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Strategy2Market
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Product Development System Experts
Product Development System Experts

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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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As consultants, one trait we see is the inability of managers and leaders to make a decision. Consequently, a number of issues occur because of a manager’s indecision. For example, a project continues to fester in development, and everyone knows it should…

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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…

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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 rules that must be followed.  In some ways they are similar to…

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7 Key Questions When Developing a Powerful Value Proposition

We recently asked a project team to describe the value proposition for their new product. From the broad range of responses we received, it was obvious that team members differed substantially in their definition of what constitutes a value proposition.…

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“I’m so sick of office politics.”

I recently rediscovered an article that reminded me of why “office politics” exists: it comes down to Powerlessness.

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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…

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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…

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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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Who is your medical device customer?

When determining the user needs for your medical device, you must design for your customer.  There is a natural tendency to focus on the target user of the device.  Who is your customer?  The answer to that question is more complicated. Below are examples…
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