“Including patient perspectives in the R&D process makes the process richer, more relevant, and ultimately more effective … today’s [dialysis] machines have a negative effect on a patient’s quality of life and also place a significant burden on the healthcare system … there will need to be some breakthroughs in the innovation process from where we are today to a “wearable” system … CDI has that mindset of putting together that chain of advancements and [making] discoveries that will get us there.”
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Kassandra Thomson (KT): Tell us about your background and what your role is in your current position.
Paul Citron (PC): I’m technically retired, but I like to say I’m gainfully unemployed because of my participation on a number of university and start-up advisory boards and volunteer work on behalf the National Academies of Engineering and Medicine (NAE, NAM) and The American Institute for Medical and Biological Engineering (AIMBE). My professional career (32 years) were at Medtronic, the world’s largest medical device company, with terminal roles as vice president of corporate R&D and vice president of technology policy and academic relations. I have also been visiting professor at universities where I taught medical technology corporate entrepreneurship at the graduate level.
KT: How would you describe your areas of expertise that you bring to the table as a member of the CDI Scientific Advisory Board?
PC: My expertise that may be of benefit for the CDI relates to the R&D process for moving innovative medical device ideas from the bench to the bedside. Included in this is an understanding and appreciation of the complexities of the medical innovation ecosystem and how to successfully navigate it.
KT: What are your thoughts about the CDI’s goal of transforming dialysis and in particular the goal of developing a wearable dialysis device? I would love to hear your thoughts on that and also tie it into what challenges you see, particularly associated with the development of a wearable.
PC: The goal of developing a “wearable device” or even one that markedly improves the patient’s quality of life is a highly sought-after unmet medical need. The era of kidney dialysis began in the 1940s in the Netherlands using the concept, quite literally, of a washing machine to cleanse blood of waste components in cases of end-stage renal failure. In spite of its crudeness, this device – really a prototype – demonstrated proof of concept. Today’s dialysis machines have evolved and become much more technologically sophisticated. Nevertheless, they bear a strong functional resemblance to earlier renditions. Although therapeutically effective, today’s machines have a negative effect on a patient’s quality of life and also place a significant burden on the healthcare system. Quite realistically, going from the large conventional machines, it’s not just a matter of making things smaller. I think the reality is there will need to be some breakthroughs in the innovation process from where we are today to a “wearable” system. Replicating a kidney’s functions is an understandably daunting task. Key challenges for dialysis include: Are we conducting sufficient R&D at academic and industrial laboratories? Is dialysis improvement viewed as strategic healthcare priority? Are there low-hanging technological fruit that be rapidly evaluated, validated, and applied to improve outcomes? Can incentives be put in place to encourage increased investment in advancing dialysis? The wearable system I think clearly should be, and can be, an aspirational goal in the short term, but whatever work is being done to make advancements needs to have that goal as a touchstone and as a long-term strategy to have that happen. That’s not intended to be a negative comment, I think it’s a reflection of how technology in healthcare really advances. It takes a series of seemingly small steps that continue to align on the current architecture or footprint, and then all of a sudden one day you see that, wow, we really, over the last 3, 4, 5, 10 years, made so many advancements that have achieved certain goals that we didn’t even visit at the start. My background was in cardiac [devices], and the first implanted devices were quite literally the size of a hockey puck, and they were really primitive by today’s standards. They were “dumb” devices, they functioned pretty much like a metronome delivering a shock to the heart once every second, very unprogrammable, very short battery life time – all, by today’s standards, negative. Medtronic, where I came from, just announced two days ago they got approval for an implanted pacemaker that’s the size of a large vitamin pill that is implanted without open heart surgery into the heart and it’ll last about 10-14 years. It not only paces the ventricle but it synchronizes its activities to the upper chambers of the heart. That took a long time to get there, but the point is those kinds of major improvements that do happen, can happen, and will happen if you put clever minds together to address the roadblocks to getting there and, even more importantly, conduct the research that’s necessary to discover ways to get over those technological and physiological roadblocks that keep you from attaining this desired goal of a wearable kidney. The history strongly supports the notion that it’s attainable, the question is how long will it take. But in raising that question, it’s important to note that along the way will come major improvements in the current delivery system that will address patients’ unmet needs in the treatment of dialysis. So it’s a journey, it’s one that requires investment, it’s one that requires time, it’s one that requires clinical evaluation, it’s one of knowing what the patient’s needs are and, even more importantly, what are their unmet needs that people haven’t yet appreciated. But I think CDI has that mindset of putting together that chain of advancements and [making] discoveries that will get us there. So the question is when.
KT: Thank you. That leads nicely into the next question – one of the principles the CDI was founded on is making sure we are engaging patients and hearing the patient voice right from the get-go, so that how we’re designing the technologies and the solutions we come up with are actually going to meet their needs. I’m curious about your thoughts on that level of patient engagement right from the beginning, and also do you see this kind of patient engagement elsewhere or is this somewhat unique?
