scholarly journals Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software

2021 ◽  
Vol 8 ◽  
Author(s):  
Staci J. Kearney ◽  
Amanda Lowe ◽  
Jochen K. Lennerz ◽  
Anil Parwani ◽  
Marilyn M. Bui ◽  
...  
Keyword(s):  
Life Cycle ◽  
Product Development ◽  
Product Life Cycle ◽  
Critical Role ◽  
Clinical Aspects ◽  
Product Life ◽  
Early Evaluation ◽  
Regulatory Affairs ◽  
Product Regulation ◽  
Total Product

Manufacturers of pathology imaging devices and associated software engage regulatory affairs and clinical affairs (RACA) throughout the Total Product Life Cycle (TPLC) of regulated products. A number of manufacturers, pathologists, and end users are not familiar with how RACA involvement benefits each stage of the TPLC. RACA professionals are important contributors to product development and deployment strategies because these professionals maintain an understanding of the scientific, technical, and clinical aspects of biomedical product regulation, as well as the relevant knowledge of regulatory requirements, policies, and market trends for both local and global regulations and standards. Defining a regulatory and clinical strategy at the beginning of product design enables early evaluation of risks and provides assurance that the collected evidence supports the product's clinical claims (e.g., in a marketing application), its safe and effective use, and potential reimbursement strategies. It is recommended to involve RACA early and throughout the TPLC to assist with navigating changes in the regulatory environment and dynamic diagnostic market. Here we outline how various stakeholders can utilize RACA to navigate the nuanced landscape behind the development and use of clinical diagnostic products. Collectively, this work emphasizes the critical importance of RACA as an integral part of product development and, thereby, sustained innovation.

Study on Geometric Tolerances Information in Integrated Manufacturing Processes

2010 ◽  
Vol 37-38 ◽  
pp. 1292-1295
Author(s):  
Yan Chao ◽  
Hai Feng Zhang ◽  
Li Qun Wu
Keyword(s):  
Life Cycle ◽  
Data Model ◽  
Manufacturing Process ◽  
Product Life Cycle ◽  
Critical Role ◽  
Manufacturing Processes ◽  
Product Life ◽  
Internet Technologies ◽  
Geometric Tolerance ◽  
Geometric Tolerances

Tolerance information plays a critical role in many steps of the product life cycle. It is especially important due to the advances in Internet technologies and increasing integration requirements from industry. In this paper, geometric tolerances information in manufacturing process (IMP) is studied, and the layered conformance level of geometric tolerances is established according to ASME Y14.5-1994, STEP and DMIS. An EXPRESS-G data model of geometric tolerance information in IMP is established. The XML language is used to represent and program the geometric tolerances information in IMP.

scholarly journals Analysis of Innovation based on Technometric Model to Predict Technology Life Cycle in Indonesian SME

2017 ◽  
Vol 1 (01) ◽  
pp. 29
Author(s):  
Augustina Asih Rumanti ◽  
Vania Hadisurya
Keyword(s):  
Life Cycle Assessment ◽  
Life Cycle ◽  
Product Development ◽  
Product Life Cycle ◽  
Stages Of Development ◽  
Product Life ◽  
Development Stages ◽  
Medium Level ◽  
Technology Life Cycle

Forecasting technology is one way that can be used to predict product life cycle. Product life cycle is very important to know, especially by organizations, that are in small medium level, like SME. This research will be conducted in SME Surya Usaha Mandiri, Daerah Istimewa Yogyakarta.Forecasting product life cycle that has been done, will direct this research toward the stage of product development. Stages of development of the products are a necessary stage for an organization, especially in SME, to innovate the product. The purpose of this research is to propose the development of products, such as the stages of innovation that can be done in SME Surya Usaha Mandiri, forecasting conducted based on life cycle assessment of products and technology components using technometric model. The results of this research are proposed innovation based forecasting and product life cycle assessment in SME Surya Usaha Mandiri using technometric model.

scholarly journals APPROACH FOR SUSTAINABILITY CRITERIA AND PRODUCT LIFE-CYCLE DATA SIMULATION IN CONCEPT SELECTION

2020 ◽  
Vol 1 ◽  
pp. 1979-1988
Author(s):  
S. Y. Kwok ◽  
J. Schulte ◽  
S. I. Hallstedt
Keyword(s):  
Life Cycle ◽  
Product Development ◽  
Product Life Cycle ◽  
Concept Selection ◽  
Data Simulation ◽  
Product Life ◽  
Strategic Integration ◽  
Sustainability Criteria ◽  
Trade Offs ◽  
Alternative Solutions

AbstractCompanies struggle with identifying relevant sustainability aspects strategically, assessing alternative solutions quantitatively, and making trade-offs. This paper reports results from a prescriptive study with an aerospace company, and presents the Sustainability Criteria And product life-cycle Data Simulation (SCADS) approach. Based on strategic integration of sustainability indicators, this approach aims to enable visualisation and comparison of the sustainability implications of different concepts in early design phases of product development.

