Step 7.8

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

Navigate Findings

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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