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 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.

scholarly journals The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices

2017 ◽  
Vol 11 (2) ◽  
Author(s):  
Tina M. Morrison ◽  
Maureen L. Dreher ◽  
Srinidhi Nagaraja ◽  
Leonardo M. Angelone ◽  
Wolfgang Kainz
Keyword(s):  
Life Cycle ◽  
Computational Modeling ◽  
Modeling And Simulation ◽  
Medical Devices ◽  
Product Life Cycle ◽  
Product Life ◽  
Regulatory Decision ◽  
Total Product ◽  
Regulatory Submissions ◽  
Computational Modeling And Simulation

The total product life cycle (TPLC) of medical devices has been defined by four stages: discovery and ideation, regulatory decision, product launch, and postmarket monitoring. Manufacturers of medical devices intended for use in the peripheral vasculature, such as stents, inferior vena cava (IVC) filters, and stent-grafts, mainly use computational modeling and simulation (CM&S) to aid device development and design optimization, supplement bench testing for regulatory decisions, and assess postmarket changes or failures. For example, computational solid mechanics and fluid dynamics enable the investigation of design limitations in the ideation stage. To supplement bench data in regulatory submissions, manufactures can evaluate the effects of anatomical characteristics and expected in vivo loading environment on device performance. Manufacturers might also harness CM&S to aid root-cause analyses that are necessary when failures occur postmarket, when the device is exposed to broad clinical use. Once identified, CM&S tools can then be used for redesign to address the failure mode and re-establish the performance profile with the appropriate models. The Center for Devices and Radiological Health (CDRH) wants to advance the use of CM&S for medical devices and supports the development of virtual physiological patients, clinical trial simulations, and personalized medicine. Thus, the purpose of this paper is to describe specific examples of how CM&S is currently used to support regulatory submissions at different phases of the TPLC and to present some of the stakeholder-led initiatives for advancing CM&S for regulatory decision-making.

Coordination of Product Life Cycle with Product Usage Mode

2011 ◽  
Vol 268-270 ◽  
pp. 97-100
Author(s):  
Heng Wang ◽  
Jin Chang Hou
Keyword(s):  
Life Cycle ◽  
Customer Satisfaction ◽  
Service Quality ◽  
Product Life Cycle ◽  
Life Cycle Management ◽  
Management Options ◽  
Product Life ◽  
Product Usage ◽  
Product Service ◽  
Total Product

For achieving better environmental performance of products or product systems, it is essential to manage total product life cycle. This paper describes a method for supporting product life cycle management by comprehensive product life cycle simulation, which is a basis for designing and evaluating total product life cycle. For life cycle evaluation, it is important to seek for the better product services, at the same time to seek for lower environmental burden and life cycle management costing. For this purpose, a product usage model is proposed, where customer satisfaction is measured by offered product functionality. The same level of customer satisfaction can be achieved by various different life cycle management options. By taking examples of technologically immature short-life products, like mobile phones, effect of difference of required product service quality is investigated, and appropriate product management strategy is discussed for improving product service quality.

Life Cycle Management for Improving Product Service

2011 ◽  
Vol 58-60 ◽  
pp. 652-656 ◽  
Author(s):  
Heng Wang ◽  
Jin Chang Hou
Keyword(s):  
Life Cycle ◽  
Customer Satisfaction ◽  
Service Quality ◽  
Product Life Cycle ◽  
Life Cycle Management ◽  
Management Options ◽  
Product Life ◽  
Cycle Simulation ◽  
Product Service ◽  
Total Product

For achieving better environmental performance of products or product systems, it is essential to manage total product life cycle. This paper describes a method for supporting product life cycle management by comprehensive product life cycle simulation, which is a basis for designing and evaluating total product life cycle. For life cycle evaluation, it is important to seek for the better product services, at the same time to seek for lower environmental burden and life cycle management costing. For this purpose, a product usage model is proposed, where customer satisfaction is measured by offered product functionality. The same level of customer satisfaction can be achieved by various different life cycle management options. By taking examples of technologically immature short-life products, like mobile phones, effect of difference of required product service quality is investigated, and appropriate product management strategy is discussed for improving product service quality.

scholarly journals Multi-dimensional Understanding of the “Product” in the Marketing Decision Process

2010 ◽  
Author(s):  
Rodica Boier
Keyword(s):  
Life Cycle ◽  
Decision Process ◽  
Product Life Cycle ◽  
Product Category ◽  
Product Management ◽  
Product Life ◽  
Marketing Decision ◽  
Total Product ◽  
Complete Set ◽  
Technical Features

The paper starts from the observation that students often experience difficulties in identifying the complete set of aspects involved in making product decisions, but also in understanding the correlations established between these elements. The review of the information required by product management reveals a set of interrelated aspects among which the most important refer to: product category; the needs that the product addresses; usage situations and fields; the product life cycle; seasonality of manufacturing/purchasing/usage; the path from technical features, such as attributes and functions, to the benefits (advantages) for the client; “total product”; the set of related products; the tangible/intangible relationship a.s.o. The paper may be used as a checklist to identify the requisite steps in the multidimensional research, which precedes the decision process of the product marketing.

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