Numerous and complex sequence of activities in medical device development often result in time consuming and expensive engineering processes. In this study, patient and designer requirements were identified and integrated within a novel framework which supports medical device design through a consolidated understanding of user-experience whilst directly coalescing the applicable regulatory requirements in terms of product compliance and certification. This assists in the development of safe and reliable products which reflect the need for increased usability considerations during design.

Occupational therapists modify mass-produced and universally-designed assistive technologies (ATs) to fulfill the specific needs of people with disabilities. We interviewed ten occupational therapists with experience in modifying ATs in order to understand adaptation processes. Our findings reveal the reasoning behind adaptation, common ATs that require adaptation, as well as the collaborative nature of adaptation. We propose a new framework called Adaptable Universal Design (AUD) that blends Universal Design with the need to adapt ATs in order to fulfill unique and specific user needs.

Task clarification poses various challenges to designers as they need to understand the different needs of users before translating the requirements into specifications and aptly conceiving product concepts in the subsequent design stage. This paper presents a descriptive study for the evaluation of a framework and its implementation as a computer-based prototype tool, proposed to assist designers in generating and understanding affordance-based requirements for speech and language therapeutic toys. Results show that early design support is beneficial to both experienced and novice designers.

This work investigates the application of origami as the underlying principle to realize a novel 3D printed hand orthosis design. Due to the special property of some origami to become rigid when forming a closed surface, the orthosis can be printed flat to alleviate the most of the post-processing, and at the same time provide rigid support for the immobilized limb in the folded state. The contributions are the origami-based hand orthosis design and corresponding computational design method, as well as lessons learned regarding the application of origami for the hand orthosis design.

The aim of the paper is to identify from the perspective of designers, what is required to optimally design smart habilitation devices for additive manufacturing, whilst ensuring a high quality multi-user experience. Semi-structured interviews were conducted with designers to identify the key requirements to develop such devices. The outcome of this study will provide a preliminary framework for designers to take advantage of the state-of-the-art of design for additive manufacturing in order to meet the expectations of multiple users of smart devices for pediatric occupational therapy.

This paper presents an open-source novel intravenous cannulation task trainer developed during the Covid- 19 pandemic for unsupervised clinical skill practice. Multiple user errors were uncovered when observing 13 registered nurses using the task trainer during a two-hour unsupervised skill training session. These insights raise the question of how OSH needs to share more than just device descriptions and assembly instructions- as designs are being shared only in its current state of an ongoing project, sharing insights, user errors and test results should be encouraged and prioritized.

How does change occur in healthcare settings? In this paper, we take a design-based approach to healthcare research. From researcher-patient interactions to information sharing between practitioners, we examine how clinical research can mediate a change of routines and illuminate potential new system structures. Using a hospital-based cognitive care clinic as an example, we demonstrate how the inclusion of new actors, tools and resources was able to shed light on the prevalence of hearing loss among mild cognitive impairment (MCI) patients and lay the framework for new care pathways.

A case study during pandemic revealed the major drawbacks of the traditional product development process for MedTech industry. Disruption of conventional manufacturing, urgent need for accelerated design and production, faster regulatory approval have challenged the industry. In this paper the conventional medical product development process is explored based on the intramuscular injector case study. The study revealed core areas for improvement of the medical devices development process. The paper proposes the Lean-Agile methodology with the incorporated elements of Concurrent Engineering.

The concept of Health Systems is ubiquitous in the healthcare literature. However, the question ‘what is a Health System’ is not easy to answer. The emerging field of Health Systems Design is by nature multi-disciplinary, involving several disciplines with different ontological commitments and diverse perspectives and interpretations of health and system. To avoid confusions in communication and facilitate engagement between the design and health communities, it is important to begin an open exploration of the fundamental concepts of Health Systems. This paper is a first step in that endeavour

Citation is a key metric in academia, and it can help to understand how ideas travel between disciplines. In this article, we report on a citation analysis of forty-four articles identified during a systematic literature review of healthcare design research published in six leading design journals. Using the Web of Science's categorisation of journals, we analyse which disciplines cite these forty-four articles. We find that these articles are much more cited in technology and engineering journals than in health sciences. We discuss these findings and the limitations of the study.

