Posts related to product development
In today’s digital health environment, product teams must validate concepts faster, communicate ideas more clearly, and test functionality earlier in the lifecycle. Google AI Studio Pro has introduced a set of new features that make this possible at a level… Read More »Prototype in Hours With Google AI Studio Pro
Bringing a new medical device to market is challenging – especially for early-stage startups balancing innovation with regulatory compliance. One concept that often trips up founders is the “Legal Manufacturer” in medical device regulations. What is it, and should you… Read More »Outsourcing the Legal Manufacturer Role in MedTech: What Founders Need to Know
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a strategic roadmap to phase out the requirement for animal testing in the development of monoclonal antibodies and other therapeutic drugs. This represents a pivotal transformation in regulatory… Read More »FDA’s Landmark Shift Away from Animal Testing
Introduction Over the past decade, South Korea’s adult thyroid cancer screening program has been known for its aggressive approach, offering widespread ultrasound screening to asymptomatic adults. This strategy led to a sharp rise in thyroid cancer diagnoses, predominantly small papillary… Read More »South Korea’s Thyroid Cancer Screening: Too much good?
As we step into 2025, the FDA has introduced a draft guidance that is set to reshape the regulatory landscape for AI-enabled medical devices. For those unfamiliar, an FDA draft guidance outlines the agency’s current thinking on a topic and… Read More »Happy New Year 2025: A New Era for AI in MedTech
In today’s healthcare system, only the sickest patients in intensive care units (ICUs) receive continuous, close monitoring. These setups often involve bulky, uncomfortable wires attached to patients, gathering data on their vitals. However, the future of patient monitoring is rapidly… Read More »The Future of Patient Monitoring: Continuous, Predictive, and Preventative
Hello Readers! I hope this post finds you well. I’ve been quite busy with several exciting projects recently, which has kept me from posting as often as I’d like. However, during a recent call with a company’s management team, I… Read More »Getting close to your customers
AI in Healthcare The potential for Artificial Intelligence (AI) to transform healthcare is vast, offering new pathways for enhancing diagnostic accuracy, personalizing treatment plans, and streamlining healthcare services. This short introduction is for anyone curious about AI’s role in modern… Read More »Understanding AI in Medicine: Classical Machine Learning vs. Neural Networks
In an unsurprising turn of events, Supersapiens, a promising entrant in the medtech and healthcare industry, recently announced its closure. The company, known for leveraging Abbott’s Freestyle Libre—a groundbreaking medical product for glucose monitoring—sought to revolutionize how athletes monitored and… Read More »Supersapiens: A Cautionary Tale of Ambition and Accessibility in Medtech
Happy New Year! As we embark on 2024, we’re excited to present our first post of the year, tailored for those new to the medical device industry. This article will guide you through the intricate world of medical device classifications… Read More »Navigating Medical Device Classifications: A Primer for Industry Newcomers