Medical Device NPD — Biological testing is very expensive and consumes a good deal of elapsed time. For example, biocompatibility testing can cost tens of thousands of dollars and take months to complete.
Case studies and author experience.
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The knowledge intensive nature of NPD makes cognitive processes such as knowledge creation, knowledge transfer, codification and learning very critical. In particular, interpretive barriers can emerge among actors that are involved in the NPD process.
Semi-structured interviews and case study observations.
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Complications in use and unintended impacts on the user impede adaptation and use of new technologies. 
case study findings
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Cognitive maps are graphic tools used to represent concepts and ideas that individuals associate with some specific issues and the relationships among them. The analysis of cognitive maps is a means to identify different perspectives and interpretive differences that emerge during the NPD process. The cognitive maps provide a common basis for establishing a shared understanding among NPD team members.
Semi-structured interviews and cast study observations.
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Medical Device NPD — Chemical characterization (ISO 10993-18) of materials, can substitute for biological testing, to establish equivalence of new devices to predicate devices.
Case studies and author experience.
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Technology Road Mapping facilitates the NPD process in many ways: — It helps the NPD team identify the members and ensure that the right capabilities are in place at the right time to achieve the objective. — It helps the NPD team generate a common view among members, and to communicate that view and plan to customers, suppliers, partners and other groups. — As a strategic management tool it enables companies to link their technological capabilities to their product and business plans, so that strategy and technology development go hand in hand.
Authors experience and as applied within a case study.
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Consider adopting the NexGen Stage-Gate process, where the NPD process has been streamlined by removing all the non-value added activities. This NexGen process is also more flexible and adaptable, where steps and stages overlap.
Authors' research experience. This new process has been borrowed from lean manufacturing.
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Keep the formal structured NPD process for effective new products while adding improvisation within stages, in order to avoid chaos.
Survey. Conclusion of the study
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Practice spiral development, where a virtual prototype is created very early in the process to get immediate feedback from consumers. The build-test-feedback cycle is done quickly and often creating a loop type process.
Authors' research experience. Top performing companies use spiral development.
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Reduce NPD cycle time by overlapping activities performed in different stages
Survey. Conclusion of the study
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Stage/Gate Model — Authors substantiate the value of a Stage/Gate model for conducting NDP processes.
Survey. Authors conclusions drawn from analysis of Project Manager self-reports (n = 392)
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Use improvisation particularly at development stage as it benefits speed (reduces product cycle time).
Survey. R squared = .026 for the interaction: (development x improvisation)
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Based on manufacturer's policy, the CORE instrument can be applied at different stages including design, fabrication or product assembly.
Conceptual model, instrument creation and application in case study settings.
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Benchmarking involves reviewing the practices of other firms because of their known reputation for good performance. Firms that establish their industry benchmarks based on NPD practices, rather than based on NPD performance, were more likely to apply design-manufacturing integration (e.g., train personnel in new design methods, have manufacturing sign-off on design reviews, or restructure into cross-functional teams). The focus here is on product-process development integration — that set of focused, disciplined, rigorous practices designed to concentrate efforts on evolving from concepts to market introduction.
Survey of 43 U.S. firms.
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Comparing Academic and Corporate inventors, each identified the process elements within three categories: 1) Most Critical: Academics — none/Corporate — customer needs analysis. 2) Most Time Consuming: Academics — documentation of design work in technical memos/Corporate — Beta testing. 3) Most Problematic: Academics — technical problems arising during development; testing, data analysis, evaluation, and reporting/Corporate — Defining the market and its growth potential.
Eleven structured interviews involving five academics, five corporate and one hybrid approach, where each mapped their individual approach to NPD drawing from a set of Stage and Step activities.
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Cross-Functional Teamwork — In the Testing and Validation (Pre-Testing) Stage, two forms of cross-functional teamwork are recommended: 1) R&D can partner with Marketing to ensure Marketing understands the product's technical specifications, attributes, usage constraints, and required maintenance, which must be communicated to the consumer. 2) Marketing can partner with Manufacturing to coordinate their expectations for design specifications, and functional capabilities, so that what emerges from the production line matches what is described in the sales brochures. Combining all three teams is considered counter-productive in this stage. Instead, the Marketing Team should serve as the broker of communication between the other two teams.
Survey of 236 managers at 16 firms.
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Design for Manufacturing (DfM) is an approach to product design whereby the elements of quickness, ease and economy of manufacturing are addresses simultaneously. The DfM process involves the following: — Estimation of manufacturing costs from preliminary designs; — Reduce and minimize the cost of individual components; — reduce and minimize the cost of assembly; — reduce and minimize the costs of supporting production and production overheads; — consider the impact of DfM decisions on other factors such as structural rigidity, environmental concerns and functionality.
