Decision Gate 3

Primary findings

Secondary findings

Primary findings

Barriers

In a complex environment, determining precisely why a particular knowledge translation process failed may be challenging. Applying a systems approach may help to elucidate contributing factors.
Application of Graham’s Knowledge-to-Action Process model in occupational therapy.
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Carriers

Cross-functional team membership — Internal team members communicated more frequently with external personnel when they shared similar functional backgrounds. The more functions represented on the team, the greater the external communication by the team as a whole, and better management-rated performance.
Literature Review — 1969  — 1994.
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One company established an NPD process with carefully staged decision-making, rigorous process reviews, and strict timelines. Yet, skillful project champions would maneuver to win continued support at each level of project review. The company then reassigned project managers so that the more empirically included truth seekers were in charge of early stage reviews, and more commercially included success seekers managed the later stages. That simple change improved NPD productivity.
Private sector experience in pharmaceutical industry.
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Models

Knowledge Translation — A wide range of models contribute insights for increasing awareness, interest and use of knowledge generated through research activity, among targeted stakeholder groups. Categories of such models include: 1) Organizational Innovation; 2) Social Science Research Utilization; 3) Nursing Research Utilization; 4) Health Promotion.
Literature review, synthesis and author expertise.
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Methods

Anticipating and meeting customer demands requires more teamwork and participation of project personnel in decision-making. This requires an overall understanding of NPD business by team members and their leaders.
Survey of 87 manufacturers.
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By setting up clear-cut screens or hurdles, new product cross-functional teams as well as management will know the ground rules during any step of the process.
Author experience
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Companies that could benefit from an early-stage empirical analysis should create a new, separate organization focused on truth seeking  — or outsource this function to qualified academic researchers. A small team manages the operation, recruiting both internal and external staff and consultants with expertise and objectivity. The teams design critical experiments to rule in or rule out a product's key attributes. Teams should be small and fluid comprised of persons motivated by intellectual curiosity. No one follows any of the projects into the later NPD stages to maintain their objectivity.
Private sector experience in pharmaceutical industry.
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Corporate management commitment influences the outcomes of NPD processes directly by resource allocation and sponsorship, or indirectly by structuring the organizational context in which the project occurs. High level commitment should be sought at each Decision gate.
Three case studies supported by 18 interviews.
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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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Experiential. During the first three or four stages of the NPD process, management is relying primarily on one person to make a recommendation about whether to proceed.
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Four Best Practices in the NPD process are: 3) Metrics on how well the NPD process is working — These metrics focus on if projects are following the process and if effective gates are being held.
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: 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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Gate Reviews are scheduled for certain dates at which the NPD team either presents or explains why they need more time. For those projects experiencing delays, the Gate Review managers listen to the reasons for being late and help the NPD team to brainstorm solutions. Most Gate Review managers have some technical experience so they are generally helpful to the NPD team. In many cases, the Gate Review managers are one level up from the NPD technical community, so the decisions are made at a relatively low level for smaller projects. Larger projects are reviewed several levels higher and the gate review deadlines are firm.
Industry experience.
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Knowledge Creation Cycle is depicted as having three generations descending through a funnel, to represent how knowledge is sifted and filtered so that only the most useful knowledge is left for application. First generation knowledge is that created through research activity or through experiential activity. Second generation knowledge results from a process for the identification, appraisal and synthesis of studies or information related to a specific question. Third generation knowledge is embodied in summaries, practice guidelines and decision aids, where the knowledge is available in formats that meet the needs of targeted stakeholder groups.
Summary of the Knowledge to Action Model and its application to knowledge translation.
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NPD begins when there is a commercial target and concept in mind that is strictly development and not research. Activity that precedes NPD is called Knowledge Build where project managers need flexibility to conduct research. For technologies and products completely new to the company, the Knowledge Build team may present the project's potential in a qualitative fashion. The technical leadership will make a Gate decision about sponsoring that research project. If no, the budgeted resources go back to other Knowledge Build activities. If yes, then the team develops the technology through the next stage. If the technology is far enough along, the team transfer the project to the business side and begins the normal Stage/Gate NPD activities.
Industry experience.
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One approach for resolving conflicts between competing project plans is to authorize the simultaneous pursuit of design and development activities until a clear choice emerges.
Conclusions drawn from case studies and experience.
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Senior and Project Team management turnover issues are common in industry, and the effects on NPD are difficult to control. Good NPD protocols to manage Decision Gates mitigate these issues by verifying management match to project, supported by a plan of succession.
Conclusions drawn from case studies and experience.
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Senior management and the product development team review the work periodically at "review" points, when key managerial decisions are made. Such decisions include whether to finalize the specifications now or in a future review, and even whether to redirect or cancel the project because of the product's low profit potential.
Case Study. Researcher identified themes of the product development processes of three different firms.
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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 0 — Concept Research. This stage identifies new market opportunities, determines customer needs and conducts high-level evaluations of the opportunity and its strategic fit. This activity concludes with the management approval of an integrated business plan for the project, which is then updated at the conclusion of each subsequent stage.
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

