Total Product Life Cycle Research Articles

Strategic Environmental Assessment (SEA) Process towards the Sustainable Design and Construction of Computer, Communication, Network Engineering, Machine Learning and Artificial Intelligence Systems

Strategic Environmental Assessment (SEA) Process towards the Sustainable Design and Construction of Computer, Communication, Network Engineering, Machine Learning and Artificial Intelligence Systems

Strategic Environmental Assessment (SEA) Process for Green Materials and Environmental Engineering Systems towards Sustainable Development-Business Excellence Achievements

Strategic Environmental Assessment (SEA) Process for Green Materials and Environmental Engineering Systems towards Sustainable Development-Business Excellence Achievements

Analytical Chemistry in the Regulatory Science of Medical Devices.

In the United States, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all Food and Drug Administration-regulated products. Good regulatory science facilitates consumer access to innovative medical devices that are safe and effective throughout the Total Product Life Cycle (TPLC). Because the need to measure things is fundamental to the regulatory science of medical devices, analytical chemistry plays an important role, contributing to medical device technology in two ways: It can be an integral part of an innovative medical device (e.g., diagnostic devices), and it can be used to support medical device development throughout the TPLC. In this review, we focus on analytical chemistry as a tool for the regulatory science of medical devices. We highlight recent progress in companion diagnostics, medical devices on chips for preclinical testing, mass spectrometry for postmarket monitoring, and detection/characterization of bacterial biofilm to prevent infections.

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

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.

Strategic Environmental Assessment (SEA) Process for Sustainable Mining and Mineral Management Development

Strategic environmental assessment (SEA) process can be broadly defined as a study of the impacts of a proposed project, plan, project, policy or legislative action on the environment and sustainability. SEA process has been aimed to incorporate environmental and sustainability factors into mining and mineral (MM) project planning and decision making (MMPPDM) process. Sustainable MM development is a kind of development that meets the needs of the present without compromising the ability and efficacy of future generations to meet their own MM needs. Environmental Impact Assessment (EIA) process can be defined as the systematic study of the potential impacts (effects) of proposed MM projects, plans, programs, policies or legislative actions relative to the physical-chemical, biological, cultural, and socio-economic components of the total environmental product life cycle. The primary purpose of the EIA process is to encourage the consideration of the environment in MMPPDM process and to arrive at actions that are environmentally compatible. MMPP-DM process should include the integrated consideration of technical or engineering, economic, environmental, safety, and health, social and sustainability factors to achieve business excellence. The objective of the study is to conceptualize SEA process for the MM sector based on fifteen number of sustainable detailed project reports (DPRs) submitted by the extension learners of Diploma in Entrepreneurship and Business Management (DEBM)...

Increasing Product Confidence-Shifting Paradigms.

Leaders in the pharmaceutical, medical device, and food industries expressed a unilateral concern over product confidence throughout the total product lifecycle, an unsettling fact for these leaders to manage given that their products affect the lives of millions of people each year. Fueled by the heparin incident of intentional adulteration in 2008, initial efforts for increasing product confidence were focused on improving the confidence of incoming materials, with a belief that supplier performance must be the root cause. As in the heparin case, concern over supplier performance extended deep into the supply chain to include suppliers of the suppliers-which is often a blind spot for pharmaceutical, device, and food manufacturers. Resolved to address the perceived lack of supplier performance, these U.S. Food and Drug Administration (FDA)-regulated industries began to adopt the supplier relationship management strategy, developed by the automotive industry, that emphasizes "management" of suppliers for the betterment of the manufacturers. Current product and supplier management strategies, however, have not led to a significant improvement in product confidence. As a result of the enduring concern by industry leaders over the lack of product confidence, Xavier University launched the Integrity of Supply Initiative in 2012 with a team of industry leaders and FDA officials. Through a methodical research approach, data generated by the pharmaceutical, medical device, and food manufacturers surprisingly pointed to themselves as a source of the lack of product confidence, and revealed that manufacturers either unknowingly increase the potential for error or can control/prevent many aspects of product confidence failure. It is only through this paradigm shift that manufacturers can work collaboratively with their suppliers as equal partners, instead of viewing their suppliers as "lesser" entities needing to be controlled. The basis of this shift provides manufacturers with a newfound respect for their suppliers, and it will allow manufacturers to finally address true root causes that can lead to a marked increase in product confidence. In the past decade, pharmaceutical, medical device, and food manufacturers have increased their focus on controlling and managing the performance of their suppliers in an effort to improve the confidence of the materials going into the final marketed products and to improve patient and customer confidence in final product reliability and safety. Concerned that product confidence has not improved, Xavier University launched the Integrity of Supply Initiative in 2012 with a team of industry leaders and U.S. Food and Drug Administration officials. Through this initiative, data generated has revealed that manufacturers either unknowingly increase the potential for error or can control/prevent many aspects of product confidence failure. Product confidence can be improved by shifting the focus from controlling supplier practices to controlling the practices of the manufacturers themselves.

Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011

ImportanceThe US Food and Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle.ObjectiveTo characterize the clinical evidence generated for high-risk therapeutic devices over the total product life cycle.Design and SettingAll clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through ClinicalTrials.gov and publicly available FDA documents as of October 2014.Main Outcomes and MeasuresStudies were characterized by type (pivotal, studies that served as the basis of FDA approval; FDA-required postapproval studies [PAS]; or manufacturer/investigator-initiated); premarket or postmarket; status (completed, ongoing, or terminated/unknown); and design features, including enrollment, comparator, and longest duration of primary effectiveness end point follow-up.ResultsIn 2010 and 2011, 28 high-risk therapeutic devices received initial marketing approval via the PMA pathway. We identified 286 clinical studies of these devices: 82 (28.7%) premarket and 204 (71.3%) postmarket, among which there were 52 (18.2%) nonpivotal premarket studies, 30 (10.5%) pivotal premarket studies, 33 (11.5%) FDA-required PAS, and 171 (59.8%) manufacturer/investigator-initiated postmarket studies. Six of 33 (18.2%) PAS and 20 of 171 (11.7%) manufacturer/investigator-initiated postmarket studies were reported as completed. No postmarket studies were identified for 5 (17.9%) devices; 3 or fewer were identified for 13 (46.4%) devices overall. Median enrollment was 65 patients (interquartile range [IQR], 25-111), 241 patients (IQR, 147-415), 222 patients (IQR, 119-640), and 250 patients (IQR, 60-800) for nonpivotal premarket, pivotal, FDA-required PAS, and manufacturer/investigator-initiated postmarket studies, respectively. Approximately half of all studies used no comparator (pivotal: 13/30 [43.3%]; completed postmarket: 16/26 [61.5%]; ongoing postmarket: 70/153 [45.8%]). Median duration of primary effectiveness end point follow-up was 3.0 months (IQR, 3.0-12.0), 9.0 months (IQR, 0.3-12.0), and 12.0 months (IQR, 7.0-24.0) for pivotal, completed postmarket, and ongoing postmarket studies, respectively.Conclusions and RelevanceAmong high-risk therapeutic devices approved via the FDA PMA pathway, total product life cycle evidence generation varied in both the number and quality of premarket and postmarket studies, with approximately 13% of initiated postmarket studies completed between 3 and 5 years after FDA approval.

Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) infrastructure: A think tank report from Medical Device Epidemiological Network Initiative (MDEpiNet)

The MDEpiNet is a public-private partnership between the US Food and Drug Administration's Center for Devices and Radiological Health and participating partners. The PASSION program is an MDEpiNet-sponsored program that aims to demonstrate the goals of MDEpiNet by using cardiovascular medical device registries to bridge evidence gaps across the medical device total product life cycle. To this end, a PASSION Think Tank meeting took place in October 2014 in Silver Spring, MD, to facilitate discussion between stakeholders about the successes, challenges, and future novel applications of medical device registries, with particular emphasis on identifying pilot projects. Participants spanned a broad range of groups including patients, device manufacturers, regulators, physicians/academicians, professional societies, providers, and payers. The meeting focus included 4 areas of cardiovascular medicine intended to cultivate interest in 4 MDEpiNet disease-specific/device-specific working groups: coronary intervention, electrophysiology, valvular disease, and peripheral vascular disease. In addition, more general issues applying to registry-based infrastructure and analytical methodologies for assessing device benefit/risk were considered to provide context for the working groups as PASSION programs going forward. This article summarizes the discussions at the meeting and the future directions of the PASSION program.

