Carnegie Mellon University

Featured Project: Hopeband

Original Article By Josh Quicksall, Featured in Spring 2019 MSE Update

There is an epidemic. It is prevalent in cities and communities both large and small. And this epidemic is killing thousands every single year: opioid drugs.

Heroin, oxycodone, and fentanyl are among a class of drugs known as opioids. And their widespread abuse is leading to unprecedented rates of overdose death in the United States. In fact, according to the U.S. Department of Health and Human Services, opioid overdose accounted for over 42,000 deaths in the US from 2016-17.

Alongside their client, the pharmaceutical consulting firm Pinney Associates, a group of MSIT-ESE students took on the challenge of developing a technology solution to address the skyrocketing number of overdose deaths each year.

The four members of Team Hashtag, as they dubbed themselves, partnered with their project sponsor Pinney Associates in the fall of 2017 after watching a presentation by Pinney’s Steve Pype and the CEO of Pinney spin-off Harm Reduction Therapeutics, Dr. Michael Hufford.

Pinney Associates is a consulting leader in prescription-to-over-the-counter (Rx-to-OTC) switch, the support of marketed consumer healthcare products, pharmaceutical risk management, abuse potential assessment, and abuse-deterrent drug products. Their team is responsible for the Rx-to-OTC switch of nicotine therapy replacement products, such as Nicorette, in the mid-1990’s.

Just this past year, a non-profit pharmaceutical company, Harm Reduction Therapeutics, spun out of Pinney Associates with the goal of making naloxone, a life-saving opioid antagonist which can reverse overdose, widely available over-the-counter at a low cost.

But while making naloxone widely available is a good first step in combating overdose, there is a catch. “Having naloxone on hand doesn’t matter if you overdose and there is nobody nearby to administer it,” Harm Reduction Therapeutics’ CEO Michael Hufford notes. “Having a cheap but reliable device that can detect overdose could be absolutely central in saving lives. But that is an immense technical challenge. And so we looked to Carnegie Mellon and the Masters of Software Engineering programs to help us address this.”

For their part, the members of Team Hashtag found the project concept exciting, but also daunting. “The project was intimidating not only because it was massive, but also because this wasn’t a project where you could simply deliver the code,” explains team member Puneetha Ramachandra. “There was a burden of real societal responsibility to the project. Lives were on the line. This had to be done properly.”

“I’ve started and sold medtech companies where we had labs in garages. You have to have this can-do spirit; you have to find the way forward. And we absolutely got that from this team. Each time we came back to them they exceeded our expectations "

- Dr. Michael Hufford, CEO Harm Reduction Therapeutics

But developing a solution properly is just what the team did, eventually building a prototype wristband that can detect overdose in the wearer. Using pulse oximetry, the device monitors the amount of oxygen in the user’s blood by measuring light reflected back to a sensor on the skin. When paired over Bluetooth to a mobile phone, the sensor takes numerous readings on an ongoing basis to establish a baseline reading. Then, if the user’s blood oxygen levels drop for more than approximately one second, it switches an LED on the display from green to red. The device also cues the paired mobile phone — via an app which the team also developed — to send out a message with the user’s GPS coordinates to his or her emergency contacts.

While the approach sounds simple enough, the project was not without its challenges. One of the most significant hurdles was simply understanding what constitutes an overdose. “Even if you asked a group of doctors what defines the overdose, even they would struggle to give you a concrete answer,” team member Rashmi Kalkunte Ramesh notes. “They have to physically assess the person for a variety of signals. It was on us to cull those signals and select a method of reliable, accurate assessment. We eventually honed in on a wrist-mounted pulse oximetry device as the best approach.”

And their solution wasn’t just good enough to impress their clients; it was also clever enough to allow the team to beat out 97% of all submissions to the Robert Wood Johnson Foundation’s Opioid Challenge competition, placing them in the finals of the national competition. As a part of the Health 2.0 Conference in September in Santa Clara, the team went head-to-head with some of the most promising, well-funded healthcare entrepreneurs during the final round of competition, ultimately taking home third place and a $10,000 prize.

And while the team is thrilled to have even been a part of the competition, they are equally as excited to see how the device continues to grow and evolve. “There are so many ways this product could be even better,” notes team member Soham Donwalkar. “I can absolutely see additional sensors being incorporated to give a machine learning back end a bigger dataset to work with, reducing the number of false positives, for example. Or, once clinical trials are open, assembling a much larger, more diverse corpus for ML training that encompasses a wide range of physical variables — like age, sex, race, etc. — that could affect what an overdose state looks like!”

At the end of the day, their clients couldn’t be happier. “I wasn’t expecting something that was quite so turnkey,” remarked Pinney’s Steve Pype. “Initially, we were thinking this might be a proof of concept. But here we are: The project is almost finished and they’re still refining the prototype.”

And Harm Reduction Therapeutics’ Hufford agrees. “I’ve started and sold medtech companies where we had labs in garages. You have to have this can-do spirit; you have to find the way forward. And we absolutely got that from this team. Each time we came back to them they exceeded our expectations — they had a solution that worked even better than before; they had a prototype that was even more refined than last time,” Hufford enthusiastically notes “And that’s what a successful start-up feels like. The only way to make it, to generate a lot of return for investors, is to constantly raise the bar. And they did that over and over again. Their passion, humility, dedication, and cleverness is simply so inspiring. Working with CMU and the MSE programs was one of the smartest moves we could have made.”