INCREASING UTILITY: DESIGNING MEDICAL DEVICES AND APPLICATIONS FOR REMOTE MONITORING

Transcription

1 INCREASING UTILITY: DESIGNING MEDICAL DEVICES AND APPLICATIONS FOR REMOTE MONITORING 2011 Design of Medical Devices Conference April 12-14, 2011, Minneapolis, Minnesota, USA Lori Lucke, Anne Mickelson, Jeremy Maniak Minnetronix, Inc. St. Paul, MN, USA ABSTRACT Remote monitoring of medical devices has long been discussed as a means of improving access to patient data. Beyond patient data there is additional information within the medical device that can be valuable for remote access applications. Expanding remote monitoring to include service and maintenance, market analysis, inventory management, and post market surveillance systems can add significant value to the device. It is not enough to simply add a remote access module to the medical device. Careful design of the device and the remote application are necessary to make the information within the device accessible to those who can use the information. This paper discusses methods for designing a system that can be applied to many types of devices and increase the utility of the information supplied to the user. INTRODUCTION Wireless networks have become commonplace in many industry markets. Hospitals and clinics, once wary of adoption of wireless networks, have been rapidly employing these technologies to support clinician communications and Wi-Fi connections for patients and visitors [1,2]. The penetration of wireless network coverage is now over 80% of the U.S. hospital marketplace [1,2]. Much of the initial work and support of wireless environments for the medical market was focused on the development of wireless technologies to transfer patient data and medical records. This work continues today with the development of new standards to support wireless data transfer [3]. For medical device designers, the existence of wireless networks in hospitals and clinics makes it possible to add new services to their devices. Utilizing this network to implement remote patient monitoring has been difficult due to the lack of insurance reimbursement [4]. At the same time remote monitoring of devices is becoming a mature market in many industry applications. Enabling the device to connect to a network increases the services that a company can provide to their users [5]. Utilizing the network for remote device access for purposes other than patient monitoring provides a better model for reducing the cost and extending the service of a medical device. Medical device designers of large equipment (e.g. imaging equipment) have long been able to support connection to a network. The large capital intensive equipment could support the additional development cost for remote access [6]. In the past few years, the capital cost to add the necessary hardware support to smaller less capital intensive devices has dropped significantly. This is being driven by the industrial market [7] among others. The size and cost of the modules needed to connect to the network are no longer the limiting factor to support remote access to a medical device. With capital constraints largely removed, the difficult part of the design is to make the data in the device accessible to the user of the data. To do so, requires support at both ends of the device. First the device must be designed to be accessible and then a model must be designed for accessing the device. In this paper we discuss the effort necessary to make remote monitoring of a device successful. CORE VALUE PROPOSITION The key to extending the value of remote monitoring to smart medical devices is in these four core concepts: Remote Service and Maintenance Market Analytics Inventory Management System Post Market Surveillance System Each of these concepts expands the utility of the device. These concepts are expanded on in the following sections. REMOTE SERVICE AND MAINTENANCE Current medical device and diagnostic equipment can contain an expensive capital equipment component critical to the proper delivery of the desired clinical benefit. This equipment can include a vast array of sophisticated electrical and electromechanical assemblies such as radio frequency (RF) generators, ultrasound generators, and fluid or blood pumps. Clinician satisfaction with a particular medical instrument such as this includes the company s ability to properly service and maintain the equipment in a manner that minimizes the clinical down time and overall clinical impact. This level of service places high demands on medical device companies that have many devices placed in several locations across the globe. 1

