Voice of the Customer

One of systems engineering’s core functions is to understand the user needs for a product or service, and seamlessly translate those needs into design requirements. We’ve helped our medical device customers do this for many years. A complete set of user needs is worth its weight in gold, as it minimized surprises during validation which may include product redesign!

Recently, we’ve begun “practicing what we preach,” to better understand our customers needs. Once we have fully vetted our customers’ needs (overlaid with the business and employee needs), they can be translated into our product and service offerings with a sound justification. My favorite process is still “Voices into Choices: Acting on the Voice of the Customer.” I used this process back in my days at Covidien (now Medtronic). It’s out of print, but available used for a few bucks. We’ve just started defining our objective statement and identifying our matrix of customers. We’ve identified some unique areas of exploration, even before speaking with our first customer.

We wrote a paper on using Voice of the Customer in medical device development. Check it out here.

Thoughts on Agile in Healthcare

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As noted in my previous blog post, I attended and presented at the INCOSE Conference on Agile in Healthcare last month. Here is my presentation. It was great to hear perspectives on being agile in healthcare product development, and discussing best practices with many thought leaders from major medical device manufacturers. I picked up two ideas that I’d like to investigate further and integrate into CMD’s┬áprocesses as it makes sense.

First was the concept of agile practices in hardware development. While I don’t think a full-on scrum methodology makes sense for hardware (though it can be done with modified sprint cycles), I do appreciate the simplicity of a kanban-style backlog and project management process. In addition to kanban, I received some great insight on how to better integrate software and hardware development into sprint cycles.

Second, I’d like to investigate the SAFe agile framework further (P.S.: not an endorsement of SAFe). SAFe extends agile methodologies to the project and enterprise levels. A couple of medical device manufacturers with highly mature product development processes are using SAFe (or customized versions of it). It requires a good bit of tailoring to fit within a Quality Management System, but if done well, I think it has great potential for developing and maintaining a streamlined portfolio of safe and effective products.