The Importance of Collaboration between Health System and Product Developer

It is quite refreshing when health systems are willing to meet with novel technology companies. Hopefully, they realize that by meeting with a new company, the health system can provide feedback that will be integral to the DNA of the product. At Output Medical, we welcome the challenge of visiting health systems and sharing our value proposition with physicians, nurses, supply chain, and purchasing personnel. While we want these healthcare professionals to learn about the problem that our product addresses, we especially want to listen to feedback and collaborate on how we can improve our clinical value.

Recently, Output Medical visited a prominent health system in Kankakee, Illinois. We feel extremely fortunate that we were able to meet with various healthcare professionals that play a critical role in overseeing the nephrology department as well as the ICU. While the nephrologists acknowledged that urine output is indeed recorded most every hour, they are not always in the ICU in a fashion where they can track the hourly trends. Moreover, if the urine output data was automated and populated into the electronic medical records (EPIC), it would be extremely advantageous for the physician. Nurses, who were also present at the meeting, discussed the accuracy of manual urine output measurements. There is not always time to measure the exact mL output of urine- over time this can add up. It is no one’s fault, there is a lot going on in the ICU and only so many staff! With automation, the nurses can still use the drainage bag visual to double check output readings.

Finally, we were able to have a very honest conversation about the bottom line value proposition: can Output Medical show that recognizing AKI early can reduce cost and length of stay for the patient? Can Output Medical improve 30-day mortality? There is indeed data to support these theories, and moreover, we would love the opportunity to pilot our product and develop clinical data in collaboration with health systems.

We recognize the need to be fiscally prudent and want to work with potential client sites to develop quality initiative programs that demonstrate how our device can help manage the cost of high risk AKI patients.

Call us today, and ask: how can Output Medical help us reduce the cost of care management for his risk ICU patients?

Output Medical HydroLink Usability Study at Jump Trading Simulation and Education Center

Output Medical’s Formative Usability Study took place at Jump Trading Simulation & Education Center on Monday, May 15th though Tuesday, May 16th. The study was designed for the purposes of testing the usability of Output Medical’s HydroLink device. The HydroLink system is a Class II, 510(k) exempt medical device that is designed to automate urine output measurement in the ICU. The device is registered and cleared with the FDA; this study had no involvement with any FDA processing. Over the course of the study, 12 Intensive Care Unit (ICU) and Critical Care Unit (CCU) nurses participated.

The study was conducted in one-on-one simulated use sessions with all 12 particpants. The study duration was approximately 60 minutes per participant. With each participant, the HydroLink device was evaluated through simulated use. Prior to performing and tasks or simulated use, all nurse participants received an in-service training from the moderator.

The usability of the device was evaluated based upon ease of learning and ease of use once the participant was educated on how to use the device and subsequently given the opportunity to install and use the device.  The usability began with a cognitive walk-through followed by a simulated hands-on interactive set up of the device. During the simulated set up, the participant was encouraged to think aloud and verbalize his or her thought process.  However, if the participant struggled with simulated tasks, (e.g. struggles for thirty seconds), the moderator provided assistance. All verbalization, requests for help, and additional actions by the participant were documented by the moderator, a third-party observer, and participant feedback was formalized in a survey following the simulated use trial.

Overall, the simulation proved that the product is quite simple to use, scoring very well on the Likert scale. The main concerns the nurses had with the device were sterility, device location, and alert duration. These concerns will all be taken into consideration when the HydroLink device is updated for clinical use. Many of the tasks involved in device setup were only foreign to the nurse due to it being the first time seeing the device. Most nurses mentioned that if they had more experience with the device, the tasks would be quite simple.

The Output Medical team gained excellent feedback and resounding positive notes on the device. The electronic health record integration was a major highlight, as this functionality has the ability to drastically improve nursing efficiency as hospitals aim to get away from manual charting. The final takeaway was that the HydroLink device is not difficult for nurses to learn and would be a welcome addition to the ICU environment. 

 

Automation: No longer Nice to Have… But Need to Have!

Hospital systems believe overall cost reduction and efficiency are their top two financial priorities, Health Leaders recently reported. With the healthcare industry continually looking to cut costs and improve efficiency, automation of manual tasks can be an important part of a strategy for performance improvement.

