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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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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 be a medical device. How do we get started? Answer: More companies are being introduced to medical devices. This is a business area that has grown and technology companies provide some fresh perspectives on better…
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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 ……
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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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How To Identify Medical Device Customers and Their Needs

In a previous blog, I covered the importance of identifying all your medical device users and provided examples of some of those users. Once the users are identified, you need to determine how they will use the product and their needs. There are multiple ways to identify the users and their needs. I prefer the…
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Are the best product ideas internally or externally developed?

A burning question from our clients:  Do we get better product ideas from internal professionals, such as engineers, designers, marketers and product management, or from external sources? (Poetz and Schreier 2012)[i], reviewed past academic literature and conducted a study to answer this  question. Arguments range from “A truly creative product idea is outside the scope…
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Fix the process and culture will follow

Over the years, I had clients that complained about their culture, and were looking for a quick fix. I sounded like a broken record but my usual answer was; “Fix the process and an improved culture will follow.” …
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