By: Tom White
In healthcare, innovation is not a luxury but a necessity. This rings especially true for emergency medical devices, where swift and efficient delivery of life-saving medications often means the difference between life and death.
Visionary Rx Bandz, an innovative BioTech company founded by Jessica Walsh, has modernized patient-centric auto-injectors that will disrupt the marketplace. Designed to deliver a wide spectrum of life-saving medications, these devices withstand the most demanding activities, whether for active kids or our Special Forces, without compromising efficacy.
Rx Bandz evolved from Walsh’s personal experience and a passion for solving problems. The journey began when she had her first severe allergic reaction. “I was stung by a bee and had a massive anaphylactic reaction. Since I was prescribed auto-injectors, I have to carry them at all times. They were really big and bulky. I wound up duct-taping them to my arms. They are completely impractical for a normal or active lifestyle. I knew there had to be a better way,” Walsh recalls.
Alarmingly, but not surprisingly, 60 percent of people like Walsh who are prescribed an auto-injector do not fill the prescription or carry it with them. She shares, “That means they’ve had a severe allergic reaction, and they’re at risk of dying. They choose not to carry a device because they can’t afford it or it doesn’t fit into their lifestyle. It is too large, bulky, and can be embarrassing to carry, so patients don’t buy it or carry it. Auto-injectors are also often intimidating and confusing to use, which leads to errors or delay in administration, both of which are life-threatening. Those are serious problems.”
Walsh, being the type of individual who sees a problem as an opportunity, began looking for a solution to help the millions who suffer from severe allergies or other life-threatening conditions. “This kind of innovation, this game-changing technology we are creating, can save lives around the world.”
Finding a better way is going to save lives
“I’ve always been curious. I like taking stuff apart. Traditional auto-injectors are expensive, and they expire each year. I thought to myself, ‘Are you kidding me? What makes these cost so much? What’s inside?’ I cut it open and was appalled. I felt like one of those kids with a cereal box. There’s a toy inside, and you think it’s going to be huge, but it turns out to be minuscule.
The amount of epinephrine is about .3 mL, about the size of a raindrop. Why do we need something so big to deliver this small amount? And the costs are inequitable. How can we make this smaller, less expensive, durable, and easier to use so people won’t be at risk?”
Building the Rx Bandz team
Bringing a game-changing technology to the market requires fortitude and skill. Walsh knew she would have to draw from her expertise from leading complex multi-region, million-dollar projects for the international construction-engineering company Bechtel.
“I navigated various regulatory pathways, built teams, and ensured projects were completed on time and within budget.” That experience, managing high-stakes projects and steering her way through a sea of regulations, prepared her for leadership at Rx Bandz, but she knew she needed an experienced team to pull this together.
Bringing a disruptor to the market requires the passion and expertise of a world-class team and dynamic leadership with the ability to oversee and deliver on multi-step projects. Reaching across the country, Walsh brought together a dream team of experts with backgrounds in pharmaceuticals, medical devices, regulatory affairs, clinical medicine, military leadership and engineering. They share a passion for bringing this life-saving technology through FDA approval and to market.
Harsha Murthy, Rx Bandz’s Chief Strategy Officer, brings extensive pharmaceutical licensing experience and strategic insight to drive business development, and he has a proven track record to guide Rx Bandz’s growth. He has a background in senior executive roles, founding private equity firms and leadership positions in pharmaceutical companies, and his academic credentials include a B.A. from Duke University and a J.D. from Stanford Law School.
She continued, “Stephen Harhen is Rx Bandz Chief Technology Officer. He is brilliant and can envision all the nuances of how a device will work, from initial design to the time it is in the hands of patients. A former Johnson & Johnson biomedical engineer, he brings technical leadership and creativity that has propelled us forward.”
The medical team at Rx Bandz is also brimming with distinguished professionals with extensive backgrounds in the military and pharmaceutical sectors who are driven to see this medical device go to market and save lives. Dr. Yosyong Surakitbanharn is the Chief Drug Development Officer. He spearheaded the successful development of other epinephrine auto-injectors during his tenure as Director of Formulation Development at Verus Pharmaceuticals.
Thomas Gardner is Vice President of Regulatory Affairs, and he shares over 30 years of extensive experience in regulatory, quality, product development and technology within the medical product industry, including product development and FDA filings. David Dlugo oversees quality management, bringing decades of experience with medical devices and having served as an advisor to the FDA. Dr. Sean Hollonbeck (Army COL, ret), ran several Army medical facilities and served six tours as a combat physician in Afghanistan and Iraq. He knows what physicians and medics need.
A Broader Vision
Walsh’s vision for Rx Bandz extends beyond individual users to encompass broader applications, including delivering critical medications in high-stakes situations. The significant impact of the MiniJect and its potential to radically improve the delivery of medications on the battlefield was recognized by the Department of Defense with 13 contracts.
“Our military have been wonderful supporters of our technology. They need our device to deliver anti-chemical warfare agents, to stop pain, and for non-compressible hemorrhages, which means injuries where compression doesn’t stop the bleeding. The Department of Defense is super enthusiastic. With MiniJect, the military can deliver drugs via compact auto-injectors that are now only available through needle syringes or by setting up an intravenous line that requires advanced medical training. Non-compressible hemorrhages are the number one preventable death in the military and maternal deaths worldwide. Around 14 million women will develop postpartum hemorrhage, and 70,000 of them will die annually when a shot of TXA with our auto-injector could have helped save their lives. “
Earning Awards and Accolades
“The FDA’s community outreach programs recognize our work and awarded three grants to Rx Bandz through its New England and Southwest Device consortiums,” Walsh explains. She has also won RESI Lifesciences International Innovation and other prestigious awards.
Moving Forward
To create a truly novel auto-injector that will revolutionize the industry takes not only a great team but also millions of dollars for development, especially as the device requires FDA approval before it is sold on the market. “Our continued success also depends on our investors.
“The auto-injector market is valued at $55 billion-plus, which offers a great opportunity for mission-focused, military and life-science investors to be part of our Series A, as we take our growing pipeline of devices and drugs through FDA approval,” notes Walsh. “We have strategic manufacturing partnerships and an established supply chain in place, and we are working on this as if lives depend on it because, for millions of us, it does. Together, we are doing something remarkable that will provide a game-changing solution and save lives around the world.”
Learn more about Rx Bandz and its mission to revolutionize life-saving technology and improve healthcare outcomes worldwide.
Published by: Martin De Juan