Agile and Medical Device Development

Lean-Agile principles and more specifically, the Scaled Agile Framework, can be used to greatly improve the medical device development process. From meeting regulatory requirements like providing complete traceability in hardware and software development to improving the speed and reliability of which updates are tested and released, the benefits of adopting these best practices are well documented.
In order to achieve this however, organizations must take the first step in truly understanding what this organization-wide “transformative” mindset requires.
Join the Continuous Engineering Experts’ Bryan Smith as he welcomes Dr. Harry Koehnemann - SAFe Fellow and SPCT - from Scaled Agile, Inc. to the show, as they discuss how medical device companies can leverage new techniques in agile development to reduce costs, increase productivity and accelerate innovation throughout their organizations.
0:01:50 - What is Agile and how is this different than the Scaled Agile Framework (SAFe)?
0:02:54 - Do you have to be a really large organization to get the benefits of SAFe…or can you be a smaller org.? What’s the sweet spot?
0:04:10 - How massive can the Scaled Agile Framework go? Are we talking a few hundred or even a few thousand engineers here?
0:05:16 - Can you define the terms “Alignment” and “Value Streams” for our audience? What do they mean?
0:09:20 - Can you give us a little background information about the Scaled Agile Framework and how it got integrated with systems engineering?
0:12:20 - How does SAFe deal with documentation (requirements, design, etc.) and testing?
0:14:36 - Let’s talk about a medical device company for example, how can SAFe specifically benefit them with regards to compliance requirements?
0:15:28 - What is the definition of “done” in this scenario?
0:17:36 - What’s the first real step leadership must take in order to get started in an organization-wide “lean-agile transformation”?
0:22:45 - Can you tell us what an Agile Release Train is and how this would apply to the medical device development process?
0:25:15 - You have an upcoming “Executive Briefing” webcast on February 13th that goes a little deeper into how the medical device development process can benefit greatly by adopting SAFe. Can you give us a little preview?
Want to learn more?
Join us on Tuesday, February 13th at 1pm Eastern for a free live webinar and get your questions answered:
How to Revolutionize the Medical Device Development Process in 2018 and Beyond.
bit.ly/321_MedDeviceBriefing

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Great content. Helps provide clarity around how to get started.