MONITOR PATIENTS VITAL SIGNS 34 KEY DATA: FACT FILE Technology Vital signs monitoring Established 2010 Type Start up Location Milton, Oxford Employees 14 CEO and Co-Founder Dr Keith Errey A serial entrepreneur, he was a founder of an early spin-out from Oxford University, Oxford Lasers Ltd. He then set up Oxford Synergetics Ltd to identify technologies suitable for commercialisation. Prior to establishing Isansys he was the co-founder and CEO of Toumaz Technology, now Toumaz Group (LSE). He has physics degrees from Oxford University and the University of New South Wales, Australia. Isansys has developed a novel vital signs monitoring and analysis platform which can be used to monitor patients 24-hours-a-day in hospitals or at home using cloud-ready wireless devices and predictive algorithms. THE NEED Healthcare providers face severe problems meeting the growing demand for medical services under tight budget constraints, making it urgent to find ways of delivering more for less. One solution to this is remote monitoring systems that use wireless, sensing and information technologies to collect and analyse patient data. They show particular promise in addressing issues related to in-hospital patient safety as well as the inexorable rise of chronic conditions that require patients to continue receiving healthcare monitoring at home. BARRIERS Despite the promise of the new technologies, actual adoption by healthcare providers has been slow. In Isansys view the reasons for this are that: systems are not offered as sufficiently usable, integrated and approved medical solutions; they often require healthcare providers to adopt new workflows and care pathways; and, most critically, healthcare providers do not have the evidence and user experience to prove the economic and clinical benefits to their payors.
35 START UP Isansys was established by Keith Errey and Rebecca Weir to overcome these barriers by providing what they call the missing links which will allow healthcare providers to benefit from these enabling new technologies. Both had worked at wireless sensor innovator, Toumaz Technology (now Toumaz Group) where Errey had been CEO and Weir, with a biochemistry background, had led the clinical trials activity. Looked at from the healthcare provider s perspective what was needed most, they believed, was a single source provider who could navigate the technology landscape and the regulatory framework in order to secure the real benefits that the new technologies promised. The company had an early hospital customer in the Netherlands who was able to articulate the requirements for the wireless devices and system. Their aim was to determine whether wearable vital sign monitors could provide the same information at the bedside as expensive monitoring equipment in an intensive care unit. Isansys was able to trial its Lifetouch TM cardiac smart patch sensor and gain valuable experience in a clinical setting. Lifetouch TM smart patch sensor Isansys was founded on the belief that the way to do this was: firstly, to create a complete, scalable, low cost technology platform, which would overcome the barriers of technology integration and data accessibility; and, secondly, to provide the platform as a managed service, which would reduce the technology risk for healthcare providers and remove the up-front capital cost. CLINICAL HEALTHCARE FOCUS From the beginning, the founders recognised that the focus of Isansys should be clinical healthcare, particularly hospitals, rather than the tele-health monitoring of long-term chronic care patients at home. Hospitals provide the environment in which the status of patients change rapidly (hence shorter times are necessary to validate new devices and techniques) and also where corroborating data is available, through current standard monitoring methods.
36 EARLY LEARNINGS The success of these first trials, in early 2011, provided Isansys with three key learnings which shaped the future direction of the company, says Errey: 1. The importance of working closely with doctors and, importantly, nurses, to discuss their problems and needs rather than trying to drive through a technology solution; 2. The need to make sure the wearable devices and the overall system are medically-compliant by implementing a full quality system and compliance process from the very start of the company s operation; 3. Recognition that ultimately it is a data service business rather than a medical device business but the sensor devices must provide clinically validated, reliable and accurate data in order to bring real benefits to patients and providers. PRODUCT DEVELOPMENT Unable to find and purchase suitable devices (wireless wearable products for consumer fitness and health are neither clinically validated nor accurate, says Errey) Isansys set up an in-house engineering team to develop the company s first product, the Lifetouch TM cardiac monitor, a wireless smart-patch that analyses the patients ECG and provides continuous heart and respiration rate measures along with real-time heart rate variability. THE DISAPPEARING DEVICE The components which make up wearable devices have fallen sharply in price making it possible to reduce the cost of a total monitoring system to the point where it can be deployed in homes and hospitals. The Lifetouch TM was developed in accordance with what its founders call their philosophy of the disappearing device, a product that disappears in size, in cost, in complexity and ultimately into the Cloud. It was released as the first Cloud Ready medical device in May 2011 following approval as a Class IIa device under the European Medical Device Directive. DATA DRIVEN The ability to collect large physiological data sets has led clinicians to ask how they can make better use of the data to improve outcomes for their patients. Isansys answer was to develop its Patient Status Engine as a platform which allows clinicians to acquire and analyse patient data in a clinical setting [See next page, The Patient Status Engine (PSE) Digitising the Patient] so that they can grow the necessary evidence base. It provides a complete system that continuously and wirelessly captures, analyses and stores securely vital sign and other physiological data. The PSE Gateway and Lifetouch TM Digital Sensors
