How to avoid influencing summative evaluations
Observations are an integral part of summative evaluations, the final validation that a device’s user interfaces are safe to use. During a summative evaluation, the manufacturer sets up a set of...
View Article3 Tips to Get the Most Out of Observation Sessions
Observation can be a powerful tool. It allows industrial designers to better understand how a product will be used by different users in different environments. Setting up an observation session can be...
View ArticleAlarm Fatigue – The Alarm that Cried Wolf
Alarm fatigue is a multifaceted problem, and its presence is influenced by a variety of factors. Preliminary investigation into the intended use environment of a medical device is a crucial step in...
View ArticleEmpathic design uncovers unspoken women’s health needs and wants
It goes without saying that women are anatomically different from men. Health conditions affect women differently and women have different health concerns than men. Because of this, more companies and...
View Article10 things I learned from Bad Blood
What Yeast, Richard Nixon, a CIA agent, a Teenager, Donald Trump and $9 billion dollars have to do with a Fake Medical Device Bad Blood: Secrets and Lies in a Silicon Valley Startup was at the top of...
View ArticleThe Bleeding Edge and 510k approvals
A couple of nights ago I watched The Bleeding Edge on Netflix. It’s a documentary about medical devices, or rather about side effects of medical devices. If you have not seen it yet, I recommend...
View ArticleA “Pressing Issue”- Reliability Testing in Medical Device Development
On a quiet Monday morning, before the first cup of coffee has been poured, a faint sound can be heard coming from inside the organized chaos of an engineering lab. Tucked away in a corner, somewhere...
View ArticleFirst-to-Market strategy, trade-offs and tips for medical devices
In a previous medical device company, I worked on a project where First-to-Market (FTM) was a deemed a priority for the company’s survival. To meet that highly compressed timeline, we decided to skip...
View ArticleWhy an early PFMEA is important
It behooves designers to look at the assembly processes early, with a focus on how we can stop critical faults or those that are likely to happen. Process Failure Modes and Effects Analysis (PFMEA) is...
View Article5 tips for Production Readiness
We asked our new product introduction (NPI) team to reflect on their collective experiences transferring medical devices from design to production. Their top tips for production readiness are listed...
View ArticleHealth Hackathons: events with lasting impact
Hackathons are a fantastic environment for networking between academia and industry, and a real opportunity for students and young professionals to showcase their skills. On the last weekend of...
View ArticleLean for Small Scale Manufacturing
When most people think of Lean Manufacturing, they think of large, gleaming, gazillion square foot manufacturing spaces where every surface is clean, meticulously labelled and taped off. Happy workers...
View ArticleReduce hidden costs by increasing Supply Chain visibility
The most common question supply chain professionals get from clients is “How can we reduce the cost of this project?” Cost reduction is always a challenge – especially in a low volume, complex...
View ArticleCommon pitfalls when ramping medical device manufacturing to high volume
Many entrepreneurs underestimate the importance of ramping up medical device manufacturing in a small and controlled way – sort of a slow ramp. They often overestimate how quickly they’re going to...
View ArticleWhy manufacturer flexibility matters during product launch
When choosing a manufacturer to launch your medical device, there are a lot of things to consider and options to compare. Cost, quality and lead time usually lead the list. Which ones are most...
View ArticleHow to improve sensor measurement accuracy in Medical Devices
Using Matched Filters Anyone who has taken a signals and communications course has likely heard of matched filters. Intuitively these filters use knowledge of the form of a transmitted signal to pull...
View ArticleMost read medtech blogs of 2018
Four new medtech blogs and three new authors joined our 2018 “most read” list. Regulatory was the most popular topic, followed by electrical engineering, software, and supply chain. How ISO 13485:2016...
View ArticleOur 10 most viewed videos in 2018
StarFish Medical videos are created to help viewers learn about medical device design, development and manufacture. They are also a great way to get a better sense of the people you will be partnering...
View ArticleWhen do you need a Quality Management System (QMS)?
“When do I need a Quality Management System (QMS)?” is the most common question that we get asked by new clients who are just entering into the medical device field. The answer depends on your target...
View ArticleFighting acute lymphoblastic leukemia (ALL) with CAR-T regenerative medicine
Chimeric antigen receptor T-cell (CAR-T) therapy is a rising shining star in Regenerative Medicine. Medical devices will be involved in many of the processes involved with CAR-T therapies. From blood...
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