An aging population along with more people in the healthcare system will require more care, and staffing levels in healthcare will not be able to keep up. A shortage in staffing is a potential threat that hospitals must prepare for. The looming shortage of nurses demands efficiency and the elimination of redundant work and manual tasks. At Output, we want to help the charge towards automation.

Once the industry transitions to population health automation goes from a “nice to have” to a “need to have.” There are not enough care providers to continuously monitor and check in with large patient populations for this new model of care. A report by the Institute for Health Technology Transformation says, “Automation makes population health management feasible, scalable and sustainable.”

Automation is often linked to a negative connotation in association with the loss of jobs in manufacturing industries. However, the goal is to remove counting tasks that require little cognitive value, and instead allows highly trained professionals to focus on more clinically-relevant work for productivity.

Make no mistake: automation cannot replace doctors and nurses. Not close.  However, automation can be blended in to their workflows to make a wide swath of care delivery processes much more efficient and to improve productivity.

When looking for ideal areas to apply automation in the healthcare environment, a standardized, repeatable process is the first thing to look for. Within hospital walls, a common procedure that is performed on a large population of patients on a routine basis, like urine output measurement, is a prime area to apply automation tools.

Clinical Studies on the Horizon

We are thrilled to be on the cusp of clinical studies that will help justify the need for automating urine output measurements.  We have spent upwards of four years internally testing and designing our product. It has taken patience, focus, and discipline. But now, Output Medical is in a position to collaborate with medical institutions in order to validate the product value as well as learn more about the product’s relationship with its future users.

It will be critical to compare our device with standard ICU urimeters in order to prove urine output automation can maintain/improve accuracy. Urine output is vital information and it needs to be precise for the clinical team to make critical decisions. We hope to begin this study in the coming months!

Over the years, we have been able to conduct quite a bit of human factors analysis, where we have interviewed over 50 nurses about the potential of the device. It is now time to conduct a usability study where we will be able to see nurses interact with the product first hand. This will get us the feedback we need to better understand our product’s integration with the ICU. This version of clinical research is going to perfectly complement our more traditional comparative study because it will offer the best insight into our user.

It is an exciting time for Output, and we are pleased to share our journey with you! Please be on the lookout for future announcements about Output Medical clinical research!

Data Is King

In our world, data is king (if not God). It is the fundamental marker of our product’s success and patients’ quality of life. In order for nurses and physicians to rely on us, we need to deliver high-fidelity urine output data. The best way to hold ourselves accountable is clinical research. Given our 510(K) exempt pathway to market, we do not need clinical studies to commercialize. Nevertheless, we want our product to be up to nephrologist standards in order to avoid errors in manual urine output measurement. While one of many young medical device companies, our goal is to help continue the movement for improving standards of care. With well-established clinical standards, we can best partner with physicians and deliver the data they need to treat patients as well as perform critical research.

We are thrilled to have abstracts submitted to the AKI & CRRT Conference as well as the PAPS (Pacific Association of Pediatric Surgeons) conference. Moreover, we will be attending the AKI & CRRT Conference next week in San Diego where our abstract will be on display in the poster sessions. We are thrilled to exhibit our product for the first time and engage nephrologists about urine output and AKI. A passage from our AKI & CRRT abstract reads:

"AKI impacts many aspects of patient’s quality of care: it increases mortality, cost of care, length of stay, and readmission rates. This condition can be prevented, or, once diagnosed, the severity can be limited, with earlier detection of urine output. Currently, urine output is measured in hourly intervals (often in intervals of 4 hours) through a transparent, pliable plastic container. This method only detects 77% of low urine output episodes and requires ICU nurses to spend approximately 5% of their time measuring and recording urine output. This method also creates a significant burden to hospital systems, considering only 50% of patients who develop AKI actually receive timely and sufficient care per ICU management protocol."

We fully understand that larger companies have more access to funding for clinical research. With this in mind, we will continue to reach out to industry partners in attempt to form a collaborative effort on improving clinical studies. It is imperative that small and large companies work together to best deliver urine output data. Moreover, with reliable data, physicians can utilize superior diagnostic measurements to advance their research. Better data leads to better quality of care.

