scholarly journals Understanding The Medical Product Development Process: Continuing Professional Development For Life Science Professionals

2020 ◽  
Author(s):  
Rogelio Rodriguez
Author(s):  
Stephen R. Karpen ◽  
J. Kael White ◽  
Ariana P. Mullin ◽  
Inish O’Doherty ◽  
Lynn D. Hudson ◽  
...  

Abstract Introduction Patient-level data sharing has the potential to significantly impact the lives of patients by optimizing and improving the medical product development process. In the product development setting, successful data sharing is defined as data sharing that is actionable and facilitates decision making during the development and review of medical products. This often occurs through the creation of new product development tools or methodologies, such as novel clinical trial design and enrichment strategies, predictive pre-clinical and clinical models, clinical trial simulation tools, biomarkers, and clinical outcomes assessments, and more. Methods To be successful, extensive partnerships must be established between all relevant stakeholders, including industry, academia, research institutes and societies, patient-advocacy groups, and governmental agencies, and a neutral third-party convening organization that can provide a pre-competitive space for data sharing to occur. Conclusions Data sharing focused on identified regulatory deliverables that improve the medical product development process encounters significant challenges that are not seen with data sharing aimed at advancing clinical decision making and requires the commitment of all stakeholders. Regulatory data sharing challenges and solutions, as well as multiple examples of previous successful data sharing initiatives are presented and discussed in the context of medical product development.


Author(s):  
Andrea CAPRA ◽  
Ana BERGER ◽  
Daniela SZABLUK ◽  
Manuela OLIVEIRA

An accurate understanding of users' needs is essential for the development of innovative products. This article presents an exploratory method of user centered research in the context of the design process of technological products, conceived from the demands of a large information technology company. The method is oriented - but not restricted - to the initial stages of the product development process, and uses low-resolution prototypes and simulations of interactions, allowing users to imagine themselves in a future context through fictitious environments and scenarios in the ambit of ideation. The method is effective in identifying the requirements of the experience related to the product’s usage and allows rapid iteration on existing assumptions and greater exploration of design concepts that emerge throughout the investigation.


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