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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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Why Traditional Strategy Does Not Win

Many firms are experiencing the limitations of traditional approaches to strategy as their businesses change due to new technologies, new global competitors, the creation of whole new industries and changing customer needs. Some of the symptoms include:…
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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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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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How Many Design Reviews Do I Need for Medical Device Product Development

Question: How many design reviews are required during medical device product development? Answer: There are many factors that go into determining the number of design reviews needed.  21 CFR Part 820 and ISO 13485 both require design reviews (Additional information is also found in FDA Design Control Guidance for Medical Device Manufacturers and in ISO/TR…
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