Home Use Devices and SaMDs in Patient Self-Care: Concept to Develop Excellenct Products in Digital Health Peter Rasche, Laura Barton, Katharina Schäfer, Sabine Theis, Christina Bröhl, Matthias Wille, Alexander Mertens Chair and Institute of Industrial Engineering and Ergonomics of RWTH Aachen University, Germany The German healthcare system is characterized by digital change. In recent years, a trend towards the entry of start-ups and medium-sized enterprises into this sector has developed. These types of companies in particular are facing enormous challenges due to the industry and the ongoing digital change. This article presents the fundamental developments and challenges of these companies. Further solutions developed by the Tech4Age research group are presented briefly. Finally, this article describes how these solutions can be integrated into a formal concept for the promotion and further development of SMEs and start-ups in the German health industry in order to enable them quickly and comprehensively for the development of excellent digital health products. INTRODUCTION In recent years, the number of products developed and supplied by start-ups in the healthcare industry is rising in Germany (Herberz et al., 2018). These companies have innovative ideas and are agile enough to face the fast changes this industry is shaken by. Nevertheless these companies are facing enormous challenges, too. These challenges are aligned to the nature of a start-up or medium-sized enterprises (SEM) but also to the home healthcare sector itself. Aim of this paper This paper gives a brief overview about challenges start-ups and SEMs face if developing digital healthcare products for the German healthcare system. Additionally corresponding tools are presented which were developed by the Tech4Age research group to support start-ups and SMEs to achieve excellence in developing digital health products. Finally, this article presents a systematic approach to develop start-ups and SMEs sustainably towards an excellent development process for digital health products. DEVELOPMENT OF DIGITAL HEALTH PRODUCTS The development of software differs in its process from the classical products. The EN ISO 9241-210 standard defines an iterative process based on continuous evaluation and improvement. It is precisely this procedure that has proved its worth during development. Against this background, the Tech4Age research group continues to pursue this approach and presents hurdles and challenges in implementing this process in the medical technology industry. However, it must be pointed out that in this consideration we exclude the restrictions regarding a quality management system or documentation obligations for medical devices and their development that apply due to national as well as international regulations. This article deepens the challenges arising from the application of EN ISO 9241-210 in the context of the development of digital medical devices, especially for start- ups and SMEs. For a comprehensive overview, the challenges are sorted according to the steps of EN ISO 9241-210. These steps comprise the points ‘understand and specify the context of use’, ‘specify the user requirements’, ‘develop product design solutions’ and ‘evaluate product design solutions’ in the sense of a iterative cycle. Understand and specify the context of use Within the scope of this step, the context of use of the product to be developed, including its potential users, the intended work task and the system environment, is to be examined and defined as the starting point. Challenges The German health care system is changing. Due to increasing cost pressure and an aging society, cost-effective and efficient solutions are needed to deliver healthcare services. Digital health products are seen as a promising contribution to the success of this transformation. Nevertheless this process is aligned with several challenges related to the context of healthcare services. One challenge is the fact that digital health products are not just delivered by certain medical devices but also by consumer products as smartphones or tablet-PCs. Thus, medical service providers have to rethink the context of their services as they are not just dealing with patients but also somehow with consumers. At least patients might experience the delivered health service or digital health product as a consumer product (Eysenbach, 2000; Parry et al., 2014). Another challenge related to the first one is the ongoing trend of technology migration from clinic to home care setting (Devine et al., 2004; Fu, Weick-Brady, & Tanno, 2012; Pfannstiel, Krammer, & Swoboda, 2018; Steiner, Joos-Braun, & Pfister, 2018). A rising number of services and products which were formally delivered or used just in clinical context are now also used within the home care one as telematics enable the surveillance of patients over great distance. Examples for this trend are home dialysis or chemotherapy (Polinski et al., 2017; Tennankore et al., 2018). Besides just the migration also the mobility of medical devices and services evolves due to digitalization (Stankovic et al., Copyright 2018 by Human Factors and Ergonomics Society. All rights reserved. DOI 10.1177/2327857918071041 Proceedings of the 2018 International Symposium on Human Factors and Ergonomics in Health Care 189