2 The benefit of improving the service of medical equipment through remote device monitoring is clear. Through Wi-Fi or cellular connectivity, the device fleet would be able to send relevant performance data to a secure server. A web accessible application would analyze and filter the results in order to provide insight as to current, and potential issues, such that service could be targeted and prioritized. Service personnel would then be able to remotely diagnose the issue and identify a corrective action, such as the replacement of a particular part or upgrading the device software. The availability of actionable on-demand knowledge of an entire fleet of medical devices would offer improved customer satisfaction while improving service efficiency for device manufacturers. MARKET ANALYTICS Medical device sales and marketing professionals have limited access to information in the field. In order to understand and respond to sales trends individuals manually collect data from various clinical sites in order to create a summary report of how a particular sales or marketing initiative is performing. Due to the resource intensive nature of this exercise, it is limited in the scale and scope of its use, leading to strategic decisions based on very limited actual usage data. This results in the inefficient utilization of sales and marketing professionals and the inability to quickly determine the impact of market initiatives. By designing the medical device to capture pertinent data and relevant usage metrics, on-demand reports reflecting clinical usage patterns can be generated. This would allow sales managers to see same day revenue (sales) by account reflecting actual product utilization and demand. Market opportunities can quickly be identified for a targeted sales visit, promotional activity or product training seminar. Furthermore, the ability to combine information across various accounts and regions creates the ability to monitor the success of promotional marketing activities in a real time manner without impacting clinicians or hospital operations. This capability represents a step change in the amount and quality of information available to medical device sales and marketing departments. INVENTORY MANAGEMENT SYSTEM Medical device inventory management is another key aspect of customer satisfaction in the medical space. Companies who fail to have the necessary product available when needed by the clinician can face significant sales barriers when contracts are ready for renewal. In order to limit potential exposure to these stock-outs and backorders medical device manufacturers tend to increase levels of carried inventory throughout the distribution channel resulting in high inventory and storage costs. The connected medical device can be designed and developed to address this class of operational issues as well. Online information linkages between device usage and Enterprise Resource Planning (ERP) systems hold the promise of real-time usage and inventory adjustment based on actual use. These capabilities could simultaneously increase customer satisfaction through the elimination of stock-outs and reduce the cost of inventory required to deliver that level of service by creating a direct electronic linkage from clinical use to distribution and manufacturing. POST MARKET SURVEILLANCE SYSTEM As the medical device industry has matured, regulatory agencies have continually increased requirements surrounding post market surveillance. Companies are expected to proactively monitor the performance of their devices in the field and respond to all potential issues. Successfully accomplishing this drives improvements in patient safety and satisfies necessary regulatory requirements for ongoing operations. Current best practice is to monitor field complaints and identify and implement necessary corrective actions, but the data provided in complaints can be incomplete or inadequate, limiting a manufacturer s ability to properly correct issues. A medical device designed to include post market surveillance features combined with wireless connectivity would enable device manufacturer s to monitor the performance of their medical equipment over time as it relates to the device performance requirements. Devices operating out of specification would generate an alarm and automatically indicate a complaint to be evaluated. Complaints received through traditional mechanisms could be investigated by examining the performance of the medical device along with the operating conditions at the time the complaint occurred. Implementation during the system design phase is critical for this to be completed in an efficient manner to avoid the need for additional device hardware or excessive server data storage. DESIGNING THE DEVICE TO BE ACCESSIBLE Much of the work regarding remote accessibility of medical devices has been focused on supporting the transfer of patient data [8,9]. The device itself must be designed to support collection of the information necessary to make remote access successful. A summary of the types of information necessary to make accessible within the device is shown in Table 1. Designing a model for handling this information that can be applied to a variety of devices requires the following attributes: identification storage Information transfer Scalable models Security of data Resource analysis to allow for data collection without impacting device performance Communication protocols segregation Prioritization of access requests 2

3 Including a remote access module within the device as part of the overall system architecture can assure that the device has the support for remote access and allows the introduction of remote services. It is also important to consider the compliance requirements for the device. Including a wireless module may introduce additional safety and electromagnetic compatibility concerns [11], risk management requirements, as well as requiring FCC certification. Designing the system for compliance as well as for data management is necessary for the success of the remote monitoring applications. One of the keys to designing for compliance is to use a design team with medical device design experience [12]. The key to the success of the design of the device is to include the remote access applications as part of the initial system requirements for the device. Then the device can be properly architected and developed to support the remote application and proper planning can occur for the risk management and compliance activities. Providing a generic framework for the remote access support within a device also reduces the development time and cost for supporting the application. Table 1: Accessing Information From Within a Device Set User Examples Sales and Sales Marketing Representati ve disposables) Marketing Inventory data (e.g. Number of procedures, number of Protocols, Device configurations Patient Clinician Patient parameters, Device parameters, Patient Procedural data, Patient trending data, Case data Service Maintenance Service Technician, Engineer Hospital Biomed Service Log, Alarm Log, Software Revision Number(s), Odometer Totals (Elapsed Time Running, Fluid Volume Pumped, Battery Run Time), Power Information (Voltages, Battery Current), Temperature, New software upgrade, Deluxe Diagnostic test Last Preventive Maintenance (PM), PM scheduling, Odometer Totals (Elapsed Time Running, Fluid Volume Pumped, Battery Run Time) Hospital Engineering Manufacturi ng Other Materials/As set Manager Risk Manager Software and Electronic Engineers Manufacturi ng assembler, technician Hospital Biomed, Clinician Tracking data Alarm log, Activity Log Alarm log, Activity log, log, Service log, Hardware diagnostic data (e.g., voltages, temps, battery current) Device configuration data, Serial Numbers, Software revisions Custom drug library, Custom alarm limits, Custom device configuration 3

