INNOVATIVE HEALTH STRATEGIES

A novel product designed for opioid overdose rescue

Innovative Health Strategies developed a wearable, compact and auto-injecting opioid targeted device for overdose rescue

Welcome

We are a small but diverse group that brings together medical, engineering and business skills to create products that improve life. We are a think tank matching needs and opportunities with our collective abilities to real life solutions. 

We are currently directing our efforts toward reducing the increasing societal burden resulting from deaths due to opioid overdoses. The opioid use disorder has been designated as a worsening epidemic by the CDC with over 109,000 deaths in the USA alone due to opioid overdoses in 2021, and an approximate economic cost of over 500 billion dollars. Unfortunately, most overdoses are unintentional, may occur unwitnessed, and/or in the absence of antidote, and the rapid onset of cognitive dysfunction and unconsciousness that frequently accompany an overdose may render self-administration of antidote impossible, even if available.  

To address the question of how deaths due to opioid overdoses can be better prevented, we have designed a non-invasive, wearable, compact (4x3x3 cm) device that has the capacity to monitor, 911-report, and automatically treat opioid overdoses. Our system is fully described in a recent report (Hypoxia driven opioid targeted automated device for overdose rescue. Scientific Reports 11:24513, 2021). 

Evolution of the Opioid Crisis

The opioid addiction rate in the United States was estimated at 6.2/1000 in 2018. The age-adjusted rate of opioid overdose deaths in 2021 was ~ 30.3/100,000. From 1990 to 2017 over 500,000 deaths were due to opioids, greater than 90% of which were unintentional (JAMA). 

Data from the Center for Disease Control (CDC) suggest that three distinct waves of drug abuse have shaped the continued rise in opioid related deaths. The initial wave of opioid overdose deaths occurred in the 1990s and primarily involved prescription opioids. Misinformation about the addictive potential of opioids, together with a lack of medically sound data related to how to better control chronic pain led to overly ambitious prescribing of opioids, and with it an increase in opioid abuse, and opioid related deaths. Spatially, the very nature of drug accessibility resulted in clustering, that is, led to pockets of opioid abuse within communities. 

Greater vigilance by State agencies in the monitoring of physician prescribing habits, and the increasing demand for providers to employ an evidenced based approach to the treatment of chronic pain syndromes, led to a reduction in the availability of legally dispensed opioids. Ease of access to, and lower cost made heroin increasingly the opioid of choice for abuse in the early 2000s. Beginning in 2010 heroin eclipsed prescription pain killers as the dominant cause of opioid overdose deaths.

The third, and current wave contributing to opioid related deaths occurred in 2013, and involved the influx of synthetic opioids, particularly illegally manufactured fentanyl (IMF), made largely in China, and distributed to the United States from Mexico. IMF is relatively easy and inexpensive to synthesize, and approximately 100x more potent than morphine. Of the 100,000 opioid overdose deaths recorded in 2021, 73% involved synthetic opioids, such as IMF. Given the widespread availability of the synthetic opioids, their potency, and relatively low cost, it is not surprising that the opioid crisis geographically has become fairly widespread throughout the United States, although regional clustering is still observed. 

Economic Impact of the Opioid Crisis

Economic impact of the opioid crisis and opioid related overdoses

A number of models have been used to quantify the cost of the opioid crisis based on methodology proposed by the Council of Economic Advisors. Most of the models take into consideration (a) criminal costs, including the economic burden that derives from both prosecution, and imprisonment, (b) health care costs over and above those incurred by non-addicts, (c) costs associated with child welfare and family assistance, (d) governmental costs in the form of education, and (e) lost wages resulting from a lack of productivity. Given that there are over 2 million opioid addicts in the United States, it is reasonable to conclude that the overall cost of the opioid crisis is hundreds of billions of dollars annually.

If one focuses on health care costs of overdoses alone, opioid related emergency room (ED) visits were 178 per 100,000 population in 2014 as estimated by a National Health Care Statistics report, and comprised between 0.4 and 0.9% of all ED visits. About half of the visits involved individuals under the age of 34, with almost 80% involving those under the age of 54. Approximately 57% were males. A striking statistic is that 8% of those admitted to the ED with a diagnosis of opioid overdose died within a year. The figures for in-patient stays in 2014 were 224.6 per 100,000 population, with an annual growth rate of 5.7% since 2005. As one might expect, there was a direct correlation between ED visits and in patient hospitalizations (r=0.85).

The per capita cost of a non-fatal overdose was estimated at $198 in 2018. The opioid related mortality cost that same year was $1838 per capita. Thus, the real health care cost of opioid related overdoses in the United States, which includes both non-fatal and fatal overdoses, has been estimated at $666 billion. Given the fact that both ED visits, and hospitalizations for opioid related overdoses have increased steadily over a decade, the former figures significantly underestimate the current economic burden of opioid related overdoses. 

Our Vision and Our Role

Our vision for the future in dealing the opioid crisis, and our role in mitigating opioid overdoses

The strategies that have been employed in the United States heretofore to mitigate the opioid crisis have clearly not been successful in reducing overdose deaths, and suggest the need for a new approach to the opioid crisis. If opioid addiction is viewed as a medical illness, rather than a crime, one approach to stemming the rising tide of opioid related deaths would be to invest in multidisciplinary rehabilitation centers that offer novel approaches to addiction treatment, in addition to traditional methods of therapy. In such centers, services would continue to be provided by addiction specialists, behaviorists, and social workers, and psychological counseling together with both medically assisted and non-medically assisted therapy would still be made available. For those who choose to enter the medical arm of therapy, conventional suboxone, and methadone would be dispensed, as is currently being done. However, for those who select the non-medically assisted arm of treatment such centers would offer the alternative of wearing our device.  