Authors experience and as applied to a case study.
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ExxonMobil evaluates in detail nine elements at each successive stage of the NPD process: 1) Strategic fit of the project with the company's objectives and strengths; 2) Market attractiveness; 3) Technical feasibility; 4) Supply and entry point (there must be an idea of how to supply this new product); 5) Sources of competitive advantage; 6) Legal/public policy/safety, health and environmental aspects; 7) Financial attractiveness; 8) Killer variables — which are those events or changes in market conditions or new technologies that could dramatically alter the situation for the project; 9) Plan to proceed, at least to the next Stage/Gate.
Industry experience.
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Integrated Product Design supports four related dimensions within product development: 1) Integration of business processes (concept-design-manufacturing); 2) Integration of the work flow and applications that support tasks; 3) Multiple projects that must be coordinated in a program addressing the entire assembled product; 4) Integration of the organizations that participate in the implementation of the IPD system, including suppliers, vendors, customers and the manufacturer.
Authors experience and as applied within a case study.
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Knowledge gaps in the NPD project team directly influence the quality and efficiency of its deliverables. Even small changes in the design can introduce weaknesses or failure points, even when all materials are kept the same. It is critical to ensure that the team is comprised of people with the appropriate variety of skills and experiences.
Case studies and author experience.
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Management should explicitly take into account industry developments when deciding on the level of investment in industrial design. Industrial design's positive impact on company performance is highest when the strategy of integrating this approach into NPD is relatively new for the industry involved.
Literature review and semi-structured questionnaires completed by manufacturing firms (n = 47).
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NPD Project Team and Functional Group — information disseminating, engendering ownership, creating discipline, information seeking, facilitating cross-functional planning — This communication is a combination of the uncertainty reduction activities as well as the engagement capabilities. When the members of the functional groups have a sense of ownership, they are proactive in seeking information they require, and providing information that will be necessary in advanced stages.
Case study analysis.
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Physical models are the single presentation format that is readily understood by most customers, to ensure that the evolution of a product's design is kept consistent with customer requirements. Creating a visually accurate prototype is not sufficient. It must display a high level of realism and represent every characteristic of the product. Rapid prototyping is a method for achieving the required level of accuracy and completeness.
Case studies in industry.
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Survey of 236 managers at 16 firms. Cross-Functional Teamwork in NPF — The study considers the relative value of various combinations of three organizational groups: 1) R&D; 2) manufacturing; 3) marketing, in cross-functional teamwork. Results show success depends on function-specific and stage-specific patterns of teamwork in five ways: 1) Different NPD stages suggest different combinations of teams; 2) The importance of a given function in integration depends on the stage; 3) Joint involvement between pairs of groups is generally more beneficial than among all three; 4) Effective cross- functional integration requires attention to paired communication between hub and non-hub functions; 5) The integration patterns suggested here do not generate conflicts across objectives or between groups.
Survey of 236 managers at 16 firms.
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Technology Road Mapping — a powerful technique for supporting technology management and planning. These are especially important attributes for exploring and communicating the dynamic linkages between technological resources, organizational objectives and the changing market environment (e.g., customer needs). The results of the Road Mapping process is a 'road map' showing the stakeholders how to get where they want to go. Generically speaking, a road map is a time-based chart consisting of a number of layers that typically include both commercial and technological perspectives. The road map enables the evolution of markets, products and technologies to be explored together, along with the linkages and discontinuities among the various perspectives.
Author experience and as applied in a case study.
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Ten methods used in various Stages of the NPD Process are listed in the Appendix and discussed in the paper: 1) Brainstorming; 2) Morphological analysis; 3) Synetics; 4) Delphi Method; 5) Focus Group; 6) Product Life Cycle; 7) Concept Test; 8) In-home Use Test; 9) Quality Function Deployment; 10) Limited Roll-Out. While most manufacturers are familiar with many of these methods, they report using them in various and sometimes wrong stages — so they are not applying them properly and in a focused manner.
Literature review and survey of forty-five manufacturers.
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The basic idea of participatory ergonomics is that the workers/users themselves actively partake as designers, generate ideas and design their (own) working environment or living space. By being engaged in the process of change, people can actively contribute to the solution of their own problems.
Literature review.
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The decision to incorporate new information into the design process should strike a balance. While it is important to incorporate useful information, management must differentiate between static and dynamic information, and consider the timing of incorporation. Incorporating later in the process increases the cost of re-working the design.
Mathematical model creation and analysis.
