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Designing Medical Devices for All Users

Who is the user of your medical device?  We often design our products with either the end user or the major skilled user (such as a physician) in mind. Medical devices are often touched by someone in addition to the final intended user.  As medical device designers, we need to consider all the different users […]

What Does a Pretotype Have to Do With My Medical Device?

What is a pretotype Have you heard of pretotyping?  It means to test the initial appeal and actual usage of a potential new product by simulating its core experience with the smallest possible investment of time and money.  In other words, “Make sure you are building the right IT before you build it right.”  The […]

Exciting Times for Medical Devices

Have you noticed how the medical device world is changing?  It’s an exciting time.  After years of improvements to the same primary product categories, we are now seeing an explosion in the number of new and different products. Below are some of the things that seem revolutionary. Explosion of custom devices such as prosthetics, invisible […]

Why You Should Use Prototypes

Why Use Prototypes Why do you use prototypes? To better understand the customer? To determine whether the technology works? To see whether your product concept is manufacturable? All of these are valid reasons to use prototypes during product development.  However, sometimes companies wait until late in development to collect feedback.  They often think the prototype […]

Stop Using Medical Device Design Controls as Your Product Development Process

Some companies use medical device design controls as their product development process. In this article, we discuss why design controls should be a subset of the product development process and how to integrate design control

Post-Launch Surveillance

Question: I’ve heard that the FDA wants medical device companies to take a more comprehensive view of product life cycles.  However, we are not sure what is expected from the regulations and how they might integrate into our product development process. We are currently using a phased and gated product development process.  Can you provide […]

Show the Benefits of Medical Devices Using Health Economics

Integrating Health Economics into Medical Device Product Development Healthcare costs continue to rise at rates higher than inflation.  Payers, such as Centers for Medicare and Medicaid Services (CMS), insurance carriers, and even provider purchasing organizations (e.g., a hospital purchasing group), need to control their costs; while users want the latest technology.  Before adopting new technologies […]

Beyond the Risk Management File

When we work with medical device companies we find that the Risk Management File (required by regulatory bodies and specific to user and patient safety) is integrated into the product development process. However, project risk is often ignored or is a one-off risk exercise that is rarely revisited throughout the project.  If you don’t manage […]

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