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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 in separate blogs. Let’s start with Discovery. Discovery At the highest level, Discovery is about: Solving the customer’s problem Ensuring there is a market Establishing technical feasibility Identifying project risks 1. Solving the Customer’s Problem…
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How to Identify and Manage Project Risk

Project risks come in many different forms, from those the project team anticipates to the ones they discover when an unexpected problem crops up. In product development, there are many sources because you interact with so many parts of the organization in order to commercialize the product. However, there are some simple steps you can…
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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 excerpts from an interview with Southwest Airlines’ CEO Gary Kelly, brought out the need to address airline capacity issues on the ground and in the air. Responding to a question on the impact of lack…
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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 sacrificing speed and innovation because it is too hard to get through the process? Current Problem In today’s business world, we frequently see larger or established companies buying new or smaller companies (fast growing) in…
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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 that? Answer: Medical device product launches have some …

Why Usability Testing Matters for Medical Devices

Some medical device product development teams skip usability testing when developing new products.  Reasons include, ‘it takes too long’ or ‘we already know how the product is going to be used’ or ‘we’ll test usability during design validation’.  User feedback is frequently collected by showing mock-ups or through structured data collection, as opposed to usability…
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