An Effective Design Process for the Successful Development of Medical Devices

Author(s):  
Mike Colvin
Author(s):  
Katharine McCoy

This presentation, reflecting a politics undergraduate thesis, will explore the design process behind the ballots that voters use in democratic elections around the world. Ballots are an inherently political objects, and in many cases, the most direct line of communication a citizen has to the government of their country. As such, the design of the ballot affects the legitimacy of higher level electoral and democratic institutions. This project argues that by co-opting the language of product design, a universal ballot design process would make more efficient ballots across the globe.   Product design starts with a brainstorming stage that explores at the user, the goal of the object, and the context of its use to create an effective design. By applying these observations to the process of designing a ballot, each electoral commission can produce a more effective ballot. Currently there is no standardization for ballot design other than ensuring that electoral commissions tried to make it “friendly.” By examining cases of bad ballot design, it is possible to see what element of the design process was missed or misused to create a process that corrects for these mistakes. This project examines poorly designed ballots in Florida, Scotland, and Colombia to explore the large-scale effects these small design choices make, and how to fix them. 


2021 ◽  
Author(s):  
Magdalena Görtz ◽  
Michael Byczkowski ◽  
Mathias Rath ◽  
Viktoria Schütz ◽  
Philipp Reimold ◽  
...  

BACKGROUND While digital and data-based technologies are widespread in various industries in the context of Industry 4.0, the use of smart, connected devices in healthcare is still in its beginnings. Innovative solutions for the medical environment suffer from difficult access to medical device data and high barriers for market entry due to proprietary systems. OBJECTIVE In the proof-of-concept project OP 4.1, we show the business viability of connecting and augmenting medical devices and data through software add-ons by giving companies a technical and commercial platform for the development, implementation, distribution, and billing of innovative software solutions. METHODS The creation of a central platform prototype requires the collaboration of several independent market contenders, amongst them medical users, software developers, medical device manufacturers, and platform providers. A dedicated consortium of clinical and scientific partners as well as industry partners was established. RESULTS We demonstrate the successful development of the prototype of a user-centric, open, and extensible platform for the intelligent support of processes starting with the operation room. By connecting heterogeneous data sources and medical devices from different manufacturers and making them accessible for software developers and medical users, the cloud-based platform OP 4.1 enables the augmentation of medical devices and procedures through software-based solutions. The platform also allows for the demand-oriented billing of applications and medical devices, thus permitting software-based solutions to fast-track their economic development and become commercially successful. CONCLUSIONS The technology and business platform OP 4.1 creates a multi-sided market for the successful development, implementation, distribution, and billing of new software solutions in the operation room and in the healthcare sector in general. Consequently, software-based medical innovation can be translated into clinical routine fast, efficiently, and cost-effectively, optimizing the treatment of patients through smartly assisted procedures.


Author(s):  
Ben Lauren

This case is useful as a model for institutions creating media labs in small spaces with a limited budget and advances a discussion of effective design among scholars, K-12 educators, a range of industries, and the corporate sector. By addressing how small spaces can function effectively for users, the author encourages representatives from these areas to design media labs in usable ways. The study begins by arguing for a user-centered approach to designing digital media labs in order to engage stakeholders in the design process. Then, the chapter explains the process of how the author engaged users while piloting several iterations of the Florida International University Digital Writing Studio, reporting what was learned about designing the space. Finally, the study investigates the usability of the Digital Writing Studio through a usability test meant to investigate the functionality of the space for collaboration among users. This case demonstrates a challenge that many must take on at a time when budgets are being cut and space is difficult to secure. Usability methods of inquiry can help create a space designed in part by stakeholders—a method that this case argues can be built into annual program assessment.


Author(s):  
Fabiola Cortes_Chavez ◽  
Alberto Rossa-Sierra ◽  
Elvia Luz Gonzalez Muñoz

This article presents a comparative analysis of birthing beds, using two different design processes to realize if one improves user satisfaction by improving the design process. We present a comparative study between the traditional product design process (consumer product design) and the new design process based on hierarchies (proposed in this study), which improves the final design and increases user acceptance. The study focuses on pointing out the importance of a new design process for medical devices, which can improve the characteristics of the product design and thereby increase user satisfaction. The main contribution of this new process focuses on showing medical device designers the importance of considering the hierarchy of users around a medical product, considering the fluctuation of the patient's health status since depending on the progression of the disease, the patient needs the attention of various users. In turn, final users need to solve specific problems in each phase, and design needs to be prepared for each user's particular needs around the birthing bed and the patient.


