Barriers to medical device innovation

Barriers to medical device innovation

The US Food and Drug Administration (FDA) has defined a medical device as a health care product that does not achieve it's purpose by chemical action or by being metabolized. This means that a vast number of products are considered medical devices. Such devices play an essential role in the practice of medicine. The FDA classifies medical devices in three classes, depending on the risk of the d...

Barriers to innovation in continuing medical education.

INTRODUCTION Criteria for maintenance of certification (MOC) emphasize the importance of competencies such as communication, professionalism, systems-based care, and practice performance in addition to medical knowledge. Success of this new competency paradigm is dependent on physicians' willingness to engage in activities that focus on less traditional competencies. We undertook this analysis ...

Barriers to Adopting Agile Practices When Developing Medical Device Software

Agile methodologies such as XP and Scrum are founded upon the four values and twelve principles of agile software development. A software development project is only considered to be truly agile if these values and principles are followed. However, software developed for use in medical devices must be regulatory compliant and this can make the process of following a single agile methodology suc...

Barriers to innovation in the field of medical devices MedicAl devices : MAnAging the Mismatch

Entrepreneurial Performance and Innovation in the Medical Device Industry

Entrepreneurs in high technology industries often have prior experience at incumbent firms, but we know little about how knowledge obtained at the prior employer impacts entrepreneurial performance. Drawing on previous work from management, economics, and organizational sociology, I assess the impact of prior industry experience on entrepreneurial performance and innovation in medical device st...