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Yuval Yeret

EE Times - Using agile methods in medical device development - 0 views

www.eetimes.com/document.asp

medical agile case study

shared by Yuval Yeret on 08 Dec 14 - No Cached
  • FDA and other regulatory agencies fundamentally want to see that your product has safety in mind. To do so, they require complete traceability through the hardware and software. There is even a fairly new standard, IEC 62304, adopted worldwide that is wholly focused on software traceability from requirements through architecture to tests.
  • Medical devices companies are going primarily agile to respond to change and effectively manage technical complexity by collaboratively building solutions with their partners and customers to ultimately deliver what the customer wants before the competition does.
  • demo the new functionality created after each iteration to your customers, using web-based meets. Using these tools enables you to get immediate feedback from your customers throughout the project. Continuous customer feedback reduces the risk of building the wrong solution. The fact is in most cases you can’t make the release cycle more frequent since it includes giving tests to regulatory agencies. This is a tedious process that makes sure the device is safe. Doing the whole release cycle more frequently can be way too time consuming.
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  • ou could also give a version to select customers as long as it will not be directly used for care or diagnosis on current patients. The idea there is the customer gets the current iteration in house for say a blood analyzer. They could load it with real patient data and test out the new functionality as long as it is not used to diagnose an existing patient, since it has not gone through regulatory
  • agile development has gotten so popular in medical device companies that the AAMI (Association of Medical Instrumentation) is currently working on new guidance for mapping agile to a medical standard called IEC 62304.
  • In conclusion, agile development works and is being used in medical device development. The issue is you need to have a good toolchain that allows for complete traceability across the entire lifecycle in order to comply with standards. It is also very important to integrate and test frequently. This, in turn, leads to the need for build automation. With all of this in place, agile development for medical devices becomes much easier to make work.
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