Turning a "Cold-Call" into a Partnership

When you are a young company eager for impactful connections with KOLs (key opinion leaders), it is logical to be cautious with “cold-calling.” I am here to tell you that I completely understand the logic behind timid engagement in the early-going. However, I firmly believe that is the incorrect way to look at the situation- at least in the healthcare industry. Physicians are, for the most part, innovators in their own right. They most certainly want to be a part of (and engage!) a community that is looking to improve patient outcomes and cost of care. That’s right, Doc! We are trying to help!

Recently, we had a wonderful experience that can be used as a case-study for this theory…

We located a group of articles that were developed at a conference surrounding our disease state last year. Physicians broke up into focus groups and based on their conversations and literature, created various hypothesis surrounding acute kidney injury. After reading the articles, we met as a team to dissect each article, and created our own pieces of literature that related AKI and our company’s goals. Then, we simply reached out to the authors with our thoughts on their work, how it related to our device, and our additional literature. More than half of the authors responded with a willingness to speak. From there, we met with a few of the physicians at a local conference, and even got to spend time visiting a world-class institution!

Our visit was truly special, as we got to spend an entire day discussing acute kidney injury, the current studies surrounding the disease state, and how our device can support future clinical research. We feel so honored to be in the position to engage such influential thought leaders, and cannot wait to make our dreams a reality in the form of a clinical study!

My advice to other young healthcare companies is to take the risk and reach out to KOLs. You might be surprised at how willing they are to speak with you and learn about your cause!

Kidney Week 2016

The American Society of Nephrology was in our city (Chicago!) for Kidney Week 2016, and it was an excellent experience for our team. We were fortunate enough to meet with distinguished, leading physicians as well as governing bodies in the kidney treatment field. After gaining insight as to what are necessary improvements to fluid output management, the Output Medical team is excited for 2017! We will be launching clinical trials and reaching commercialization- getting ever closer to our vision of standardizing urine output measurements and acute kidney injury management.

The overarching theme of our conversations during Kidney Week was that urine output data is still not where it needs to be in terms of reliability. This impacts two paradigms of Nephrology: care management as well as predictive modeling. Of course our goal is to positively impact care management by creating a more accurate and reliable system for urine output measurements that can support nurses and physician’s decision making. But we also verified with key opinion leaders that the value of accurate urine output data goes much further than current care management.

Research is such a vital part of Nephrology, maybe more so than in other focuses, because decision making is tied to specific biomarker values and predictive values.  And while creatinine is an established biomarker for AKI research, urine output has yet to be fully adopted as a biomarker into predictive research models due to its inaccuracy. Output Medical wants to overcome this limitation by our technology-enhanced automation process.  The research potential is incredible!  For example, we can potentially create new biomarkers for AKI, such as the change in urine output over various hour increments.  If we can help create a platform for Nephrologists to advance their predictive research, we can really make an impact!

We wish all our friends and family a wonderful holiday season and a happy new year! We look forward to sharing our journey with you in 2017!

Establishing a Research Ecosystem

There is significant research being performed on quantified algorithms and urinary biomarkers to improve the detection and diagnosis of AKI.  However, many of the research excludes urine output as a metric or data input.  It is important to recognize all the challenges in obtaining high-fidelity urine output measurements in the different clinical settings. The lack of availability of automatic urine meters are often impeding factors in applying the strict urine output based AKI criteria definition.

Despite these difficulties, the results of recent studies establish the absolute necessity for urine output assessment in patients for diagnosing and staging AKI.  Applying these criteria can increase the sensitivity and specificity of the AKIN classification system, as oliguric patients without sCr change have an increased mortality, dialysis requirement and longer length of ICU stay than non-AKI patients. Applying the AKIN classification system without the urine criteria significantly underscores the incidence and grade of AKI and potentially delays the prediction and diagnosis of AKI in any algorithm.

In the near future, Output will aim build an ecosystem to refine existing algorithms with high fidelity urine output measurements, and introduce additional data input into these algorithms by developing immunoassays to detect established, well-researched urinary biomarkers. The goal to develop an improved quantitative analytics model to predict and diagnose acute kidney injury by incorporating high fidelity urine output measurements into existing AKI predictive and diagnostic algorithms.

