iPill Co-Founder John Hsu on Solving the Opioid Crisis at Home

Medication adherence costs $105 billion per year.  iPill uses remote monitoring technology to address opioid abuse and diversion to combat the opioid crisis.

As a physician, when some patients came to clinic early after finishing their opioid supply, they would demand more opioids. When I told them that I was worried about dependence and addiction, some would threaten bodily injury or bad reviews or bad satisfaction scores. Going home after a particularly difficult clinic, I used a card fob to drive and get dinner. I went to the bank automated teller machine (ATM) to get money. Eating alone, I asked myself how I could make my practice better — couldn’t I just duplicate the process? Break into a bank ATM and the bills are sprayed with a purple dye. In the hospital, we use a DEA-approved solution to destroy unused pills. The solution was born. I could use a mobile app as a biometric key to access a dispenser that would only dispense opioids to the patient I prescribed at only the prescribed dose and time. Secure storage, active control dispensing, and destruction of unused pills at tampering and prescription expiration to reduce potential for abuse and diversion. Lives could be saved, medical expenses reduced, and healthcare could be improved.

Almost 30 years as a physician in anesthesia and chronic pain management has taught me about the difficulties of medication management and patient compliance around prescribed opioid therapy. It has given me domain expertise around the problem. 

 My experiences as a person and understanding of people gave me the experience to put several ideas together to develop iPill. Building the startup was a learning process. There are several parts to learn including FDA regulatory affairs, patent and contract law, mechatronics engineering, software, hardware, marketing, supply chain, commercialization, distribution, and the very complicated US healthcare system. I reached out to great mentors to increase my knowledge around these topics and because of the social impact of the project have actually come on board as team members. So although it may appear as though this is a founder driven startup, I have a full team working together to push forward the iPill to success. My experiences in another startup influenced my decision to step away from medicine to be the CEO of iPill.

I hope the iPill will improve medication adherence. The child-resistant cap was developed by Dr. Herni Breault in 1967 and made a federal mandate in 1970. We sent a man to the moon in 1969 — but haven’t upgraded the child-resistant cap for 54 years. Each day 130 people die from opioid overdoses, and 67% of patients who overdose do not have an opioid prescription. It has gotten so bad that one in four opioid overdoses now involves children and teens.  

We need to address the opioid crisis with another approach. Currently we use Narcan, for overdosed patients and Suboxone for addicted patients. This is treating the symptoms without addressing cure. That is one of the reasons why the opioid crisis is 20 years old with yearly double digit increases in the overdose death rate.  

My vision for the future is that we do things “differently” so we can save lives, reduce the $696 billion dollar price tag for addiction, and improve care.

Building the team has been very satisfying. We are experts in different fields that have come together as friends with a common goal. All of us have been affected by the opioid crisis and feel the need to put aside other activities and devote ourselves to the iPill. Having team members who know what is needed to be done makes my job as a CEO shift to the chief encouragement officer. The team includes:

• CTO Aliasgar Morbi, Ph.D. Mechanotronics engineer
• COO, Chris Baker, MBA McKesson supply chain, Marketing
• Board member, Sherie Hsieh, BS, Toxicologist 
• Board member, Nick Spring, BSc,  med device and pharma
• Board member,  Peter Weinstein, PhD, JD, Legal counsel
• Consultant Business development, Lacarya Scott, MS, MBA
• Consultant Channel development, Romy Seth, BASc BSc, 
• Consultant FDA regulatory, Ginger Cantor RAC, MBA
• Consultant FDA Pharmacy Regulatory, Robert Nickell, Pharm D
• Consultant Quality systems, Kyle Rose, MBA
• Consultant Design Engineer. Bruce Sargeant, BSEE
• Consultant Manufacturing, Tony Chang, BS 
• Consultant Cybersecurity HIPAA, Matthew Clark, BS
• Consultant Marketing & Government outreach, Sean Evins, MBA 
• Consultant Commercial, Chris Buckley, BA 
• Consultant Software, James Yang, BS
• Consultant Scientific Advisor, Daniel Sessler, MD Clinical

MedicaSafe and TAD by Intent Solutions are two closest competitors. There are many pill reminders which are passive dispensers. MedicaSafe, TAD, and iPill are active pill dispensers. iPill is   different from a clinical and reimbursement perspective. iPill enforces medication adherence. We use two-point biometric authentication. This means that the person prescribed is the only one that can access opioids, and they can only access the prescribed dose. We utilize the patient’s own smartphone to reduce costs. We destroy unused pills on tampering and at prescription expiration, so abuse and diversion are significantly reduced. Break into the Medicasafe and TAD devices and all the opioids are accessible by anyone — which makes them realistically an expensive child-resistant cap.

