Astero StarFish

What’s the worst mistake you can make when developing a medical device?

worst mistake you can make when developing a medical deviceHow many have you made?

We posed the question, “What’s the worst mistake you can make when developing a medical device?” to our team of engineering, design, quality, regulatory and manufacturing experts. The answers were fast and furious (well, filled with enthusiasm) and in no particular order of importance, May you read and learn from our mistakes, a few from friends, and folks we consider family…

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Lorenzo Gutierrez

Top 10 COVID-19 Medical innovations

COVID-19 Medical innovationsRapid technological advancement is often triggered by external events such as international conflicts, political pressure, economic downturn, competitions or disease.  The COVID-19 pandemic has triggered the drive for technological advancement. Scientists, engineers and innovators have risen to the challenge by doing that which they do best – designing, building and prototyping.
Here are my top 10 COVID-19 medical innovations.

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Josh Coutts

Addressing ingress protection for home healthcare medical devices

Ingress Protection for Home Healthcare medical devices What the standard says and what you should know.

Increasingly medical device technology is filtering down from hospitals and into patients’ homes.  Designers need to understand and address the impact of this transition on the medical device design when addressing ingress protection for home healthcare medical devices
60601-1-11 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment introduces additional IP requirements beyond those in 60601-1, that cover a larger classification of devices and may impact a home healthcare device.  These requirements are intended to protect patients and devices against the increased likelihood of liquid ingress in a home use environment and the associated risks such as electrical shock or impaired functionality.

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Hannah Rusak-Gillrie

Formative Evaluations and Tests, and When to Use Them

Formative Evaluations and TestsA critical component of Human Factors input during product design is evidence – based, user-centered feedback, gathered from conducting formative usability activities. We use two main approaches to gathering such feedback: Formative Evaluations and Formative Testing.  This blog details the differences between these methods, and the appropriate circumstances for their application.

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Tim Park

Tools and tips for holding COVID-19 friendly brainstorming meetings

Brainstorm Better Brainstorm Better with COVID-19 friendly brainstorming meetings

Just because your team is working from home due to COVID-19, doesn’t mean your ability to work collaboratively has to suffer.
Our design team has been working collaboratively between two offices on opposite ends of  Canada for more than three years now. Holding a meeting online might not seem as effective as holding one in person, but being able to have all participants at a computer actually offers a number of benefits.

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Virginia Anastassova

FDA Breakthrough Devices Program Update and Advantages

FDA Breakthrough Devices Program Update and AdvantagesThe FDA Breakthrough Devices Program provides several advantages for novel devices that meet the inclusion criteria and can significantly reduce a product’s time to market. The Breakthrough Devices program implemented by FDA in 2018 has superseded the Expedited Access program that was introduced in 2015. The program is gaining popularity with 11 designations in 2016, 19 in 2017, 55 in 2018 and 50 designations as of May 2020.

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Deborah Pinchev

COVID-19 Testing Authorizations in the US and Canada

canstockphoto79336868This blog provides an overview of COVID-19 testing authorizations and developments of the COVID-19 pandemic in the United States and Canada. In the world of regulated health care products these tests are known as in vitro diagnostics (IVDs) and fall under the medical device definition in most jurisdictions.
Almost 6 months since both the FDA and Health Canada (HC) issued initial policies and guidances on the COVID-19 test kits (another term used to describe IVDs), there has been a lot of activity from manufacturers and laboratories to get COVID-19 test kits out in the market.

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Helen Simons

Submitting a medical device application under the Health Canada Interim Order

K:MarketingBlogsSubmitting under the Health Canada Interim OrderOur experience submitting under the Health Canada Interim Order

Prime Minister Trudeau announced StarFish Medical’s participation in the  NGEN Canadian Emergency Ventilators project on March 31, 2020, as part of Canada’s Plan to Mobilize Industry to Fight COVID-19. StarFish Medical was asked to help supply ventilators for the Canadian healthcare system and to develop them rapidly so that they would be available for use should current supplies be insufficient.
We were very keen to participate in such a worthwhile endeavour and jumped straight into it.

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Alexandra Reid

Medical Device Coverage & Reimbursement Tips and Trends

Medical Device Reimbursement

Expert Advice from the 16th Annual Medical Device Coverage & Reimbursement Conference

A medical device sponsor must feel like they have successfully climbed Mount Everest when they receive their approval from the FDA – but in reality, they’ve only reached the first Base Camp. There is still a challenging uphill climb before receiving the real prize – reimbursement for their medical device.
To learn more about that process, I attended the 16th Annual Medical Device Coverage & Reimbursement Conference. This blog includes a few highlights to help guide your reimbursement journey:

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