A couple of nights ago I watched 
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 my 2018 summer fun reading list. It was released in May 2018 and written by John Carreyrou (the two time Pulitzer winning journalist at the Wall Street Journal that questioned the validity of the diagnostic device work done by Theranos).
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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 identifying key desirable, and undesirable features – including auditory cues and warnings.
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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 quite time consuming. Finding the right participants and holding sessions is a lot of work. Here are three tips to make the most of your time.
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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 scenarios that capture all of the tasks that the device is expected to perform. The manufacturer creates environments that mimic the real use, capturing the finest details, all the way down to playing recordings of expected sounds within that given environment.
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Working in partnership with the Ministry of Health, the main funding entity in Ontario, EXCITE now offers customized, flexible services to help companies understand:
- the evidence they need to meet key stakeholder decision-making requirements to access the province’s market,
- the relevant systemic barriers that could slow adoption and uptake,
- the system changes that need to occur to support successful system implementation of the new technology.
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When I arrived at StarFish with my idea for a patient handling device, I had just completed my engineering degree and was searching for further education in medical device development. Fortunately for me, StarFish provided master-level classes (albeit unaccredited) in project management, including Dealing with Vendors 101: Expect Delays and QMS 201: How to Maintain Your Sanity. I’m leaving Victoria with a much greater knowledge of my startup’s path to market, and a highly vetted network of medical device experts just a phone call away who will help us get there.
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Are you developing a device that performs a more effective treatment, incorporates novel technology, or is like nothing else on the market? If the answer is “yes” then the new FDA program for breakthrough medical devices may be your best regulatory option.
Are you a manufacturer of a medical device that is in the early stages of development interested in gathering clinical data in the United States? Your device design will likely change, but the information needed is best gathered through clinical experience as opposed to non-clinical testing.
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Bringing medical devices to market in a single country can be a regulatory challenge. The process often becomes much more complex when marketing in multiple countries and navigating medical device international regulations. A comprehensive understanding of current regulations in each country of interest is required as device laws and regulations are constantly changing. If you’re just starting to think of marketing a medical device in a country outside of Canada, Europe, or the United States, here’s what you need to consider:
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Jul 31
Did you ever wonder what your co-workers aspire to do during their lifetime? Here are bucket list answers from StarFish employees that may give you a feel for what it’s like to work for, or with, us. They may even inspire your summer vacation.