I had the pleasure to interview Mir Imran, CEO and Founder of Rani Therapeutics. Mir is a prolific healthcare innovator and entrepreneur who has been developing and commercializing breakthrough medical innovations for more than 40 years. Since 1995, Mir’s innovations have been developed at his life science R&D lab and incubator, InCube Labs. As an entrepreneur, Mir has founded more than 23 life sciences companies; 15 of his companies have seen “liquidity events” (IPO/Acquisition). Mir now holds more than 400 issued patents and is perhaps most well-known for his pioneering contributions to the first FDA-approved Automatic Implantable Cardioverter Defibrillator. Mir has received a number of industry accolades for his work including being named one of the most inspiring people in life sciences (PharmaVoice) and one of the “Top 50 Medical Device Inventors of All Time” (QMed). Mir has also been recognized as a fellow for both the National Academy of Inventors (NAI) and the National Academy of Engineering (NAE). He holds an M.S. in bioengineering and a B.S. in electrical engineering from Rutgers. Mir also attended CMDNJ/Rutgers Medical School.
Can you tell us a story about what brought you to this specific career path?
When we spoke earlier this year, we had discussed the impact a summer job during my undergraduate years had on my desire to create medical devices. My time spent developing a communications device for a young girl, living with cerebral palsy, helped me to understand the positive impact my work could have if I focused my engineering talents in the fields of health and medicine. Now, more than 40 years later, I’m still on the path that she helped me to discover.
I also owe a great deal to my mother, who celebrated my inquisitive nature from an early age and provided me the freedom and encouragement I needed to explore and understand. I’d break my toys to take them apart and try to see how various things worked. When other kids would break their toys, they would get in trouble. My mother had a different, creative solution — buy toys in pairs: one for discovery, and one to play. This provided me with an enormous amount of intellectual freedom to explore and learn.
Can you share the most interesting story that happened to you since you began leading your company?
My most interesting stories are those that capture the unique moments of discovery that contributed to the creation of the RaniPill™ capsule. When trying to solve for problems that have never been encountered before, you find that the inspiration for invention can come from the most unlikely of places.
One such discovery came as we were searching for a harmless method of producing the force needed to deploy a needle from the capsule. Like the rest of the RaniPill™, the method for needle deployment needed to be able to safely pass through the body or be naturally digested. We worked tirelessly on creating a solution before the perfect answer was found in a spicy meal – or more accurately, the heartburn I received after eating it.
Feeling discomfort, I dropped two Alka Seltzer tablets into a glass of water. As the tablets dissolved, I quickly realized that the energy of those dissolving tablets was exactly what was needed to provide the force that could power the RaniPill™ and push the needle into the intestinal wall. This moment of inspiration led to a critical piece of the RaniPill technology.
Can you tell our readers a bit about your background and expertise in the healthcare field?
I’ve been immersed in healthcare innovation for the last 40 years. During my career, I have developed and commercialized dozens of medical devices, many of which became standards of care. These include the first FDA-approved automatic implantable cardioverter defibrillator, a low-pressure balloon and aspirator system for preventing embolisms in catheter-based interventions, and the EEG monitoring sensor array used by astronaut John Glenn on his last space mission, among many others. Over the years I have founded 22 life science companies that have led to more than 700 issued & pending US patents. I am passionate about applying the process of innovation to the development of solutions to chronic diseases. Improving the lives of patients is what keeps me motivated.
What makes your company stand out? Can you share a story?
Achieving oral delivery of biologics is considered the holy grail of medication delivery. At Rani, we’re creating something that has never been done. There are no existing blueprints that we can follow. We have to invent process and procedure from the ground up at every step of the way.
This need for constant invention is supported by our approach to innovation and workplace culture. At Rani, we embrace failure and learn from it so that our teams know that experimentation is encouraged and supported.
I define innovation as the process of identifying and understanding of problems, and the ability to frame the problems in a way that solutions can be found. One of the best ways to do this is to leverage the perspectives of multiple disciplines, so that you can gain insight into problems from every angle.
Our approach to innovation has similarities to the approach of the Stanford Biodesign program. There students of different backgrounds come together to shadow a professional – such as a cardiac surgeon – and identify as many problems related to the day-to-day work experience of the surgeon as they can. Because of their different areas of focus, a comprehensive list of problems can be determined, explored, and better understood.
By taking these approaches, we’ve been able to build a culture where innovation can thrive, which has led to the development of the RaniPill™.
Can you share with our readers about the innovations that you are bringing to and/or see in the healthcare industry? How do you envision that this might disrupt the status quo? Which “pain point” is this trying to address?
One of the main challenges to achieving better patient outcomes is compliance. Compliance is often poor, especially when the primary responsibility for administering medicine falls to the patient. However, in the case of painful self-injections, compliance is poor. This can be a significant problem as non-compliance can accelerate the progression of a disease.
