A thorough Customer Needs Assessment is the initial step in the development of a medical device. Proven Process assembles a team of managers and engineers that investigate the gaps between our customers' current product design and the desired use, performance and cost point of manufacture. A technology and regulatory assessment is conducted collating user needs, human factors, design demands, predicate outcomes and global regulatory requirements for the proposed diagnostic, surgical or therapeutic device. For this effort, Proven Process will collaborate with our customer to demonstrate that suitable technologies and processes exist which meet the various demands.
A Customer Needs Assessment is vital so that all follow-on phases of the development can be programmed to fulfill the ultimate goals of all stakeholders.
Potential innovations will be identified, schedules will be planned and costs proposed to manage a program that will bridge the defined gaps to produce marketable devices. Core to the Customer Needs Assessment is the accurate identification of key stakeholders within the process, as well as transparent, concise and timely communication of the project's progress.