Using Medical Device Symbols
Key updates in ISO 15223-1:2021 Symbols are a universal language. When looking at smiley and sad faced emojis anyone from around the world can differentiate the meaning between the two. That is the...
View ArticleWhy Medical Device Startups Should Listen to The Ecosystem
A Three-Pronged Strategy to Stay Ahead A medical device is a convergence point where various technologies and regulations come together to impact patient health. Within the diverse ecosystem of the...
View ArticlePros and Cons of Virtual Audits
Over the last year and a half, so many things have changed. We’ve had to adopt new practices to ensure the safety and wellbeing of not only ourselves, but also our friends, family and the general...
View ArticleAlgorithm Aided Design – Personal Data Driven Medical Device Design
Personal data driven design is here. With Algorithm Aided Design (AAD) and the ability to adjust your design with rules, mathematics equations and parameters, a custom design is fast to produce and...
View ArticleThe Effect of Formative Test Fidelity
Why it’s important to simulate realistic use for medical devices The degree to which users, environment, and test articles are realistically simulated for a medical device formative test has a...
View ArticleHow Human Factors and ID Impact Medical Device Commercialization
Inspired by our annual Industrial Design/Human Factors newsletter, our QA/RA. Project Management, EE, ME experts, President, and ID/HF Manager shared insights and examples of how ID and human factors...
View ArticleTechniques for translating user and patient insight into tangible design
Creating reality from the intangible. In this blog I will highlight tips and techniques to help industrial designers and human factors researchers translate user and patient insights into medical...
View ArticleHow to Conduct Particulate Pre-Testing for ISO 18562-2:2017
Recently we conducted pre-testing (testing done in-house to increase confidence before undertaking more expensive formal testing) for ISO 18562-2:2017 Biocompatibility evaluation of breathing gas...
View ArticleFive Steps to Medical Device Development Success
In my experience, a product’s best chance at successful commercialization is to ensure it follows a Five Step Development process. Company value, and user safety will rely on the due diligence required...
View ArticleMedical Device NPI & Commercialization Lessons Learned
Discover Strategic Sourcing, Exit Value, and Timing lessons learned from engineers, NPI (New Product Introduction) experts, manufacturing, and senior managers with 20 plus years of medical device NPI...
View ArticleWhat to Consider when Choosing a Camera Sensor for a Medical Device
Part 2: Incident Irradiance, Exposure, Gain, and Frame Rate Camera sensors are common components of medical devices. In this blog I will discuss in detail how incident light irradiance, exposure time,...
View ArticleOur 10 most read medical device commercialization blogs of 2021
Two new medical device commercialization blogs, one returning champion, and two new authors join our 2021 “most read” list. Electrical engineering amd regulatory articles tie for the most popular blog...
View ArticleKey Ingredients for Medical Device Innovation
The word innovation is often thrown around like many other business buzzwords. Real medical device innovation takes effort and is truly valuable. Here are a few key ingredients that will improve the...
View ArticleTop 10 medical device commercialization videos in 2021
Our 2021 top 10 medical device commercialization videos include 4 new videos. They join favorites from previous years and cover topical and perennial subjects including 2021 updates, optimizing founder...
View Article12 Favorite Reads from 2021
This blog is inspired by a LinkedIn post from Arash Samimi and the upcoming holiday break. “I often think of reading books as a means to create a worldview. I want to know what the world looks like...
View ArticleWhat do Mil-Spec Anodizing Types and Classes Mean?
Let’s talk about what an anodized finish actually is. A core finishing technique around the world, anodizing is highly valued in the medical industry to promote longevity of devices. It is a...
View ArticleFDA Action Plan for AI/ML in SaMD (Software as a Medical Device)
Artificial intelligence (AI) and machine learning (ML) technologies have a huge potential to change the way we look at our current health care practices. AI/ML enable new insights derived from the huge...
View ArticleWhat Resolutions for 2022 Reveal About StarFish Company Culture
You may not be able to tell a book by its cover, but resolutions offer a peek into individual plans and priorities. When combined, they even offer a glimpse of company culture. Our employees share...
View ArticleStatistical Techniques for Streamlining Medical Device Design Verification
Many techniques can be employed in order to simplify formal verification testing. These techniques expedite the product development process and reduce cost. During verification planning, the required...
View ArticleDeveloping and Running an Industry-Integrated Human Factors Engineering Course
Although engineering students graduate from their program well-equipped with the theoretical concepts taught in class, they often lack practical knowledge regarding their particular industry [1]. Such...
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