Stakeholder Engagement With Prototypes During Front-End Medical Device Design: Who Is Engaged With What Prototype?

2020 ◽  
Author(s):  
Marianna J. Coulentianos ◽  
Ilka Rodriguez-Calero ◽  
Shanna R. Daly ◽  
Kathleen H. Sienko
Keyword(s):  
Medical Device ◽  
Stakeholder Engagement ◽  
Three Dimensional ◽  
Identification Problem ◽  
Problem Definition ◽  
Concept Generation ◽  
Device Design ◽  
Structured Interviews ◽  
Medical Device Design ◽  
Front End

Abstract Stakeholder engagement with prototypes during the front-end phases of medical device design can support problem identification, problem definition, and early concept generation. This study examined what prototypes were leveraged to engage specific types of stakeholders during front-end medical device design. Analysis of semi-structured interviews with 22 design practitioners in the medical device industry revealed some common associations of prototype choice for particular stakeholders. A few associations are highlighted: designers engaged users with physical three-dimensional (3D) prototypes, financial decision-makers with physical 3D and two-dimensional (2D) prototypes, government and regulatory stakeholders with 2D prototypes, and expert advisors with digital 3D prototypes. The rationale provided by practitioners revealed the intentional selection of prototype form for specific stakeholder engagements.

scholarly journals Medical Device Design Practitioner Strategies for Prototype-Centered Front-End Design Stakeholder Engagements in Low-Resource Settings

2019 ◽  
Vol 1 (1) ◽  
pp. 957-964
Author(s):  
Marianna J. Coulentianos ◽  
Ilka Rodriguez-Calero ◽  
Shanna R. Daly ◽  
Jocelyn Burridge ◽  
Kathleen H. Sienko
Keyword(s):  
Medical Device ◽  
Interpersonal Relationships ◽  
Design Process ◽  
Stakeholder Engagement ◽  
Active Role ◽  
Structured Interview ◽  
Device Design ◽  
Middle Income ◽  
Medical Device Design ◽  
Front End

AbstractPrototypes have the potential to provoke discussion and to encourage stakeholders to play an active role during design engagements in the front-end phases of a design process. However, detailed descriptions of stakeholder engagement strategies in front-end design are lacking. The aim of this research study was to understand how design practitioners prepare and manage stakeholders for engagements involving prototypes in the front-end phases of a medical device design process. Design practitioners at companies developing mechanical and electromechanical medical devices for use in low- and middle-income countries were interviewed following a semi-structured interview guide. Interview transcripts were analysed, and inductive codes were developed. The findings suggest that design practitioners manage the group composition of stakeholders, review the project and prototype(s) with stakeholders at the start of the engagement, and show the progress of prototypes to stakeholders over multiple engagements. These strategies shed light on the importance of handling interpersonal relationships during stakeholder engagement with prototypes.

Single Versus Multiple Prototypes: Medical Device Design Practitioners’ Rationale for Varying Prototype Quantities to Engage Stakeholders During Front-End Design

2020 ◽  
Author(s):  
Ilka Rodríguez-Calero ◽  
Marianna Coulentianos ◽  
Shanna R. Daly ◽  
Kathleen H. Sienko
Keyword(s):  
Medical Device ◽  
Stakeholder Engagement ◽  
Device Design ◽  
Design Decisions ◽  
Medical Device Design ◽  
Front End ◽  
Design Alternatives ◽  
Design Activities ◽  
Single Versus ◽  
Critical Consideration

Abstract Engaging stakeholders during medical device design processes, especially during front-end design activities, is a critical consideration for successful product design, which includes the safety and effectiveness of devices. The use of prototypes with stakeholders is encouraged by proponents of human-centered design, but guidelines for front-end stakeholder engagement with detailed descriptions of prototyping practices are lacking. One important question design practitioners must ask for each stakeholder engagement is how many prototypes to use. This study investigated reasons design practitioners chose to use one or more prototypes to engage stakeholders during front-end design activities within their design projects. Participants described using multiple prototypes, for example, to allow stakeholders to compare across different design alternatives, and to convey to stakeholders that multiple alternatives are being explored. Participants described using a single prototype, for instance, to probe for deep responses about a narrow topic and to refine a single concept through feedback. These results have the potential to inform design decisions and pedagogical approaches to prototyping use.

Standardizing the patient-specific medical device design process via a paper-based pro-forma

2020 ◽  
Vol 6 (2) ◽  
pp. 233-258 ◽  
Author(s):  
Sean Peel ◽  
Dominic Eggbeer ◽  
Peter Dorrington
Keyword(s):  
Medical Device ◽  
Design Process ◽  
Quality Management System ◽  
Regulatory Compliance ◽  
Patient Specific ◽  
Device Design ◽  
Structured Interviews ◽  
Medical Device Design ◽  
Starting Point ◽  
Pro Forma

