Tag Archives: AAMI

Two little words… many interpretations

Risk Management…

… Two words that can elicit impassioned debate and sharp disagreement within an organisation, even with ISO 14971 in place to help!

We’ve been working closely over the past year with some of the world’s largest players in healthcare (and some of the smallest too) on just this subject.  Unsurprisingly, each organisation nneds a different flavoured way to identify, evaluate and control risks during development.  Now comes an opportunity to both share our (anonymised) experiences and learn from others in the field, as I (Matthew) get together with industry peers, AAMI and FDA later on this month at a Risk Management Summit in Washington DC.

The goals of the summit include:

  • Build a shared perspective on risk management among the diverse stakeholders who have roles in its application in healthcare technology
  • Identify barriers that are holding us back from that shared perspective and generate ideas for removing the obstacles.
  • Develop a shared plan for growing the discipline and practice of risk management in healthcare technology.

I’m looking forward to the summit and the opportunity to visit with friends who’ve moved to the DC area since my last trip.  If previous experience is any measure, this summit should be lively and deeply informative.

If you’re attending too, let me know, perhaps we can meet up over coffee or lunch.


We produced a summary report from our last summit meeting, let us know (*protected email*) if you’d find a summary of the Risk Management Summit of use.

What difference does a year make?

A little over a year ago, I was fortunate to be involved in the AAMI/FDA summit on healthcare technology in the home setting, in Washington DC. Over the course of two packed days, the summit developed 5 calls to action:

  • Deepen all stakeholders’ understanding of use environments—and their remarkable variability.
  • Coordinate multiple and recurring transitions in care to improve patient safety.
  • Adopt a systems approach—encompassing people, workflows, therapies, technology, and payment—to redesign the full spectrum of healthcare in nonclinical settings.Remember the patient front cover
  • Standardize and simplify.
  • Design with empathy.

[If you’d like a refresher, please read my blog about the meeting, or click on the “Get in touch” tab (to the right) for your copy of our report on the summit, which highlighted key industry concerns and clear actions to resolve them]


Fairly dry stuff, so what’s actually changed in the 14 months since then?

There’s a growing realisation amongst developers of the breadth of locations where their products could be used. A realisation that is important to designing and developing the right devices.

Much activity is visible in the US healthcare system to streamline the multitude of transactions and hand-overs that exist in patient care, in large part a result of the burgeoning adoption of a systems approach to healthcare technology. Indeed, many of AAMI’s news items in 2014 were about integration of health IT systems with patient care, and standardisation of interfaces. Perhaps when we look back in 2-5 years, we will see the fruits of all this, with greater interoperability between devices.

Recently published guidance from the FDA goes some way to requiring better understanding of at least 3 of the summit’s calls to action. “Design Considerations for Devices Intended for Home Use”, recognises the unique risks and challenges the non-clinical setting presents for many medical devices. Usefully, the agency have suggested several considerations to help minimise these risks during device development. As a natural consequence, there’s now the expectation that organisations demonstrate how they’ve considered and addressed these risks, as part of the pre-market submission.

More on this topic in a future blog…

Where next?

Even the casual observer will have seen an explosion in “health” and “wellness” related smartphone apps and tools to support managing diseases better. That’s great for the tech-savvy, however this must be balanced with the realities that for the agegroups most likely to need such support;

  • Less than 30% of wealthier adults over 65yrs own a smart phone,
  • Less than 10% of poorer adults in that age group own one.

So smarter technology isn’t always the answer.

You may not be surprised to learn that Human Factors lies at the heart of the changes required to overcome the barriers. That’s not just HF in development of devices, but also in healthcare management technology, and the challenges presented by more and more devices (and combination products) being used alongside each other, in the home setting. It’s also about greater understanding of, and empathy with, the eventual users.

How can you best make your product ready for the future where use outside the clinical setting is the norm?