Procuring Industrial Service Solutions, Exploring Enablers for Co-creating Value

Optimizing complex hardware and services into service solutions may significantly reduce the total product life-cycle cost for a customer. Research regarding the customers’ perspective is still scarce, however. Hence, the purpose of this paper is to explore value perceptions among buyers of industrial service solutions developed for complex product platforms. The study is based on the experiences of one commercial and three governmental customers procuring service solutions for aviation products. As could be expected, direct financial benefits in the form of cost reduction were an important motive for the studied organizations. In reality, however, it turned out to be difficult to verify if these goals had been fulfilled. This may be seen both as an indicator of the complexity of the business, and the lack of clear baseline data, when the new service provider entered the field. Still, the customers were satisfied with the partnership, with several of them eager to learn from the provider, even if the learning process was painful.During the procurement process itself the quality and richness of the relationship with the new partner was important for signaling capability. End-users, however, seemed to be under-used and not sufficiently involved in the relationship during this process. The results also show that continuous proposals for improvements from the service provider are highly valued among customers.

Development of the integrated product information model for product sustainability assessment

The sustainability of a product is evaluated using the product sustainability index (ProdSI) methodology. This methodology is based on the total product life-cycle and a 6R approach. When it comes to product information models, it is difficult to extract required information to evaluate certain elements of ProdSI from the currently available geometry-based product data models. This paper discusses the development of an integrated product information model that will provide all such information, and will facilitate the ProdSI assessment process. The proposed model combines information about geometry and topology along with function, behaviour, manufacturing processes and product sustainability related information.

Cost planning in the stage of product development

The total product life cycle cost can be planned based on one of the methods of global cost estimation. Also, total product life cycle cost can be planned based on cost plans and estimates by phases of the product life cycle, such as the phases of development, production, use and termination of the life cycle. By identifying the specific activities related to the relevant phases of life cycle as corresponding cost drivers, it is possible to accurately determine the total cost of individual phases using suitable methods known in the literature. This paper presents planning possibility respectively cost assessment of product development phase.

Evaluation of Sustainability Performance of Product Design Element Concepts Using Analytic Hierarchy Process

ntegrating sustainable product design into the design process has been acknowledged nowadays by many companies for producing sustainable products. The integration should be implemented during the early stage of product development process so that the sustainability of the product can be evaluated before manufacturing the product. Although a number of studies have been conducted on the integration in many aspects along with many approaches, evaluation of the sustainability of the product during its total life-cycle while it is being designed has not been comprehensively investigated. In this paper, Analytic Hierarchy Process (AHP) is used to evaluate product design element concept during conceptual design stage by providing a weightage of sustainability metrics throughout the total life-cycle of product and finalize the preferred product design configuration by selecting the highest sustainability index of the design element concept. The approach is useful for product designers to design many concepts of product design elements and then to select the most likely sustainable design element to configure in one complete product. An example of an armed chair is used to demonstrate this approach.

