The FDA is asking stakeholders to submit public comments on how it should use any portion of the user fee funding that may be distributed to external organizations—other than NEST—to support premarket RWE in medical device evaluation and development.
The MDDT program was developed in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Drug Abuse (NIDA), National Institute of Dental Craniofacial Research (NIDCR) and National Cancer Institute (NCI) as a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices.
Although designed for software, Agile’s fundamental values are equally relevant to medical devices.
While a systems engineering approach will not, in and of itself, resolve all challenges currently faced by the medical device industry, it is the cornerstone and framework for allowing organizations to begin addressing these challenges by adopting a more holistic, efficient and systematic approach to product realization.
This installment covers what’s missing and what pain does it cause. Without systems engineers, what is the impact to project teams and organizations?
This week we explore the collected knowledge of work by three research institutes (National Academy of Sciences, Seoul National University and UC Santa Barbara) to image possibles within our medical device design and development applications.
Aging has important implications on design, the most significant of which puts emphasis on graphic and product user interfaces.
Ideation sessions can provide an effective platform for creating novel and innovative ideas. With so much material and so many ideation methods available, however, one of the biggest challenges is selecting the most appropriate ideation method. How do you go about selecting a method to ensure you are addressing a problem in the most effective way?
Viewing product development from purely a calendar perspective will limit the real view of success.
While an apple a day may not always keep the doctor away, a wireless patient monitor just might.