…no doctor or nurse should be “bonused” money by the hospital if they perform certain procedures. For example, giving a nurse a bonus because he/she installs a certain number of PICC lines per month and increasing reimbursements will produce an outcome of more complications due to PICCs.
Asa part of my interview series with leaders in healthcare, I had the pleasure to interview Gary Warren. Gary is the president and CEO of ivWatch, who has championed the development of a non-invasive device that fulfills a huge unmet patient safety need in health care. On a mission to improve patient care, Warren pulls from his personal patient journey and years of professional leadership in rapidly emerging markets to inspire a movement of change in healthcare. For more than 30 years, he has gained extensive experience practicing engineering and business disciplines within a range of environments, from startups to large public companies as well as government programs.
Can you tell us a story about what brought you to this specific career path?
I worked for 14 years at NASA, led teams running advance concepts at Symantec, one of the world’s largest software companies, as well as supported venture-backed startups in tech. I have been successful in some entrepreneurial pursuits and have failed when failure was toxic. I had been told many times throughout my life that “you can’t have both” when it comes to mathematical aptitude and business acumen. However, I was able to build on both my engineering and business skill sets, and without them, I wouldn’t have been in a position to bring a promising technology through the commercialization process and start a biomedical technology company.
Can you share the most interesting story that happened to you since you began leading your company?
I started ivWatch a little over eight years ago. Three years later and well into a quest to solve this large unmet need in vascular access, I took a headfirst fall from about seven feet. I was seriously injured and required the reconstruction of my right forearm and elbow with an unplanned gall bladder removal in the middle of this nightmarish experience.
Over the past five years, I have had eight surgeries at several top-rated hospitals with half of these surgeries due to complications from previous surgeries. I used to joke with people that no one dies from a broken arm until I started this spiral down in health which included a deep Staphylococcus Aureus infection from an implant followed by a pulmonary embolism caused by a catheter. My broken arm turned into a series of life-threatening complications. All of a sudden, I was a deep participant in our healthcare system experiencing the exact problems I formed a company to try and solve. It became real. It became personal.
I sit here today with a limb causing me persistent issues and feel the lasting effects from the blood clots that lodged in my lungs caused by a peripherally inserted central catheter (PICC) line. On top of that, I’ve experienced more intravenous infiltrations from drugs such as radioactive dyes, contrast agents and antibiotics than I can recall.
I cannot find any of these IV complications in my health records. When I complained about a painful IV, I was ignored. When I asked to not have a PICC line put in, I received one anyway. Thinking there might be an opportunity to help with our products at ivWatch, one of the hospitals I was treated at (an executive) told me “We don’t have IV infiltrations.” The tragedy I have learned is that addressing patient safety is a very hard road to travel and takes a back seat in the budgetary process. We have to change that.
Can you tell our readers a bit about why you are an authority in the healthcare field?
Creating a market for a new medical technology is much different than creating a “we do that too” product in an established market. I have led ivWatch since inception and have effectively secured steady funding to get to the stage where customers include world-class hospitals, who rank in the top within their respective categories. Between my personal journey through the healthcare system, my work as a scientist over the last 30 years, and my business background in commercializing breakthrough technologies, we are on the path to change the standards of practice for the most common medical procedure performed in the world.
What makes your company stand out? Can you share a story?
Recently, a customer told me, “you are not just a medical device company, you are creating a movement.” Their patients and families of patients are vocal about requesting our technology be used. That was validation that we are doing the right things, the right way, to offer a real product to enhance healthcare.
While infiltration is a common term within hospital walls, IV therapy risks are typically the furthest thing from a patient’s mind when receiving treatment or going in for surgery. There is a need for patient awareness on this topic as IV lines are truly a lifeline for the sick and injured. As more patients become aware of this high failure rate, they are going to expect continuous monitoring to ensure that things are going right.
What is equally important, is educating the general public before they need medical treatment.
If your child has the flu and requires a trip to the emergency room, most parents know what symptoms to look out for — however, if that child needs hydration fluids through IV therapy, parents aren’t as familiar of the signs and symptoms of IV infiltration, and the damage it can cause. It was important for us early on as a company to help fill in some of the gaps for both patients and medical care providers. We formed and sponsor an online resource, myIV.com, that provides answers to questions related to IVs — from the most basic to complex, as well as materials for hospitals to provide their patients before, during or after an IV procedure.
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?
The technology is a huge leap forward for non-invasive biological sensor monitoring. But before you get into the science, it’s important to set the stage about the huge issue in health care ivWatch technology addresses. Peripheral intravenous (IV) therapy is among the most common invasive medical procedures performed worldwide. Approximately 90 percent of patients admitted to hospitals receive IV therapy and unfortunately for the patient, it is well documented that these IVs often fail before the completion of their IV treatment. The failure incidences are as high as 50 percent and of those failures, 20–23 percent are due to infiltration which occurs when fluid or medication leaks outside of the intended vein and into the surrounding tissue.
ivWatch breakthrough technology monitors what is happening below the skin and into the tissue during drug/fluid delivery and can detect leakage within a few drops. It’s essentially “surveillance under the skin” with the ability to detect an event far before signs are visible to the human eye. The ivWatch Model 400 consists of three components:
- ivWatch Patient Monitor, for monitoring and alerting
- A non-invasive biosensor that uses visible and near-infrared (NIR) light
- A disposable sensor receptacle that is placed next to a peripheral IV
Prompt identification of infiltrations reduces the risk of injury to patients undergoing peripheral IV therapy and improves the likelihood of receiving the correct dosage of medications delivered intravenously.
