For Medical Devices

Assurance cases can reduce the time to market for products requiring regulatory oversight, for example, medical devices, while building a strong case for a product’s safety and effectiveness.

Assurance cases are a method for communicating the safety, effectiveness, and performance of a product by demonstrating how the submitted evidence supports the manufacturer’s claim.

Advantages Over Stand Alone Medical Devices

Mobile health technology is a booming field both at the consumer and professional levels. There are currently more than 100,000 personal health tracking apps available for smartphone users. These apps range from simple step trackers to diet analysis apps, sports performance tracking, and more. Professional uses for the smartphone are growing just as fast, from telemedicine to remote patient monitoring, to even replacing certain standalone medical devices.

Replacing? Yes. The smartphone has numerous advantages over standalone medical devices. Some are obvious. Others, however, are only starting to come into their own.

The Power Of Digital Twins and Digital Threads

“Digital Twins” and “Digital Threads” are recent terms, but the concepts they represent should be familiar. A digital twin is a virtual representation of a physical product, much like a simulation or digital mockup (DMU). A digital thread, on the other hand, is a product lifecycle management tool.

The difference is that digital twins and digital threads address the additional needs created by interconnected devices and applications.

Changing How Medicine Is Practiced

Technology has influenced medicine in a major way. New types of artificial intelligence aid in diagnosing and treating conditions, and the rise of telehealth makes medical care more accessible and convenient. One less appreciated field, however, is having a major impact on how medicine is practiced today: Robotics. Here are some of the ways medical robots are improving how medicine is practiced today and how this field is expected to evolve over time.

Role of AI

Perhaps the biggest revolution in computing in recent years has been the move to the cloud. No longer are individuals and organizations tied to their specific hardware: With cloud computing, it’s easy to scale up or down with just a few clicks and, typically, at a low cost. However, many are unaware of just how intertwined artificial intelligence is with the cloud’s rise and its use both today and in the future. Here are some of the ways artificial intelligence makes the cloud an intelligent cloud.

For Consumers: IoT Devices and Software

In May of 2021, President Joe Biden signed the Presidential Executive Order on Improving the Nation’s Cybersecurity (14028) as part of a greater effort to enhance software supply chain security. As part of the order, the National Institute of Science and Technology was tasked with issuing guidance for labeling consumer internet of things devices and software.

A Top Priority

Technological developments in recent decades have been a driving force in improvements in medicine. Today’s medical devices give doctors and others in the field far greater ability to see details that would previously have been missed, and the dropping cost of medical technology makes these devices more accessible. However, these advantages come with some downsides. In particular, poor security can put patient data at risk, and certain types of malware can render devices inaccurate or even unusable. Cybersecurity now must be a top priority for practices of all sizes.

Will it Impact How Medicine is Practiced?

The medical field is notoriously reluctant to adopt new technologies, as the high stakes of changing how medicine is practiced means new technologies have to be thoroughly vetted before being implemented. However, the promise of blockchain technologies means a growing number of medical entities are taking a close look at using it as a foundational technology across a range of areas, and this momentum is only expected to accelerate in the coming years. Here are some of the reasons why blockchain technology is poised to have a major impact on how medicine is practiced worldwide.

Revolutionizing IoT

The term “LTE” is certainly familiar to anyone following mobile connectivity over the years. For those operating in the embedded space, however, a technology called LTE-M is revolutionizing how Internet of Things and other connected devices can operate across a wide range of industries. Here are a few facts about this burgeoning technology and its present and future impact on the embedded environment.

Accelerating AI

Despite how complex modern computers seem, their basic architecture hasn’t changed much since they started implementing what’s known as Von Neumann architecture. The real “brains” of computers lie in the CPU and the RAM, the latter of which stores program code and data. While modern RAM is amply fast for a wide range of tasks, the connection between the RAM and CPU can function as a bottleneck for certain tasks; in particular, many artificial intelligence implementations are restrained by how quickly the processor can access data stored in RAM. Recent developments, however, aim to mitigate this limitation, potentially leading to far more capable AI implementations and allowing developers to craft new means of harnessing the potential of AI.