4 DESIGNING A MODEL FOR DEVICE ACCESS The device system must also be architected and designed such that a diverse set of users can easily access the information desired without the need to understand the either the scale or scope of the underlying data. These users span from sales and marketing professional to field service engineers and regulatory affairs. Much of the raw data desired by these various groups is the same, but the manner in which they want to analyze and view it is very different. For example, the sales and marketing professional may want to view device usage by account or hospital while the service engineer may want to locate and remotely troubleshoot a problem device. At the heart their quest is device performance data, but the manner in which they want to view it to address their need is very different. The solution to this has 2 key components: 1) server applications that filter and sort the raw device data into subclasses and 2) a customizable web based user interface with a landing page architecture. These design attributes enable the development of a high performance customizable user interface making it easy for diverse groups of users to quickly access the data they need, and in the manner in which they want to see it. Of critical importance to this customizable web-based user interface is usability and human factors. Well known techniques can be utilized to make the user interface of the web client usable [13,14]. The diversity of the user groups of the device information makes this more challenging. Yet this is critical to the success of the remote access application. In order to design a usable interface for these diverse user groups, user profiles and task analyses should be performed to understand the work flow and tasks to be performed. Concepts and working prototypes can then be tested with representative users from each user group to assess the interface to ensure that it meets the needs of each group. This user feedback will then be incorporated into the final interface design. Well known techniques can be utilized to make the user interface of the web client usable [13,14]. Although the design of the web-based interface is not in itself a medical device, it is necessary to fully understand all the interactions with the device to ensure no hazards are introduced by the remote access application when it is accessing the device. Understanding and testing the application and the device as a system is necessary to ensure proper access to the device. Developing a generic framework for the web-based remote access service can reduce the cost and time necessary to develop the remote application. The development of remote access service providers is expected to enhance this process. significant value to the device. Adding a wireless module to the device is not sufficient to support remote access. Careful design of the remote data handling both within the device and the remote service application allows for significant expansion of service opportunities. The development of a scalable generic method that can be applied to a variety of devices is necessary to support this activity. REFERENCES [1] Baker, S., Hoglund, D., Medical-Grade Mission-Critical Wireless Networks, IEEE Engineering in Medicine and Biology Magazine, March/April 2008, [2] Solovy, A., Hospitals Cut the Cords, Hospitals and Health Networks Magazine, August [3] Zhang, Y., and Ansari, N., Wireless Telemedicine Services Over Integrated IEEE /WLAN and IEEE /WIMAX Networks, IEEE Wireless Communications, Feb., 2010, [4] Mannion, P., The path to money in medical systems design., EE Times EE Life, Sept [5] Allmendinger, G., Lombreglia, R. (2005). Four Strategies for the Age of Smart Services. Harvard Business Review, 83:10, [6] Dvorak, P., Remote Monitoring, Medical Design, April [7] Ramamurthy, B., Bhargavi, S., ShashiKumar, R. Development of a Low-Cost GSM SMS-Based Humidity Remote Monitoring and Control System for Industrial Applications, International Journal of Advanced Computer Science and Applications, October [8] Noorzaie, I.. Survey paper: Medical applications of wireless networks. wireless.htm, April [9] Myers, S., Grant, R., Lugn, N., Holbert, B., Kvedar, J., Impact of Home-Based Monitoring on the Care of Patients with Congestive Heart Failure. Home Health Care Management & Practice, 18:6, 2006, CONCLUSION Remote monitoring of medical devices can be effective for many applications beyond the transfer of patient data and medical records. Expanding remote monitoring to include service and maintenance, market analysis, inventory management, and post market surveillance systems can add [10] de Jonge, M., van der Linden, W., Willems, R.. eservices for Hospital Equipment. In 6 th International Conference on Service-Oriented Computing (ICSOC 07, 2), 2007, pp [11] Witters, D., Seidman, S., Bassen, H, EMC and Wireless 4

5 Healthcare, 2010 Asia-Pacific Symposium on Electromagnetic Compatibility, April 2010, 5-8. [12] Lucke, L., Anderson, D., and Smith, D., Harnessing Experience for Efficient Medical Device Product Development., Design of Medical Devices Conference, April [13] Johnson, J., GUI Bloopers 2.0: Common User Interface Design Don'ts and Dos, nd ISBN: [14] Butow, E. User Interface Design for Mere Mortals, 2007 First ISBN:

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