Assessing the Risks and Success Factors of Telehealth Development Projects in an Academic Setting

Introduction

The U.S. healthcare system is facing challenges to meet the growing healthcare needs of its population. Under the pressure of high cost, rapidly increasing aged population, and the need to limit face-to-face patient contact due to the coronavirus disease 2019 (COVID-19) pandemic, the future direction of healthcare delivery is moving towards a home-based, personalized, and decentralized model. With the advancements in medical and information technologies (e.g., motion capture sensors, electronic health records, wearable devices, etc.), as well as data analytics, telehealth technologies are gaining importance in healthcare services. Telehealth technologies not only reduce the cost of care but also improve the quality of care and expand access (Tuckson et al., 2017). They also hold great promise to enable the care delivery shift from hospital to home-based setting. However, the development of a successful and cost-effective telehealth solution can be complex (Cho et al., 2008).

Translational research, often described as “bench to bedside” research, seeks to move technological discoveries, such as telehealth technologies, into healthcare practice to improve patient health and well-being. Multiple barriers can slow the progress or even prevent the success of translational research projects. Furthermore, current practice typically takes a piecemeal approach to development that rarely looks beyond developing and testing a prototype (Cho et al., 2008; Contopoulos-Ioannidis et al., 2003; Searles et al., 2016). The large gap between scientific discovery and a successful product is referred to as the “valley of death” (Butler, 2008; de Graaf et al., 2015) and many promising academic-based translational research projects fail to cross it (Roberts et al., 2012). Thus, performing an effective project risk management is essential for the successful translation of telehealth technology from academia into healthcare practice.

The Project Management Institute defines project risk as “an uncertain event or condition that, if it occurs, has a positive or negative effect on a project’s objectives” (Project Management Institute, 2000). Project risk management involves identifying, assessing, controlling, monitoring, and preventing the risks throughout the project. Project risk management also helps outline project attributes that can be used to respond to risks. Throughout this paper, such project attributes are referred to as success factors.

Many studies have highlighted the significance of an effective project risk management in translational research (Pietzsch et al., 2009; Schwartz & Macomber, 2017). Several researchers have proposed decision support tools to manage the risks in translational research projects. Wang et al. (2010) proposed a framework based on QFD and Balanced Scorecard. Their framework aims to align the project risks with the firm’s strategic objectives in a drug development project. Inoue & Yamada (2010) conducted another study in pharmaceutical research. They presented a case study of the application of FMEA as a performance improvement tool in early drug discovery. Kirkire et al. (2015) developed a fuzzy FMEA to mitigate the risks in different stages of medical device development and illustrated the application of the method in a dental manufacturing company. Kirkire & Rane (2017) suggested using grey Decision-Making Trial and Evaluation Laboratory (DEMATEL) methodology to analyze the cause-and-effect relationship of success factors for medical device development. None of these studies considered both the project risks and success factors in the same framework. Also, there is a lack of research focusing on medical device development in an academic setting.