Implementing predictive and diagnostic algorithms into the management of AKI is a principle point of discussion as per the KDIGO and ADQI initiatives.  There have been attempts to incorporate such models into retrospective reviews to attest clinical utility in decision-making.  Yet, variables from these patient-specific models are often constrained to the clinical care specific to that population; for example, models for cardiac surgery patients include cardiopulmonary bypass time and number of bypass grafts.

However, a number of variables commonly appear across many of the existing models (i.e., age, baseline renal function, medications, diabetes, hypertension, etc.); these variables may be better suited for a generalized model. Most models had modest predictive success with area under the receiver operating curves (AUC) approximating 0.75; a few models reached AUCs as high as 0.9, although the sample sizes were smaller and there was a pre-selection of high-risk patients.

Many of these predictive models and other similar studies on AKI diagnostic specificity and sensitivity fail to include urine output and trends in urine output as a data input into the model.  Urine output is either considered unreliable data or not statistically significant to decision making. Output Medical aims to change that.

When Innovation Meets Academia

As a Physician, you are trained to think a certain way and process information in a structured manner.  This thought process helps you diagnose clinical conditions and identify the optimal therapy based upon the diagnosis.  You start by evaluating the patient in a structured manner, performing a physical example, and then creating a differential diagnosis based upon the findings.  This thought process is inculcated to all medical students and residents, and the learning of this takes place within the culture of academic medicine.  This culture instills respect for medical students, residents, and attending physicians who are senior to you.

While this mentality is essential to training and mentoring high quality clinicians, it does not provide the more fertile proving ground for innovation.  Innovation, by nature, requires unconventional, disruptive thinking that challenges the established norms.  Academic medicine values structured thinking along a core set of medical principles.  The better one understands the medical principles and the established thought processes, the better one can create a differential diagnosis.

Hence lies a paradox for physician innovators: how to adhere to the culture of academic medicine while recognizing opportunities for innovation.

The paradox can be easily resolved when you realize that you can be both a great clinician and a great innovator.  To be a great clinician one must understand the medical fundamentals extremely well and understand when and how to implement these principles in patient management.  To be a great innovator, one must see opportunities for improvement; yet those opportunities do not become clear until a firm understanding of the clinical principles are obtained.

At Output Medical, we pride ourselves on establishing a strong, clinical culture.  We review the academic literature regularly for new trends in Acute Kidney Injury (AKI) care management.  Our unit economic model, in which we define our cost structure and protocols for use, are based upon set clinical guidelines.

Given our understanding of the clinical principles behind urine output and AKI, we are confident that our product will make an impact.  Further, we understand how key opinion leader Nephrologists would view this innovation relative to current standards for care management.  We have studied the existing AHRQ guidelines for current urine output management, and we understand how our device would support future research efforts.

Our fundamental adherence to clinical guidelines has allowed us to reach this point. We are both humbled and excited by the prospects of supporting clinical research efforts in oliguria and AKI management that will lead to the development of new guidelines and protocols for care management.  

The Art of Storytelling

Output Medical’s marketing and communications strategy is simple, yet elegant: tell the story. Storytelling is a timeless tool that can help both a startup or a Fortune 500 company connect with their audience. Our goal is to use the narrative to lay out of all entities that make Output Medical drive forward the mission to become leaders in the Acute Kidney Injury space. As we move towards our clinical trials at the University of Chicago and OSF-Peoria, there will be quite the need for analytical detail. From a marketing perspective, however, it is critical to humanize the experience and the vision that is Output Medical.

Here are the key roles in Output’s narrative….

The Heroes

The heroes in our story are the healthcare professionals, hospital administrators, and procurement officers. The healthcare professional team comprised of nurses and physicians create the foundation for healthcare. Nurses will interact with our product on an hour to hour basis, and moreover will be on the frontlines of acute kidney injury diagnosis. Physicians will interpret the information that our product gives the nurses, making decisions on whether or not the patient needs to be moved to dialysis or surgery. Hospital administrators and procurement officers are the ones who help innovation reach hospitals and healthcare systems. Without their support, Output cannot aid healthcare providers.

