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@ShahidNShah

FDA

A collection of 4  Posts

How to tackle vague requirements in health IT and medical device software using fuzzy logic and storytelling

These days it’s pretty easy to build almost any kind of software you can imagine — what’s really hard, though, is figuring out what to build. As I work on complex software systems in government, medical devices, healthcare IT, and biomedical IT I find that tackling vague requirements is one of the most pervasive and difficult problems to solve. Even the most experienced developers have a hard time building something that has not been defined well for them; a disciplined software requirements engineering approach is necessary, especially in safety critical systems.

Shahid N. Shah

Writing safety critical software using an agile, risk-based, approach should be the norm in modern medical device development

I first started using and mentoring developers on agile software development techniques like eXtreme Programming (XP) and Scrum over a decade ago. Often called “lightweight” methodologies, agile software development lifecycles have been generally misunderstood as lacking enough rigor and sophistication to be used in safety-critical systems. Many have erroneously assumed that Agile, Scrum, and related methodologies can’t really be implemented in risk-focused “important” industries like medical devices because they believe only classic waterfall will be accepted by the FDA.

Shahid N. Shah

FDA’s new draft guidance on mobile apps and what it means to health IT vendors

The FDA released the (currently non-binding) “Draft Guidance for Industry and Food and Drug Administration Staff on Mobile Medical Applications” earlier this week. I knew many of my clients and readers would be asking about the ramifications of this new guidance so I read the document as soon as it came out. In general I was impressed by the FDA’s balanced approach to patient safety and their desire not to stifle competition; overall I thought they were not looking to overreach their purview and I think they succeeded (except for the part on clinical decision support, discussed further below).

Shahid N. Shah

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