Because this group is at the greatest risk for recidivism, those who opt in for wearing the device would be subject to rigorous admission and follow up procedures. Our device depends on the level of oxygen saturation in the blood in order to detect an overdose, as monitored by reflectance pulse oximetry. Oximetry readings are continuously monitored by a microcontroller, which simultaneously sends a GPS-trackable 911-alert, and administers opioid antidote once significant oxygen desaturation is detected in the wearer. We have chosen an oximetry reading of 90%, which corresponds to a partial pressure of oxygen in arterial blood of ~60 mm of mercury, to trigger the device alarm. This value in otherwise healthy individuals is a sign of severe hypoxia, and an indication of an opioid overdose in this setting. To enhance the specificity of our alarm, we would initially only enroll candidates for wearing the device who, by history and physical exam as well as baseline oximetry readings, have normal cardiopulmonary function. As our experience grows, we subsequently envision tailoring use of the device to those with manifest evidence of disease providing the balance of safety and efficacy permits. 

Following entry into the device arm of non-medically assisted therapy, individuals would be followed up in clinic on a daily basis, at which time the device would be interrogated for compliance. (The device can be interrogated, both in real time and retrospectively to ensure compliance of use.) Subsequent visits would be incrementally extended to a maximum of 2 weeks at the discretion of the attending, at which time system use will be assessed, and device components will be replaced as needed. The device is meant to be worn 24/7. Individuals who fail to wear the device, as prescribed will be given a warning, and removed from the protocol in the event of continued non-compliance. Individuals who overdose will be given counseling, and placed on probation. In the event of a second overdose, they will be removed from the device arm of the clinic, and referred for medically assisted therapy. The device is sufficiently compact, being 4x3x3 cm, to be easily covered with adhesive cellophane to permit bathing

We view the device’s role as a means of facilitating the journey towards becoming opioid free for those individuals who elect not to enter a medically assisted arm of therapy. Since these individuals are at high risk for recidivism, we envision the device functioning as a fail-safe to prevent fatal opioid overdoses. If our goal is realized, the economic savings alone will more than justify its use. 

About Us

Charles Bandoian, MBA CMA Chief Executive Officer

Charles Bandoian has a Masters Degree in Business Administration from the University of Windsor in Windsor, Ontario, a Honors Bachelor of Commerce from the University of Windsor in Windsor, Ontario and a Bachelor of Science in Chemistry from the University of Windsor in Windsor, Ontario. Charles has a wide variety of experience in health care and social service organizations. His experience includes serving as Chief Executive Officer for Innovative Health Strategies, LLC, Chief Executive Officer for Heartland Health Service, a Federally Qualified Health Center Peoria, Illinois, Chief Financial Officer for Access Community Health, a Federally Qualified Health Center, Chicago, Illinois ,Executive Vice President of Administrative Service for One Hope United, Chicago, Illinois, Vice President of Finance for the Family Link, Inc., Chicago, Illinois and Comptroller for Lagrange Memorial Hospital, Lagrange, Illinois. Charles is a Certified Management Accountant and a member of the Institute of Management Accountants. Charles cares about the Opioid crisis, Innovation, Health, Social Services, and Science and Technology

Thomas J Santoro MD, Chief Medical Officer

Dr. Santoro received the MD degree at New York University. He trained in Internal Medicine at Duke University Medical Center, and did a Fellowship in Rheumatology at the National Institutes of Health. During his 30-year tenure in academic medicine, Dr. Santoro wore the hats of clinician, educator, biomedical researcher, and administrator. He held faculty positions as Professor of Medicine at the Medical College of Ohio (University of Toledo), the University of North Dakota School of Medicine, and the University of Illinois Chicago (Peoria campus), where he also served as Associate Dean for Graduate Medical Education. He is the author of over 50 peer-reviewed publications, and is listed in Marquis Who’s Who in America. Dr. Santoro joined Innovative Health Strategies in 2019 because of its commitment to providing unique solutions to medical problems that impact society, both socially and economically. His particular area of interest is in mitigating the rising death toll due to the opioid use disorder. 

Mohammad Imtiaz, Chief Engineering Officer

Mohammad Imtiaz received a Doctor of Philosophy (PhD), Biological and Biomedical Sciences, Biophysics from The University of Newcastle, Australia and a Bachelor’s Electrical Engineering from Wichita State University, Wichita, Kansas. Mohammad’s experience includes Assistant Professor Bradley University, Peoria, Illinois, Assistant Professor, University of Illinois College of Medicine Peoria Illinois, Conjoint Senior Lecturer, The University of New South Wales, Sydney, Australia, Senior Postdoctoral Scientist, The Victor Chang Cardiac Research Institute, Sydney, Australia, Conjoint Senior Lecturer, The University of Newcastle Australia, Newcastle, Australia. Mohammad cares about the Opioid Crisis, Civil Rights and Social Action, Disaster and Humanitarian Relief, Economic Empowerment, Education, Environment, Health, Human Rights, Poverty Alleviation, Science and Technology, and Social Services

Our Device

Hypoxia Driven Opioid Targeted Automated Device for Overdose Rescue

 This device is designed to be compact, wearable and attaches to the skin adhesively. It continuously monitors the physiological state of the wearer for an opioid-overdose. Upon detection the device injects the antidote, and alerts first responders.

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