ParadigmHTM Podcast ParadigmHTM Podcast

The FDA's oversight is crucial as it covers various aspects of the medical device industry, including the path to market, post-market surveillance, device recalls, and key definitions. Medical devices are categorized into Class I, II, and III, with each class subject to different levels of regulation. HTM professionals in healthcare organizations play an essential role in ensuring compliance with FDA guidelines to manage medical devices safely and efficiently, benefiting patient care outcomes.

Understanding the total cost of ownership is necessary in evaluating technology but the expenses are just one piece of the return on investment equation. You need to look at the revenue and expenses, and be clear on you financial assumptions.

If you are assessing healthcare technology for purchase or investment you not only have to consider the technical aspects but also the financial aspects of the technology. Total cost of ownership is not just a purchase price. You can't buy a car and never put gas in it. (I know... unless you have an electric vehicle, but don't mess with my metaphor)

Learn how to to review clinical research with a critical eye and also find out more about my habit of drinking too much soda.

Continuation of the determination and validating of "real science", we now take a deeper dive into clinical research methodologies.

Last episode we covered gold standard comparisons of measurements devices. Now lets talk about gold standard comparisons of screening devices. We will touch on the ever-confusion terms of sensitivity and specificity through an illustration about... what else... fishing!