Development and use of analytical quality specifications in the in vitro diagnostics medical device industry

Powers, Donald M.; Greenberg, Neil

doi:10.1080/00365519950185319

Cited by 12 publications

(8 citation statements)

References 4 publications

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“…Clin. The design control loop is not closed until the finished in vitro diagnostic system is adequately validated to meet the customer needs, including the laboratory's analytical quality specifications (9). are listed in the Cumulative Index, which appeared in connection with the contents of this journal Volume 27, 1989 says should be considered for clinical use.…”

Section: Introductionmentioning

confidence: 99%

Quality Specifications for Cardiac Troponin Assays

Panteghini¹,

Gerhardt²,

Apple³

et al. 2001

Clinical Chemistry and Laboratory Medicine

129

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The objective of this report is to help to improve the quality of immunochemical determinations of cardiac troponins. The guidelines are intended for use by the manufacturers of commercial assays and by clinical laboratories performing troponin analyses. The main goals of the document are that: 1. Manufacturers endorse, or at the minimum, address the enclosed recommendations. All package inserts for troponin immunoassay procedures include information on method design, and on pre-analytical and analytical performance characteristics as outlined in this document. 3. Manufacturers and the scientific community selectand design research projects that further the knowledge and the definition of the issues addressed in this document.

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Section: Introductionmentioning

confidence: 99%

Quality Specifications for Cardiac Troponin Assays

Panteghini¹,

Gerhardt²,

Apple³

et al. 2001

Clinical Chemistry and Laboratory Medicine

129

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“…In the case of medical devices, directives of organizations such as the FDA and the European Commission request user need analyses, human factors engineering or field trials (Patel et al, ; Money et al, ; Ratcliffe, ; Martin and Barnett, ; Schaeffer, ). These requirements are higher for firms that follow industrial standards such as those of the International Organization for Standardization (ISO) or the International Electrotechnical Commission (IEC) (Powers and Greenberg, ; Money et al, ). Additional requirements for user integration might be mandated by other entities, mainly as a prerequisite for obtaining funding or grants for development (Davey et al, ; Martin and Barnett, ; Martin et al, ).…”

Section: Resultsmentioning

confidence: 99%

Stakeholder integration in new product development: a systematic analysis of drivers and firm capabilities

2016

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In this article, we develop a conceptual model of stakeholder integration in new product development (NPD) that (i) explains the drivers of the process and (ii) proposes a framework of capabilities that firms need for successful stakeholder integration. The focus lies on external stakeholders that directly influence the adoption of new products. We conduct a systematic literature review and content analyze a sample of 96 peer-reviewed journal articles. The study is restricted to the medical device industry to enable the use of specific search terms and the consistent categorization of information. We dedicate a section to showing how the framework applies to other settings. The drivers of stakeholder integration are classified into push factors (i.e., expected benefits for the focal firm) and pull factors (i.e., expected benefits for the stakeholders). This study provides an initial model of how stakeholder integration works based on its drivers. In addition, three related stakeholder integration capabilities emerge: stakeholder identification capability, stakeholder interaction capability and stakeholder input integration capability. The paper proposes a description of these capabilities for stakeholder integration in NPD and, thus, contributes to stakeholder theory and research on the management of NPD. The results open new paths for empirical testing and offer practical guidance on how to successfully integrate stakeholders in NPD processes.

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“…The resultant designs are used to develop medical devices that have higher market usability (Gould and Lewis, 1985), improved equipment safety and efficiency (Lin, 1998) and may be successfully used and maintained (Fouladinejad and Roberts, 1996). Another reason for the higher user involvement at design stage is the requirement of formal design processes that should begin and finish with customer needs under regulation such as ISO 9001 (Powers and Greenberg, 1999). Nevertheless, each stage of the medical device technology lifecycle is important and user input during each stage of the medical device lifecycle would be definitely important and required.…”

Section: Identified Threementioning

confidence: 99%