Soapbox

New Technologies Tackle Big Global Health Threats

By Robert Ward
November 18, 2019


• Categories: 04-Product Design & Development, 05-Quality/Regulatory, Business Analysis, Combination Products, Market Access, Soapbox

Sepsis is a life-threatening medical emergency that is non-discriminatory. The progression from infection to organ failure to septic shock is swift and claims the lives of 6 million people, globally, each year. The CDC even warns that, “anyone can get an infection, and almost any infection can lead to sepsis.” Due to this inherent risk, we need to encourage innovation in the medical world that brings solutions to stop sepsis in its tracks.

There are a number of treatments we can deploy to help those infected, but the reality is that sometimes our tried and true methods are not so fool proof. Antibiotic resistance is on the rise and is an increasingly alarming epidemic that further complicates effective treatment. It is estimated that nearly 2 million Americans are infected with antibiotic-resistant microbes each year—that is more cases than there are people in Rhode Island.

The process from initial discovery to clinically approved medicines is lengthy—nearly two decades—and it is difficult to reach success. While researchers and developers of pharmaceuticals are testing new compounds, there has not been a new, approved class of antibiotics since 1980.

The medical community has its work cut out, but there is still a lot of promise.

We live in the age of advanced, data-driven technology, and the medical world is the perfect area to deploy such methods to save lives and improve overall care.

Early Detection Using AI

It is essentially a race against the clock when it comes to combating sepsis and antibiotic-resistant superbugs. Like any ailment, identifying the issue early on allows for treatment to be more effective and successful. Testing for sepsis can take up to three days before the results can be identified. While doctors and nurses are highly trained to look for the early signs, sepsis can fly under the radar, delaying treatment.

Sepsis Watch, developed by the Duke Institute for Health Innovation, employs artificial intelligence and machine learning to assess a patient’s unique data, including vital signs, lab test results and medical histories, in real-time. The Duke University Hospital completed the initial phase of their pilot program in their emergency department with a promising outlook for the future. The result? Clear and accurate identification of the early stages of sepsis, giving medical professionals the gift of time.

Multi-dimensional Treatment

Researchers recently confirmed that bacteria can change shape while inside the human body, providing further evidence to the concern that antibiotics can have limited effectiveness as a standalone treatment, further compounding the rise of antibiotic resistance as one of the biggest threats to global health. The World Health Organization predicts that antibiotic resistance could lead to 10 million deaths a year by 2050. While it’s clear we should continue being good stewards of current antibiotic methods and encourage the development of new antibiotics, the fact remains: Evolution proves that our bodies will resist at some point.

Treatment can no longer be one-dimensional. Pairing antibiotics with medical devices designed to treat patients with both drug-resistant and drug-susceptible bloodstream infections is the comprehensive solution we need to move towards.

One such technology is a blood filter designed to remove pathogens from the bloodstream—of the type of pathogens that can make sepsis and antibiotic-resistant superbugs so difficult to treat. As the filter works by simply “filtering” dangerous pathogens out of the patient blood, it works on a wide spectrum of pathogens and does not promote ongoing antibiotic resistance or germ mutations. As a patient’s blood flows through the device, it passes over beads that mimic the receptors on human cells that pathogens use to colonize when they invade the body. The pathogens are captured and adsorbed quickly.

The device just earned CE Mark in the European Union, and the company expects that FDA approval is not too far behind. The goal is to address the unmet need for quick and effective treatment options for bloodstream infections while avoiding furthering the threat of antibiotic resistance.

Fostering a Technological Evolution

The outlook on sepsis and antibiotic resistance is dire, but there is plenty of opportunity for more advances. We in the medical community must encourage innovation and creativity to battle our biggest health threats.

What can we do in the medical and technology communities to encourage innovation?

• Hire the best: Bring together diverse and hungry talent with the right skillsets.
• Challenge each other: Question everything to enable problem solving and further development.
• Partner with other innovators: We are stronger together and should take advantage of what we collectively bring to the table.

We know that there is enormous energy and work developing new technologies and treatments across the spectrum of healthcare. Applying the predictive trend of Moore’s Law would suggest that the rate of growth of new ways to treat a disease that is one of the most expensive in the hospital and the most catastrophic to patients will continue to progress. I’m optimistic that what we have in front of us now, along with what is surely to come, will one day make sepsis something far less consequential than it is today. And I welcome that day.