Not only must new IoMT patents make it through the typical granting process, the market’s size suggests that post-grant challenges may become increasingly common.
The latest version of ISO 13485 already contains several requirements that do not exist in 21 CFR 820. In advance of the new proposed rule’s release, this article presents a summary of the potential changes’ impacts on medical device manufacturers once the proposed rule becomes final.
Despite the best efforts of those responsible for data integrity, the potential for human error is directly and indirectly impacted by the corporate, the national/regional , and quality culture of an organization.
Reimbursement rates have not risen as rapidly as device and medical supply costs, putting cost pressures on hospitals. This, in turn, increases pricing pressure on device manufacturers, as consolidated health systems have more negotiating power.
This article -- the second in a two-part series -- examines how to navigate the complex problem of optimizing data quality while controlling for study costs and time constraints when employing independent HFE testing agencies.
It is critical that companies in the medical device space have comprehensive, well-written, and descriptive procedures not only for documentation, but for assessing the impact of any and all changes, no matter how minor.
This article is about an organization that can best be described as a “rudderless ship,” where Lean thinking was embraced, but implementation was scuttled by shifting priorities and reorganization, among other things.
While regulations are in place to help minimize EMI, some amounts are unavoidable, and larger amounts can be generated in rare circumstances, or in the event of device malfunction. Thus, preventative measures, including EMI shielding and filtering, must be employed to protect both implantable medical devices and their host patients.
The guidance looks at what constitutes a manufacturing site change, when a manufacturer should submit a PMA supplement, what documentation should be submitted to the FDA with a site change supplement, and more.
In addition to my career as a pharma industry consultant, I’m a writer. While I don’t claim to be the next Ernest Hemingway, I do consider myself a decent writer. I’ve put in the 10,000 hours of writing Malcolm Gladwell told us it takes to be an expert in his 2008 book, Outliers: The Story of Success. I’ve always had a passion for writing. At 24, I made a serious commitment to become a real “writer.”
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