Design-Driven Integrated-Comprehensive Model CDFS Strategic Relationships

2014 ◽  
Author(s):  
Sasan T. Khorasani
Keyword(s):  
Supply Chain ◽  
Life Cycle ◽  
Product Development ◽  
New Product Development ◽  
Product Life Cycle ◽  
New Product ◽  
Added Value ◽  
Second Phase ◽  
Star Model ◽  
Product Life

Measuring quality in design-driven innovation is part of the larger subject of product design, supply chain management and new product development (NPD). In other words, better design and supply chain integration increase the efficiency and effectiveness of the production development process. In this work, I have studied the role of understanding the needs of customers and design approaches for new products through a combination of customer feedback and participation of designers in the first phase of new product development. Furthermore, I discuss why the incorporation of both designers and customer needs is important to design-driven innovation. In the second phase of this study, I present several case studies in terms of supplier-buyer relationships in order to find a solution that achieves a long-term relationship (the alliance-star model) in new product development, which is a crucial problem in the Blue Ocean Strategy. Finally, by presenting the CDFS (Customer-Designer-Firm-Supplier) strategic model, we show schematically the integrated-comprehensive process approach for creating a new innovative product from the concept phase through to the end of Product life cycle. This model presents the process of new innovation, which can ensure added value during Product life cycle.

Regulatory Aspects of Total Product Life Cycle

2004 ◽  
Vol 6 (6) ◽  
pp. 761-766 ◽  
Author(s):  
Ethan D. Hausman ◽  
Sousan S. Altaie
Keyword(s):  
Life Cycle ◽  
Product Life Cycle ◽  
Product Life ◽  
Regulatory Aspects ◽  
Total Product

scholarly journals Evaluating the role of simulation in healthcare innovation: recommendations of the Simnovate Medical Technologies Domain Group

2017 ◽  
Vol 3 (Suppl 1) ◽  
pp. S8-S14 ◽  
Author(s):  
Amin Madani ◽  
Benoit Gallix ◽  
Carla M Pugh ◽  
Dan Azagury ◽  
Paul Bradley ◽  
...  
Keyword(s):  
Life Cycle ◽  
Product Development ◽  
Conceptual Framework ◽  
Product Life Cycle ◽  
Online Survey ◽  
Product Launch ◽  
Product Life ◽  
Product Effectiveness ◽  
Healthcare Innovation

BackgroundInnovation in healthcare is the practical application of new concepts, ideas, processes or technologies into clinical practice. Despite its necessity and potential to improve care in measurable ways, there are several issues related to patient safety, high costs, high failure rates and limited adoption by end-users. This mixed-method study aims to explore the role of simulation as a potential testbed for diminishing the risks, pitfalls and resources associated with development and implementation of medical innovations.MethodsSubject-matter experts consisting of physicians, engineers, scientists and industry leaders participated in four semistructured teleconferences each lasting up to 2 hours each. Verbal data were transcribed verbatim, coded and categorised according to themes using grounded theory, and subsequently synthesised into a conceptual framework. Panelists were then invited to complete an online survey, ranking the (1) current use and (2) potential effectiveness of simulation-based technologies and techniques for evaluating and facilitating the product life cycle pathway. This was performed for each theme of the previously generated conceptual framework using a Likert scale of 1 (no effectiveness) to 9 (highest possible effectiveness) and then segregated according to various forms of simulation.ResultsOver 100 hours of data were collected and analysed. After 7 rounds of inductive data analysis, a conceptual framework of the product life cycle was developed. This framework helped to define and characterise the product development pathway. Agreement between reviewers for inclusion of items after the final round of analysis was 100%. A total of 7 themes were synthesised and categorised into 3 phases of the pathway: ‘design and development’, ‘implementation and value creation’ and ‘product launch’. Strong discrepancies were identified between the current and potential roles of simulation in each phase. Simulation was felt to have the strongest potential role for early prototyping, testing for safety and product quality and testing for product effectiveness and ergonomics.ConclusionsSimulation has great potential to fulfil several unmet needs in healthcare innovation. This framework can be used to help guide innovators and channel resources appropriately. The ultimate goal is a structured, well-defined process that will result in a product development outcome that has the greatest potential to succeed.

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