Suggested Resources for Lean and Agile Product Development

Here are some good online resources: http://www.leanprimer.com/downloads/lean_primer.pdf – good overview of lean principles written by two software management consultants (Craig Larman and Bas Vodde) who include aspects of software agile methods as well. http://theleanthinker.com/ – a blog by Mike Rother with lots of good observations and real-life issues involved in changing an organization to lean http://www.lean.org/ – Lean Enterprise …

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Medical Device Software

Challenges Adopting Agile Methods for Medical Device Software

After more than 20 years, agile methods for software development are well-established, with extensive information and expertise available for anyone who wants to adopt them: https://www.agilealliance.org/ – Agile Alliance is a non-profit organization; good material for beginners (Agile 101) and many articles and links https://www.scrumalliance.org – Scrum Alliance is a non-profit organization; has many articles and links …

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Medical Device Documentation Map

Compiling all of the DHF documentation for a new medical device can be confusing, even for experienced engineers.   That’s why I created this “map” of document interdependencies.   It’s a way to help explain graphically how the many documents fit together for a new product.   Some key points in the map are: Risk analysis …

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Accelerating Medical Device Development with Lean and Agile Methods

If you missed Aaron Joseph’s presentation on “Accelerating Medical Device Development with Lean and Agile Methods”, you can get the slides at http://www.slideshare.net/AaronJoseph7/lean-agile-feb2017patcaajosephss In his talk he shares how medical device companies can take advantage of lean and agile methods for speeding up hardware and software development if they understand how to adapt their quality system …

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Modern Approach Document Files

Don’t Rely on Documents to Manage Your Documentation

Medical device product development involves many design and testing challenges. It also involves the challenge of documentation—writing and managing hundreds or thousands of pages of compliance documentation. The traditional approach to this documentation challenge is to manage the product documentation simply as a set of documents, usually Microsoft Word or Excel files. Figure 1 illustrates …

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video

Accelerating Medical Device Development While Improving Compliance

If you missed Aaron Joseph’s talk “Accelerating Medical Device Development While Improving Compliance”, the material is available as a video. He explores how to accelerate medical device development with lean and agile methods. Companies in multiple industries have found that lean and agile methods speed up their product development while simultaneously improving quality and cutting …

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