Joe Kiani is a busy man. As the founder, Chairman, and CEO of Masimo Corporation, a global medical device manufacturer, Kiani has been a leader in patient safety and healthcare innovation for more than 20 years. Under his leadership, Masimo has grown from a “garage start-up” into a successful, publicly traded company employing more than 3,000 people worldwide.
Kiani is also the founder of the non-profit Patient Safety Movement Foundation, with a mission to drastically reduce the more than 200,000 preventable patient deaths that occur in U.S. hospitals every year from medical errors and hospital acquired infections (HAI).
With an engineering education, Kiani brings a slightly different, and refreshing, perspective to the complex challenges facing the healthcare industry. This different perspective is what gives him hope that much of the needed change is achievable and can leverage what has already been accomplished by other industries. Below are the highlights of my interview with Mr. Kiani.
Szczerba: The lack of interoperability of medical devices in clinical environments has been blamed (either rightly or wrongly) for both increased costs and decreased quality of care. What do you feel the major impediments to interoperability have been?
Kiani: Any time you’re dealing with a complex socio-technical system such as health information technology (IT), you’re going to have significant obstacles to true interoperability.
In healthcare, some of the roadblocks include the sheer variety of products, devices, and technologies in the patient care system. From patient diagnostic and monitoring equipment, to administrative and electronic health record systems, there are so many ingredients that go into the patient care continuum that it’s daunting to get so many diverse elements to interoperate.
Likewise, diverse clinical environments pose a challenge to interoperability. The needs of a physician’s office, an emergency department, a medical-surgical floor, and home health care are different. Yet, the same patient may experience all of those environments during the course of care.
However, some of these challenges can be overcome if the medical technology companies would be willing to share the data that their products collect. That’s why the Patient Safety Movement Foundation has called on medical technology companies to sign public pledges that they will share their data and make it the patient’s data, which will help create a “Patient Data Super Highway” for each patient.
If we can bring the monitors, therapeutic devices, and IT all together with intelligent, predictive algorithms in this Patient Data Super Highway, then physicians, along with patients and their families, can be informed of dangerous trends; lives can be saved; and the process of care can be improved substantially, further reducing cost.
Szczerba: The traditional “blame game” for device interoperability issues has providers blaming device manufacturers and device manufacturers blaming regulatory agencies. Do you feel that providers bear some of the responsibility with this issue? If so, what role do you feel they need to play going forward?
Kiani: The regulators are not the problem. And, while I believe providers could exercise their buying power to dictate interoperability, ultimately the medical technology companies need to come together and provide interoperability solutions. Some medical technology companies and providers pursue buying practices that create walled gardens, which block information sharing between their products and different systems.
We’ve been suggesting that Congress should grant the Office of the National Coordinator for Health Information Technology (ONC) the authority to investigate and decertify products that pursue information-blocking practices. While respectful of patient privacy regulations under HIPAA, we should not provide incentives or reimbursement to providers for purchasing products that do not openly share data with hospitals, patients, and all parties that can use the information to improve patient safety.
Technology solutions should openly share information, particularly when patients’ lives are dependent on it.
Szczerba: What does the term “integrated clinical system” mean to you? Do you believe the healthcare industry has a common understanding of what an integrated clinical system is, much less how to build and validate it?
Kiani: An integrated clinical system is one that accomplishes sets of tasks together, and provides decision support to all stakeholders. In a healthcare setting, medical devices would report to each other so that the central electronic health record and relevant data would be available to clinicians for the benefit of patients.
I think there’s a general lack of understanding of how true interoperability could benefit patients. I read in the Los Angeles Times that 80% of medical errors in hospitals involve communication problems between healthcare professionals. I believe many of these errors could be avoided if devices could “talk“ to each other, and could even shut each other off or alarm when a measurement on another product is approaching a dangerous level.
But we’re moving in the right direction. At the close of the first Patient Safety, Science & Technology Summit in 2013, nine medical device companies signed pledges to share their data. At the end of the second-annual Summit this year, 20 new medical technology companies pledged to make their devices interoperable so the patient data collected and displayed on their products are accessible for patients and clinicians. (Watch Joe Kiani’s address at the 2014 Patient Safety, Science & Technology Summit, below).
Szczerba: The FDA has limited experience in validating complex clinical system-of-systems (systems that don’t have a predictable output and / or include integrated devices from multiple manufacturers). What guidance would you offer the FDA to help them acquire the expertise in these areas?
Kiani: I don’t know that you’d need to burden the FDA with this aspect of healthcare or to reinvent the wheel. Congress could grant the ONC – which has healthcare IT expertise – authority to validate and help standardize health IT systems.