PC: Including patient perspectives in the R&D process makes the process richer, more relevant, and ultimately more effective. Patient engagement, and clinician engagement, I think are a necessary component, sometimes underappreciated by technical people. As good as engineers are for solving problems, they lack the granular, first-hand knowledge of the dialysis experience. If the designers of the hardware do not have an appreciation for how their designs, their innovations, are actually used, and what the users’ experience is around that product, they’ll probably miss the mark. I’ll give you an example, it’s I think trivial in some ways, but understandable. Back in the early days of portable computers, the designers had a choice of whether to use a portable computer that had a backlit screen that could be useful in a dim environment, or have a screen that wasn’t backlit that you needed a lot of ambient light to be able to read the screen. Well, not really appreciating how a typical pacemaker was put into the patient, the designers just knew that the operating theater was brightly lit. Why did they know that? Because they watched the TV shows of operating rooms, with large lights over the patient table. But in reality, the room in which a pacemaker was implanted was dark because the physician needed to image the heart using fluoroscopy, and that produced a very faint image that required that the computer be backlit. It sounds trivial by today’s standards of portable computers, but the price difference between a computer that was backlit versus one that wasn’t was several hundred dollars, so the engineers just assumed, “why do we need to spend the money on a backlit unit?” And, lo and behold, it was useless in the room in which the pacemaker was implanted. The point I’m trying to make is that, had the engineers sufficiently interacted with the customer, they would have known they needed to use a backlit system. But the same is true with virtually every other kind of technology – unless you understand the subtleties that are involved in how the device is used, you probably will miss some needed capabilities, features, or aspects, and probably build in some things that are not needed because it might be “engineering elegant” to do certain things [that are] low-value capabilities for the user, the patient and the clinician. [Knowing] what not to do and where you shouldn’t over-design a product is as important as under-designing it. And that’s where the patient input, the user aspect becomes very, very valuable. Some small design aspects may make a device easier or harder to use in the real world setting of the patient. There are subtle things that only a patient population appreciates, and you either overlook them in the design process if you don’t interact with the patient, or you over-design and make the device too complicated or add features that delay availability because you’re trying to make it more elegant than it needs to be. It’s the adage that “perfection is the enemy of the good”. We can point to a number of examples in the real world where a perfected product lost out to a less-perfected product because the less-perfected product met more of the users’ needs than the really sophisticated product. Those kinds of concerns really underlie the importance of having that open interaction between the users and the designers.
KT: I really admire the involvement we’ve gotten from our patients as well as our human factors team and how they’ve engaged them in all of the work they’ve been doing. With the last few minutes here, can I get your take on what you are most excited about being part of our Scientific Advisory Board?
PC: First of all, something that most people can’t see and appreciate is how involved the members of the advisory board are, and how open and candid they are with positive and negative feedback. The people are impressively engaged, so that’s worth noting. The other aspect is the leadership is world-renowned, and these are people that, on the clinical side Dr. Himmelfarb, and on the scientific side Dr. Ratner, they are without question international thought leaders. And the reason that’s very important is that they talk and interact with colleagues around the world. Solutions to the possibilities of what a dialysis unit can be in the future will probably not come only from people at UW. Bits and pieces will come from all over, and by virtue of their international reputations for leadership and attendance at symposia, they bring together like-minded people from around the world. And around the water cooler, that informal discussion, “ah ha” moments will occur where in talking to people that are engaged in this general area solutions will arise that may not have been thought of at UW, but can be implemented by UW, and vice-versa. The University of Washington has been a leader in dialysis treatment for kidney failure since the 1960s. Also in the 1960’s UW’s Center for Bioengineering was founded. This center has evolved over the decades and has gained an international reputation as a respected leader in bioengineering and particularly in biomaterials, molecular engineering, and regenerative medicine – all relevant for advances in dialysis. The Center for Dialysis Innovation is a collaboration between UW Medicine and UW Bioengineering that shares a common mission and culture to make meaningful advancements in the treatment and care of individuals suffering from kidney failure. This is a dynamic partnership. What has me particularly excited is the launching of the IDEAS (Innovations in Dialysis: Expediting Advances Symposium) conferences. IDEAS brings together researchers, physicians, members from industry and government representatives who are committed to improving kidney failure treatments and outcomes. Such gatherings provide a forum to present the latest findings from around the world. More importantly, forums such as IDEAS encourage conversations among individuals that can spark solutions to problems and lead to serendipitous innovations. They also create a professional network of expertise that can be harnessed to accelerate progress. So, what’s exciting is the activity is being led by people that attract thought-leaders from all over, and good things come from that.
KT: Thank you very much for your time.