Elana Gordon and David Ovalle’s October 2024 piece in the Washington Post “Fatal overdoses often happen when users are alone. Hotlines, sensors can save lives.” Provides an excellent overview of the challenges in identifying and treating opioid overdose in a timely manner, as well as the many solutions in existence and in development to address this plague of unwitnessed overdoses.
This article also provides an excellent third-party perspective on the risks and challenges for a technology like ours, principally or primarily:
At Resilient, we agree that these are risks, all businesses, and especially startups face risk, and we would like to share our approach in how we are mitigating these risks.
When Charlie and I started Resilient Lifescience in 2022, we thought our first FDA application would be for the Resilient System, our closed-loop device that can detect and reverse an opioid overdose with a subcutaneous injection of naloxone. Since then, we’ve realized that we can get to market faster (and therefore help people sooner by breaking our FDA application to three stages:
Not only does this approach get our products to market sooner, but it staggers the expenses associated with the clinical studies that use Resilient Technology. An additional benefit to this approach is that when we submit the final FDA approval application for the Resilient System, The FDA will already be confident in the performances of our Resilient Pulse and Resilient Monitor. Therefore, we believe that the final approval will be less challenging than if we’d presented the Resilient System without the two previous predicate devices.
One question we’ve received related to this approach is “will there be a market for just the overdose detection technology without the naloxone administration?” - Our response is “yes”; if you reference David and Elana’s article, you’ll see people are already taking advantage of motion sensors, the Never Use Alone Hotline, and Products from the Brave Co-op to detect an overdose and call for emergency response. These products are all currently in use and saving lives today. We expect the Resilient Monitor to join this range of products to protect individuals at risk of overdose.
We’ve taken two key approaches to ensuring there will be demand for Resilient Tech once it’s on the market:
While the article cites sluggish sales of the Masimo Opioid Halo, it’s important to understand the background of that technology. The Opioid Halo was born from a 2018 FDA innovation challenge to develop products to combat the opioid epidemic.
Masimo, who’s core business is selling patient monitoring systems to hospitals and other care providers, entered this challenge by building a software application to work with the hardware from their existing Radius PPG, which is a monitor for patients in an ambulatory care setting. So while the software is groundbreaking and has great potential to save lives, the hardware aspect of the product was not designed for the specific needs of people who use opioids; either prescribed or not.
Our technology is designed from the ground up for people who use opioids.
In preference testing that compared Resilient’s form factor to the Masimo Opioid Halo (as well as other technology in development), 74% of participants strongly preferred the Resilient form factor to other worn devices.
To date, we have successfully:
Our research has generated important insights that make us confident in the future adoption of Resilient Technology:
Despite our significant research to date, there’s nothing like actual sales to demonstrate the market for a product. Higher-fidelity sales testing tools such as pre-orders are not allowed for medical devices before FDA approval, so the next significant opportunity to prove this market will likely be early sales of our FDA approved technology.
Every business (and especially every startup) carries inherent risks. We believe that by thoroughly understanding these risks, and taking steps to mitigate them as early as possible, we can ensure our future success.
