If you’re reading this, chances are you have a great idea for a medical device and you’re starting your design.   You probably have an electrical element to your design. As tempting as it is to start ordering parts and tinkering, there are a few preliminary documents you can create to help you choose the right parts.  Eventually you’ll need a design that must pass the requirements of IEC 60601-1.

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FDA Regulation of E-cigarettesThe FDA Regulation of E-cigarettes aims to fill a technology regulation gap. Whether it’s the FAA and recreational drones or the USDA and the latest strain of genetically modified corn, widespread use of new technology is often followed by new regulation. And regulators have long struggled to keep pace with the seemingly endless stream of innovation that enters society. It’s not necessarily new technology itself that instigates regulation but rather the refinements that allow it to become widely available to the general public.
The past decade has seen vaporizers and e-cigarettes become widely available and while these products are capable of delivering nicotine in the form of smoke-like vapor, they technically have not met the definition of a “tobacco product” and therefore have been unregulated. Until now that is.

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Medical Device Generated DataIs Device Generated Data part of your medical device plans?

We live in a digital era, and if you are in the medical device design and development business, it may be wise to think digital health. There is an undeniable shift from stand-alone technology to integrated systems even for devices with specialized functionality. Granted, devices with unique diagnostic or therapeutic functionality still have a place in the market place, but those capable of uploading data into a server, the cloud, or even directly into an electronic health record are more attractive to hospital and tertiary care buyers.

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PMO (640x376)The point of  a PMO (Project Management Officer) is to have somebody responsible for all of the actions a company does in project management. The PMO makes sure Project Manager (PM) practices are consistent and there is the right balance of relationship management and technical management. Are we cutting to the chase at the right times, digging deeper at the right times and having a consistent approach to client focus while getting the product right throughout the organization?

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3 budget monitoring strategies to help predict the unpredictableBudget monitoring for innovation projects

As a junior technical project manager, my job is to support senior project managers by monitoring and controlling longer-term projects with large teams. I also manage shorter-term projects with smaller teams. During my first year at StarFish Medical, I have worked on over ten projects with a wide variety of technical focuses and team compositions. I collect and maintain data on project budgets, schedules and tasks in order to help our teams predict and respond to challenges.

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