Here’s how medical device makers can capitalize on the strategic priorities and transparency initiatives at FDA’s CDRH. Lisa Olson, RCRI Scott Gottlieb has now settled into his role as FDA’s new commissioner and is putting his stamp on the agency. Interestingly, he has started with some very specific points of focus that have bubbled to […]
Minneapolis, MN – Aug 31, 2011 – Regulatory & Clinical Research Institute or “RCRI”, a leading medical device consulting firm announced today it has selected Lisa Griffin Vincent, Ph.D., M.A., as its new Chief Operating Officer and Sr. Principal Advisor. Based on her previous executive and scientific leadership successes, Dr. Vincent will guide RCRI operations during a time when significant economic, regulatory, and industry dynamics hinder advancement of medical device firms and associated service organizations.
In today’s dynamic environment, there is a need like never before for clinical data. In addition to IDE’s, companies are finding themselves doing clinical studies for 510(k) products as well as market approved products. Once the protocol is written and the sites are being selected, the next big task is developing a site budget that is comprehensive and defensible. This can be an overwhelming task, especially if you are a not an accountant and are uncomfortable with developing budgets. This paper will provide an overview of clinical study site budgets, describe the importance of creating a defensible study budget, provide a process for building a site budget and discuss tips for negotiating the budget.
Human Factors Engineering (HFE), also known as usability engineering or ergonomics, is the study of how humans interact with machines and complex systems. As medical devices are becoming more complex human factors considerations are becoming more complex, this paper looks at some of the critical factors in helping medical device companies reduce human error in designing medical equipment.