product innovation blog

Simple Understanding of Design and Process Verification/Validation

Simple Understanding of Medical Device Design and Process Verification/Validation

What Do I Need to Know About Medical Device Verification and Validation Question: What are the differences between medical device ...
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How to Start When You are New to Medical Devices

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 ...
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New FDA Focus – Case for Quality

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 ...
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Launching Your Medical Device Product Doesn’t Have to Be Complicated

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 ...
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Why Usability Testing Matters for Medical Devices

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 ...
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How To Identify Medical Device Customers and Their Needs

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

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.  ...
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Medical Devices Undergo Extensive Safety Testing; Is This Really Necessary?

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 ...
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Regulatory Requirements Do Not Prevent Integration of Lean and Agile Methods into Medical Device Product Development

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 ...
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Medical Device Companies: Ten Tips on Nailing Down Your Requirements Early

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 ...
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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 ...
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medical device design controls and product development

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 ...
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Balancing Medical Device Innovation and Clinical Trial Obligations

Balancing Medical Device Innovation and Clinical Trial Obligations

Product development is about delivering products to the customer, which contain the features and quality that they are willing to ...
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Human Factors – Changes You Should Know and Why You Should Care

Human Factors – Changes You Should Know and Why You Should Care

The FDA issued a new guidance, Applying Human Factors and Usability Engineering to Medical Devices in early Feb 2016.  On ...
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Integrating Business and Design Controls in Medical Device Product Development

Integrating Business and Design Controls in Medical Device Product Development

Product development is a necessary function to grow your company.  However, medical device product development often focuses solely on following ...
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Day in the Life of Leaders in Healthcare Innovation

Therese Graff, Partner at Strategy 2 Market, will be speaking at an event sponsored by [email protected], Booth Healthcare, Graduate Women in ...
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What Can We Learn from the Theranos Experience?

Theranos, a blood testing laboratory, has been the subject of media scrutiny after a number of articles were published in ...
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Design Controls: Just Good Design Practices

In the world of medical device product development, we often hear complaints about the burden of design controls.  However, when ...
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Designing medical devices for all users

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

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 ...
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