For those suffering from chronic diseases, a new self-treatment medical technology device offers hope for more freedom. Expecting hyper-scale growth, Enable Injections implemented SAP S/4HANA for immediate scale to become a $1 billion business.
The needle is so tiny, you almost have to hold it up to the light to see it — it’s the size of three hairs held together. This minuscule needle and its supporting medical technology might change the future for many chronic disease patients.
Because the needle is hidden inside an unprecedented medical technology device, patients will never actually see it. A patient will stick the yo-yo-sized device on their abdomen and the needle stays hidden inside. They then simply push a button to self-administer medication.
“There’s nothing like it in the world,” says Tim Flaherty, CFO and spokesman for Enable Injections. He explains that the startup’s device is currently undergoing clinical trials before attaining the final approval from the U.S. Food and Drug Administration (FDA).
Flaherty shows the device to visitor Megan Starshak as they tour the company’s Cincinnati, Ohio-based research and production facility.
“The device doesn’t feel clinical and scary,” Megan shares, and she knows a great deal about needles and pain. At 18, a doctor diagnosed her with the chronic autoimmune disease ulcerative colitis, similar to Crohn’s Disease. Since then, Megan has tried every treatment available to ease her symptoms, which include chronic fatigue, urgent bowel movements, and abdominal pain.
“My highest pill count per day was 28.” Now, Megan goes to a clinic for a nurse-administered IV that injects medication directly into her veins. “At the time, the IV was my last option to avoid surgery,” she explains.
Growing Need for Viable Treatment Options
Megan is one of 57 million people in the U.S. expected by 2020 to live with a chronic disease, according to the World Health Organization, including diseases like psoriasis, arthritis, Crohn’s disease and ulcerative colitis, asthma, multiple sclerosis, and cardiovascular diseases, as well as many types of cancer, though not including diabetes. Unfortunately, current IV-administered treatments can be both exhausting and burdensome on both the patient and the healthcare system, according to the U.S. National Institute of Health (NIH) .
These two reasons prompted Enable Injections to begin developing its self-infusion device nearly a decade ago. “With this device, I could be self-treating right now. You could do it at home, at school, at work,” Flaherty explains. “So it has the potential to be life-changing.”
Some European countries already allow patients to self-treat some chronic diseases. But the results have raised some concerns, including the risks of under- or over-dosing. U.S. medical companies like Enable Injections must counter those challenges in order to get FDA approval to bring their devices to market.
“Today, we are a pre-revenue company. Pharmaceutical companies reimburse us to develop the device,” says Flaherty. Enable Injections currently partners with seven pharmaceutical customers, with some programs in clinical trials. Overall, the company has raised more than $80 million to bring its device to the U.S. market.
“Some of our [pharmaceutical] customers are talking about buying millions of devices a year per drug. You add four or five customers to those volumes, you can get to be a billion-dollar company really quick,” Flaherty shares.
The pharmaceutical companies will skin the infusion devices with their own brands and pharmacies will bill patient insurance for the drug-device combination package. The drug companies will likely determine the cost, according to Flaherty.
Enable Injections Vows to Do It Right the First Time
Anticipating hyper-scale growth, leaders at Enable Injections vowed to “do it right the first time.” Their goal was to deploy the right technology backbone upfront through a phased-in approach and avoid costly and problematic makeshift upgrades later.
“We recommended that Enable Injections choose SAP for this initiative, not only because it could support businesses scaling from startup to full production, but specifically because of the FDA-regulated requirements that are necessary for quality and trials, production design., and inventory traceability — and to do that in a way to actually make a profit as a business,” shares Don Dickinson from SAP gold partner Dickinson + Associates.
“They’re going to need the scale the cloud provides. So we’ve come up with the right way in the cloud to give them the platform to support their needs now but will scale as they go to a very large organization with the volumes of business they’re expecting,” he explains.
“We’ll be able to flip the switch and scale as large as we need to be,” says Flaherty. “Eighty percent of the pharmaceutical companies also use SAP, so it shows our partners that we’re serious about doing business with them.”
As Megan tours the production plant with Flaherty, she watches the assembly-line process through windows that protect the sterilized environment. Workers in white smocks, hair nets, and gloves operate two production lines, one for 10 milliliter medical treatments and another for 20 milliliter treatments.
Currently, the startup employs less than 200 developers, engineers, technicians, and medical experts. But once the device is in market the company will look at contract manufacturing to automate this process, in order to scale to production for high volumes quickly.
“They’re thinking about quickly growing their workforce, recruiting them, and onboarding within FDA-regulated requirements,” explains Dickinson. “They need the ability to track learning and training that goes on with all these employees. SAP SuccessFactors software supports the FDA validation requirements.”
Patients like Megan hope self-treatment devices like this from Enable Injections will add more freedom to their lives. “It’s great to see something like this come to life and come to market,” she says while holding a device prototype. “As a chronic illness patient, I think it’s important for us to be able to control what we can and make things easy when we can — because we’re never going to be able to control all of it.”