Supporting medical device development: a standard product design process model

Medina, Lourdes A.; Kremer, Gül E. Okudan; Wysk, Richard A.

doi:10.1080/09544828.2012.676635

Cited by 69 publications

(61 citation statements)

References 24 publications

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“…Medina et al (2013) provided a comprehensive description of a medical device development process model, highlighting the multi-staged approach to design evaluation, resolution of user concerns, and adaptive actions in device design and delivery [21]. Blanford et al (2014) noted that challenges in device usability are minimized before market introduction to patients when incorporating the concept of "work as done" rather than "work as imagined" models of medical device design (fitness for purpose) [19] .…”

Section: Discussionmentioning

confidence: 99%

“…Prior to that pivotal study, research was conducted to understand the feasibility of the concept of a vaginal bowel control system. Medical device development involves multiple stages of evolution driven by patient and clinician feedback derived from investigational trial use and standard care delivery [19][20][21]. Feasibility studies are intended to provide initial information about the safety, effectiveness, and acceptance by both patients and clinicians of a new therapy in a small, sample population.…”

Section: Introductionmentioning

confidence: 99%

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A Staged Feasibility Study of a Novel Vaginal Bowel Control System for the Treatment of Accidental Bowel Leakage in Adult Women

Takase-Sanchez¹

2017

SOJGOW

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BackgroundAccidental bowel leakage, or fecal incontinence, impacts the quality of life in women of all ages. A minimallyinvasive vaginal bowel control system was designed to reduce accidents and provides a new health care option for women. MethodsA feasibility study was conducted to evaluate fit, patient comfort, and ease-of-use of this novel vaginal bowel control therapy at home to better inform device design, treatment delivery, and the design of a subsequent pivotal clinical trial protocol. Staged evaluations were performed in women without and with self-reported accidental bowel leakage of any severity. Wear duration progressed from an initial one-time, in-office fitting to extended-wear periods at home. Device-related adverse events were collected in all subjects exposed to the device. Treatment responses were collected at baseline and after 1-month wear in women with accidental bowel leakage. Additionally, device comfort and satisfaction were assessed. ResultsEighty-six women were fitted with forty-five women continuing to wear the vaginal bowel control system for ≥ 1 week. Fifteen women with fecal incontinence were extended to ≥ 1-month wear. Nine minor devicerelated adverse events were reported. Eight of 9 women who completed diaries experienced ≥ 50% reduction in episodes at 1-month wear. Device comfort and satisfaction were high.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A Staged Feasibility Study of a Novel Vaginal Bowel Control System for the Treatment of Accidental Bowel Leakage in Adult Women

Takase-Sanchez¹

2017

SOJGOW

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“…Furthermore, a stronger culture for regulation would encourage marketing teams, in particular, to take a more proactive approach in gathering postmarketing surveillance information that would improve compliance and could advance improved medical device innovation outcomes. As Medina et al (2013) explain, "the regulatory requirements […] play a substantive role in shaping activities and decisions in the [development] process." Consequently, regulatory requirements must always be at the forefront of all considerations regarding MDD.…”

Section: A Culture For Regulationmentioning

confidence: 99%

“…routes to regulatory compliance; how regulations impact innovation etc. ), there is scant empirical evidence to support medical device companies in the management of regulation-bound technology innovation (Medina, Kremer, & Wysk, 2013), despite the necessity of regulatory compliance to gain and maintain marketing approval. Additionally, the medical device industry is highly competitive and historically slow to share its modus operandi.…”

Section: Introductionmentioning

confidence: 99%

Regulation - Do or Die: An Analysis of Factors Critical to New Product Development in a Regulatory Context

O'Dwyer

Cormican

2017

Journal of Technology Management & Innovation

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This study explores new product development in a strict regulatory and historically secretive environment. Adopting a systems perspective and a mixed methods approach in our research, we examine medical device development in Ireland. Findings indicate that the possession of a regulatory strategy expedites the rate of commercialization, so too does the generation of clear product definitions and marketing claims in the earliest developmental phases. Moreover, results suggest that if the regulated industry strengthens its culture for regulation by prioritizing regulation over speed to market, by encouraging cross-functional team collaborations, and by taking a more proactive approach in post-marketing surveillance activities, it has the potential to improve customer satisfaction and enhance product innovation. This study provides unique empirical data enriched by the homogeneity of its sample. It also contributes guidance to practitioners of new product development within a regulatory context.

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“…This paper aims at describing the role of industrial designers within the agency mandated processes using a multiple case study methodology to identify contemporary approaches in device development. Case study methodology is commonly used to assess user engagement as well as design and development practices Patricia Grocott, Weir, & Ram, 2007;Medina, Kremer, & Wysk, 2012;Taylor, Furniss, & Blandford, 2007;Yin, 2013). A total of 18 cases were developed with participants from both the EU and US.…”

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confidence: 99%

Designing Industrial Design in the Highly Regulated Medical Device Development Process. Defining our valuable contribution towards usability

Privitera

2017

The Design Journal

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Abstract:The role of industrial design in medical device development is scantily described in literature. Yet, based on design practice in industry and as evident by design competitions, clearly industrial design is active in the practice of developing medical devices. Only one article provides a description of industrial design activities and contribution to the practice of medical device design and includes the following areas: aesthetic design, form giving, human factors application and testing, along with contextual inquiry/ethnography methods (Petrie & Copeland, 2011). Further, in instances where team disciplines or members are defined, such as the study by Martin, Clark et al whereby team members included: engineering, nursing, medical physics, and clinical physiology, design or industrial design is missing (Martin, Clark et al. 2012, Grocott, Weir et al. 2007). This paper aims at describing the role of industrial designers within the agency mandated processes using a multiple case study methodology to identify contemporary approaches in device development. Case study methodology is commonly used to assess user engagement as well as design and development practices Patricia Grocott, Weir, & Ram, 2007;Medina, Kremer, & Wysk, 2012;Taylor, Furniss, & Blandford, 2007;Yin, 2013). A total of 18 cases were developed with participants from both the EU and US. For this study industry participants were selected by type: medical device manufacturer (large/medium/small) and design firms that have primary focus in designing for medical device development. Participants include the major manufacturers of laparoscopic surgical devices, orthopaedic implants, assistive surgical technologies, endovascular devices, neurovascular devices, critical care devices, cardiac assistive technologies, neurologic diagnostic devices, and general hospital equipment. Results indicate ID leadership was found within large and small organization but are challenged on implant focused device companies; the influence of ID included the application of human factors principles, aesthetic form and branding; ID influence was limited by the lack of clinical training in regards to science and medicine; and the value of industrial design was not well incorporated within agency promoted design S2190 MARYBETH PRIVITERA control processes. This paper defines ID practice in medical device development and concludes with a proposed graphic of the regulatory mandated design process highlighting ID involvement.

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Supporting medical device development: a standard product design process model

Cited by 69 publications

References 24 publications

A Staged Feasibility Study of a Novel Vaginal Bowel Control System for the Treatment of Accidental Bowel Leakage in Adult Women

A Staged Feasibility Study of a Novel Vaginal Bowel Control System for the Treatment of Accidental Bowel Leakage in Adult Women

Regulation - Do or Die: An Analysis of Factors Critical to New Product Development in a Regulatory Context

Designing Industrial Design in the Highly Regulated Medical Device Development Process. Defining our valuable contribution towards usability

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