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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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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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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 is it different from the current Design Controls? Answer: Design controls were enacted in 1997 by the FDA as a way to improve medical device quality.  However, they observed that products can be fully compliant…
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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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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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Why Integrating Business Elements into Your Medtech Development Process Is So Important with Therese Graff

Therese Graff, Partner at Strategy 2 Market recently discussed why you should integrate business elements into your medtech product development process. Listen to this informative podcast hosted by Greenlight.guru with Therese Graff, Partner, Strategy 2 Market. http://blog.greenlight.guru/integrating-business-elements-into-medical-device-product-development   Strategy 2 Market helps companies increase growth and decrease product development complexity. www.strategy2market.com © 2016 Strategy 2…
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