The Enemy

The antagonist in Output’s story is manual fluid output measurements. Essential vital measurements such as heart rate, body temperature, blood oxygen, and blood pressure are automated; why is urine output still measured manually? For many ICU patients, urine output is just as important a physiologic parameter. Manual measurements can often be inaccurate, which has the potential to increase mortality, cost of care, length of stay, and readmission rates. The manual method creates a significant burden to hospital systems and is certainly getting in the way of our heroes’ mission.

 

The Resolution

The resolution to this narrative is the automation of urine output measurements when Foley catheters are used.  The ability to communicate via EMR will allow nurses and physicians to work together like never before; and more importantly, will allow healthcare professionals to detect acute kidney injury in the transient phase. Nurses have far too many tasks to accomplish in their shift; kneeling down to read a number off of a bag, manually enter it on paper, and then type it into the computer need not be an additional one!

 

Output Medical looks forward to sharing its story with you.

From Concept to Culture

The book, “Good to Great”, by Jim Collins describes how certain companies make the transition from ‘good’ to ‘great’ companies.  In the book, Collins describes certain principles seen ubiquitously throughout these companies: leadership, people, honesty, passion, discipline, and detail orientation.  With the growing success of Output Medical, the level of responsibility to be a strong leader becomes ever more paramount.  I cross reference experiences gained leading and self-managing Output Medical with anecdotes and principles cited in the book to learn what I am doing well and what I can do better.

For example, Collins describes a Level 5 leader in the book as somebody who embodies strong leadership, the ability to gain trust, and genuine humility.  And he fills the book with fascinating examples of capable CEO’s who fit this criteria leading their respective companies to strong performances and profitability.  These anecdotes inspire me to work hard, continue to improve as a leader, and earn the trust and respect of the Output Medical family. 

Being a strong leader is extremely critical for Output Medical in the coming months.  As we enter into the final phases of pre-revenue product development, we will expand our team at all levels: executive board, management team, and employees.  During this growth period, it is my duty to the company, and the Output Medical family, to become the best leader possible as my actions, decisions, and presence reflect the company.

I represented Output Medical at the American Medical Association Annual Meeting, at the MacGuireWoods Health Care Private Equity Summit, and at the Association of Corporate Growth Health Care Conference by exemplifying the positive characteristics defined by Collins.  And I will continue to do so at future networking events.

More importantly, as we begin to look to expand the Output Medical family as advisors, we should ask ourselves: Will they embody our culture? Will they help build our vision?  Will they represent Output Medical well?

These are questions that I ask myself regularly, and to which I dedicate my improvement as a leader.

The Importance of Partnerships

Output Medical owes a great deal to the many partners that have helped shape our success to date.  From our early partnerships with Insight Product Development and other local Chicago-based entrepreneurial organizations, to our newly forged relationships with the American Medical Association (AMA) and the National Kidney Foundation (NKF), we recognized that we need to find the right people and organizations to help move Output Medical forward.

Partnering with Insight Product Development gave Output Medical instant engineering capabilities commensurate to some of the largest medical device corporations.  With Insight’s experience taking hundreds of medical devices to market, we knew we had the right engineering partner to develop our product with the perfect blend of usability and clinical relevance.

To fulfill our mission of improving patient management among high risk acute kidney injury (AKI) patients, Output Medical is building relationships with key organizations like the AMA and NKF.  These organizations represent the thought leaders in health care.  By working together, Output Medical learns about key trends and changes in AKI management, and with this knowledge, we refine the design of our devices to meet the needs of the Physicians and Nurses managing these patients.

We are a problem-oriented medical device venture.  We are keen to learn as much about AKI and work to keep up with the ever growing clinical literature in this space.  This is precisely why we value our relationship with the AMA and NKF.

In working with the AMA, we learn about key policy trends and how health care systemically approaches clinical innovation.  In fact, the AMA has a three-tiered strategic plan that emphasizes three areas of priority:  Accelerating Change in Medical Education; Professional Satisfaction/ Practice Sustainability; and Improving Health Outcomes, which includes a strong emphasis on disease education and prevention in underserved and at-risk communities.  This mission could not fit any better within Output Medical’s mission of establishing set standards and protocol for AKI management to improve clinical quality metrics for high risk AKI patients and improve Nursing efficiency.

