Privately held Eitan Group wants to bring more infusion pumps into people’s homes. Can it compete against the established players?
Officials at the Eitan Group want to disrupt the infusion pump market by selling devices that are more connected and software-based — able to be used not only in hospitals but in the home.
Eitan is probably best known for its Q Core Medical company that makes Sapphire infusion pumps, which have been around for more than a decade. But Netanya, Israel-based Eitan also has its Avoset Medical business, marketing what it describes as simple, easy-to-use pumps for home healthcare settings. Sorrel Medical, Eitan’s third subsidiary, makes a wearable injector device that delivers biological drugs for chronic diseases.
Eitan in coming years is looking to grow the $50 million in annual sales it’s averaged over the past three years. The company in March hired Roger Massengale, previously VP & GM of Avanos Medical (formerly Halyard Health) as its North American CEO. Eitan opened its U.S. headquarters in Aliso Viejo, Calif., in June and is expanding its team there.
Seeking to make waves in the infusion pumps business is no light matter. The market’s established players are some of the largest companies in the medical device industry, including Medtronic, BD, Baxter, Smiths Medical and ICU Medical. (Representatives at BD, Baxter and Medtronic could not be reached or declined to participate in this article.)
Massengale thinks Eitan has an edge because of its vision and deep knowledge of the market — and its small size, which allows a flexibility and boldness that larger firms have difficulty achieving.
“If you understand what the customer is trying to do and you have an intimate knowledge of what the customer is trying to do, you can act more quickly and more boldly on a limited basis of knowledge and trust your gut and knowledge. I think that’s what small companies can do,” Massengale told Medical Design & Outsourcing.
Julie Utterback, senior equity analyst for healthcare at Morningstar, sees a potential opportunity for Eitan Group in the global infusion pump market, which Research and Markets last year valued at about $12 billion.
“Technologies that can successfully move patients from an in-hospital care setting to an at-home care setting could be a powerful force in certain niches of the infusion pump market, like cancer care,” Utterback told MDO.
Roots with Q Core and Sapphire
When Boaz Eitan started the group in 2005, he didn’t want to be in the medical device industry. He was looking to invest in the technology market and had three criteria: a market bigger than $1 billion, an interesting technology and specifically no medical devices because the space was so regulated. And yet, after he and son Shaul Eitan looked at hundreds of companies, the only one that caught their attention was Q Core, an infusion pump maker then on the verge of bankruptcy.
Years later, that initial acquisition prompted an interesting insight for Boaz Eitan.
“We realized that regulation is not a bad thing. It’s a great thing,” he told us. “Two reasons: One, it makes your product much better. They really know what they’re asking for. It’s not a nuisance and it’s really important. Second, once you are in, your competitors normally have a great difficulty in crossing the regulatory barrier.”
Q Core scored a major break in early 2013, when Hospira agreed to exclusively distribute the company’s Sapphire multi-therapy infusion system in key markets. Later in the year, Hospira introduced Sapphire in the U.S. after its FDA clearance.
After Pfizer bought Hospira for $15 billion in 2015, then sold the infusion pumps business to ICU Medical in 2017, the SapphirePlus infusion system came under the ICU Medical umbrella, temporarily constricting global distribution. Eitan arranged fresh terms that ultimately led expanded footprints in new markets.
These days, Q Core Medical says it has more than 100,000 Sapphire pumps in use around the world, distributing to 26 countries.
“Sapphire has a broad portfolio of devices — I would say three main infusion device platforms, but it’s been on the market well over 10 years,” Massengale said. “It’s got a very substantial install base. It’s in hospitals and in-home care settings and home care facilities and alternate site facilities as well.”
One of the Eitan Group’s latest innovations comes out of its Sorrel Medical wearablesinjector-focused subsidiary. The idea is to turn terminal illnesses like cancer into chronic diseases, with the patient only having to take the drug once every one to four weeks at home, according to Boaz Eitan.
“The drug company experience is that normally, if you make it trivial to use for the patient and you’re asking them to become a semi-technician, to do many steps in the delivery, normally the adherence rate is really low,” he said. “Currently, overall in the industry it’s about 50% and they want to increase this adherence. What we are doing is providing a disposable pump called a pre-sealed injector where the drug and the pump comes together in one.”
All a user has to do is take it out of its packaging and attach it to the body. After pressing the start button, the pump is designed to take over, injecting the needle into the subcutaneous space to deliver the drug. Once complete, the injector alerts the user, who removes it and throws it away. The pump is also Internet-connected, able to send the information to a doctor for remote monitoring.
Pumping large-molecule biologicals poses challenges. Aggressive pumping mechanisms may cut the molecules, meaning patients won’t receive a full dose and the split molecules could become poisonous. A second problem is sterilization — most electronics can’t tolerate gamma radiation so they have to use ethylene oxide gas instead, meaning that when pump and drug are combined, there’s always one component that isn’t sterile.
“Before you deliver the drug, you cannot go through a non-sterilized area because that can infect the patient,” Eitan explained. “The specific area of the pump that is not sterilized, we have a chamber that, before we deliver the drug, we do disinfection. The disinfection is done automatically, and the patient doesn’t have to know about it. It’s done with a UV LED. We added UV LED into our product so the drug company doesn’t have to change anything in the sealing process or the sterilization process. We can assemble the full pump, test the pump and combine the pump and drug in a clean room. That makes it very easy to come to the market.”
Also, he said, although most injectable drugs are delivered in a vial, most pumping solutions or for wearable injectors only accept cartridges.
“We can deliver from the vial directly, so that the pharma companies don’t have to go through three years of transferring the drug from one container, which is normally the vial, into another container, which is the cartridge,” Eitan told us.
Overcoming cybersecurity and other challenges
Cybersecurity is always an issue in the medical device industry and infusion pumps are no exception. In 2015, it was revealed that Hospira’s Symbiq system could be accessed remotely through a hospital’s network. The FDA warned that hackers could make unauthorized changes to the dosage delivered by the pump. Hospira later confirmed the vulnerability and said it planned to phase out Symbiq later that year.
“Authorities are putting much more emphasis on cybersecurity,” Eitan said. “That goes without saying across the board. That’s not just special to infusion pumps. It’s everything that is connected can be scrutinized on that end. We feel this is great because some of the older and less-safe devices are either not going to get in the market or are going to get removed from market.”
As companies continue to innovate and the infusion pump market continues to grow, data and connectivity will be a driver.
“People want data. People want their devices to be connected because they want to extract data, not data for the sake of data. They’re looking for data that improves outcomes,” Massengale said. “The only kind of data that improves outcomes is data that provide you with an actionable insight, something that really, truly you can act on.”