Despite their best efforts, pharma companies have yet to solve this problem. Turning a biologic, which requires an injection, into a swallowable pill would see compliance rates significantly improve for millions who must endure daily self-injections. However, given the challenge of delivering biologics orally, this been a problem without a clear solution.
I find myself driven by seemingly unsolvable problems like these. This is why we have invented the RaniPill™, a swallowable robotic capsule that replaces painful self-injections. Rather than trying to convert biologics into oral formulations, we’ve invented a capsule that carries biologics into the digestive tract, and then painlessly injects the medicine into the intestinal wall. This enables us to convert most biologics into pills.
The RaniPill™ capsule has the potential to change the way that treatments such as basal insulin, Humira, human growth hormone and many others are delivered.
Let’s jump to the main focus of our interview.
According to this study cited by Newsweek, the US healthcare system is ranked as the worst among high income nations. This seems shocking. Can you share with us 3-5 reasons why you think the US is ranked so poorly?
The cost of delivering healthcare in the United States is absurdly high when compared with the rest of the world. It’s estimated that Americans spent $3.65 trillion on healthcare in 2018, and the vast majority of that can be attributed to the cost of healthcare delivery. Doctors cost more here. Tests cost more. And because the very nature of a private system means everything is siloed, we’re unable to benefit from the cost efficiencies that come with streamlining systems at scale.
Today patient data is shared only within insular healthcare networks. This lack of information sharing across networks and nationally is a great detriment to the patient’s health when they need to seek care outside of their network. It also leads to increased healthcare costs.
Our healthcare costs are sky rocketing in the United States, in large part due to the chronic disease like obesity, hypertension, arthritis, etc. For example, the CDC reports that more than 100 million Americans are living with diabetes or prediabetes. As a nation, we’re struggling with long-term conditions — and treatment options aren’t within reach for everyone.
You are a “healthcare insider”. Can you share changes that need to be made to improve the overall US healthcare system? Please share a story or example for each.
The healthcare community has been focused on the development of electronic health records for the better part of three decades, but instead of using these records as a document of medical history, e-records have largely been focused on mundane (but important) administrative functions like insurance billing. There are some organizations that are embracing electronic medical histories, but again, these are happening in the confines of the patient’s current healthcare provider. If we want to improve healthcare outcomes and reduce costs, medical histories need to be readily available to all healthcare providers (that a patient authorizes to review them), ensuring a comprehensive understanding of a patient’s history and, ultimately, a patient’s needs.
In the treatment of chronic conditions, there has been a revolution in biologic medicines and gene therapies in recent years. These have become highly effective and have had an amazing impact on the management of chronic disease. But these are often prohibitively expensive, leaving many patients to needlessly suffer with worsening conditions. We have a larger problem of access, preventing many patients from benefiting from the best possible healthcare.
It’s worth noting, however, that financial barriers aren’t the only thing limiting access to consistent quality care. Quality of care can vary greatly. What is available to a patient in an urban center isn’t likely to be the same as what is offered to a patient in rural America. But if we want to improve the health of the nation, we need to make a commitment to a consistent quality of care regardless of where it is taking place.
Ultimately, it all boils down to one top-level change: we need to be taking a holistic approach to health care. All too often, we tend to focus on single issue concerns, like the cost of prescriptions. If we step back and approach health from a holistic viewpoint, there are numerous processes and approaches we could be taking to improve the effectiveness of our health system, while also reducing the cost burden for all involved.
It’s great to suggest changes, but what specific steps would need to be taken to implement your ideas? What can individuals, corporations, communities and leaders do to help?
Insurance companies and Medicare should be taking actions to support the development of new and better therapies for chronic conditions. This can help to increase access while ultimately reducing the long-term cost burden on the healthcare system, a benefit to both insurers and patients alike. In the short term, they should be working on solutions to reduce the cost of existing therapies in pursuit of the same overall goal.
There’s value in advocating for the advancement of universal standards in the US that can improve healthcare outcomes. This would require intervention at the federal level. If a unified system of medical records, as well as the establishment of unified standards of care were embraced and implemented, patients across the US could come to count on a more consistent approach regardless of which provider they might choose. There is a lot more to cover on this topic than we have just done. My final thought for today…perhaps one of the biggest factors affecting healthcare of all is good diet and exercise!
What are your favorite books, podcasts, or resources that inspire you to be a better healthcare leader? Can you explain why you like them?
I have many interests – history is one of my favorite subjects. One of the best books on US history is Howard Zinn’s The People’s History of the United States. More recently I have read Blueprint by Nicholas Christakis and Sapiens by Yuval Noah Harari.
I’m also deeply interested in understanding how various chronic conditions impact patients and their families. Seeing medicine from the patients’ eyes is very powerful, and is an important lens for my work.