But we’re not stopping there. Biosensor development comes down to the science and depth of knowledge a company’s team has on interpreting and analyzing data. Right now, it’s about watching the IV, but we plan to leverage this technology and the amount of data we are able to collect and introduce new products using the IV site to watch a person’s overall health.
Are you working on any exciting new projects now? How do you think that will help people?
Despite education programs within the hospital and the best intentions of the clinician, we’ve come to learn that infiltrations are unavoidable. We are addressing this unmet need in a way that has never been done before.
Every infiltration is a medication dosing and delivery error that can prolong hospital stays, increase health care expenses, or cause additional patient harm. It’s not a stretch to say that drug efficacy is affected when this occurs. We’ve been told of patients waking up in surgery because the anesthetic is not going into their vein. What we’ve been seeing at recent product evaluations at hospitals across the country, is that the infiltration rate is on the high end of what is documented in medical literature. If one day we can clinically say that by using ivWatch, drug efficacy can be greatly improved, that would be ground-breaking. Improving in that area is a matter of life and death for the critically ill or injured.
What are your “5 Things I Wish Someone Told Me Before I Started” and why. (Please share a story or example for each.)
- Go deep. The importance of science has been instilled in me since the beginning of my career, but particularly in the medical field, a deep understanding of human factor engineering and clinical processes is essential to success.
- Rise above the hype. Technology can pave the way for innovation but is often littered with hype and that’s spilling over to healthcare. It’s important to not confuse the vision with the actual steps required to get there. Never forget the cautionary tale of Theranos.
- Scale the high barriers to entry. Real research and development as well as randomized-controlled studies in the clinical setting in healthcare is critical. In the regulated space, there are guidelines to adhere to and processes to define and reproduce in order to validate a product for the end users’ safety and wellbeing. You have to design and document to a standard — and that’s challenging, fun, disappointing and rewarding all at once.
- Thrive on the mission. The expectations are always high for a breakthrough technology in healthcare. All of this is compounded for first-to-market innovations, so your team has to be hungry. It’s all about persistence, and not giving in to distractions.
- Own your voice. In most endeavors, both personally and professionally when I made the wrong choice, I didn’t trust what my instincts told me. Trust your gut and understand that your voice is powerful.
Let’s jump to the main focus of our interview. According to this studycited 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?
- First, it is shocking to me that U.S. hospitals and facilities are allowed to settle and silence their patients when a complication happens or something “goes wrong.” Frankly, I believe that should be illegal. As a medical device company, any issue that is reported by a customer goes into a public database maintained by the FDA and available for anyone to search on. Why not have something similar for patients to report issues with their care or complications? Paying them money to stay silent should not be allowed.
- Second, no doctor or nurse should be “bonused” money by the hospital if they perform certain procedures. For example, giving a nurse a bonus because he/she installs a certain number of PICC lines per month and increasing reimbursements will produce an outcome of more complications due to PICCs.
- And third, we have to figure out how to flatten the insurance coverage. It is an unstable situation where more people who are insured are paying for the uninsured. My dog had an encounter with a racoon last year which resulted in me getting a $32,000 rabies shot. I have a feeling one person pays that to cover the 20 people who can’t pay that.
You are a “healthcare insider”. If you had the power to make a change, can you share 5 changes that need to be made to improve the overall US healthcare system? Please share a story or example for each.
- Create a database managed by the government where patients can report poor care and complications and make it available to the public. Allow hospitals and doctors to respond, but the word needs to get out about adverse outcomes.
- Make documentation more specific about the true impact of medical errors and complications. A recent Johns Hopkins study showed medical errors as the third leading cause of death in the U.S. I believe it is true. It needs to be documented. If I would have died from my pulmonary embolism, my death certificate would have said “Pulmonary embolism” and the PICC line that caused it would have never been mentioned. We need facts to fix the problems.
- Cover more people with health insurance. This is a sticky one and I don’t know the answer other than it needs to be fixed. Insurance is creating more haves and have nots and it is not stable.
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?
I think our lawmakers need to lead these efforts as they will not come from the health system alone. I don’t mean lawmakers that are just going to get political and tell everyone what they want to hear but a group of lawmakers, hospitals, companies and patient advocates need to disrupt the current “the hospital is always right” mentality. Together we are stronger than we are alone.
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 read engineering textbooks and technical papers all the time. I think the velocity of change in technology is so fast today that we have to continuously educate ourselves, takes classes and solve problems or our careers will stagnate in a decade. I also recently read “Bad Blood: Secrets and Lies in a Silicon Valley Startup” by John Carreyrou. Incredible book. Unfortunately, there are many more stories like this. He should start a series.
How can our readers follow you on social media?
Thank you so much for these insights! This was so inspiring!