RoddyMedical will be demonstrating the SecureMove-TLC.