Auto-injector Market: Disruption Ahead

“If everyone just made the positive changes they see needed, our world would be so different.”

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The food allergy epidemic is spurring innovation like never before across multiple fronts -- therapeutic biologics, medical devices and apps & tools for managing daily life and emergencies. Exciting things are happening in the medication delivery space, specifically epinephrine auto injectors. This space has been dominated by a small number of sleepy pharma giants for decades who have held the food allergic population hostage, charging exorbitant prices and limiting supplies of medication people depend on for survival if accidentally exposed to their allergens. At long last their market dominance is being challenged by a number of scrappy start ups that are working feverishly to deliver truly innovative auto injector solutions that address many of the shortcomings of the existing auto injector devices. These new entrants are working their way through FDA approvals leading to more and better emergency medication delivery options in the near future.

Design Thinking Transforms the Future of Auto-injectors

Allergy Force caught up with Jessica Walsh, CEO and Founder of Rx Bandz, maker of the innovative MiniJect auto-injector that’s working its way through the FDA approval process. MiniJect is a highly durable and portable miniaturized auto-injector designed to administer emergency medication – think allergic reactions or opioid overdoses or low blood sugar. Rx Bandz was founded in 2014 and has a multi-disciplinary team of 10 collaborating virtually from across the US and Europe.

Rx Bandz Founder, Jessica Walsh, is no stranger to tackling daunting challenges. She built out a wireless telecom infrastructure when the only people who carried cell phones were doctors and drug dealers. While she was not an engineer and didn’t do CAD drawings, she was someone who could get things done through a deep understanding of requirements, the ability to connect disparate dots and the ability to bring together a team with the right skills for the job.

Jessica is also deathly allergic to bee stings. She’d been stung many times as a child without any reaction, but when stung again as an adult she immediately swelled, had a lump in her throat, couldn’t swallow and broke out in hives -- with no epinephrine to be had. She made it to the ER and emerged unscathed, epinephrine prescription in hand. She now carries an EAI at all times.

She’s the type of person who takes things apart and looks inside. She took her EAI apart and was surprised there was so little medication. For all the bulk of the industry’s leading EAI devices, the medication amount that gets delivered is about the size of your pinky fingernail and the EAI itself is expensive! “You’ve got to be kidding me,” she remembers thinking. “It could be so much smaller and less expensive and still deliver the exact same amount of medication.” Jessica’s been on a mission ever since to do just that.

“It’s so easy to see something that needs to change and think someone should do it, but never act on it,” Jessica reflects. “Why can’t that someone be you? If everyone just made the positive changes they see needed, our world would be so different.”

“True innovation is a lot like sailing – you have to read the wind, read the waters…”

When the Rx Bandz team originally innovated the MiniJect auto-injector, it was a bracelet. Then the company listened deeply to patients to learn what they really wanted.

“As a founder you have to be open to honest feedback that tells you ‘your baby’ isn’t perfect,” Jessica reflects. “There’s no room for ego, even when you’re three years in with a product design you love. Being able to let go of your preconceptions about patient pain points, even when you’ve walked in their shoes, is critical.”

During the MiniJect discovery process, parents recounted the fights they have with their food allergic children about carrying their bulky EAI’s. Even severely allergic medical professionals (who should know better) reported leaving their EAI’s behind when going to events because they are too inconvenient to carry. “Beyond that, they are just plain scary,” adds Jessica. “It’s hard to wrap your head around giving yourself a shot. That needle is long and it looks like it will hurt!”

Jessica explains, “true innovation is a lot like sailing – you have to read the wind, read the waters. When the winds change, you have to reset your sails and change course to catch the wind. And so, we did."

Rx Bandz’ patient-centric approach to product design allowed the company to quickly pivot and redesign a prototype that could be carried discretely, and could fit into everyone’s life. MiniJect is only 2.5 inches long, will easily attach to something you always carry -- your phone, your pop socket, your keychain, your wallet, your belt – and is waterproof, rugged and durable.

"Customer discovery revealed that people like to keep their medical conditions private."

Rx Bandz also learned that people are self-conscious about their medical conditions and want to keep them private. While people loved the idea of a wearable EAI – like the bracelet concept -- they don’t want to wear anything conspicuous that calls attention to their medical problem.

Research participants felt that carrying an EAI — along with daily essentials you don’t leave home without — would be less conspicuous than wearing a bracelet.  Jessica recounted the thought process behind the pivot, “Why not make it different? Patients can figure out design changes if a product better meets their needs.”

The auto-injector market is about a billion-dollar market growing at 20% (give or take). The market for epinephrine auto injectors in particular is ripe for disruption, with an underserved population clamoring for easier access to more convenient device options at lower prices. Rx Bandz’ ambition has been to make life easier for people needing emergency medication, not only those with food allergies and allergies to insect venom, but people struggling with opioid addiction, epilepsy and diabetes.

A lot of creativity goes into making an auto injector as small as the MiniJect. The Rx Bandz team had hundreds of ideas, ran computer models, tested extensively. “We had springs flying across the lab,” recalls Jessica. The team didn’t give up until they had a miniature device that worked and consistently delivered an incredibly precise amount of liquid with a ¼ of a second between delivery and needle retraction.

It takes significant investment to bring an auto injector to market – whether you’re just tweaking an existing product idea, or your envisioning something radically different. The product concept received a huge stamp of validation from the New England medical community when they won first and second round grants totaling $50 K from the New England Pediatric Device Consortium. Rx Bandz spends every dollar carefully, given investors who are counting on execution and returns, and the need to pour everything into development. “We’re a small, scrappy team of talented and driven people who get the work done,” Jessica adds with pride. “I feel so lucky to be working on something that will make such a difference for people and save lives.”

“If you put your mind to something, you can accomplish anything.”

When you are food allergic you live with uncertainty. When will you make a misstep that will cause your body to go into anaphylaxis?  You should have access to epinephrine at all times, but that can also pose challenges.

Why?

The design of the currently available epinephrine auto-injectors (EAI’s) leaves you wanting more. They can be bulky to carry, temperature unstable, they may or may not have retractable needles, and they may be confusing to use, resulting in needle misfire. Their shelf lives can be short and they can be costly. Plus, there’s a complacency that sets in when you go long stretches between food allergy emergencies or you’ve never dealt with one {yet}. An “I’ve got this!” mentality can take root in your head, giving you a false sense of confidence in your ‘invulnerability’, and over time, you let your guard down and leave your EAI at home.

An auto-injector the size of a MiniJect has potential to be life changing for people with food allergies — improving adherence because it answers answer many of the current auto-injector shortcomings.

MiniJect is on an expedited pathway through the FDA review process and hopes to be in market within the next two years. The company has received FDA feedback on testing and has identified contractors for the testing work ahead. Raising additional funding – from investors large and small — will be critical for this feisty start-up with a vision to be able to ‘open the gates and release the hounds’.

When asked how the food allergy community can help Rx Bandz bring MiniJect to market, Jessica didn’t miss a beat. “We can only be successful if people tell us what’s on their minds. So, participate in surveys, share your pain points, share your stories with us on the Rx Bandz website.   It makes us better.”

This is definitely a product to keep an eye on as it wends its way through the FDA approval process.

“Because the people who are crazy enough to think they can change the world are the ones who do."

—Steve Jobs

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The Allergy Force Changemaker Series shines a light on movers and shakers in the food allergy community who drive change and bring positivity to the space for the benefit of the entire community.

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Photo Credits: Thank you to Sharon Pittaway on Unsplash for use of the first post image and to Mike on Pexels for use of the second post image