37 THE PATIENT STATUS ENGINE (PSE) DIGITISING THE PATIENT The PSE is the patient monitoring platform which digitises the patient s physiology continuously and in real-time, analysing large data sets to provide predictive and diagnostic indications to clinicians. Utilising the Lifetouch TM and the Lifetemp TM devices (the company s wireless pulse oximeter and blood pressure monitor and a continuous clinical thermometer respectively) the patient s physiology is automatically uploaded as a series of secure digital files to a patient record. Apps may be readily integrated into the platform to run either on the real time data, the stored data or a combination of the two. The PSE comes pre-bundled with several apps, such as patient charting, early warning scores and real-time HRV plots. In what Isansys says is an industry first, the PSE offers clinicians and researchers the ability to also deploy their own unique apps to aid clinical discovery, adverse event prevention and the generation of big data sets. In addition, the PSE has an API that presents the digitised patient on an interface that may be opened for straightforward integration into other hospital information systems, electronic health records, or digital health clouds. CE-READY CE marking for the wireless sensor (the Lifetouch ) with the necessary wireless network links was obtained in April 2012, and for the Patient Status Engine, in September 2013. At the time of certification, Isansys says it was the first Cloud-ready medical device of its kind, and the first to be certified as a Class IIa medical device under the European Medical Device Directive. There are patents pending on certain functional features of the Lifetouch and also some constructional features, such as the recyclability of the devices and the functionality of the system. HOSPITAL PILOTS Isansys is working with leading clinicians in four hospitals in the UK, including the Royal Free Hospital in London, helping them employ new patient monitoring technologies and predictive care methodologies. These studies are leading towards deployments that will address patient safety issues that lead to the 850,000 reported adverse events that cost the NHS more than 2 billion a year in lost bed days alone. VITALS AS A SERVICE Beyond the pilots, Isansys proposes to provide the platform as a managed service - Vitals as a Service (VaaS). Under this arrangement Isansys will supply healthcare providers with the PSE equipment and consumables, which removes the capital and technology risks, and instead providers pay Isansys on a per patient per day basis. The attraction is that the upgrade cycle in technology is now 12 months driven by advances in consumer technology, whereas it used to be a 5-18 year capital cycle. For hospital use the Lifetouch and Lifetemp devices are effectively consumables; however, the patented recovery and recycling programme incorporated in VaaS, greatly reduces the environmental impact and usage costs.
38 NHS CONTRACTS In March 2014, Isansys secured two contracts from the NHS through the SBRI (Small Business Research Initiative) Healthcare programme which is part of NHS England s initiative to enhance the adoption of innovative devices and new technologies. The contracts will allow Isansys to expand the functionality and applications of its CE-marked PSE in two key areas - improving patient safety in hospitals; and for cancer patients who have undergone chemotherapy. In the case of cancer patients, it will provide early warning notifications of sepsis in patients at home, two to three days ahead of when they might present as emergency admissions. NEXT GENERATION SYSTEM The SBRI programmes and an earlier TSB Smart award have enabled Isansys to develop the next generation Lifetouch monitors that connect with mobile gateway devices and will be presented in multiple form factors and packages for different applications including paediatrics, higher acuity monitoring and longer term surveillance of patients at home. Allied with this, the second generation PSE system will include more robust algorithms, new networking capabilities and new lower cost wireless devices with higher functionality. predict that in the near future tens of millions of Americans will be connected to devices that will automatically send their vital signs to medical professionals, relatives and concerned friends. The technology already has generated an industry worth well over $1bn a year, according to Isansys, despite concerns that the data transmitted by patients could overwhelm doctors or be spied on by hackers. THE FUTURE Isansys believes it is ahead of others in transforming the idea of a medical device as a piece of medical equipment to a Cloud based service solution. It calls this a shift in perspective which has opened up many exciting possibilities for healthcare delivery and the patient experience. It is now building the evidence base through clinical trials which will cause the barriers to adoption to fall faster and the benefits to be more quickly recognised. www.isansys.com DEMAND There is a burgeoning interest to deliver new digital healthcare solutions so that stakeholders can have access to data which improves quality of care, reduces the cost of care, and allows patients greater control over their own health. Some experts