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 The Breakthrough Devices program implemented by FDA in 2018 has superseded the Expedited Access program that was introduced in 2015.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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Kenneth MacCallum

Reference designs for medical device development

Reference DesignsReference designs for medical device development are a great way to ramp up a project faster and more cost effectively. At work, we’ve adopted a strategy of developing our own reference designs of subsystems that we believe will be useful in future projects.
A reference design is an implementation of a technology – such as a mechanism or circuit – that can be used to demonstrate and test its applicability to a particular use. Our intent is that they can be copied, modified and incorporated freely into our clients’ product designs to speed development and leverage our internal expertise.

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Aaron Philippsen

Better brainstorming for medical device product development

Better BrainstormingThis blog is about better brainstorming for medical device product development and includes using a systematic method of brainstorming that may help highlight higher quality concepts before detailed design begins.
Brainstorming for medical device product development has previousy been covered by former StarFish colleague, Boyd Allin.  I highly recommend you read that blog as well.

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Ryan Field

Spectrometer from home materials

Spectrometer from home materialsMake a real-time, wavelength-calibrated spectrometer using common household items.

Like many others, I’m currently working from home due to the ongoing COVID-19 crisis. Fortunately, a significant portion of my optical engineering work, such as research, modelling and design, can be done without going into the office. On the other hand, I generally avoid going into my lab unless it’s absolutely necessary, which has largely prevented me from doing hands-on optics work for the moment.

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Lorenzo Gutierrez

Using Smartphones as a Medical Device for Point-of-Care Applications

What makes smartphones as a medical device exciting as potential point of care platform?

Smartphones are the most widely used portable devices in the world today.  According to Statita, the number of current worldwide smartphone users is around 3.5 billion.  This means that 45% of the world’s population owns a smartphone. It is predicted that by 2023, the number of mobile device users will increase to 7.3 billion. Considering that smartphone manufacturers offer new models every year, the number of smartphones in circulation is likely three times that number or more.

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Astero StarFish

Where do you find inspiration for work?

inspiration for work

ID 76424878 © Allexxandar | Dreamstime.com

Many have paused work for a COVID-19 required break. As an essential business, our work did not pause.  We asked our content team of engineers, regulatory, quality, design, and program management creative professionals where they find inspiration for their contributions to medical device development. This blog is about finding inspiration for your work as summer and a return to work loom ahead.

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Mike Loveless

Science Fiction Medical Devices

Science Fiction Medical Devices Real medical devices from the imagination of science fiction

Many shows, movies, books and videogames feature science fiction medical devices and technologies that seem otherworldly and far beyond our capabilities. We often can’t believe a lot of them are real because their impact on the characters is so dramatic. However, the imagination and creativity of a sci-fi writer can grow from science fiction into science non-fiction with time, scientific progress and design development.

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