Managing a New Computer Device Development in a Creative ISO 9001 Certified Company: A Case Study

In a connected society and organizations working with digitized business models, standards will have more important roles than ever in shaping activity systems content, structure, and governance. While the standardization conformity/innovation duality has received great attention in literature, little research has been done on the role of managers in managing the tensions of knowledge codification required during ISO 9001 standard implementation. By utilizing Danone's Networking Attitude experience as a case study, the authors address this gap by exploring how managerial skills and practices were used to overcome the cognitive and emotional tensions related to internal knowledge codification, transfer, and use. The main contribution is to elucidate the role of managers in resolving these paradoxes and creating innovation capabilities. Further, they demonstrate the mutually beneficial relationship between knowledge codification and innovation if knowledge management is approached more as an evolving pragmatic knowing than a technical means that may create rigidity and resistance.

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User-Informed Medical Device Development: A Case Study for Pediatric Malnutrition Assessment

Global Pediatric Health ◽

10.1177/2333794x19861575 ◽

2019 ◽

Vol 6 ◽

pp. 2333794X1986157 ◽

Cited By ~ 1

Author(s):

Kristi Thaete ◽

Kasey Rowzer ◽

Karen Stephens ◽

Susan M. Abdel-Rahman

Keyword(s):

Nutritional Assessment ◽

Z Score ◽

Device Development ◽

Nutrition Services ◽

Arm Circumference ◽

Single Center Study ◽

Device Use ◽

And Shifts ◽

Mid Upper Arm Circumference

Background. Mid-upper arm circumference (MUAC) has been extensively used to classify pediatric malnutrition. Recently, MUAC z score was recommended; however, the logistics of implementation were not addressed. This study examines the usability of a device that provides MUAC and corresponding z score range in a single device. Methods. This was a single-center study of nutrition services providers. The device was applied to children aged 2 months to 18 years admitted as inpatients or seen as outpatients. Surveys incorporated benchmarking questions, assessed the ease with which respondents could perform 6 critical tasks, and provided an open-ended question to elicit feedback. Users were surveyed monthly until saturation was reached. Survey data were analyzed in aggregate and cross-tabulated by the respondents’ experience with the device. Thematic analysis of the open-ended responses followed a structured approach. Results. Sixty device users responded to the survey 280 times. Respondents were female (100%) with a mean age of 45.2 ± 13.2 years and 9.6 ± 8.0 years in practice. Increasing device use was accompanied by significantly shortened measuring times ( P < .001) and shifts in ease of performance for 5 of 6 critical tasks ( P < .05). Open-ended response themes related largely to design and materials. These were used to iteratively refine the device. Conclusions. The active engagement of end users in the real-world testing of our nutritional assessment device allowed us to refine the innovation with special attention paid to the needs of dietitians. The result is a device the majority of dietitians found easy to use, efficient, convenient, and preferable to alternative measurement options.

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A framework of intellectual capital management based on ISO 9001 quality management system: The case study of ISO 9001 certified public R&D institute

Knowledge and Process Management ◽

10.1002/kpm.333 ◽

2009 ◽

Vol 16 (4) ◽

pp. 162-173 ◽

Cited By ~ 6

Author(s):

Dong-young Kim ◽

Vinod Kumar ◽

Uma Kumar

Keyword(s):

Quality Management ◽

Intellectual Capital ◽

Management System ◽

Quality Management System ◽

Iso 9001 ◽

Capital Management ◽

Intellectual Capital Management

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Why adopt ISO 9001 certification in hospitals? A case study of external triggers and sensemaking in an emergency department in Norway

Safety in Health ◽

10.1186/s40886-017-0058-5 ◽

2017 ◽

Vol 3 (1) ◽

Cited By ~ 3

Author(s):

Dag Tomas Sagen Johannesen ◽

Siri Wiig

Keyword(s):

Emergency Department ◽

Iso 9001

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A Case Study of Physician Interaction in the Medical Device Development Process

Journal of Medical Devices ◽

10.1115/1.3442793 ◽

2010 ◽

Vol 4 (2) ◽

Author(s):

Lauren Aquino Shluzas ◽

John H. Linehan ◽

Larry J. Leifer

Keyword(s):

Medical Device ◽

Risk Perceptions ◽

User Interaction ◽

Team Members ◽

Medical Device Development ◽

Device Development ◽

Wide Range ◽

Contextual Framework ◽

Case Based

A multiphase empirical field study is being conducted at Stanford University to examine the process of physician interaction during medical device development. The initial component of this study involved creating an analytic framework for case-based research that provided a conceptual guide for the pilot case study documented in this paper. The pilot case study examined the process of engaging physicians in medical device development within the context of an entrepreneurial device company. The methods used in this study included a combination of interviews with cross-functional team members, a quantitative survey, and the collection of archival data. Data analysis first involved documenting physician-developer interaction practices that had been used within the company, from needs finding to post-market surveillance, across multiple product generations. Leading development factors involving physicians that had influenced the company’s clinical and financial outcomes were next identified. The case study illustrated the importance of working with and understanding the user experiences of a wide range of physicians when developing new products. The case also captured how physician interaction influences risk perceptions toward medical device performance for both surgeons and developers. The case likewise highlighted the benefits of a systems-based design approach, as opposed to designing products for a single technical end point. From a methodological perspective, the case study revealed the importance of examining user interaction within a contextual framework, as opposed to an isolated examination of input and output variables. The study presented in this paper has provided a foundation for future case-based analyses regarding the process of physician interaction in medical device development.

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