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Medical Devices

The Basics of Medical Device Product Development, Part 3: Commercialization

Product development doesn't end when the product is designed. You still need to launch it properly. Learn the key steps…

The Basics of Medical Device Product Development, Part 2: Development

In a previous blog, we covered the Discovery portion of medical device product development, where the outputs are an understanding…

The Basics of Medical Device Product Development, Part 1: Discovery

We generally divide medical device product development in 3 main pieces: Discovery, Development, and Commercialization. I’ll address each of these…

How to Use ISO 14971 and Project Risk Management Effectively

Medical device companies use ISO 14971 to identify and manage user risks with their devices. However, we often find these…

What Does Airline Capacity Have To Do With Lean?

Observation on Lack of Capacity A recent article in the Wall Street Journal (The Reason Southwest Stopped Overbooking), which contained…

Does Your Product Development Process Make you Anxious?

Is your product development process keeping you up at night? Has it become heavy, taking too much time? Are you…

Simple Understanding of Medical Device Design and Process Verification/ Validation

What Do I Need to Know About Medical Device Verification and Validation Question: What are the differences between medical device…

How to Start When You are New to Medical Devices

Question: We are a technology company with no experience in medical devices. Our company is developing a product which may…

New FDA Focus – Case for Quality

Question: I just heard about an FDA initiative for medical devices, called Case for Quality.  What is it and how…

Launching Your Medical Device Product Doesn’t Have to Be Complicated

Question: Introducing medical devices to the market seems more complicated than product launches I’ve done in other industries. Why is…

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