Because we are a FDA-designated breakthrough product and the Centers for Medicare and Medicaid services announced on August 31, 2020 that they will cover reimbursement of FDA-designated breakthrough products, we will be the only dispenser covered by insurance.

iPIll is a B2B company. There are four market verticals including dentist practices, addiction rehab treatment centers, clinical research organizations, and pharmacy insurers. Our goal is to start with pilots and then convert pilot users to customers. We will take the data gathered to conferences and publish papers on the success of the pilots. We’ve spoken to a dental consortium who wants to use the iPill as a tool to reduce abuse and diversion in teens after wisdom tooth extractions. Addiction rehab treatment centers want to use the iPIll as a tool to reduce the 91% relapse rate and $20,000 per year per patient on transportation cost to methadone/Suboxone clinics. Clinical research organizations see the iPill as a tool to improve patient compliance and thus the accuracy of the study data. They will use the iPill to record when patients take study drugs to improve pharmacokinetic and pharmacodynamic data. Pharmacy-insurers see iPill as a tool to decrease the cost of healthcare in their abusing and addicted members. Currently, it costs $19,333 per year per abusing patient in healthcare costs. Each opioid overdose death costs $1.8 million because of the 119 ER visits and 22 hospitalizations associated with an overdose.

It has been difficult to raise money in the opioid sector despite a 29% surge in opioid overdose deaths from the COVID-19 pandemic. I need to raise it quickly to get to market quickly. Each day we delay 130 people who are no longer with us tomorrow. I need help now.  We cannot wait for the government to pass legislation. We cannot wait for investors. iPill is today’s solution for tomorrow’s problem.

Investors have not financially supported innovations recently for fear of litigation from the US Department of Justice.The National institute of Health (NIH), the National Institute for Drug Abuse (NIDA) and the National Science Foundation (NSF) have all been approached by professional grant writers. They have all declined to fund any submission. They reason that there are many addicts that need treatment. Research needs to be supported to find a better treatment. Unfortunately, research has been unsuccessful. Despite Congress appropriating more than $30 billion in the last three years alone to these government agencies, the fact remains, the opioid crisis is 22 years old and has a yearly double digit increase in the overdose death rate. So, we have turned to the people, the 1 in 3 people in the US who knows someone who has an opioid use disorder.

 iPill is between the pharmacy and the patient — where abuse and overdose actually occurs.  We can make the most significant impact to improve care and save lives because there are no rules for monitoring self administration of opioids, no active control dispensing of dispensing to the person prescribed opioids, and no safe disposal options for patients who want to get rid of unused opioids. 

There are those who complain about the opioid crisis and portion blame to doctors, dentists, pharmacies, opioid suppliers and opioid manufacturers. Opioids are drugs that we cannot live without. Pain must be treated appropriately. All of us at iPill are the ones that will roll up our sleeves, sacrifice our time and energy to develop a solution, and make the difficult decisions to ensure it becomes a reality.

In 5-10 years, we see the patient safety of using opioids in the hospital extended to the home. In hospitals and pharmacies, opioids are triple locked in OMNICELL and PYXIS devices for secure storage. Our exit plan is to approach these two companies and demonstrate how we could extend the business plan of devices in the hospital to the home.  

The future goal of the company is to upgrade the child-resistant cap from 1967. We plan to demonstrate the proof of concept of secure storage, active control dispensing, and safe disposal of unused opioids by destruction on tampering and prescription expiration. We hope that all addictive drugs will be dispensed in the iPill as a new standard of practice.