In working with the NKF, we learn about new tools and management strategies for AKI and kidney disease in general.  The NKF has tools that establish standards in various aspects of patient management.  The organization produces clinical practice guidelines through the NKF Kidney Disease Outcomes Quality Initiative (NKF KDOQI). This program provides evidence-based guidelines for all stages of chronic kidney disease (CKD) and related complications.  We seek to work with the NKF to help establish evidence-based guidelines for all stages of AKI disease through our ability to monitor urine and produce unseen high fidelity urine output data.

These burgeoning partnerships reflect the importance that we place on organizational collaboration. From the very beginning, our success was predicated on positive relationships, and we look forward to working together and furthering the success of not only Output Medical, but of the AMA and NKF as well!

Honoring Critical Care Awareness Month

Critical care medicine has often been described as "life in the fast lane." Nobody expresses that sentiment or embodies that idea more than the nurses managing critically ill patients. These nurses spend their shifts balancing acute patient needs with physician orders and management instructions. Their days are a constant stream of tasks and activities complicated by interruptions and delays.

During Critical Care Awareness Month, we salute the nurses working tirelessly to serve their patients. Across the country, there are millions of nurses who all have a deep desire to care for patients in the greatest times of need. They are the compassionate faces at the bedside and the healing hands that work to ensure that each patient receives safe, quality care.

In celebrating Critical Care Awareness Month, we should all stand united in our support for critical care nurses and ask ourselves, how can we support these nurses who do so much to support the patients they tend to?

We at Output Medical are passionate in our support for nurses and see Critical Care Awareness Month as a celebration of critical care nurses. We strive to improve nursing efficiency and satisfaction through our innovative approach to kidney injury management. By providing more reliable and consistent data, our technology allows nurses to optimize care management and make better clinical decisions. Furthermore, nurses can spend less time collecting data and more time on actually analyzing it for enhanced clinical outcomes. 

Output Medical is working with the Nursing Research Council at the University of Chicago Medical Center to design clinical studies that will optimize nursing measurement time for urine output. This collaboration has been a great experience as we work first hand with nursing leadership and glean their insights on improving patient care.

The strong nursing presence at the University of Chicago Medical Center places emphasis on developing innovative care models improving nursing efficiency and clinical decision making. That emphasis serves as the foundation for the collaborative study between Output Medical and the University of Chicago Medical Center.

We look forward to building similarly strong relationships with nursing leadership at other medical centers. As we at Output Medical move forward with our mission of standardizing urine output measurements, we realize more than ever that our mission is to support critical care nursing.

During Critical Care Awareness Month, we salute all the critical care nurses!

Innovative Views from the AKI/CRRT and SCCM Conferences

As a friend and mentor of ours once said, “In order to succeed as an entrepreneur, you need to fall in love with the problem, not your solution.”

Put in context, for anyone building a business, especially a “disruptive” one, it is easy to lose sight of the true nature of the problem that we are addressing. In the world of business competitions, fundraising rounds, and development deadlines, the danger lies in becoming too infatuated with our solution – our “secret sauce.” How often do companies fail because they overlook certain User Need ‘X’ or forget to account for Functional Requirement ‘Y’? How often do companies shy away from a necessary pivot in their development process due to cost or time constraints? What percent of these products never make it to market or worse, are recalled due to flaws?

Over the past two months, we have had the opportunity to take time and revisit the clinical problem behind our solution by partaking in the intrepid I-Corps Program through the Polsky Center for Entrepreneurship at the University of Chicago.

First and foremost, the program provided us with a time-tested, reliable framework for building a business model. By asking ourselves key questions such as What is the Problem we are addressing? What are our Customer Segments? Who are our key influencers? and more, we allowed ourselves the time to go back to the basics in structuring our business model.

The second concrete benefit of the program was that it allowed us to take a couple trips to rediscover the core of our problem. First was to the Acute Kidney Injury and Continuous Renal Replacement Therapy (AKI/CRRT) Conference in San Diego. Filled with nephrologists and other renal experts, this conference represents the culmination of a year of research on AKI, renal replacement therapy, and contingent clinical topics. Second was the Society of Critical Care Medicine Congress in Orlando. Many times the size of the more niche AKI/CRRT, the SCCM represents the latest developments and hot topics in the care of critically ill patients.

