Creation of an online database monitoring tool for a medical device company: An insider action research

In order to stay profitable, a company must have effective strategies to remain competitive in the marketplace. Much more so, an organization must constantly improve its current processes and meet its clients’ needs. This action research was meant to increase customer responsiveness and to improve operational efficiency by improving the response time of a Medical Device Company’s Regulatory Affairs Department by introducing a monitoring tool that would gather the status of all FDA applications. It is recognized that manual interventions provide inadequacy through the tasks of the members of the department. With the assistance of action research tools, my collaborators and I have determined that the inability to provide an immediate update on a medical device product was caused by the conventional way of filing FDA documents and applications and no proper turnover of accountabilities within the RA team. To assist the medical device company in implementing the steps of Business Process Reengineering and Lewin’s Change Management Model, this action research paper analyzes the principles and benefits of these philosophies and summarizes their application to the company mentioned herein