Product Development Strategy

Although it is neither a regulatory nor a normative requirement that the proof-of-concept and feasibility study stage be incorporated in the product design and development process, however, a comprehensive consideration of the procedures at this stage will be helpful to minimize the risks in product development process and prevent the occurrence of unexpected impediments during the design verification and verification testing process. This is heavily dependent on the experience of the designers and implementors. Some of the steps include:

 

● Identification of client needs, analysis of market situation and evaluation of competition

● Preparation of concepts, plans, time tables and models

● Early-stage risk assessment

● Non-GLP functional or efficacy studies

● Early-stage regulatory efforts, clinical and medical compensation evaluation and strategy making