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There is a gap between awareness and use of tools supporting NPD development activity. Four external factors are identified: 1) Project — type of project ranges from incremental to radical changes; 2) Organization — support from top management, team cohesiveness, and technical competence. 3) Industry — different industries adopt different NPD processes which might indirectly affect choice of tools. 4) Culture — cultural differences such as Eastern versus Western.
Case studies in industry.
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There is a gap between awareness and use of tools supporting NPD development activity. Six internal factors are identified: 1) User friendliness — ease of use and ease of learning; 2) Usefulness — provides certain value to user. 3) Time — training, implementation and maintenance time; 4) Monetary cost — cost to train and use, cost to employ consultants, cost for software and cost for implementation support; 5) Flexibility — extent to which a tool can be used effectively even if some guidelines are not followed; 6) Popularity — extent to which the tool is widely or commonly used and accepted by similar industries.
Case studies in industry.
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To ensure compliance with the FDA's Quality System Regulation, medical device manufacturers should use a structured product development process to instill discipline in the product life cycle. A hierarchical approach arranges activity from Stages (phases) to Steps to Activities and finally to Tasks. Each Stage has a unique theme and set of deliverables. For example: Stage 3 — Verification & Validation. Demonstrate that the entire product offering and its supporting processes are robust and comply with the design requirement specifications and the customer's specifications prior to market introduction. All regulation, code, standards and product safety approvals must be obtained by the end of this stage. Demand building activities may be initiated in anticipation of commercial release.
Summary of the U.S. Food and Drug Administration's regulations for the research and development process underlying Medical Device manufacturing.
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Customer Optimization Route and Evaluation (CORE) evaluates and estimates customer satisfaction level regarding product attributes. It is designed to assess the quality of the design from the customer's point of view, and deliver a scale and decision-making aid for the manufacturing/service designers to evaluate the complexity of customer preferences towards a proposed design solution.
Conceptual model, instrument creation and application in case study settings.
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Knowledge about the NPD process can be captured in a range of tools including: 1) Project audits; 2) Design databases in CAD systems; 3) Engineering notebooks; 4) Collections of tests and experimental results; 5) Market research and test market results.
Conceptual model creation based on literature review.
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Product Optimization in NPD applies five tools: Conjoint Analysis; Quality Function Deployment; Concept Testing; Prototype Testing; Pilot Plant/In-Home Use Test.
Literature review and survey of forty-five manufacturers.
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Stage 6 — Scale Up & Validate involves a checklist of steps and activities. See Table 5 for the checklist.
Conclusions drawn from case studies and experience.
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Table 2 (page 146) lists five categories of intertemporal integration activities, and three levels of NPD performance. Table 2 goes on to list sets of measures appropriate for each.
Conceptual model creation based on literature review.
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The execution of various test protocols is of great important during the early stages. These tests are necessary to evaluate novel technologies, make appropriate design decisions, and gather data to support submissions to regulatory bodies. It is necessary to involved subject experts to define test strategies. Poorly designed test strategies can obstruct the NPD process.
Case studies and author experience.
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“Direct interaction with users is critical for successful two-way flows of knowledge that give researchers an accurate understanding of the context of application and provide users with valuable knowledge whether symbolic, conceptual or instrumental.”
Findings of data analysis
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For radical products, new product development speed will be increased by co-locating teams and testing products frequently. For incremental products, speed will improve if teams are spread out and testing is limited.
Survey of 75 new product development projects.
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Interdepartmental conflict is negatively related to the acquisition of market information and time/cost efficiency. Companies should therefore focus on reducing interdepartmental conflict.
Survey of 166 NPD firms.
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Most of the methods have been developed to deal with specific problems of NPD and thus are meant to be used in specific Stages of the NPD process. Out of ten methods reviewed, all one (Limited Roll-Out) are used in stages for which they are not intended.
Literature review and survey of forty-five manufacturers.
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Technology Road Mapping has been widely adopted in industry, taking forms that range from the two extremes of technology-push (divergent and looking for opportunities), and market-pull (aiming for customer defined product).
Authors experience and as applied within a case study.
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The NDP team should stop pursuing additional information when the current information repository exceeds a predetermined critical value. Continuing to collect information puts the project into a design churn loop that increases costs and delays progress.
Mathematical model creation and analysis.
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Some findings suggest that the retention of knowledge leads to better NPD performance. However, retained knowledge has also been considered a barrier to NPD activities, especially when organizations rely too heavily on organizational memory, to the exclusion of external sources of knowledge.
Source: Moorman & Miner (1997). In: Marsh, S.J., & Stock, G.N. (2003)

