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

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.

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

2020 Design of Medical Devices Conference ◽

10.1115/dmd2020-9020 ◽

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.

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

2020 Design of Medical Devices Conference ◽

10.1115/dmd2020-9046 ◽

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.

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

Applied Sciences ◽

10.3390/app11209430 ◽

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.

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Medical device design process

10.1109/iembs.2009.5333644 ◽

2009 ◽

Cited By ~ 2

Author(s):

B.L. Gilman ◽

J.E. Brewer ◽

M.W. Kroll

Keyword(s):

Medical Device ◽

Design Process ◽

Device Design ◽

Medical Device Design

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Augmented Reality Aided Medical Device Design

2019 Design of Medical Devices Conference ◽

10.1115/dmd2019-3215 ◽

2019 ◽

Author(s):

M. Robert Garfield ◽

Alex Dupont

Keyword(s):

Augmented Reality ◽

Medical Device ◽

Design Process ◽

Visual Assessment ◽

Physical Models ◽

Iterative Refinement ◽

Device Design ◽

Medical Device Design ◽

Accelerate Development ◽

Aided Design

Blurring the line between the physical and digital environment, augmented reality (AR) is the next frontier for medical device design. It is particularly useful as a means for rapid concept visualization and iterative refinement. By selectively mixing AR and physical prototypes, designers can conduct haptic evaluation alongside visual assessment. The integration of AR and traditional tools during development continues the practice of advancing design methods in parallel with technology. This paper explains the design of a mobile medical device/workstation using an AR aided medical device design process from an industry perspective. This case study demonstrates the viability and benefits of an AR aided design process pairing off-the-shelf AR technology with physical models of increasing fidelity. AR aided medical device design helps design teams accelerate development, lower prototyping costs, assess scaled designs earlier, illustrate contextual constraints, and reduce development risk.

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A Problem Well Defined is Nearly Solved

Journal of Medical Devices ◽

10.1115/1.3439645 ◽

2010 ◽

Vol 4 (2) ◽

Cited By ~ 1

Author(s):

Ryan Lewis

Keyword(s):

Medical Device ◽

Design Process ◽

Unmet Needs ◽

User Needs ◽

Clear Understanding ◽

Device Design ◽

Medical Device Design ◽

Consulting Firms ◽

Design Projects ◽

The Difference

Solving problems is simple. Understanding which problems should be solved is immensely challenging. Medical device design projects frequently begin with a search for solutions rather than a clear appraisal of needs. Understanding clinical needs, user needs, unmet needs and the differences between them is crucial. Through a process of filtering research into an array of needs the author prescribes a method to aid the designer in defining the overarching problem. This array can create a clear path to problem solutions while utilizing a methodology that fits in the context of a regulated design process. For medical device startups, design consulting firms, and corporate manufacturers, a clear understanding of the problem can mark the difference between a misguided solution and a solution that benefits physicians and patients.

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

Journal of Design Business & Society ◽

10.1386/dbs_00013_1 ◽

2020 ◽

Vol 6 (2) ◽

pp. 233-258 ◽

Cited By ~ 1

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.

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