Purpose/audience: this study targets designers, clinicians and biomedical engineers who are involved in digital surgical planning and patient-specific medical device design, either in hospitals, universities or companies. A commonly accepted, standardized design process does not exist in this specialized but highly variable field, and this can make regulatory compliance via the implementation of quality standards more difficult. Methodology/approach: an article-based design pro-forma was created based on needs identified in previous work. It was structured in order to broadly standardize the design process; consolidate planning and modelling behaviours into discrete clusters; anticipate decision-making on key product requirements; facilitate focused discussion with clients (surgeons); create a pleasurable experience for the designer; and encourage detailed reporting of design decisions and therefore to lower barriers to Quality Management System (QMS) implementation and adherence. The performance of the pro-forma was verified using observation, simultaneous verbalization and semi-structured interviews. Three participants across two contexts were observed designing without and then with the pro-forma. Their behaviours and comments were recorded, their designed outcomes evaluated and their quality compliance assessed. Findings: The design workflow was shown to be segmented and contained within distinct and repeatable steps when using the pro-forma. Reported participant confidence increased and stress decreased. Contact time between participants and clients was consolidated. Designed outputs and documented records successfully complied with generalizable aspects of the International Organization for Standardization (ISO) 13485 standard. However, it did not, and by definition could never, wholly implement a complete certifiable QMS, which must be tailored to a specific organization. Implications for practice, society or research: as demand for patient-specific devices continues to rise, and as regulatory requirements about QMS adherence extend to cover all contexts, organizations will need to react accordingly. This pro-forma offers a clear direction for how to introduce evidence-based best practices, and a starting point for full QMS certification. Originality/value: this research marks the first attempt to standardize this highly specialized design process across users, tools and contexts.

scholarly journals Global health front-end medical device design: The use of prototypes to engage stakeholders

2020 ◽  
Vol 5 ◽  
pp. 100055 ◽  
Author(s):  
Marianna J. Coulentianos ◽  
Ilka Rodriguez-Calero ◽  
Shanna R. Daly ◽  
Kathleen H. Sienko
Keyword(s):  
Global Health ◽  
Medical Device ◽  
Device Design ◽  
Medical Device Design ◽  
Front End

Out-of-the-Box Medical Device Safety

2016 ◽  
Vol 5 (1) ◽  
pp. 84-85
Author(s):  
Shannon Clark ◽  
Divya Natesan ◽  
Morgan Walker ◽  
Denise Forkey
Keyword(s):  
Risk Analysis ◽  
Medical Device ◽  
Usability Study ◽  
Device Design ◽  
Medical Device Design ◽  
Safety Risks ◽  
Related Risk ◽  
Medical Device Safety

Out-of-the-box experience is an important consideration in medical device design that not only impacts the user’s impression of the product, but can also have critical safety implications. This article discusses the basic safety questions to contemplate in a use-related risk analysis pertaining to the out-of-the-box experience, and focuses on how the most critical safety risks can be reduced or eliminated by conducting a usability study related to the out-of-the-box experience.

Design Process for a Birthing Bed, Based on User Hierarchy: Promoting Improvement in User Satisfaction

2021 ◽  
Vol 11 (20) ◽  
pp. 9430
Author(s):  
Fabiola Cortes-Chavez ◽  
Alberto Rossa-Sierra ◽  
Elvia Luz Gonzalez-Muñoz
Keyword(s):  
Medical Device ◽  
Design Process ◽  
User Satisfaction ◽  
Engineering Students ◽  
User Acceptance ◽  
Development Stage ◽  
Device Design ◽  
Design Processes ◽  
Medical Device Design ◽  
User Hierarchy

The medical device design process has a responsibility to define the characteristics of the object to ensure its correct interaction with users. This study presents a proposal to improve medical device design processes in order to increase user acceptance by considering two key factors: the user hierarchy and the relationship with the patient’s health status. The goal of this study is to address this research gap and to increase design factors with practical suggestions for the design of new medical devices. The results obtained here will help medical device designers make more informed decisions about the functions and features required in the final product during the development stage. In addition, we aim to help researchers with design process didactics that demonstrate the importance of the correct execution of the process and how the factors considered can have an impact on the final product. An experiment was conducted with 40 design engineering students who designed birthing beds via two design processes: the traditional product design process and the new design process based on hierarchies (proposed in this study). The results showed a significant increase in the user acceptance of the new birthing bed developed with the hierarchical-based design process.

A User-Centered Medical Device Design Decision Making Approach Using Hybrid Rough Cooperative Game Model

2021 ◽  
Author(s):  
Liting Jing ◽  
Junfeng Ma
Keyword(s):  
Decision Making ◽  
Medical Device ◽  
Set Theory ◽  
Cooperative Game ◽  
Rough Set ◽  
Rough Set Theory ◽  
Design Decision ◽  
Device Design ◽  
Medical Device Design ◽  
User Centered

Abstract With the advancement of new technologies and diverse customer-centered design requirements, the medical device design decision making becomes challenge. Incorporating multiple stakeholders’ requirements into the medical device design will significantly affect the market competitiveness and performance. The classic design decision making approaches mainly focused on design criteria priority determination and conceptual schemes evaluation, which lack the capacity of reflecting the interdependence of interest among stakeholders and capturing the ambiguous influence on the overall design expectations, leading to the unreliable decision making results. In order to relax these constraints in the medical device design, this paper incorporates rough set theory with cooperative game theory model to develop a novel user-centered design decision making framework. The proposed approach is composed of three components: 1) end/professional user needs identification and classification, 2) evaluation criteria correlation diagram and scheme value matrix establishment using rough set theory; and 3) fuzzy coalition utility model development to obtain optimal desirability considering users’ conflict interests. We used a blood pressure meter case study to demonstrate and validate the proposed approach. Compared with the traditional Technique for Order of Preference by Similarity to Ideal Solution (TOPSIS) approach, the proposed approach is more robust.

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