Robust global supply network design

It has been widely documented that disruptions and changes in the environment of manufacturing in a global enterprise impact the performance of the enabling supply network. The need exists for a methodology that can not only provide an objective and transparent evaluation of the efficiency and risks of a supply network configuration but that can also design supply network configurations with provably superior performance. Supply chain engineering SCE fundamentally applies the perspective and methodology of systems engineering to the domain of supply chains. SCE is the integrator of various corporate functions such as purchasing, production, distribution, and sustainment over the total product life cycle from design, through deployment, production, sustainment, and disposal. A supply chain is actually a network that consists of a diverse set of organizational and geographical components that typically change over time. The systematic design and management of such an inherently complex system requires the principles and tools of model-based systems engineering. A comprehensive and integrated model of the structure and the behavior of the supply network of a manufacturing enterprise has been developed. In this model the inherent uncertainty of the future environmental conditions in which the supply network will have to function is captured in a large number of scenarios. The variability of the profits achieved by the supply network for the various scenarios is used as a proxy for the supply network risk. The model allows for the explicit tradeoff of the systems life cycle profit with the variability of this profit. An efficient solution algorithm eliminates the vast majority of feasible supply network configurations from consideration and identifies all the Pareto-optimal configurations. However, the final selection of the network configuration depends on the risk preferences of the designer and the complexity of the enterprise. Selecting the supply network configuration with the appropriate robustness becomes one of the principal risk mitigation policies for the network and, in turn, the enterprise. The combination of the socio designer risk preferences and analysis and technical Pareto-optimization of all feasible supply network configurations creates a transparent engineering design process that finds the supply network configuration best matched to the objectives of the manufacturing enterprise.

A FORMULATION OF THE PRELIMINARY DESING PHASE USING COMPLEXITY-BASED RULES

This paper focuses on the application of complexity theory and entropy concepts in the design process. Broadly speaking, the design process involves three phases: problem definition, conceptual design and embodiment. In the conceptual design phase, concepts that satisfy the functional requirements of the desired product are identified and compared. It is said that approximately 75% of the total product life-cycle cost is committed in this phase. The conceptual design phase has two essential sub-phases, namely, obtaining a solution set and selecting the most suitable solutions. Our work focuses on the selection sub-phase. The aim within this sub-phase is to minimize the number of selected concept variants and to reduce their chances of rejection in later stages. However, the solution to this problem is quite elusive, mostly because information about concept variants is scarce and rather qualitative at this stage. A common method is to perform a cost-benefit analysis. However, the analysis relies heavily on expert intuition and is thus subjected to high uncertainties. Recently, axiomatic design is gaining popularity. This is a framework that incorporates two axioms, namely, the Independence Axiom and the Minimum Information Axiom, accompanied by several corollaries. However, criticism on the integrity of the Independence Axiom has appeared recently in the literature. Further, the formulation of axiomatic design appears to have logical flaws. Finally, the conceptual design phase, a distinct phase in the design process, cannot be distinguished clearly in axiomatic design. In this paper we try to improve the selection phase of the conceptual design by improving the existing cost-benefit approach. In this vein, performance features against which concepts would be evaluated are established. We propose the use of Kolmogorov complexity theory and entropy concepts from information theory and physics to evaluate the complexity of the performance features. The design concepts are then improved based on the rule to reduce complexity of each performance feature. Weights are finally assigned to each performance feature and an overall complexity index is obtained which is suitable to compare designs. The ideas are further elaborated on by examples.

Coordination of Product Life Cycle with Product Usage Mode

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

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.

Dynamic life cycle costing based on lifetime prediction

Reliable prediction of total product life cycle costs is crucial for the life cycle management of products. These costs are predominantly dictated by the actual operational behaviour of the product's lifetime, and cannot be sufficiently determined through deterministic calculations due to the stochastic and the dynamic nature of the problem. This is specifically true when considering running systems with unknown lifetime and operation parameters. Against this background, the paper presents a dynamic methodology for predicting life cycle costs based on product failure mechanisms, their associated critical lifetime prediction parameters and optional maintenance strategies to enable decision support for product design and use phase strategies.

VARC consensus report: the FDA perspective

The Food and Drug Administration (FDA) is responsible for protecting and promoting the public health of US citizens. In keeping with this mission, FDA's Center for Devices and Radiological Health (CDRH) is tasked with assuring the safety, effectiveness, and quality of medical devices, assuring the safety of radiation-emitting products, fostering innovation, and providing the public with accurate, science-based information about the products we oversee, throughout the total product life cycle.1 In order to enhance our ability to fulfil our mission, CDRH developed a strategic plan to identify priority areas for 2010. One of our goals is to proactively help facilitate medical device innovation and address unmet public health needs.2 To accomplish this objective, CDRH believes it is critical to leverage our regulatory authority and unique understanding of the …

