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Why You Should Use Prototypes

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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…
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How to decrease the paperwork you loathe in product development

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“Too much paperwork!” is the one of the most common and most passionate complaints we hear from our clients. The project team loathes creating it and the decision-makers loathe reading it. They don’t see the value. Yet typical product development processes requires voluminous documentation. Why so much paperwork? 1st… to make sure nothing is overlooked,…
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Got a Technology Strategy?

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Technology is another one of those nebulous terms that are hard to pin down.  You may immediately think of sciences in the laboratory.  But technology is the application of science.  The key feature of science is that it is systematized.  There is a body of knowledge, processes, and rules about how something behaves. “Technology is…
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Is Your Design Review a Tool or an Afterthought?

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Introduction Your medical device product development team has been designing the latest product and you’ve been reminded that you need to hold a design review.  “It’s required by medical device design controls,” one of your colleagues points out.  You sigh and start planning to hold the design review. Why Hold a Design Review Both FDA…
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Hurry up and WAIT – Pitfalls of the Phased and Gated Process

phased and gated process, lessons learned, batching, queueing theory, wait, queue size, batch size, product development, new product development

A phased-and-gated process suffers from speed issues, read on to learn more. ……
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The Myth of Doubling Down

Enforce product development process

It is tempting, when witnessing a failure of product development, to blame the people. Why? And what is going on? Read on …….
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Stop Using Medical Device Design Controls as Your Product Development Process

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Overview Product development is a complex process, which requires integration of business and technology to deliver a successful product.  Medical devices must also follow the requirements of design controls, which are based on engineering best practices for product development.  We often see companies using the required elements of design controls as their product development process,…
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When Expertise Trumps Authority

decentralized decision making

Decentralized decision making can speed product development, as well as, improve adaptability and ability to react to market changes….
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The Multiple Personalities of Risk

risk terminology

Let’s eliminate some of the vagueness around what we mean by risk with some definitions: assumptions, hypotheses, degree of uncertainty, risk and risk attitude….
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The Product Development Pipeline: Shifting the Bubble

Product development pipeline

Part of product development is establishing a pipeline of projects that ensure a steady supply of new products delivered over time. Often the pipeline gets clogged, slowing down the delivery of new products. In the short case study below, we discuss one set of solutions to unclog a pipeline. Product Development Case Study Case Study…
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