The prescription opioid overdose crisis in America didn’t start until the late 1990s, when pharmaceutical companies touted prescription painkillers that weren’t supposed to be addictive. As a result, medical professionals more frequently prescribed opioid painkillers.
Since then, opioid-related deaths have seen a steady increase. From 2000 to 2014, nearly half a million Americans died from a drug overdose, according to the Centers for Disease Control and Prevention. More than 50,000 people died from a drug overdose in 2015. Of those deaths, 33,000 were opioid-related.
The Council of Economic Advisers reports that the opioid crisis had an economic cost of $504 billion in 2015, and prescription opioid misuse increased healthcare and substance abuse treatment costs by $29.4 billion.
“A key solution to the current national crisis of opioid abuse is providing access to alternative pain management solutions for the people who need them,” said Shaye Mandle, CEO of the Minnesota-based Medical Alley Association. “The medical device industry currently delivers many non-opioid alternatives and can play a leadership role in addressing this epidemic.”
Medtech could play a role in helping to curb the opioid epidemic with new technologies being developed to treat chronic pain and reduce opioid prescription abuse. There are hundreds of devices and technologies currently on the market that are designed to reduce pain. These include technologies that treat acute pain, technologies that treat chronic pain, devices for medication management and pill dispensing, diagnostic tests that can monitor overdose risk, and technologies that monitor withdrawal and prevent overdoses.
“To understand the role that medical devices can play in pain management, it is important to at least understand the basic mechanism of action of opioids,” said Cary Vance, CEO of Fremont, Calif.–based back pain device company Myoscience. “Opioids act as an analgesic by inhibiting the neurotransmitters; in layman’s terms, they disrupt the pain signal transmission to the brain. Opioids may also help in reducing inflammation of the joints. Unfortunately, the action of opioids is not limited to the peripheral nervous system. They have a significant effect on the central nervous system as well. Their effect on the central nervous system can lead to extended and unwanted dependence on these drugs, even after the initial purpose of taking these drugs has been resolved.”
Medical devices for treating pain couldn’t come soon enough. In order to get to the point where devices can be used regularly to treat pain instead of prescription medication, there are some hurdles that medical device companies need to overcome.
“It is important to understand the cause and mechanism of pain,” Vance said. “The devices can then be designed to address the specific situation rather than have a one-size-fits-all solution. Also, it is important to keep the treatment localized to minimize any unwanted side effects of the treatment.”
Here are five ways medical devices are already showing promise treating pain:
1. Using cryoablation to stop pain signals
Myoscience uses cryoablation therapy to ablate signal-carrying members of nerves, stopping pain signals from traveling to the brain. Its Iovera system is able to treat several different nerves in the body for pain relief without the need for prescription opioids.
“It is very important to identify the source of the pain and the nerves involved in transmitting the pain signals to the brain. Once identified, it will be easier to isolate and treat only those specific nerves,” Vance explained.
2. Neurostimulation to treat chronic pain
Nevro’s HF10 Therapy is a chronic pain relief system that involves spinal cord stimulation. Mild electrical pulses to the nerves help interrupt the transmission of pain signals to the brain, which in turn can reduce pain. Doctors implant a small device that transmits mild electrical pulses to the spinal cord wirelessly. The pulses from the device are designed to calm the nerves and reduce pain signals to the brain. The company reports that the average opioid intake of patients was decreased by nearly 70%, and the percentage of patients not taking opioids by two years had gone from 14% to 42%.
“The largest challenge is the development of robust evidence that can influence guidelines and impact physicians’ clinical practice,” said Dr. David Caraway, chief medical officer at Nevro (Redwood City, Calif.). “Although spinal cord stimulation has been around for over 40 years, the amount of rigorous comparative evidence has been limited until recently.”
3. Non-invasive pulsed electromagnetic energy
While neurostimulation is one of the most common opioid-free pain management solutions, there are other devices that have taken another route.
Regenesis Biomedical (Scottsdale, Ariz.) created the Provant therapy system. The Provant therapy system is a non-invasive medical device that delivers dual-field pulsed electromagnetic energy to an area of pain for a therapeutic and drug-free solution. It reduces pain by inducing the natural endogenous opioids that form in the body to reduce pain. It can be used at home, twice a day for 30-minute increments. The system is recommended for use in treating postoperative pain and edema of soft tissue and is available through a prescription only.
4. A non-opioid pain relief pump
Halyard Health (Alpharetta, Ga.) developed the ON-Q pain relief system for post-operation pain relief. ON-Q is a non-opioid pain relief pump that can give a patient over three days of pain relief after surgery. ON-Q delivers an automatic, regulated flow of a local anesthetic through a specially designed catheter inserted near the surgical site or close to nerves. It also offers customizable control for personalized, continuous pain relief throughout the procedure and recovery.
5. Bedside pain management
Avancen (Mount Pleasant, S.C.) is tackling the opioid problem right from the recovery room with its MOD bedside pain management system. The system is a secure wireless patient-controlled analgesia device that houses eight doses of the patient’s pain medication and is safely secured on an IV pole. Each patient using the system is assigned a radio frequency identification wristband that is registered just to them through the device’s software program MODTrac. Clinicians enter the dosage and frequency of the medication into the system, and at prescribed lock-out time intervals, a green light will illuminate to let the patient know that they can take the next dose of oral medication, if needed. An hour after the patient takes their medication, they are asked to rate their pain on a scale of one to 10. Clinicians can then gauge how the medication is working for them.
“Data and changing behaviors is what will drive the cure for the opioid epidemic. This is based on our need for a cultural change,” said Thomas Hickey, director of business development at Avancen. “Up until this point, it has been the practice of many of the medical staff in hospitals to send patients home with a 30- to 60-day supply of opioids. This practice has occurred because the medical staff has no empirical data to rely on. In other words, that’s the way we have always done it.”
What aren’t more pain sufferers using medical devices?
More medical professionals need to become aware that there are medical devices to treat pain, according to Vance at Myoscience.
“Since the use of medical devices is recently being recognized as a viable option for pain management, very few healthcare providers are aware of what’s available,” Vance said. “So, access to such treatments and technologies can be challenging.”
Barriers to adoption include access, awareness and overcoming existing physician perceptions, according to Caraway at Nevro.
“Currently, opioid medication is easily accessible and able to be prescribed by primary care providers,” Caraway said. “In contrast, to administer spinal cord stimulation, a patient must be qualified as a candidate and be implanted by a trained pain specialist or surgeon.”
The FDA, Centers for Medicare and Medicaid Services and the President’s Commission on Combating Drug Addiction and the Opioid Crisis have all listed medical devices as a potential solution to the opioid epidemic. Even with government’s supportiveness around using medical devices to treat pain, it still takes a while to achieve regulatory approval and reimbursement from payers.
“Medical devices are regulated by the FDA and reimbursed by payers such as Medicare (CMS). The FDA and CMS are being collaborative in the process for gaining clearance and coverage to market devices,” said Scott Robey, VP of marketing at Regenesis Biomedical. “The requirements to bring a safe, non-drug solution to these patients are costly and time consuming. And for an emerging company with resource constraints, a more timely, transparent and collaborative process will help accelerate solving the opioid crisis.”