One of the most promising trends in healthcare digitalisation is the personalisation and individualisation of therapy based on virtual representations of the human body through Human Digital Twins (HDTs). Despite the growing number of articles on HDTs, to-date no consensus on how to design such systems exists. A systematic literature review for designing HDTs used for behaviour-changing therapy and rehabilitation resulted in eight key design considerations across four themes: regulatory and ethical, transparency and trust, dynamism and flexibility, and behaviour and cognitive mechanisms.

A novel application of Best Worst Method (BWM) enables one to incorporate the complexity of specific sub-criteria of technological development to assess its maturity with the pre-established Technology Readiness Level (TRL) framework. It utilizes the concept of Multi-Criteria Decision Making (MCDM) methods to determine the cardinality of endpoint quantitative processes. The model is used to determine the maturity of Class II Ventilators and to detect the consistency aspects for their selection.

User experiences of atypical conditions leading to adverse events have the potential to discover latent user needs and improve usability in design outcomes. This study introduces atypical scenarios as a design intervention to student designers working on healthcare product design projects. These atypical scenarios are framed from real-world clinical experience related to individual projects. 40 participants from a healthcare product design course comprising of 8 teams were involved in this study. Results indicate a positive influence on design and designers in terms of usability in the design process.

Healthcare services have evolved with advances in science, technology and societal needs. Despite being around for two decades, 'X-ray at Home' has seen limited adoption. Understanding its enablers and disablers can lead to insights to develop an accessible healthcare service ecosystem. Healthcare organisations have adopted design thinking to develop new products but healthcare service design is still in its introductory phase. This qualitative study describes the current state of home X-ray services in Mumbai and proposes touchpoints for raising awareness, acceptance and patient experience.

Amputees face challenges with prosthesis such as cost, long delivery periods, as well as social discomfort. Simultaneously, the prosthetists and manufacturers have a difficulty to handle such diverse issues. We thus contribute a Prosthetic Life-Cycle Service System (ProLiSS) Framework, prescribed to involve amputees in different life phases. From an evaluation of ProLiSS, we conclude that it influences how prosthetics need to be designed and that it is beneficial to perform further research to provide manufacturers with a systematic, amputee-centered development and servicing framework.

The use of serious games is more and more popular in the medical filed, mainly for home-based rehabilitation therapy. In this context, some design principles were already proposed. Designing serious game for evolution diseases assessment is challenging and necessitates a new approach of this principles. Working with physiotherapists at the origin of the Motor Function Measurement assessment scale, the development of a dedicated serious game is proposed based on new contextual principles.

Additive manufacturing offers opportunities for designed mechanical deformation within parts by integrating lattice structures into their designs. This work re-analyses and translates data on lattice structure deformation behaviours into a novel taxonomy, enabling their actions to be understood and controlled. Parallels between these actions and the four basic types of mechanical motion are identified. Creating a taxonomy method using these motions enables the future development of a DfAM framework that assimilates controlled anisotropy via lattices and aids the design of compliant mechanisms.

Design for AM (DfAM) requires the definition of Design Actions (DAs) to optimize AM manufacturing processes. However, AM understanding is still very blurred. Often designers are challenged by selecting the right design parameters. A method to list and collect DfAM DAs is currently missing. The paper aims at providing a framework to collect DfAM DAs according to a developed ontology to create databases (DBs). DBs were tested with two real case studies and geometric features to improve identified. Future developments aim at widening the database to provide all-around support for AM processes.

For the economic use of repair in the spare parts business, additive repair by Laser Powder Bed Fusion (LPBF) is a promising technology. As material can only be applied to a flat surface in LPBF, prior machining is required. The selection of the section plane requires expert knowledge, though. To provide that knowledge and recommend a suitable section plane, an expert system can be used. In this paper, a concept for such an expert system is presented and its functionality is evaluated by an example.

Additive Manufacturing (AM) enables innovative product designs. One promising research field is AM of integrated electrically structures, e.g. heating panels using Joule effect. A mayor challenge in designing heating panels using AM is the dependency of its resultant resistivity from material, process and geometry parameters. The goal-oriented design of heating panels with individual surface temperatures the interactions between these parameters need to be understand. Therefore, a data-driven design approach is developed that facilitates a design of heating panels with specific properties.