INDUSTRY EXPERT ARTICLES

Jim Kaveney writes: "In both entrepreneurship and managing AFib, I have learned that the heart and mind are not in opposition but work together in powerful harmony. Whether navigating the unpredictable rhythms of my heart or the rollercoaster ride of building a business, I discovered that resilience is born from this partnership. By harnessing the power of both, I transformed my pain into purpose, allowing me to overcome the challenges of AFib and entrepreneurship, and ultimately, to help others do the same."

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.

Our expert writes: Historically, medical device companies have provided value by producing equipment for diagnosing and treating patients worldwide. However, contemporary challenges such as heightened pricing pressures, regulatory compliance, supply chain volatility and operational inefficiencies have significantly changed the landscape for these companies.

The integration of AI in biopharma workflows is not just a technological advancement, but a paradigm shift that promises to completely revolutionize how we research, understand, and treat diseases. Read what this expert has to say.