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Newsletter V. 2020 Issue 1

The world as we know it is changing. Covid-19 has created huge disruptions and it’s harder than ever for teams to effectively communicate and develop new medical devices. Business collaboration and decision making are increasingly difficult. Fortunately plenty of organizations and companies are broadcasting new tools for collaboration. Maybe you’ve seen ads on LinkedIn for company intranet services or tips for effective Zoom meetings.

There seem to be fewer resources geared towards the basics of effective decision making. Sean Murphy’s post on “Making Business Decisions in Uncertain Times” provides a practical guide to forming business plans and a list of additional resources.

New product development is a business challenge where many decisions need to be made in an environment of uncertainty.  Product requirements are essentially a series of decisions about a new product, and the temptation under business pressures is to rush those decisions in order to complete a milestone. The danger is that product designers may then be arbitrarily constrained to a hastily written document–a document that is given much more authority than warranted. And much later in development a consultant like myself is brought in to help resolve problems with V&V testing, only to discover that the root cause was a poorly written requirements document created months or years earlier.  

It should be one of the easier tasks of product development–just write down everything the new product needs to do and move on to actually designing it.  However, the reality is much more complex and through seemingly insignificant misunderstandings, product development teams make writing and managing requirements more arduous than necessary.

This new blog post aims to demystify product requirements, guiding development teams on some key considerations in creating and utilizing requirements.


The presentation that Roger Tang and I gave at MD&M West last February titled “The Two Mindsets of Successful Medical Device Development” was well received.  This short animation illustrates one of the key concepts from our presentation:  The Alien Approach to Product Development

May 30: 7 Steps to Project Success Workshop: One Day, One Month, One year 

Details and registration

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