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Usability in the lifecycle of medical software development

A current view on human-centered design activities in German enterprises
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Current Directions in Biomedical Engineering
From the journal Current Directions in Biomedical Engineering Volume 2 Issue 1

Abstract

A close cooperation with users is necessary to ensure that interactive systems are robust, easy to use and accepted. Therefore, in medical technology, standards for usability are of fundamental importance. We investigated with the presented study how the concept of usability is currently understood and implemented in medical software companies. Interviews were conducted with 21 employees of German enterprises. Furthermore we extended an already existing quantitative online survey where 53 companies (including 24 from the health industry sector) participated in. Results show that the importance of usability is recognized by most of the respondents. Moreover, a wide variety of methods and approaches is known and implemented for exploring user needs and evaluating system prototypes. However, it was observed that human-centered design activities mainly focus on functionality, risk prevention and accessibility. Hedonic user needs and subjective perceptions (“user experience”) still play a minor role. Based on the results, practical requirements are derived and a “best case” for methodological approach is introduced.

Keywords: medical software development process; usability-methods; user experience

1 Introduction

The medical technology market has been growing for many years. Forecasts of annual growth rates confirm that this trend will be maintained in the next 5 years for the global market (5.0%–5.2% per annum) [1]. Medical technology is also one of the most innovative industries with about 11.000 patent applications in Europe [2]. The growing demand is caused by demographic changes, aging societies and an increasing use of interactive technologies, smart devices, software, and mobile applications [i.e. [3], [4], [5]].

The most important key to success for medical technology is the close cooperation with its users. A human-centered design approach helps to prevent incorrect operations through optimizing the usability at early stages of product development. Usability comprises “the effectiveness, efficiency and satisfaction with which specified users achieve specified goals in particular environments” [6]. The complete documentation of a usability-oriented design process is a necessary precondition for successful authorization procedures of medical devices [6]. Therefore, a conscientious realization of relevant standards is of fundamental importance in medical technology.

However, standards are rather general in this sector, basically determining the main requirements for products and usability-oriented procedures. So it is often up to the developer to decide which methods and instruments will be implemented for exploring specific contexts of usage as well as for evaluating product solutions. Standards neither describe the extent of measures nor when the process will be completed. Moreover, standards do not specify disciplinary background and expertise of the for the sector responsible employees.

These preconditions led to the research question how usability standards are currently implemented in German medical technology. A sub-goal was to identify perceived barriers in the realization of usability-oriented activities. A third goal was to investigate whether the consideration of an appropriate “user experience” is an important aspect in the development of medical software solutions. While usability is mainly performance oriented, user experience also includes “soft criteria” such as appearance and feelings, user emotions and motivation, acceptance as well as integrating the product in everyday life.

2 Material and methods

2.1 Method

21 Telephone interviews with German medical software producing companies were conducted. 11 enterprises were small or medium-sized (SME) and 10 were large. For the interview a semi-standardized interview guide was developed. Questions included the main phases of the software development process and the applied usability methods. Furthermore, respondents were asked to assess the importance of different product attributes. At the end, barriers and problems regarding the implementation of usability methods were collected.

2.2 Results

The results show that on a scale from 1 (“no knowledge”) to 5 (“highest knowledge”) respondents evaluate their knowledge about usability slightly higher than their practical experience with usability (M = 3.48 vs. M = 3.10).

Based on a synopsis of all the information about the three main phases of product development provided by the interviewees a summarized best case model for human-centered design methods was created (see Figure 1).

Figure 1: Best case model for named human centered design methods divided in main/sub-phases, usability-methods and invested resources.
Figure 1:

Best case model for named human centered design methods divided in main/sub-phases, usability-methods and invested resources.

Post hoc, the main phases were categorized as context of use and specification (1), design and testing (2) and reverse engineering (3). In Figure 1 the applied usability methods are shown next to the main phases. The percentages of the invested resources (time, financial costs and human resources) show that most of the resources are located in the second phase design and testing. According to the user-centered design process [7], iteration cycles within the first two phases might be necessary.

When comparing small or medium-sized businesses (SME) with large enterprises, it was apparent that the practical experience of implementing usability measures is significantly higher in case of large enterprises (d = 1.07, p = 0.03). Moreover, in large medical software enterprises the number of usability employees is significantly higher (d = 2.39, p = 0.03). While large enterprises employ nine usability professionals on average, SME only employ five.

With respect to the percentage distribution of invested resources, SME tend to invest most of their usability budget in the design and testing phase, while large companies use the budget approximately equally distributed over the three main phases. Especially for the context of use and specification (phase 1), large enterprises are in a position to invest a greater proportion of their budget (29% vs. 20.5% for SME).

When asked about the importance of different product related aspects, interviewees assessed reliability, safety and user requirements as most important aspects in the development of medical software solutions, while hedonic product attributes, such as emotions, fun and motivation are of lower importance (see Figure 2).

