Decision Gate 7

Primary findings

Secondary findings

Primary findings

Barriers

Previously committed funds and egos can prevent an organization from making the best launch/ no-go decisions. Managers should ensure that these factors are not clouding their judgment when moving forward with a project.
Survey of 314 new project projects.
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Carriers

Conducting KT with communities not traditionally involved in research application or decision making, requires clear definition of roles. Formal agreements can detail expectations and resources, but they need to be grounded in trusting and open-relationships. Establishing a reciprocal understanding of contexts, needs and expectations may require significant effort.
Casebook of KT examples drawn from Canadian population and public health projects.
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For any community-based KT to be successful, the community must demonstrate the capacity to adopt new knowledge and adapt to any changes the implementation of the new knowledge requires. Capacity-building to enhance efforts to uptake and use research are most effective when supported at the level of the organization.
Casebook of KT examples drawn from Canadian population and public health projects.
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KT is most successful when there are tangible benefits to all partners. KT works best when all partners in the initiative have the possibility of making concrete gains toward their own priorities, shared or otherwise.
Casebook of KT examples drawn from Canadian population and public health projects.
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KT must be tailored to the target community. Good KT is appropriate to its context, and local processes of knowledge uptake and utilization must be understood in order to create effective KT strategies. This is in addition to KT being timely, clearly presented and grounded in the local context.
Casebook of KT examples drawn from Canadian population and public health projects.
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KT requires constant effort. Relationships need to be carefully maintained, which is difficult given the constraints on investigators of funding levels and cycles. However, such vigilance avoids misunderstandings, reaffirms commitment to change and overcomes any attempts to undermine the effort. The most successful KT initiatives actively evolve in parallel with the needs of the user communities.
Casebook of KT examples drawn from Canadian population and public health projects.
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One company established an NPD process with carefully staged decision-making, rigorous process reviews, and strict time lines. 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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The organizational climate is crucial to the adoption and use of new knowledge, yet individuals can make a huge difference as well. A researcher's genuine passion for practice change can play a vital role in KT success. It is important to identify and capitalize on such strengths. It is also important to select participants for discussion and consensus-building groups with care, as they can be a key determinant of an initiatives success or failure.
Casebook of KT examples drawn from Canadian population and public health projects.
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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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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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Decision to kill a project — Management must be willing to abandon a technology or prototype, for any legitimate reason, including excessive manufacturing costs in terms of yield and operability.
Conclusions drawn from case studies and experience.
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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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Exxon/Mobil lists a key lesson as: Ensure that top management values and provides appropriate resources for on-going work, as well as process support for units doing NPD.
Industry experience.
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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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Implementation Issues: These include potential barriers or carriers and can b organized in nine categories: 1) Organizational; 2) Financial; 3) Legal; 4) Ethical; 5) Professional; 6) Users; 7) Logistics; 8) Cognitive; 9) Content.
Literature review grounded in practical experience of health care professionals.
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Knowledge Translation — the primary purpose of KT is to address the gap between the base of knowledge from research along with related knowledge syntheses, and the implementation of this knowledge by key stakeholders. To address the gap between what is known and what is used.
Summary of the Knowledge To Action Model and its application to knowledge translation.
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Screens should focus in with more precision and should address financial hurdles after a concept has been fully tested and a business brief has been developed. If quantitative screens are used too early in the process, few innovations will survive.
Author 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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The decision process for product launch should focus closely on the activities completed which are specific to the new product: including all categories of marketing, technical and launch activities — none can be safely ignored. Evidence of shortcuts taken in any area greatly increase risk to the NPD project overall.
Survey of 189 industrial product manufacturers with multi-factor analysis using three-stage least square analysis.
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The study mapped out what the research findings would mean to different groups of actors (stakeholders) involved. In the process they identified six Stakeholder Groups: 1) Clinicians; 2) Consumers; 3) Researchers; 4) Policy Makers; 5) Information Brokers; 6) Manufacturers.
Comparative analysis of policy-related research results and the expectations of policy-makers regarding information useful for application in their decisions.
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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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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

Customer acceptance criteria is primarily sought for go/no-go decisions later in the process, and may include product quality, sales volume, availability of resources, and customer satisfaction.
Survey of 77 manufacturing companies
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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 lifecycles.
Single subject case study
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Tips

Emphasizing financial criteria have a positive impact on new product success from the go-to-development gate to the first post-launch review; yet it is shown that the relative effect of financial criteria on new product success is significantly bigger in the latter evaluations.
Survey. Importance given to financial dimension is positively associated with new product success at the go-to-development decision (δGate2 = 0.18, p < 0.10), go-to-market decision (δGate3 = 0.30, p < 0.05) and post-launch review (δGate4 = 0.42, p < 0.01).
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Evaluation criteria used in earlier stages may reappear later in the process. This may be necessary as a result of: changes to product and marketing plans occurring during development; changing customer expectations; changing competitive landscape; and later screens can be more informed than earlier versions- lending to better results before making huge commercialization investments.
Survey of 314 new product projects.
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Fuzzy Gate approach - Permit the project team to decide when to stop Stage level work and proceed to the next Decision Gate, particularly when NPD cycle time is considered critical to market success.
Survey. Author conclusions drawn from analysis of Project Manager self-reports (n = 392).
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Market opportunity criteria relate positively with project success at the initial screening, the market launch gate, and the post-launch review.
Survey. The relative importance of market opportunity correlates positively with the new product success at the initial screening(εGate1 = 0.40, p < 0.01), go-to-market decision (εGate3 = 0.23, p < 0.05), and post launch review (εGate4 = 0.18,p < 0.10).
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Product launches into international markets often schedules sequence of launches into the various markets, because of supply limitations, regulatory differences, and the variation in drivers within each market segment.
Conclusions drawn from case studies and experience.
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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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The following factors should be scrutinized prior to initiating commercialization activities: superior consumer fit, clearly defined promotion plan; sizeable new technology requirement; clear product definition; likely trade adoption; compelling market size potential; lucrative potential market; direct response strategy; clearly identified brand strategy; and global product compatibility.
Survey of 314 new product projects.
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Use information regarding customer acceptance and product performance when making decisions at gate 6 and 7. Customer satisfaction and quality are also important criteria to consider at these gates.
Survey of 166 managers from Dutch and UK companies. Seventy-three to fifty-nine percent of companies used these criteria at this point in the NPD process.
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When reviewing prototypes for market introduction, management needs to objectively understand what will constitute success and when expectations are not being met. The tough decision to stop a project only happens when management in all functional areas, has a clear understanding of these issues.
Conclusions drawn from case studies and experience.
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Secondary findings

Carriers

An analysis of over 2,500 research studies showed that seven general factors could account for most scientific knowledge dissemination and utilization efforts: 1) Linkage; 2) Structure; 3) Openness; 4) Capacity; 5) Reward; 6) Proximity; 7) Synergy.
Source: Havelock, R (1969). In: Estabrooks, C.; Thompson, D.S., Lovely, J.J.E., & Hofmeyer, A. (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)

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)

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)