Moving away from using ethylene oxide in sterilization for medical devices remains difficult with the current minimal market interest to address what is considered a niche problem.
There are many ways to wage wholesale death and destruction upon the microscopic world. Chemical, thermal, radiation, and other energy-based means abound. The real challenge has always been to find a method that would not cause equal damage to what is being sterilized, or the humans in the room. Metal surgical tools can be rendered safe with heat and steam, but when plastics exploded into medical use starting in the 1960s, a new form of low temperature chemical sterilization grew rapidly alongside it.
Today, according to FDA, more than 20 billion devices sold in the United States every year are sterilized with ethylene oxide (EtO), accounting for roughly 50% of devices that require sterilization. To meet this demand, there are over 100 different EtO gas sterilization facilities sprinkled across the United States. Some of these, like the now-famous Willowbrook, IL facility, began operation in the 1980s, 30 years before the U.S. Environmental Protection Agency (EPA) would classify EtO as a human carcinogen. Community advocacy groups, government officials, and medtech industry organizations are readying themselves for what is sure to be a monumentally difficult challenge to resolve.
Aside from the legal and ethical challenges, the technical and logistical challenge around steering those $20 billion devices safely out of the EtO pipeline is overwhelming. Alira Health, a global consulting firm, listed sterilization as one of the top major concerns of the medical industry in their recent 2022 contract manufacturing report, on par with raw material shortages and domestic workforce challenges.
Some of the most encouraging developments have been seen in the response of FDA to the EPA’s actions. Since the Willowbrook plant shutdown in 2019, FDA has launched multiple pilot programs to make its processes around sterilization more flexible. These include pilot programs to streamline changing sterilization methods, re-evaluating dosing requirements, and launching multiple innovation challenges.
In the meantime, many people are asking a seemingly reasonable question: why have we not come up with a better way by now?
While FDA can reflect on and review its own processes to remove barriers within its systems, priming the pump for fundamental new technologies is a tougher challenge. Both FDA’s Innovation Challenge announcements brought in less than 25 interested companies apiece. Compare this to Medtech Innovators 2022 Cohort, which boasted a 5% acceptance rate from over 1000 startups applying to the accelerator program.
While Medtech Innovator works across the entire clinical product spectrum, the seemingly minimal interest in sterilization innovation is confusing considering the market demand. The existing sterilization infrastructure is at near 100% utilization, with yearlong backlogs developing with every plant shut down. The global sterilization products and services market, which includes many applications in food, veterinary care, and pharmaceuticals, was worth an estimated USD $13.7 billion in 2022. It will likely reach $20 billion in the next five years. It seems like just the kind of demand that most startup founders could only dream of. So, where are they?
Until recently, entrepreneurs faced the intense inertia of the “if it isn’t broke, don’t fix it” approach of the sterilization industry. The idea of moving away from a well-established process was considered of minimal benefit, if not outright dangerous. Even the rash of in-hospital sterilization products that were developed under COVID-19 were intended to meet the local niche needs of health providers, not as a replacement for the bulk sterilizers.
This push back from industry incumbents was bolstered by the intense domain knowledge needed to work in the field. Rendering objects consistently sterile, whether by chemical, thermal, or radiation-based means, is a highly technical process. It touches on packaging design, statistics, chemistry, and microbiology, along with both fluid and thermodynamics.
Finally, there is the stealth nature of industry challenges. Sterilization tech companies fall clearly in the class of companies that are “underappreciated, undervalued, and misunderstood”, as described by the authors of McKinsey’s recent book, the Titanium Economy. As a society, consumers are hyper focused on product innovation in fields that impact them directly — such as medical devices — but are nearly blind to the processes that create those products — sterilization. This lack of popular awareness translates into a lack of resources and funding opportunities for those working in the space.
So, to summarize why we have not done better than EtO: minimal market interest to address a highly technical and expensive problem that few people outside the industry knew existed.
What is encouraging is that two of the three aspects of that answer are changing rapidly. Both public and private groups are showing intense interest in new sterilization technologies since 2019. For the first time in its 10-year history, the grand winner of the previously mentioned Medtech Innovator 2022 cohort was not a startup with a medical device, but the self-sterilizing packaging company Phiex Technologies. Four more new technologies are making their way through FDA’s Innovation Challenge, priming them to be the regulatory body’s new go-to favorites among EtO alternatives.
While demand and awareness are growing, commercializing and scaling a new sterilization technology remains a tough technical challenge. EtO has 60 years and thousands of different products worth of process data to fall back on every time it is applied to a new device. New technologies will experience sharp learning curves as they scale beyond their current product niches. As these limits are discovered, whether they are material, sustainability concerns, logistics, or simply cost, it is unlikely that a single monolithic solution will swoop in to fill EtO’s place. Innovation is needed not just to find a new “winner”, but to simply meet the highly complex and dynamically evolving needs of medical’s ongoing supply chain disruption.