Step 5.4

Refine beta prototype to finalize invention claims.

Primary findings

Barriers

Barriers to accomplishing effective Design Reviews include the following: — The DR team consists of people who are unevenly matched in skills and knowledge. — Product developers tend to press on with little communication among related departments. — The product development schedule is often cramped and allows for little time and flexibility for changes in response to DR. — The DR team may lack the expertise, resources or authority to to make the process effective. — During the concept phase of the design process, the DR team has little basis on which to provide feedback. — Product Design managers view DR to be separate from design, thereby leaving little scope for conducting DR of drawings, specifications etc. — DR is an additional demand on both the design and engineering teams, both of which are under constraints.
Authors experience in industrial engineering, physical medicine and rehabilitation, and as Editor-in-Chief of the International Journal of Industrial Engineering.
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Definition of Product Requirements
Survey of manufacturers (n=80). One third of respondents identified Incorrectly defined requirements as the most significant problem, particularly the incorrect translation of top-level requirements into sub-system requirements.
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Models

Design manufacturing integration is positively associated with NPD project efficiency, if product design and manufacturing personnel act in truly cooperative ways, overall project efficiency should increase.
Survey of 137 completed NPD projects. The degree of design and manufacturing integration significantly differed across the project groups in the expected direction.
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Methods

Create and maintain high levels of integration between Marketing and Research & Development functions and product prototype development, product launch and cycle times will all have increased proficiency. Market forecast accuracy and technological core competency fit will also be improved with function integration. Be sure to implement integration at step 4.1.
Survey. A multiple regression analysis revealed significance between integration and: product prototype development proficiency (F=70.80); product launch proficiency (F=122.74); product development cycle time (F=13.84), market forecast accuracy (F=75.65); and technological core competency fit (F=39.64), all interactions significant at the p<.001 level.
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Design Review does not create good ideas, but instead ensures that good ideas work as well as possible. Design Review involves six actions: 1) Collect and compile information; 2) Define quality targets; 3) Evaluate product and process designs and supporting operations; 4) Proposition of improvements; 5) Definition of subsequent actions; 6) Confirmation of readiness to move to next stage.
Authors experience in industrial engineering, physical medicine and rehabilitation, and as Editor-in-Chief of the International Journal of Industrial Engineering.
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Design for Quality/Design Review — the systematic process of bringing complex products to the market quickly, while ensuring product design quality meets customer requirements, within cost and time constraints. Design Review is is generally applied at the general design stage, and to a lesser degree, at the detailed design and pilot building stages. Design Review is based on two premises: 1) Make the best of available knowledge and technology from both in-house and outside resources; 2) Do everything to resolve problems as they arise. Avoid passing them downstream.
Authors experience in industrial engineering, physical medicine and rehabilitation, and as Editor-in-Chief of the International Journal of Industrial Engineering.
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Failure Knowledge Network (FKN) — captures and inter-relates mechanical product quality knowledge from five areas: (i) the connection between failures and product functions, (ii) the relationship between failures and product components, (iii) the correlation between failures and organizations, (iv) the association between failures and product processes, and (v) the conjunction among different failures. FKN information is represented in a four-dimensional matrix that includes components, functions, processes and organization. Each element in the matrix is a failure scenario and represents the related failures within the corresponding dimensions. Conventional factors of failures are embodied in the FKN representation. They include event, detection, effect, severity, solution weight, cause, monitor, reappearance, operation, efficiency and precaution. The indexes of each factor are provided by subject matter experts and are set in accordance with the correlation between corresponding characteristics and failures
Failure knowledge based decision-making in product quality.
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Manufacturers involved various external groups to varying degrees at the completion of the product development process as follows: customers (39%), suppliers (44%), competitors (9%), universities/research institutes (14%).
Analysis of survey data from 557 firms across five industries in Europe.
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The cost of reworking a design is based on three factors: 1) As more is time spent on an activity using outdated information, the amount of cumulative work that must be modified will be larger. Hence, rework time is an increasing function of the time between two successive incorporations of new information; 2) Rework time is dependent on how much the information and the activity are related. In general, a change in major input needs longer rework time than a change in minor inputs; 3) The degree of sensitivity which implies the robustness of the activity to changes. A larger degree of sensitivity indicates a longer rework time frame.
Mathematical model creation and analysis.
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Tips

Be flexible with managing resources to have higher levels of success with product development execution.
Survey of 120 development projects from 57 firms. Hierarchical regression was significant, beta = .179 at p<=.1
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If your company's strategy is that of an analyzer, one which makes new concepts or innovations more efficient, consider using design tools such as CAD/CAM (computer aided design/manufacturing) to improve your new product development performance.
Survey. Analyzers were found to significantly make more use of CAD/CAM tools than defenders.
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Test commercial assumptions (e.g., pricing and sales forecasts) early — the validation/scale-up stage should include testing of all key project premises, commercial as well as technical.
Conclusions drawn from case studies and experience.
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Secondary findings

Methods

Use of methods such as design for manufacturing (DFM) to encourage the integration of product and process design decisions has been associated with lower product costs and better conformance quality.
Source: Youssef (1994), Swink (2002), Sanchez and Perez, (2003). In: Swink, M., Talluri, S., & Pandejpong, T. (2006)

Tips

Use computer based tools to help shorten design time, reduce costs and improve quality.
Source: Karagozoglu and Brown (1993). In: Koufteros, X. & Marcoulides, G. A. (2006)

Review IP protection and obtain final approval from regulatory and reimbursement agencies — as needed.

Primary findings

Models

NPD process needs more examination of Product Characteristics, Marketplace Characteristics, Strategy Synergy, and Product Quality as predictors of new product performance.
Literature review of 815 NPD articles published in the 10 leading marketing, management, NPD and R&D journals from 1989 to 2004.
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Methods

Human Performance Technology (HPT) extends Human Factors studies by considering four factors influencing performance driven by the desired function: 1) Information — does the person have it and should it reside internally or externally; 2) Environment — how design of systems, devices and work processes help or hinder performance; 3 Selection - does the person have the requisite abilities; 4)Motivation  — are there clear goals and feedback mechanisms. These issues are important to the end-user/customers; to the manufacturers and to regulatory bodies such as the FDA.
Medical Device Industry experience.
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Performance Drivers: One is the Quality of Execution. Eight activities distinguish best from worse performers: 1) Conducting a post-launch review (8.2); 2) Assessment of product's value to business (2.1); 3) Test market or trial sell to a limited set of customers (7.13); 4) Concept testing to determine customer reaction to product and gauging purchase intent before Development begins (4.11); 5) Idea Generation (1.3); 6) Customer tests of products under real-life conditions (6.3); 7) Detailed market study/research or Voice of the Customer (4.3, 4.13); 8) Pre-launch business analysis (7.7, 7.8, 7.9).
A quantitative survey of 105 business units, supported by team's experience in NPD modeling, consultation, application and analysis.
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Regulatory bodies in different nations have different requirements and different approaches to specific tests. It is possible and helpful to identify a global submission strategy that can, at least partially, be used for several nations or global regions. It is particularly important to interact with regulatory personnel to stay up to date on current regulatory requirements.
Case studies and author experience.
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Tips

Alliances involving technology acquisition must ensure they have a sound business case where the purpose of the alliance is clearly defined and any Intellectual Property (IP) issues are carefully described and discussed. IP issues are particularly important when the acquired know-how needs to be customized to the NPD context. This may create co-invention scenarios where claims and ownership can become issues.
Literature review, author's industry experience with case study.
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