These conferences provided us the opportunity to realign our mission and envisioned product with the problem of manual methods of Urine Output measurement. We took the time to speak with physicians and researchers to confirm our core principles and also gauge where the greatest opportunities for impact lie. Through these discussions it became clear that effective clinical care requires an amalgamation of various data points. For renal care and AKI diagnosis, these data points include urinary biomarkers in real-time, instant readings of serum markers, and robust urine output measurements, among others.

Additionally, much of the research that was presented at these conferences directly or indirectly emphasized the necessity of innovative tools and collaborative protocols for more timely diagnoses and interventions and also the importance of “big data” which will serve as a focal point for meeting increasingly high standards of medicine.

Another component of our core problem is the feasibility of such a device in the ICU. At first glance, developing an automated solution to UO measurements might appear to be a breeze. However, no solutions could be termed a success to date. Why is this the case? To start, UO can be a tricky thing to measure. The variation of flow rates is immense which prevents many types of technical solutions from performing well. Furthermore, urine is non-homogenous, especially in the critical care patient population. Hematuria and hyper/hypovolemia, for example, can significantly alter the constitution of urine. An ideal device solves these problems, while remaining low-profile in the often-crowded ICU. A device cannot create an interruption to the normal workflow, but rather it should help enhance it. These essential issues, among others, were enumerated to us in person and continue to be key design considerations moving forward.

Looking back on our experience with the I-Corps program, one of the largest lessons of emphasis is that successful innovation derives from truly adequately-addressed problems and needs. For us, the problem at hand is that current UO measurement and AKI diagnostic methods are not acceptable, and past devices have failed to address the challenges of developing such a device. By jumping at the chance to speak with experts in these fields of AKI and critical care medicine, we have strengthened our value proposition and made some great connections along the way. And if these two conferences are any indication of things to come, then the state of innovation in healthcare is strong.

Defining the New Standard

Output Medical's mantra - "the new standard" - reflects our passion to improve and standardize urine output measurements among high risk acute kidney injury patients. Through our experiences managing patients and reviews of the medical literature, we found a surprising lack of consistency in urine output measurements protocol. This inconsistency stems from the fact that all hospitals still measure urine output manually. That is an incredible thought, that in an age where innovative companies are building image-guided robotic systems to attack cancer cells, we measure urine output manually!
Not only do such manual measurements of urine output affect clinical quality of care, it affects research in the field of acute kidney injury management. There are numerous publications studying acute kidney injury in which the urine output based definition of acute kidney injury were omitted in the analysis due to poor measurement and data quality. One seminal study in particular highlights the gross limitations in kidney injury research indicative of the improvements needed in urine output measurements: Huber M et al., "Cardiovascular-Specific Mortality and Kidney Disease in Patients Undergoing Vascular Surgery". This study was among the first to demonstrate significant long term co-morbidities and mortalities among vascular surgery patients that develop peri-operative and post-operative kidney injury. And in the paper the authors comment on the limitations in data quality due to poor urine output measurements and data recording:
"We had only limited data concerning urine output among patients with CKD [chronic kidney disease]; if available, those data could have strengthened our analysis."
If we are to advance the field of acute kidney injury we must establish a standard protocol for urine output measurement. Standardization involves automating the urine output measurement, data-recording, and data-analysis process. An article soon to be published in the "Canadian Journal of Kidney Health and Disease" highlights the efforts of an Acute Dialysis Quality Initiative (ADQI) workgroup on acute kidney injury and big data to address the importance of standardization. We at Output Medical are passionate about automating the detection of acute kidney injury using the established criteria, RIFLE/KDIGO. And we believe that automation is the first step to standardization.Hence the mantra, "the new standard".
We are currently recruiting academic medical centers and community based hospitals to collaborate with Output Medical and establish clinical studies that would automate the detection of acute kidney injury using RIFLE/KDIGO criteria in real time. Please contact us if you are interested in supporting the advancement of acute kidney injury research!