medical device
A Secure Product Development Framework (SPDF) is a set of processes that help identify and reduce the number and severity of vulnerabilities in products. It encompasses all aspects of a product’s lifecycle, including design, development, release, support and decommission.Think of the SPDF as a…
BlogHow do UX designers create interfaces for highly specialized knowledge domains such as robotic surgery or material science analytics when they do not have training or expertise in those subjects? With digital transformation happening across scientific, manufacturing and government…
BlogRansomware attacks frequently target medical institutions, taking offline equipment connected to the internet, such as phones, email and electronic health records, until the victimized organization pays up. Last year, at least 299 hospitals suffered such attacks, according to the Institute for…
BlogSoftware is central to nearly all of today’s medical devices – essential to the diagnosis, treatment and management of medical conditions. But from the FDA’s vantage, there are two types of medical device software and the difference between them comes down to a pair of small but vital words: “in”…
BlogAs a result of ongoing digital transformation, many industrial and IoT devices have small, embedded computer touch screens for control of the device. These screens are in the ballpark of small tablet-sized or smartphone-sized screens or even smaller than a phone screen. Designing the interface for…
BlogAccording to a 2022 FBI report, 53% of digital medical devices and other internet-connected products used in hospitals had known critical vulnerabilities caused by issues including unpatched and outdated software. In today’s world, where evolving cyber threats loom large – ransomware attacks alone…
BlogToday’s medical devices are more capable than ever. But with those capabilities comes complexity – which in turn makes developing these devices more challenging. Creating a future-proof medical device solution, from CT scanning machines to patient-monitoring equipment, requires building on a…
Blog“AI is a robot perched on our shoulder, not the creator at the keyboard.” –Ann Handley Just five days after OpenAI released its chatbot ChatGPT on Nov. 30, 2022, it had signed up 1 million users. A month later it had more than 100 million, making it the fastest-growing consumer application in…
BlogRight before the holidays, I had the opportunity to attend the annual Interservice/Industry Training, Simulation and Education Conference (I/ITSEC) tradeshow – the world's largest modeling, simulation and training event that presents the latest tools and techniques for building training and…
BlogAs you read the title to this blog no doubt some feelings popped into your consciousness that you associate with the word ‘beautiful’, like high quality, effective, highly usable, sophisticated, maybe even expensive. But you may have also thought ‘oxymoron.’ We don’t usually think…
BlogWith all the focus on the Metaverse these days – especially for using it to make shopping more engaging and interactive – it's easy to forget that there are many applications of virtual reality (VR) that go well beyond the retail space. One significant application is creating a purely digital…
BlogThe software-as-a-medical-device (SaMD) lifecycle encompasses two important and often confusing processes: verification and validation. Verification comes before validation and provides the evidence that the specified requirements have been met and that design outputs match design inputs.…
BlogFocusing on challenges related to developing AI-based Software as a Medical Device (SaMD), this blog explores current regulations and guidelines in the U.S and EU. For more on SaMD, join us at 1 pm EST on March 3 for a live webinar 5 Key Considerations at the Start of SaMD Development. We'll…
BlogIn the first installment in ICS’ series What You Need to Know About Developing SaMD we provided an overview of software used within a healthcare environment and touched on key regulations in the U.S and in the EU. In this article, we take a closer look at some of the regulatory considerations for…
BlogSoftware that meets the definition of a medical device, commonly referred to as Software as a Medical Device (SaMD), is subject to different requirements than software that does not meet this strict definition. In ICS’ new series What You Need to Know About Developing SaMD we explore the…
BlogAs 2020 wraps up we wanted to update you on the Project RED project, a non-profit initiative to develop an affordable emergency ventilator effective at treating the most common respiratory conditions associated with Covid-19 and other illnesses. Even though there are currently two FDA-approved…
BlogIn the era of COVID-19, accelerating scientific R&D takes on new urgency. For today’s research scientists, accessing and making sense of the information needed to support their discoveries is a challenge. Why? Scientists conduct less hands-on wet and dry lab work than in the past and instead…
Blog“What happens if ___ fails?” As technology-powered medical devices gain widespread acceptance in clinical practice and device complexity and capability expands, device safety becomes more critical than ever. So too does the need to evolve these devices to ensure they become safer for a more…
BlogThis ongoing series provides a close-up look at our work helping two non-profit organizations, RespiraWorks and Project RED, create low-cost ventilators to fight COVID-19 in countries with developing economies. Progress reports will be posted regularly. June 4, 2020 No one…
BlogIf you’ve ever tried to recruit busy professionals like physicians to test your software or other product, you know it can be a challenge. Doctors are notoriously overscheduled. Their mental energy is focused on their patients. And, in a profession where time is money, they can’t be incentivized by…
BlogFor medical device makers, it’s best to embrace the FDA regulatory process early as substantial time and effort is needed to prepare for approval. The FDA requires device makers to prove through appropriate testing that use errors are greatly reduced and that a device does not allow use errors to…
BlogIn a guest article on Medical Design Technology's website, Dorothy Shamonsky, Director of UX R&D at Boston UX, takes a look at interface and human factors design in medical devices in order to ensure they are safe to use with patients. Read the full article here.
Basic pageIn an article published in MassDevice, the online journal of the medical devices industry, we discuss how consumer electronics and medical device development teams have different priorities and require different approaches. Carefully choosing team members not only for relevant…
Basic pageThe medtech industry is among the most traditional. Product development has historically followed a classic, top-down waterfall approach focused squarely on the technology, not the user. Though greater attention is paid to usability these days thanks to FDA guidelines and compliance…
BlogBoston UX and ICS are exhibiting at DeviceTalks, the educational forum bringing together engineering, product development and commercialization professionals to share the challenges and best practices of getting medical devices to the market. They'll explore the trends and technology…
Basic pageThis blog launches our new series on software design of medical device user interfaces (UI), which will explore usability, safety, risk management, key regulatory standards, usability testing, and wearable medtech user experience (UX) design. Building great software has always been…
BlogInnovative cancer-treatment systems. Operating-room environmental control systems. Advanced infusion pumps. Life-critical ventilators. Easy-to-operate automatic external defibrillators. Integrated Computer Solutions (ICS) is pushing the medical device industry forward with high-performance…
BlogHere at ICS we’re excited about how the Internet of Things (IoT) is changing the lives of people every day — a topic we’ve been covering from all angles. For instance, my colleague Jeff Tranter described how IoT fits into the Qt ecosystem while Dorothy Shamonsky has written about the design…
BlogFor connected IoT devices — including smart home and medical devices — to be truly transformative they need to deliver a well-designed and intuitive user experience. Running. It’s my thing. My favorite form of exercise. A way to clear my head. Usually, running loves me as much as I love it. But…
BlogConsumer electronics and medical device development teams have different priorities. Match your team to your goal. Today’s consumers have high expectations. Not only do they want products that solve their immediate problems, they want new and innovative products that make their lives…
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