Fresh off his success in developing a battery-powered, temperature-controlled mug that was flying off shelves in Starbucks Corp. stores a decade ago, inventor and serial entrepreneur Clay Alexander didn’t have far to look for his next challenge.
The founder of Westlake Village-based Ember Technologies decided he wanted to apply similar technology to life-or-death situations in the health care arena.
“That’s when a team from the Mayo Clinic approached us and asked us to make a reliable refrigeration technology box that they could use to transport temperature-sensitive vaccines and other medications to a remote Haitian village that was desperate for the medications,” Alexander says.
Alexander and his team came up with a pair of battery-powered cubes packed with refrigeration technology and sensors to keep a constant temperature just above freezing.
That project between 2017 and 2018 marked the start of Ember LifeSciences and its Ember cubes that have become the first self-powered, temperature-controlled containers capable of transporting medications requiring cold storage almost anywhere in the world.
Replacing wasteful and ineffective packaging
For decades, the primary method of transporting these vaccines and other crucial medications has been cardboard boxes lined with frozen gel packs or the equivalent.
“There has been some tinkering with the insulation for the boxes used for cold storage transport, but essentially, it’s the same technology that was in use 50 years ago,” says Dan Bell, chief strategy officer at Durham, North Carolina-based Marken UPS Healthcare Precision Logistics. “But it’s passive technology that exposes medications to temperature excursions.”
That’s the term used in the logistics industry for when the temperature inside the transport container deviates from the required range. While each type of medication has a specific temperature range, the most frequent range is between 2 degrees and 8 degrees Celsius (35 degrees and 46 degrees Fahrenheit).
However, if the standard container with its liquid gel ice packs is left out in the sun too long, the frozen packs start melting and temperature inside can spike, rendering the vaccines or other temperature-sensitive medications ineffective, Bell says.
This is no small problem. According to a range of studies cited by Ember LifeSciences, at least 25% of all temperature-sensitive medications that are transported are rendered ineffective by these temperature excursions. Alexander says this translates to a loss of $35 billion a year in medications rendered useless.
And there’s one other major downside: tons of single-use packaging, including non-biodegradable Styrofoam.
Controlling temperature combined with tracking
Alexander says all this makes cold storage transport of medications an industry ripe for disruption.
He’s no stranger to such disruption. A self-described inventor who claims at least 300 patents to his name, Alexander turned his attention to temperature-controlled products nearly 20 years ago. The innovation was installing an onboard computer and an array of digital temperature sensors. Those sensors relay information back to the computer, which then makes decisions on inducing a convection heating component. The use of convection currents helps evenly distribute heat to achieve the desired constant temperature.
In 2012, Alexander formed a company called Ember Technologies, and four years later, he unveiled the company’s signature mug product in a partnership with Seattle-based Starbucks. To date, Alexander says cumulative sales of the mug have exceeded $500 million.
Switching to cold storage transport
Shortly after developing the prototype medicine cold-transport cubes used by that Mayo Clinic team in Haiti, Alexander and his team at newly formed Ember LifeSciences honed the technology. They added one crucial feature: software that constantly tracks the location of the cubes until they reach the end use location. While carriers such as FedEx Corp. and United Parcel Service Inc. do put tracking labels on boxes they ship, those tracking labels are only in effect while the medication box is in their custody.
The team at Ember also added a “return to sender” feature that displays the return address for the cube. This makes the Ember cube fully reusable.
The Ember cube is meant to be portable and modular: Its interior medicine storage dimensions measure about 7 inches by 6 inches by 3 inches.
According to Bell of Marken UPS Precision Healthcare Logistics, no other product on the market offers both self-regulating temperature control and tracking.
He notes that other companies, such as Stockholm-based Envirotainer, have temperature-controlled containers for the transport of medications, but not in combination with the tracking technology.
“They are the first mover in this space, though eventually other companies will follow suit,” Bell says.
Ember LifeSciences also benefitted from the Covid-19 pandemic, which exposed the shortcomings of the existing cold storage medication transport system. Hundreds of millions of vials of Covid vaccines had to be transported all around the globe at cold temperatures; bottlenecks in the “last mile” portion of the transport system limited availability of the vaccines in some areas during the crucial first few weeks.
Reaching patients in Amish communities
Unlike Ember Technologies, which is primarily direct-to-consumer, Ember LifeSciences has a business-to-business model. Customers include pharmacies, distributors, pharmaceutical companies, hospitals and other care providers.
One of Ember LifeSciences major customers is University of Pittsburgh Medical Center Chartwell, an alternative site pharmacy. President David Benedict says his pharmacy deals mainly in specialty medications, home infusions and enteral therapy. Unlike most medications picked up from a standard pharmacy, most of the medications at UPMC Chartwell must be kept at cold temperatures.
“For a long time, we used traditional Styrofoam cardboard coolers with lots of ice coolers in them,” Benedict says. “Everything was single use, which is incredibly wasteful.”
Also, anytime there was a delay in shipping, there was always the risk that a temperature excursion could ruin the medications, which range in cost from $5,000 to $250,000 per container.
Benedict says he was made aware through specialists at UPMC of the Ember cube and immediately saw it as a better alternative, especially for treatments involving fecal transplants in the home.
UPMC Chartwell now leases about 100 Ember cubes that are routinely sent out to patients. Once empty, the patients or their caregivers can press the “return to sender” button and the cube is soon on its way back to UPMC Chartwell’s facility.
But not all the cubes are immediately returned.
“The Amish community in Pennsylvania doesn’t use refrigeration or electricity,” Benedict says. “Instead, they use root cellars for cold storage. But that doesn’t work for these temperature-sensitive medications. The Ember cubes are the only way to keep the medications at a consistent cold temperature.”
Looking ahead
Alexander says Ember LifeSciences has raised roughly $76 million to date, including a $16.5 million series A round led by Greenwich, Connecticut-based Sea Court Capital that was announced in January. Prior to that, two major investors were Dublin, Ohio-based pharmaceutical and medical products distributor Cardinal Health Inc. and refrigeration company Carrier Global Corp. of Palm Beach Gardens, Florida.
He says that later this year, the company plans to formally launch its second-generation Ember cube, which is roughly half the weight of the first-generation model. The cost to make the cube is also expected to drop about 50%, with much of the savings passed on to customers through lower lease rates.
Looking even further ahead, Bell of Marken UPS Precision Healthcare Logistics says there will be a need for transport of medications at much colder temperatures than the current standard of a few degrees above freezing. He specifically cites nuclear medication.
“We’re talking about near cryogenic levels, or deep frozen, which is going to be a much tougher thing to handle,” he says. “That’s the next frontier.”