2009 ◽  
Vol 3 (1) ◽  
pp. 21-27 ◽  
Author(s):  
G.A Aitchison ◽  
D.W.L Hukins ◽  
J.J Parry ◽  
D.E.T Shepherd ◽  
S.G Trotman

The design process for medical devices is highly regulated to ensure the safety of patients. This paper will present a review of the design process for implantable orthopedic medical devices. It will cover the main stages of feasibility, design reviews, design, design verification, manufacture, design validation, design transfer and design changes.


2021 ◽  
Vol 4 (1) ◽  
pp. 36-55
Author(s):  
Helena Sandman

Rapid urbanisation and, as a result fast growing informal areas, increase the need for affordable housing. This urgent need requires new forms of input from the architects active in the Global South. The profession must adapt and evolve. Based on previous research, I argue that to build sustainable communities, the residents must be heard and be part of the development process. To involve residents, architects can use new contextually suitable and effective design methods. The study comprised action research on an affordable housing design project in Zanzibar, Tanzania. This paper presents the early stages of a design process for a project still in progress. A close look at the Zanzibar case reveals four human-centred methods from the design discipline to the architectural design process: applied ethnography, empathic design, contextual design, co-design and participatory design. Through the analyses of these different methods, I explored the importance of empathy while designing in settings with contextual constraints. The study revealed the potential of developing empathic methods from the design discipline in the context of architectural design. Further, it suggests that empathic methods can be used by architects pursuing sustainable development. 


Author(s):  
Tomoyuki Hiroyasu ◽  
Hiroshi Yamakawa

Abstract A structure, whose characteristics are less modified by any changes of external forces, boundary conditions and productive errors, has advantages for its practical use. This character is called robustness. In the consecutive study (Yamakawa and Miyashita, 1991), the authors studied the structural design with robustness and proposed a new structural concept called “Robust Structure.” Robust structural design is more useful when the structures are designed in the upper flow of the design process than in the lower flow. Robust structures can be designed by minimizing the sensitivities of the reference function relative to the variable parameters. However, the sensitivities provide only the local information even when their values are evaluated. Therefore, it is not clarified whether robust structure designed by the sensitivities has wide robustness or not. To conquer this problem, this paper shows robust structural design method using the fuzzy sets. In this method, the variable parameters are shown with fuzzy sets and then obtain the wide robustness. It is also pointed out that robust structural design using sensitivities can design wide robust structure in certain cases. Because robust structural design using fuzzy sets needs a lot of numerical iterations, it is important to figure out the effective design method of wide robust structures. In this paper, an idea is proposed how to design wide robust structures. The numerical examples designed by two different methods using sensitivities and fuzzy sets are shown. Further more, the proposed idea is discussed with these examples.


2018 ◽  
Vol 22 (1) ◽  
pp. 201-218 ◽  
Author(s):  
Jaehyun Park ◽  
Arkalgud Ramaprasad

Purpose The purpose of this study is to explore an ontology of designer-user interaction with a knowledge management foundation. To address this research gap, the authors ask the following research question: what types of knowledge on designer-user interactions are associated with design function and approach in creating effective design outcomes in a collaborative design process? Design/methodology/approach Based on ontology of a knowledge management foundation and 99 design projects, the authors conceptualized the ontology of designer-user interaction, which considers design role, function, approach and outcome as a knowledge of designer-user interaction in the design process. Findings Based on this analysis, the authors theorize an ontology of designer-user interactions with five dimensions: participant, role, function, design approach and design outcome. Also, this study presents a case study of how this ontology could be applied into the actual projects. Originality/value In this study, the authors explore an ontology of designer-user interaction with a knowledge management foundation, because previous interdisciplinary design studies have not formalized the types of designer-user interaction. To address this research gap, the authors ask the following research question: What types of knowledge on designer-user interactions are associated with design function and approach in creating effective design outcomes in a collaborative design process?


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