How They Interact

Artificial intelligence, and machine learning in particular, is transforming various fields in a profound manner. Although the medical field has a reputation for being slow to adopt various technologies, AI and ML are currently changing how medical devices are being designed, potentially leading to better outcomes for patients. The FDA is taking an active role, helping to provide guidance for medical device designers and manufacturers. However, the fundamental nature of AI and ML presents challenges for regulation, and the FDA is in the process of developing regulations that both allow potentially useful devices to come to market while ensuring patients and doctors can expect devices to be safe and beneficial.

Is It Finally Coming?

Medical devices must meet strict scrutiny. In order to be sold in nearly any market, a device needs to be rigorously shown to be effective and safe. However, medical device designers and manufacturers have long had to deal with competing regulations, most notably the FDA Quality System Regulation, which sets the rules for devices sold in the United States, and the ISO 13485, an international standard used in the European Union, Japan, Canada, and other nations. In order to ease the process of bringing products to the market, the FDA has a goal of harmonizing its requirements with those of ISO 13485, but various factors have delayed this transition and even raised questions over how and whether it can be implemented in a timely manner.

US Task Force Plans to Share Government Data with Academia and Private Sector

On June 10th, 2021, the White House administration launched an effort to provide additional government data to artificial intelligence researchers. The move, which aims to ensure the United States remains at the forefront of AI research, will provide invaluable data to academia and the private sector for developing new tools.

In addition to offering access to data, the initiative may also provide access to government-run computing power, which can be especially useful for cutting-edge academic research.

The initiative seeks to provide a broad range of data, including information about health, driving habits, and demographics.

The Matter Standard

Although Google, Apple, and Amazon are often fierce competitors, there are areas where collaboration between these tech giants can prove beneficial for all. When it comes to the use of Internet of Things devices in residential and commercial environments, adoption has been slow. An initiative formerly known as Project CHIP was recently renamed Matter, and its wide support is poised to provide benefits to tech giants and startups alike.

Helping Medical Device Innovation

While advances in the scientific process, imaging, and other factors have played a major role in the advancement of medicine, medical devices have been one of the primary linchpins driving advances that extend and improve peoples’ lives. Ensuring these devices are safe and effective, however, is a critical task: Poor regulation can lead to a market marred by ineffective and, even worse, dangerous products. In the United States, the FDA is at the forefront of this task.

Two Linked Technologies

The concept of cloud computing has matured over the years, and its benefits are clear. Serving as the connection between end devices and the cloud, the edge’s role has transitioned from a necessary compromise to the cloud paradigm to a valuable tool to improve operations. With the rollout of 5G technology, edge computing is set to undergo a bit of a revolution. Here are some of the ways these technologies will interact in the coming years.

Innovative Uses

Anyone who’s used a smartphone has experience with capacitive touch devices. While capacitive technology is mature and affordable, there is still ample untapped potential, and innovative user interfaces that are coming to the market at a rapid pace.

Capacitive touch devices are generally considered to be the first touch screens, invented in the mid-1960s. However, it was resistive touch screens that became popular, particularly when touch technology took off in the 1990s.

Resistive screens and interfaces physically measure when pressure is applied to the surface, giving them excellent accuracy but requiring a significant amount of force to use.

The New Date Is May 26, 2021

The European Medical Device Regulation (MDR) is finally set to take over, marking a significant shift from the Medical Device Directive (MDD). While medical device manufacturers and many entities involved in the supply chain received a bit of a reprieve when the date moved back from its initial scheduled launch in May of 2020, regulators have indicated that there will be no further delay despite challenges posed by the scope of the new directive and the COVID-19 pandemic.

High performance, Low Power, Low Cost BLE for IOT Applications

One of the challenging aspects of placing increasing numbers of IOT sensors into consumer and industrial applications is compromised link budget due to non-ideal placement of devices around absorptive or conducting surfaces, and non-ideal antenna and packaging configurations, as well as long range.

Benefits Include Increased Performance, Reduced Power Needs and Enhanced Miniaturization

The global 3D IC (three-dimensional integrated circuit) market will reach a value of $22.30 Billion by 2027. The increasing demands for smart devices and the importance of miniaturization in the electronics industry are influencing the market growth.

As it's become more difficult to shrink existing processes, stacking up is the way to increase integration. Stacking can be done die-on-die, die-on-wafer, wafer-on-wafer, or in combination.