Szczerba: You’ve been a supporter of Interoperability and Patient Data Accessibility Pledges. In most other industries, convergence to a set of viable standards is usually driven by market forces – and not by a “coalition of the willing.” What is your argument to other CEOs of for-profit companies as to why they should participate in such a pledge, as opposed to letting market forces play themselves out? If the “coalition” decides against your company’s current interfaces and standards, how does that weigh against the course of natural business operations of a for-profit entity?
Kiani: First of all, it’s the right thing to do. People are dying because of this lack of interoperability. People could be saved with smart, predictive algorithms if the Patient Data Super Highway existed. Secondly, none of us has all the data, and, therefore, with incomplete data, no one entity is going to be able to make the profits they hope to make from utilizing data to improve patient care. But if they all share the data, some companies may end up making profits from the data, and, more importantly, patients’ lives can be saved. Twenty years from now, when we have retired, we will have lost our chance to do the right thing. But today, if we all join in and do the right thing, when we retire, we can not only feel good about the way we helped patient care, but we may ourselves benefit from the better care that would be made possible.
The “coalition of the willing,” as you put it, is not trying to create new standards for interoperability. In this day and age, that is not the real issue. The real issue is getting companies to share the data their products are purchased for freely. So there should be no fear that some standard will be established that will leave some companies at a disadvantage.
Szczerba: As the founder of the Patient Safety Movement Foundation and the CEO of Masimo, you’re in a unique position to be one of the “watchers” as well as one of the “watched.” How do you disentangle these roles in your mind and still be true to the objectives of both organizations?
Kiani: I believe transparency is most important in this situation. That is one reason we make it clear, both on our website and at our meetings, that the Masimo Foundation for Ethics, Innovation and Competition in Healthcare is the founder of the Patient Safety Movement Foundation.
I do recognize that I probably could be more effective in rallying healthcare stakeholders under the nonprofit Patient Safety Movement if I weren’t also the CEO of a for-profit medical technology company. But I’m not ready to retire from Masimo yet, and I don’t want to delay advocating for patient safety and dignity.
I’d like to remind everyone that doctors, nurses, and hospital CEOs get paid for what they do to help patients. I’m glad they’ve chosen this wonderful business of patient care, and I am glad that they are paid to do so. I, too, have chosen the business of patient care. I have dedicated my life to patient safety. With Masimo, the technologies we invented have transformed patient care and safety with noninvasive monitoring technologies that people didn’t think were possible. Secondly, my advocacy for ethics, innovation, and competition in healthcare, is trying to fix misaligned incentives such as the one between hospitals, GPOs, and medical technology companies to help eliminate preventable deaths.
Szczerba: The January 2014 Department of Justice announcement about potential kickbacks between CareFusion and patient safety advocate Chuck Denham has generated much discussion. As the head of both a for-profit and a non-profit entity in this space, (1) what mistakes do you feel the healthcare industry, as a whole, made to allow this situation to occur, and (2) what changes do you feel the healthcare industry needs to make going forward to limit the likelihood of similar situations from happening again?
Kiani: The first part of your question assumes that we have all the facts, and I don’t know that we do. That said, transparency remains, in my view, most helpful. In the Patient Safety Movement, we are asking for full disclosure from all participants. I am happy we have the Sunshine Act, but I sometimes jokingly call it the “flashlight act”, because the act didn’t go far enough. The Sunshine Act should have mandated disclosure of all payments made to anyone in the healthcare industry, including GPOs, administrative people in hospitals, nurses, etc. – not just physicians. Transparency can be a powerful disinfectant to misaligned incentives.
Szczerba: Many provider organizations and academic research institutions are building “innovation centers” to address the complex challenges facing the healthcare industry. Unfortunately, most of these “centers” are little more than large rooms where companies show off stovepiped capabilities and where very little innovation takes place. How can we stop these centers from becoming nothing more than showrooms and actually be a driver for innovative clinical solutions?
Kiani: I think these centers should focus on educating the clinicians and patients on the challenges that cause preventable deaths and the actionable solutions (e.g., Actionable Patient Safety Solutions or APSS) that are available to eliminate them. They can help implement these, and then provide feedback centrally to the Patient Safety Movement on how to improve the APSS. There also can be incentives, such as National Institutes of Health (NIH) grants, that would bring industry, scientists, and clinicians together to develop innovative solutions to prevent harm and enhance safety for our patients.
Szczerba: Some would say there is almost a “perfect storm” in the healthcare industry, with technological, legislative, regulatory, and financial forces all in play. With all this in mind, look ahead six years to 2020. Tell me what you think the healthcare industry will look like at that time.
Kiani: By nature, I’m an optimist. We will have the Patient Data Super Highway, we will be offering our patients safety and dignity in our hospitals, and we will have seen the realization of the Patient Safety Movement’s mission to have ZERO preventable deaths by 2020.