The rate of change in the field of oncology has continued to accelerate, with an information doubling expected to occur every two months – or expanding at the rate of 64x per year. The oncology field has long since crossed the line that individuals can keep pace with the rate of increasing knowledge…

While it is inarguable that the new biologics will revolutionize medicine, including the eventual arrival of the long-heralded ‘personalized medicine’, it also invites the question, “Are we entering the Golden Age of molecular diagnostics?”. It certainly seems so…

Intuitive Surgical shipped their first surgical Robotic Assisted Surgery (RAS) in 1998. In the twenty-five years since, the technology has become ingrained in most surgical procedures. Incredibly, the market itself is projected to grow 7-fold over the next 7 years. This growth has created a crowded market with over 125 companies entering the RAS market in recent years….

The expanding impact of Digital Health and Digital Therapeutics is being felt by the EP sector.  Remote monitoring of implantable cardiac devices (ICDs), cardiac resynchronization therapy devices (CRT-Ds), and pacemakers have been shown to improve patient outcomes. More recent work applying convolution neural network (CNN) based artificial intelligence (AI)…

The trend toward extending care management from the hospital through urgent care clinics, providers offices, and to the home environment has provided for tremendous improvements in care and a reduction in operating costs, but that trend also has generated a new generation of significant technical challenges and has not yet bent the curve on overall healthcare costs…

Remote cardiac monitoring and diagnostics are seen as providing tremendous advantages to cardiologists, while keeping patients out of the hospital environment.  This post examines the key challenges a medical device company must overcome when developing dependable cardiac monitoring systems, including…

Connectivity in medical devices is no longer a novelty; the ability to gather and exchange data across a network of devices is often a required part of any modern system. Devices with more sophisticated connectivity offer extensive potential improvements….

After a period of relative calm in the medical imaging market, we are now in the early stages of another era of rapid evolution. Introduction of Digital Health capabilities in medical imaging, of which Artificial Intelligence (AI), and increased interoperability are merely two, has dramatically accelerated in just the past few years. Our recent piece is a deep dive on the current state of AI in the medical imaging space…

The rapid growth of artificial intelligence capabilities presents seemingly inexhaustible potential, but with that comes challenges and unknowns. Our latest piece outlines key considerations and potential pitfalls of integrating AI into your radiation oncology treatment planning systems…

As anyone responsible for the development of new products knows, software engineers come in two distinct flavors; engineers that work at the application level and engineers comfortable working at the hardware level.  While this is, obviously, a gross oversimplification, the basic division is true…

The topic of cybersecurity for medical devices has steadily grown since 2001.  In that year, after September 11, there were a number of technically philosophical talks and papers warning that cyber terrorism, later dubbed cybersecurity could become an issue for medical devices.  At the time it was considered to be of mild interest, but few imagined that anyone could be so twisted as to attack hospitals or life saving devices.

Like most sectors of the US economy, the Covid pandemic has laid bare every existing product development challenge that the Medical Device industry has had for years.  We review what existing vulnerabilities led to the greatest disruption and the importance of mitigation for these vulnerabilities for the benefit of quality and predictability of development, not just for disaster readiness.

This article focuses on four takeaways from the FDA’s recently released Cyber Security Guidance (Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA – April 8. 2022) that we think are of particular importance: Software Architecture Implications of Cyber Security, Threat Modeling (ongoing), Treatment of Off-The-Shelf (OTS) Software, and Transparency Requirements.