Results from Process Quality Assessment Instrument and the Output Quality Assessment Instrument can provide essential information to support risk-based go/no-go decisions during NPD product life cycles.
Single subject case study
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Technical feasibility criteria are typically employed for go/ no-go decisions during the development stages of activity. Criteria may include project total cost, product quality, availability of resources, and customer satisfaction.
Survey of 77 manufacturing companies
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Tips

Designing appropriate screening and evaluation “gates” to help prioritize 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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Equivocality — the presence of multiple and conflicting interpretations about a phenomenon, with higher levels of equivocality representing confusion and a poor understanding of the referenced context. In situations of high equivocality seek to integrate information about both supplier products and about customer requirements. In situations of low equivocality, seek to integrate information about supplier processes.
Survey.
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Results show that placing importance on customer acceptance criteria correlates positively with project success at every stage of the process.
Survey. Customer acceptance dimension is positively associated with new product success at each and every of the review points (γGate1 = 0.26, p < 0.05; γGate2 = 0.30, p < 0.05; γGate3 = 0.24,p < 0.05; γGate4 = 0.26,p < 0.05).
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Technical criteria are significantly correlated with product success at the go-to-development decision gate.
Survey. Technical dimension is positively correlated with new product success at the go-to-development decision (αGate2 = 0.40,p < 0.01)
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The company is moving away from the current practice of only relying on its direct customers for input and feedback. Almost 100% of decisions to kill a project (where NPD is stopped after the first decision gates) are the result of not understanding the end consumers — that is, the customers of our company's customers. The reality is that the end consumers have a significant role in determining a new product's value.
Industry experience.
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Secondary findings

Carriers

Knowledge Producers can facilitate the uptake of their research by addressing five questions: 1) What should be disseminated? 2) To whom should it be disseminated? 3) By whom should it be disseminated? 4) How should it be disseminated? 5) With what effect should it be disseminated?
Source: Lavis, J et at (2003). In: Graham, I.D., Logan, J., Harrison, M.B., Straus, S.E., Tetroe J., Caswell, W. et. al. (2006)

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)

Methods

Decision-making process regarding the funding of R&D proposals involves different people performing four different roles within the decision process: 1) Approvers; 2) Takers; 3) Shapers; 5) Influencers.
Source: Woodhead (2000). In: Klerkx, Laurens & Leeuwis, Cees (2007)

Diffusion of Innovations — Four main elements influence the spread of a new idea: 1) The idea; 2) Communication channels; 3) Time; 4) A Social System. When presented with new information/ideas, individuals progress through five stages when considering use: 1) Awareness; 2) Persuasion; 3) Decision; 4) Implementation; 5) Adoption. Once adopted by some members of a social system, the idea is shared over time with other members via communication channels.
Source: Rogers, E (12003). In: Estabrooks, C.; Thompson, D.S., Lovely, J.J.E., & Hofmeyer, A. (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)