Unstable product specs and project scope creep can increase the time to market and possible product failure.
Source: Cooper, R. G., 2001. In: Cooper, R. G. & Edgett, S. J. (2008)

A Technology Road Map presents the desired objective and how to achieve it.
Source: Probert & Radnor (2003). In: Mulebeke, J.A.W., & Li, Z. (2006)

Boundary Spanning — external integration can impact innovation speed and frequency by facilitating coordination with boundary groups.
Source: Parthasarthy & Hammond (2002) p.79. In: Koufteros, X., Vonderembse, M. & Jayaram, J. (2005)

A formal new product development process necessary for product success with five key stages (initial screening, business analysis, development, pre-testing, and launch) or 13 equivalent key activities. 
Source: NASA (no specific citation); Cooper, 2001; Cooper & Kleinschmidt, 1986; Song et al, 1998. In: Samra, Y.M., Lynn, G.S. & Reilly, R.R. (2008)

A literature review found two differences between studies of the early R&D Stages (3,4,5) and the later NPD Stages (6,7,8): First the R&D project studies cited a larger number of factors listed as critical to success, than did the NPD projects. Second, studies with a marketing orientation put more emphasis on internal organizational factors (e.g., launch & marketing) as critical, while studies with a technical orientation put more emphasis on external environmental and market factors as critical.
Source: Calantone & di Benedetto (1988). In: Balachandra, R., Friar, J.H. (1997)

An NPD Model shows that technical and marketing activities complement each other at each stage of the NPD process, which takes place within an environment defined by the firm, the marketplace, and the nature of the project itself.
Source: Cooper (1980). In: Calantone, R.J., diBenedetto, C.A. (1988)

Consider increasing speed to market as a way to increase product success
Source: Cooper, 1994; Cooper & Kleinschmidt, 1994; Ridderstrale & Nordstrom, 2000.. In: Samra, Y.M., Lynn, G.S. & Reilly, R.R. (2008)

Consider increasing new product development proficiency level as a way to increase new product success
Source: Cooper & Kleinschmidt, 1987a. In: Samra, Y.M., Lynn, G.S. & Reilly, R.R. (2008)

