medical device

Is Linux OS the Right Platform for Your Medical Device?

Today’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…

Does ChatGPT Have a Role in Medical Device Software Development?

“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…

Accelerate Development of Your Digital Twin Training Simulator

Right 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…

My Beautiful Medical Device

As 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 about medical…

Creating Digital Twin Training Solutions in VR for Medical Devices

With 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…

Explore the SaMD Verification and Validation Process

The 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.…

Algorithms, Data Quality Key to Safe AI-based Software as a Medical Device

Focusing 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 cover…

Regulatory Considerations for Medical Device Software

In 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…

What You Need to Know About Developing Software as a Medical Device

Software 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…

Nearing the Finish Line with Project RED’s Low-Cost Ventilator

As 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…

It’s Time to Fix Scientific Software

In 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…

Developing Safe Medical Devices Means Following These Principles

“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…

ICS Works with Non-Profits to Develop Low-Cost Ventilators

This 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…

Need Physicians to Test Your Medical Device? Here's How to Recruit Them

If 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…

Tackling Medical Device Usability Design Early Speeds FDA Approval

For 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…

Medical Device Design Considerations, Ensuring Usability and Safety

In 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. 

Consumer products and medical device development challenges differ – so should teams

  In 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…

Growing Influence of UX is Reshaping Medical Device Development

The 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 regulations, …

DeviceTalks Boston 2019

Boston 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…

Focus on Usability Can Limit Medical Device Recalls

This 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 challenging.…

Transformational Medical Devices Deliver Better Patient Outcomes

Innovative 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…

How the IoT and a Focus on UX are Leading a Medical Device Revolution

Here 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…

The Difference Between Connected Devices that Simply Look Cool and Those that Truly Improve Your Life Lies in the User Experience

For 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…

A Look at How Consumer Electronics and Medical Device Product Development Teams Differ

Consumer 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…