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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 ……
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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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7 Steps to Integrate Medical Device and Lean Product Development

In a previous blog, we covered why medical device companies often don’t use lean product development with their product development.  You’ve thought about it and made the decision to try using lean product development.  The objections from Quality and Regulatory are many.  You know there must be a way, but you just need some help…
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Medical Devices Undergo Extensive Safety Testing; Is This Really Necessary?

As part of ongoing efforts to encourage more physical activity among children, McDonald’s added the “Step it” fitness tracker to Happy Meals.  After only a few days, following reports of skin irritation caused by the wrist worn fitness tracker, McDonald’s decided to remove the fitness tracker from Happy Meals. In July, 2016, the FDA released…
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Regulatory Requirements Do Not Prevent Integration of Lean and Agile Methods into Medical Device Product Development

Lean and agile are frequently used terms in product development.  The advantages of these techniques to improve time to market are well known.  Some medical device companies feel that lean and agile techniques cannot be used because of design controls.  However, the regulations don’t prevent the use of those techniques during product development. In the…
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Medical Device Companies: Ten Tips on Nailing Down Your Requirements Early

Medical device product development teams often think they need to have all the customer requirements and design inputs defined when they enter design controls. In this posting, I’ll explain to you why it isn’t necessary to have them completely defined upfront and ways to add more detail over time.  In our experience, we find teams …
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