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Medical Device News Magazine publishes feature articles from industry experts on medical device technology, regulation, reimbursement, and business strategy.
Christopher Cauble’s view is that the U.S. healthcare market is big enough that good profits can be made without having to bother with the hassle of foreign patent protection, particularly patent protection in China. Read on to learn more.
As an AI researcher and practitioner deeply embedded in the healthcare and life sciences sectors, Dr. Masood sees the passage of California’s SB 1047 as a complex issue with significant implications. He writes this controversial bill, now heading to Governor Newsom’s desk, represents a fundamental misunderstanding of AI as a general-purpose technology. It attempts to regulate the technology itself rather than focusing on specific, problematic applications.
Envoy Medical has taken a different approach with its fully implanted hearing devices, and it looks to turn the industry on its… ear. “Listen” to what Brent Lucas, CEO of the company has to say.
When it comes to reproductive care, more options, more accessibility, more affordability and a better focus on women’s choices should be everyone’s goal for the medical community by 2030.
Along with the rising sophistication of inpatient medical devices, data acuity in remote patient monitoring devices is also on the rise. Virtual telemetry, for example, enables the continuous collection of health data like heart rate and blood pressure from nearly anywhere a patient may be located.
Both HFE and UE are based on the international usability standards IEC 62366-1 and IEC 62366-2 with consideration of risk management (ISO 14971). By planning and integrating usability testing for human interaction with medical device technology throughout the device lifecycle and risk management processes, HFE/UE ensures that medical devices meet the complex needs of healthcare professionals and patients, and that user-related and use-related risks are eliminated or mitigated.
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