A recent article in a business journal asked “how can you be a good leader if you don’t know what leadership really is?” In an effort to answer this question, the article offered no less than thirty definitions, obtained from “30 business owners and experts”. While this list of answers points out the difficulty of arriving at a conclusive definition of leadership, I submit that it can be boiled down to one word: responsibility.
No one wants delays in medical device approval by the FDA. Yet, in 2013, nearly 60% of 510k submissions were given a designation of Refuse-to-Accept (RTA), indicating that the FDA would not even consider the submission in its current form. An RTA designation significantly delays the approval process. How does medical device software affect the chances of a 510(k) or PMA submission not being reviewable?
When it comes to standards governing the design and manufacture of medical devices, the sheer number of applicable standards can be dizzying to the software developer. Numbers and letters seem to hover over everything: ISO 13485, ISO 14971, 21 CFR Part 820, 93/42/EED, etc. While it might be understandable that a software development company would want to ignore all of the standards as inapplicable to their work of designing software, a working knowledge of these standards is important for the successful integration of software into a medical device.
We have three values at Velentium: Honorable, Results ++, and Humble Charisma. They might come across as pithy little sayings, but they mean a lot to us, so I try to talk about them frequently to make sure that they are fully understood. So, what does it mean when we say we are Results ++?
Technical innovation has allowed many strides in healthcare, but it also presents its own set of problems. In a recent study of hospital-based nurses, over half indicated that they had witnessed a medical error that was caused by lack of coordination between patient care devices. In addition, almost half of those surveyed also stated that interaction with bedside devices was the most inefficient use of their time.