I was recently inspired by Dr. Konkani’s AAMIBlog post, “Applying User Experience and Design Thinking to Medical Device Design.” The importance of implementing, iterating, and continuously improving medical devices is vital to the health and […]
We are on the cusp of major change in the health technology field, and those who do not innovate are on a path of becoming irrelevant. Our members understand the need to demonstrate resiliency in […]
User Experience (UX) and design thinking can be applied in every stage of the product design, development, marketing, and postmarket surveillance. UX is critical to make sure the product is designed to meet the end-user’s […]
You are having surgery. It’s relatively minor, hoping to relieve the leg pain you have while walking. After the procedure is done, the surgeon tells you everything went well expects you will soon experience relief […]
A recent post on AAMIBlog asked the question, “Will Unique Device Identifiers Live Up to the Hype?” As a self-proclaimed UDI enthusiast, I would argue that, while the UDI program isn’t perfect, it is a […]
The ongoing roll out of unique device identifiers (UDIs) promises several expected benefits derived from medical devices possessing UDI codes. The Food and Drug Administration (FDA) recently published Medical Device Safety Action Plan that describes […]
This year, I had the opportunity to attend a conference and take part in panel discussions with the main topic of “the customer comes first.” A number of the questions posed to the panel centered […]
The FDA’s database for medical device recalls has a search function that includes a pull-down menu for the root cause of the recall. These root causes correspond to the single “FDA Determined Cause” on each […]
As healthcare technology management (HTM) professionals, we understand how challenging it is to manage medical device recalls, perform field safety correction, and advise affected customers. All three of these notifications (i.e., recalls, field safety correction, […]
This year, we’ve seen an even hotter-than-usual debate about the servicing of medical devices and healthcare technology, thanks in part to calls for new standards, a congressional mandate for an FDA report on the subject, […]
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