Improvise as you go along with no formal and structured new product development process (improvisation school of thought) 
Source: Moorman & Miner (1998). In: Samra, Y.M., Lynn, G.S. & Reilly, R.R. (2008)

Use a structured new product development process to ensure new product success (structured school of thought) 
Source: Cooper & Kleinschmidt (1986, 1987a & b, 1991); Mllson & Wilemon, 2002; Shepherd & Ahmed, 2000). In: Samra, Y.M., Lynn, G.S. & Reilly, R.R. (2008)

Using a flexible and structured new product development process (with fuzzy gates) skipping or combining stages (flexible school of thought) 
Source: Cooper & Kleinschmidt (1995) . In: Samra, Y.M., Lynn, G.S. & Reilly, R.R. (2008)

As might be expected, product performance is significantly enhanced if those responsible for manufacturing are included in the product design process.
Source: Bergen & McLaughlin (1992). In: Ettlie, J.E. (1995)

Close integration between product planning and manufacturing process decisions helps control the product offerings, stabilize process requirements, improve process technology choices, and increase net cash flows over time.
Source: Kim et al (1992). In: Ettlie, J.E. (1995)

Creating user ownership of the R&D process and its outputs, requires early and continued involvement in the entire R&D process.
Source: Johnson et al (2003). In: Klerkx, Laurens & Leeuwis, Cees (2007)

Industrial design is a strategic tool enabling marketers to match customer requirements to a product's performance, quality, durability, appearance and price.
Source: Kotler & Rath (1984). In: Gemser, G., & Leenders, M.A.A.M. (2001)

Industrial design relates to aesthetics but also ergonomics, ease of manufacture, efficient use of materials and product performance.
Source: Group Bernard Juilhet (1995). In: Gemser, G., & Leenders, M.A.A.M. (2001)

Literature on knowledge management points out that knowledge transfer efficiency is mainly related to the uncertainty level in the process, whereas knowledge transfer effectiveness is mainly related to the ambiguity level in the process. Since uncertainty is related to the information transfer process, it can be reduced by increasing the amount of information exchanged. However, since ambiguity relates to the interpretation of the transferred knowledge it must be addressed through effective communication based on shared understanding.
Source: Daft & Lengel (1986). In: Carbonara, N., & Scozzi, B. (2006)

More than simply the creation of pleasing product shapes and styles, the industrial design role in product development can be viewed as a communicator of a firm's quality image and product integrity.
Source: Yamamoto & Lambert (1994). In: Gemser, G., & Leenders, M.A.A.M. (2001)

A universal success curve shows that the odds of commercial success for substantially new products averages 1 in 300 at the idea submission stage (or at patent disclosure stage), and 1 in 125 at the small project stage (or after a patent is granted). After the detailed analysis of Stage 4, the odds of success are 1 in 9 (11%). Even when the project reaches the stage of major development, the odds of success are typically no greater than 1 in 4 (25%). At the commercial launch stage the odds of success are still only 1 in 1.7 (60%). This success rate curve has remained essentially unchanged in the last 40 years.
Source: Stevens & Burley (1997). In: Stevens, G., Burley, J., & Divine, R. (1999)

Improvisation at the collective or organizational level (vs. individual level) can be achieved by coalescing individuals’ activities by groups, departments, etc.
Source: Chelariu et al, 2002; Moorman & Miner, 1998.. In: Samra, Y.M., Lynn, G.S. & Reilly, R.R. (2008)

There are many tools and techniques which can be applied in new product development process. These include Quality function deployment (QFD), Computer-aided Tools, Customer involvement, Design Coding, Design of Manufacture, Multi-functional Teams, Involving Key Suppliers, Project Management, Four field mapping (Maylor and Gosling, 1998; Maylor, 1997).
Source: Maylor & Gosling (1998), Maylor (1997). In: Liepe, Z. & Sakalas, A. (2008)

Use failure mode and effects analysis to improve the probability of new product success.
Source: Griffin (1992); Hockman& Jenkins (1994); Wasserman (1993). In: Ittner, C. D. & Larcker, D. F. (1997)