Investigating product innovation pathway from a modular standpoint: A case study of large aircraft assembly line.

Product innovation is a robust approach for enterprises to acquire and maintain a competitive edge. In order to support the development of enterprise product innovation, it is essential to establish an innovation pathway. Grounded in a modular perspective and considering the product innovation process, this study segments the process into product demand analysis, product module partitioning, product innovation opportunity recognition, and product innovation design. Consequently, an integrated product innovation pathway is constructed by incorporating relevant innovation theories and methodologies, encompassing the innovation process, theory, and methods. The feasibility and efficacy of this research are validated through a case study of a large aircraft assembly line, indicating that this approach effectively bolsters product innovation development and holds practical significance.

Innovation technology opportunity identification of civil aircraft mechanical connections based on generative topographic mapping.

In order to advance civil aircraft manufacturing to higher levels, there is an urgent need to identify technological innovation opportunities to help new technology development. This paper first analyses the current state of the research field and determines the topic. It preprocesses papers and patents within the research topic to obtain a base database. Then, the database is analyzed using the LDA (Latent Dirichlet Analysis) cluster analysis method. The TF-IDF (Term Frequency-Inverse Document Frequency) algorithm processes the data to obtain critical technical words. The abstracts of patents and papers are processed to construct a binary-based vector of technical keywords. The papers and patents are visualized in a two-dimensional space technology map by generative topographic mapping (GTM) to create a technology map to identify technology blank dots. The combination of technologies characterized by each technology blank dot is obtained by GTM inverse mapping. Finally, technology opportunities with a high probability of development are identified to achieve innovation opportunity identification. It also provides countermeasures for the research institution, enterprise, sector, and industry. After research and analysis, the future in the mechanical connection technology of civil aircraft is necessary to strengthen basic technology development and improve the study of intelligence, integration, and flexibility. Technology such as sensors and lasers can improve the precision and efficiency of mechanical connections.

Completeness assessment of type II active pharmaceutical ingredient drug master files under generic drug user fee amendment: review metrics and common incomplete items.

Under the Generic Drug User Fee Amendments (GDUFA) of 2012, Type II active pharmaceutical ingredient (API) drug master files (DMFs) must pay a user fee and pass a Completeness Assessment (CA) before they can be referenced in an Abbreviated New Drug Application (ANDA), ANDA amendment, or ANDA prior approval supplement (PAS). During the first year of GDUFA implementation, from October 1, 2012 to September 30, 2013, approximately 1,500 Type II API DMFs received at least one cycle of CA review and more than 1,100 Type II DMFs were deemed complete and published on FDA's "Available for Reference List". The data from CA reviews were analyzed for factors that influenced the CA review process and metrics, as well as the areas of DMF submissions which most frequently led to an incomplete CA status. The metrics analysis revealed that electronic DMFs appear to improve the completeness of submission and shorten both the review and response times. Utilizing the CA checklist to compile and proactively update the DMFs improves the chance for the DMFs to pass the CA in the first cycle. However, given that the majority of DMFs require at least two cycles of CA before being deemed complete, it is recommended that DMF fees are paid 6 months in advance of the ANDA submissions in order to avoid negatively impacting the filling status of the ANDAs.