Decision Gate 9

Primary findings

Secondary findings

Primary findings

Methods

Effective control is required for new product success. To achieve this, new product development projects should be regularly monitored and should enjoy grace periods.
Survey with significant findings.
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Four Best Practices in the NPD process are: 4) Tough and demanding Go/No-Go decision points, where projects really do get killed. Some businesses claim to have gates but a closer inspection reveals that these are largely project review points with the result that projects rarely get terminated.
A quantitative survey of 105 business units, supported by team's experience in NPD modeling, consultation, application and analysis.
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Four Best Practices in the NPD process are: 2) Performance Measurement. The use of metrics to gauge how products perform — success, profitability, Net Present Value, is a major weakness with less than 30% of firms having such metrics.
A quantitative survey of 105 business units, supported by team's experience in NPD modeling, consultation, application and analysis.
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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 4 — Commercialization. Delivering the product to customers in a controlled manner and gathering feedback on the product's performance. Includes full-scale product launch, release of evaluation tools and mass communication with customers. Manufacturing operations are ramped up to full-scale production. In addition, a post-launch evaluation is conducted to assess the actual results in comparison to projected performance and sales. The NPD team hands the product ownership and control over to the supporting organization for the duration of the product's life cycle.
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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Measures

Market opportunity criteria are typically employed for go/no-go decisions early in the process and again after launch. Criteria may include customer satisfaction, market acceptance, product quality and sales volume.
Survey of 77 manufacturing companies
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New product success — Dimensions include degree to which a new product’s profits exceeded or fell short of expectations; degree to which sales exceeded or fell short of expectations; degree to which a new product provided an entry point into an existing market for a new line of products; degree to which a new product created a market that was new to the industry.
Survey. Reported in Tables 1, 3 and 4 in the text; (see supporting literature in the next section).
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Results from Process Quality Assessment Instrument and the Output Quality Assessment Instrument can provide essential informaiton to support risk-based go/no-go decisions during NPD product lifecycles.
Single subject case study
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Tips

Consider customer satisfaction and sales in units, margin and market share when making decisions at gate 9, Terminate Production.
Survey of 166 managers from Dutch and UK companies. Between 79% to 51% of the companies reported using these criteria at this gate.
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Designing appropriate screening and evaluation “gates” to help prioritise projects and select winners for advancement. Preliminary up-front homework may include such activities as broad screening based on key market and technical capabilities and a broad financial assessment. At a second stage this may include refining product concepts and specifications ensuring stronger customer input and assessment, improved technical evaluation, and financial analysis.
Survey. Manager implications drawn from results of study.
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Secondary findings

Carriers

Organizations can deal with the tensions inherent in decision-making by focusing on meaning — the GOAL. The purpose or meaning of what the organization intends to accomplish can crate a vision that sets into motion the process through which multiple organizational interests become aligned.
Source: McGee, JV & Prusak, L (1993). In: Ho, K., Bloch, R.; Gondocz, T., Laprise, R., Perrier, L., Ryan, D., & et al. (2004)

Measures

Measures of Organizational Integration, NPD Proficiency and new product success
Source: Price, 1972; Pinto & Pinto, 1991; Ruekert and Walker, 1987a, 1987b; Miller and Friesen, 1982; Souder, 1981. In: Millson, M.R. & Wilemon, D. (2006)

Tips

Customer acceptance criteria are important at all gates, particularly after launch.
Source: Hart, et al., 2003. In: Carbonell-Foulquie, P., Munuera-Aleman, J. L., & Rodriguez-Escudero, A. I. (2004)

Market potential criteria used after launch to evaluate success or failure.
Source: Henard & Szymanski, 2001. In: Carbonell-Foulquie, P., Munuera-Aleman, J. L., & Rodriguez-Escudero, A. I. (2004)

Use market criteria during the concept screening gate 2, product related criteria during product testing gates 5 & 6, financial criteria during gates 8 & 9 (post production assessment and terminate production).
Source: Ronkainen (1992). In: Hart, S., Jan Hultink, E., Tzokas, N., & Commandeur, H. R. (2003)

Utilize financial criteria in go/no-go decisions, including payback period and discounted cash flow.
Source: Cooper, 2001, Hart et al., 2003, & Ronkainen, 1985. In: Carbonell-Foulquie, P., Munuera-Aleman, J. L., & Rodriguez-Escudero, A. I. (2004)