Figure 2: Importance of product aspects within usability-practice: 1 = very important; 2 = fairly important; 3 = rather unimportant; 4 = very unimportant (this category is not occupied).
Figure 2:

Importance of product aspects within usability-practice: 1 = very important; 2 = fairly important; 3 = rather unimportant; 4 = very unimportant (this category is not occupied).

The most important problems and barriers of the interviewees for the implementation of usability-methods mentioned were:

  • Lack of acceptance of usability

  • Lack of resources

  • Lack of evidence of the usefulness of usability

  • Lack of communication within the organisation

  • Early integration of usability in the product development process.

3 Online survey

3.1 Methods

The online survey aimed to compare the view on usability between the medical technology industry and other industries. For the assessment of usability-related aspects an online self-test developed by the Usability in Germany e.V. has been used. This online test is based on the Usability Maturity Model of Woywode et al. [8] and contains 15 items, measuring for example the usability-acceptance, and the use of standards. The self-test is available under the following link: http://www.usability-in-germany.de/aktuelles/usability-selbsttest. In the present study 24 medical software companies and 29 software companies from a non-medical background participated.

3.2 Results

The statistical analysis shows that the usability-acceptance is significantly higher in case of the medical software companies (p = 0.03). Furthermore, the interviewed medical software companies evaluated the number of applied methods higher than the companies in other areas (p = 0.02). No other differences are statistically relevant.

4 Discussion

The growing importance of usability is reaching a high level of awareness in the field of medical technology, as our results indicate. Compared to other industries medical companies stated a higher usability acceptance. In addition, respondents assessed their knowledge and practical expertise more than the average. First and foremost human-centered design methods are applied in order to enhance safety and to prevent errors in patient’s treatment. Based on the results a best case model was introduced illustrating that a wide range of well-established methods are known and used at different stages of the software development lifecycle.

Nevertheless, the interview study also revealed that certain barriers and problems are perceived. In particular, the lack of acceptance on management level and very limited resources were reported by most of the respondents. In practice, both aspects are frequently interrelated with the lack of an objective, reliable, and holistic criterion of success for human-centered design activities [9]. Future research has to find appropriate solutions in providing low-threshold procedure models which offer the opportunity to gain a realistic view on the outcome of usability measures [10].

Large companies as well as SME have recognized the importance of design and testing medical software solutions. The underlying trend shows that SME invest slightly less of their usability resources in early development phases. Engaging end users in early stages is not only valuable for finding innovative product solutions, but also a fundamental base for determining, validating, and prioritizing functional as well as non-functional requirements from a user’s point of view. Since the best case model is a synopsis of all the information provided by the interviewees, it should be noted that all companies which participated in the study differ more or less in their individual number of methods and the proportions of invested resources. Therefore, the positive comprehensive view must not hide the fact that some health systems are developed without regard to user requirements, or without the aid of any user-centered design guidelines [11].

Finally, the findings of the study show that the concept of “user experience”, including the consideration of non-task related product attributes, is a slightly unattended area in medical technology. However, the systematic investigation, design, and evaluation of a consistent user experience is not only an essential factor for maintaining competitive advantages in the market. For most interactive technologies it rather represents a very important key aspect that determines if a product is used at all and therefore directly influences the effectiveness of a patient’s treatment. A coherent experience is necessary for stimulating motivation and intention to use, e.g. in the case of medical products that patients have to apply for themselves over a longer period. Moreover, positive experiences during interaction with a system may contribute to dispel fears and prejudices that may be associated with specific treatments. While by now the concept of usability seems to be widely recognized in medical technology, user experience has to be considered even more in the future. There is a need for adapting and developing specific methods and instruments for measuring subjective experiences with interactive medical products. Extended guidelines and standards should help developers to integrate user experience more efficiently in the product design and evaluation process. Current efforts in bringing together basic requirements for the development of medical software by unifying different standards is a first step (i.e. Medical Spice, VDI). However, the consideration of a holistic experiential perspective is a challenging demand that still is to be met in the future.

Acknowledgement

The authors would like to thank Achim Oberg and Olaf Kellermeier from Usability in Germany e.V. for the successful cooperation.

Author’s Statement

Research funding: As a part of research project BeMobil the authors would like to thank the German Federal Ministry of education and research (Project number: V4ICR01). Conflict of interest: Authors state no conflict of interest. Material and methods: Informed consent: Informed consent is not applicable. Ethical approval: The conducted research is not related to either human or animal use.

References

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Published Online: 2016-9-30
Published in Print: 2016-9-1

©2016 Franziska Trauzettel et al., licensee De Gruyter.