In Response

The principal concern expressed by Pitkin et al.1 is the choice of point-of-care (POC) device used to monitor blood glucose concentrations in anesthetized patients and the potential risk of undetected severe hypoglycemia. In our protocol2 we used the AccuSoft Advantage (Roche Diagnostics, Hoffman-La Roche, Laval, Quebec, Canada), a POC device routinely used in operating rooms and previous studies assessing different glycemic control protocols.3,4 In this context, while some portable blood glucometers show falsely elevated values under hypoglycemic conditions,5 Accu-Cheks tend to display lower values during hypoglycemia and anemia, thereby presumably increasing the margin of safety in the hypoglycemic range.6 We agree with Rice et al. regarding the general limitations of such POC devices, originally designed for blood glucose self-monitoring at home and the apparent lack of “regulatory framework,” proper standardization, and evaluation in critical care.7 However, none of the patients enrolled in our protocol was “critically ill” according to the definition used by the Food and Drug Administration guidance (Food and Drug Administration. Draft guidance for industry and FDA staff: total product life cycle for portable invasive blood glucose monitoring systems. Rockville, MD: Center for Devices and Radiological Health, Oct 24, 2006. Available at: http://wwwfdagov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm079138htm), as referenced by Rice et al. Unfortunately, because of time constraints and the high frequency of blood glucose measurements, glucose–insulin therapy, as with any other algorithm aiming at tight blood glucose control in the acute care setting, depends on the results rapidly provided by POC devices rather than time-consuming central laboratory plasma glucose analysis. The relatively short 15- minute intervals between glucose measurements as dictated by our protocol and the fact that dextrose is being infused continuously, however, may be considered as an added safety feature of glucose–insulin therapy. In a recent randomized trial, completed before our investigation in patients undergoing liver surgery and designed to assess the cardioprotective effects of glucose and insulin administration while maintaining normoglycemia in 100 patients undergoing surgical coronary revascularization, we measured plasma glucose concentrations in approximately 500 arterial blood samples by using the Beckman Glucose Analyzer 2 (Beckman Instruments, Fullham, CA). We found no clinically important discrepancy between values obtained by the “gold standard” glucose-oxidase-based glucose analyzer3 and those provided by the Accu-Chek glucometer, particularly in the lower glycemic range (manuscript submitted for publication). Regardless of the protocol used or our belief in the potential benefits of strict glycemic control during and after surgery, thorough understanding of the patient's pathophysiology and the technology applied to maintain glucose homeostasis is mandatory to avoid the disastrous consequences of severe hypoglycemia.8,9 Thomas Schricker, MD, PhD George Carvalho, MD, MSc Hiroaki Sato, MD Department of Anaesthesia Royal Victoria Hospital McGill University Health Center Montreal, Quebec, Canada [email protected]

Rethinking Analytical Strategies for Surveillance of Medical Devices

Randomized trials that sometimes serve as the basis for device approval are small, short term, and generalizable to an increasingly smaller percentage of patients. Some of the most common and challenging devices are those used in hip replacement. Artificial hips are implanted in thousands to alleviate pain caused by noninflammatory joint disease and to restore patient mobility. During 2004 in the United States, although 68% of hospital stays for partial or total hip replacements were for those aged 65 years and older, younger patients will account for 52% by 2030. Using hierarchical modeling, we propose a framework for combining information from premarket and postmarket settings. Our key assumption is that device performance characteristics and outcomes obtained from 1 cohort are related to device characteristics and outcomes of the same or similar devices observed in other cohorts. We illustrate methods by jointly modeling Harris Hip Scores (HHSs) and revision-success data from 1851 subjects who participated in 3 pivotal randomized or observational studies of artificial hips. Subjects participating in randomized studies had better 2-year HHS than those in observational studies (posterior mean increase in HHS = 4.1, posterior standard deviation = 0.6). Patients implanted with ceramic-on-polyethylene hip used in 1 study had higher 2-year HHS than those implanted with a different ceramic-on-polyethylene hip in another study (mean difference = 4.2, standard deviation = 0.6). Our approach is feasible and will advance regulatory science using a transparent and dynamic new paradigm for knowledge management throughout the total product life cycle.