What Yeast, Richard Nixon, a CIA agent, a Teenager, Donald Trump and $9 billion dollars have to do with a Fake Medical Device

Bad BloodBad 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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summative evaluationsObservations 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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MaRS EXCITEWorking 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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documentationWhen 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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Medical Device International RegulationsBringing 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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