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

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https://doi.org/10.1515/cdbme-2016-0129
Keywords for this article
medical software development process; usability-methods; user experience
Creative Commons
BY-NC-ND 4.0

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  93. EyeGuidance – a computer controlled system to guide eye movements
  94. A framework for feedback-based segmentation of 3D image stacks
  95. Doppler optical coherence tomography as a promising tool for detecting fluid in the human middle ear
  96. 3D Local in vivo Environment (LivE) imaging for single cell protein analysis of bone tissue
  97. Inside-Out access strategy using new trans-vascular catheter approach
  98. US/MRI fusion with new optical tracking and marker approach for interventional procedures inside the MRI suite
  99. Impact of different registration methods in MEG source analysis
  100. 3D segmentation of thyroid ultrasound images using active contours
  101. Designing a compact MRI motion phantom
  102. Cerebral cortex classification by conditional random fields applied to intraoperative thermal imaging
  103. Classification of indirect immunofluorescence images using thresholded local binary count features
  104. Analysis of muscle fatigue conditions using time-frequency images and GLCM features
  105. Numerical evaluation of image parameters of ETR-1
  106. Fabrication of a compliant phantom of the human aortic arch for use in Particle Image Velocimetry (PIV) experimentation
  107. Effect of the number of electrodes on the reconstructed lung shape in electrical impedance tomography
  108. Hardware dependencies of GPU-accelerated beamformer performances for microwave breast cancer detection
  109. Computer assisted assessment of progressing osteoradionecrosis of the jaw for clinical diagnosis and treatment
  110. Evaluation of reconstruction parameters of electrical impedance tomography on aorta detection during saline bolus injection
  111. Evaluation of open-source software for the lung segmentation
  112. Automatic determination of lung features of CF patients in CT scans
  113. Image analysis of self-organized multicellular patterns
  114. Effect of key parameters on synthesis of superparamagnetic nanoparticles (SPIONs)
  115. Radiopacity assessment of neurovascular implants
  116. Development of a desiccant based dielectric for monitoring humidity conditions in miniaturized hermetic implantable packages
  117. Development of an artifact-free aneurysm clip
  118. Enhancing the regeneration of bone defects by alkalizing the peri-implant zone – an in vitro approach
  119. Rapid prototyping of replica knee implants for in vitro testing
  120. Protecting ultra- and hyperhydrophilic implant surfaces in dry state from loss of wettability
  121. Advanced wettability analysis of implant surfaces
  122. Patient-specific hip prostheses designed by surgeons
  123. Plasma treatment on novel carbon fiber reinforced PEEK cages to enhance bioactivity
  124. Wear of a total intervertebral disc prosthesis
  125. Digital health and digital biomarkers – enabling value chains on health data
  126. Usability in the lifecycle of medical software development
  127. Influence of different test gases in a non-destructive 100% quality control system for medical devices
  128. Device development guided by user satisfaction survey on auricular vagus nerve stimulation
  129. Empirical assessment of the time course of innovation in biomedical engineering: first results of a comparative approach
  130. Effect of left atrial hypertrophy on P-wave morphology in a computational model
  131. Simulation of intracardiac electrograms around acute ablation lesions
  132. Parametrization of activation based cardiac electrophysiology models using bidomain model simulations
  133. Assessment of nasal resistance using computational fluid dynamics
  134. Resistance in a non-linear autoregressive model of pulmonary mechanics
  135. Inspiratory and expiratory elastance in a non-linear autoregressive model of pulmonary mechanics
  136. Determination of regional lung function in cystic fibrosis using electrical impedance tomography
  137. Development of parietal bone surrogates for parietal graft lift training
  138. Numerical simulation of mechanically stimulated bone remodelling
  139. Conversion of engineering stresses to Cauchy stresses in tensile and compression tests of thermoplastic polymers
  140. Numerical examinations of simplified spondylodesis models concerning energy absorption in magnetic resonance imaging
  141. Principle study on the signal connection at transabdominal fetal pulse oximetry
  142. Influence of Siluron® insertion on model drug distribution in the simulated vitreous body
  143. Evaluating different approaches to identify a three parameter gas exchange model
  144. Effects of fibrosis on the extracellular potential based on 3D reconstructions from histological sections of heart tissue
  145. From imaging to hemodynamics – how reconstruction kernels influence the blood flow predictions in intracranial aneurysms
  146. Flow optimised design of a novel point-of-care diagnostic device for the detection of disease specific biomarkers
  147. Improved FPGA controlled artificial vascular system for plethysmographic measurements
  148. Minimally spaced electrode positions for multi-functional chest sensors: ECG and respiratory signal estimation
  149. Automated detection of alveolar arches for nasoalveolar molding in cleft lip and palate treatment
  150. Control scheme selection in human-machine- interfaces by analysis of activity signals
  151. Event-based sampling for reducing communication load in realtime human motion analysis by wireless inertial sensor networks
  152. Automatic pairing of inertial sensors to lower limb segments – a plug-and-play approach
  153. Contactless respiratory monitoring system for magnetic resonance imaging applications using a laser range sensor
  154. Interactive monitoring system for visual respiratory biofeedback
  155. Development of a low-cost senor based aid for visually impaired people
  156. Patient assistive system for the shoulder joint
  157. A passive beating heart setup for interventional cardiology training
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