Medical devices are now becoming consistently smarter and covering responsibilities. A medical device today proving it works perfectly fine when everything goes right tells us only half the story. The other half is equally important: how does the device behave when things go wrong?
Happy Path is the validation for one thing: making sure that the medical device works when nothing goes wrong..
Happy Path is the validation for one thing: making sure that the medical device works when nothing goes wrong. However, the healthcare setting is the place where everything doesn’t always work as expected. Ideally, we can always expect healthcare to be perfect. In real life, it’s not the case. If we observe a regular hospital visit in Canada, it’s always short of staff, stressed staff, irritated patients, and so on. With all these messiness, it is quite probable that the medical device may fail to perform due to the external factors.
When validations only cover the intended workflow, they miss the complexity of the real-world usage. These kinds of failures have been one of the reasons that brought up the requirement for post-market review.
Testing medical devices is not a “nice to have” – it’s a responsibility.
- Paitent with one condition
- Ideal medical equipments
- Clean environment
- Ideal recovery timeline
- Perfect load patterns
A recent retorspective on 14 years data of FDA data for robotic surgical systems has shown thousands of malfunctions including but not limited to electrical arching, imaging failures, unintended instrument activation leading to physical damage. Most of these issues occured due to non-ideal workflows.
- Patient usually have more than one health conditions
- Medical equipments might not be cleared after previous record
- Communicable diseases might not be recognized yet
- Unpredictable recovery timeline
- Medical devices may not be calibrated for minor demographics
Why we ignore off-path testing and why it is dangerous?
- Edge cases are considered in less than 5% in the controlled environemnt. While in real-life scenario, these situations happen more often than expected.
- Medical devices today are more complex than ever, they have embedded software, cloud connectivity, integrated with mobile apps and hospital systems, and generating automated decisions. This means that the permutation and combination might rise exponentially with issue in a single component.
- Medical device manufacturers that target milestones - minimal requirement for regulatory rather than deep-dive in testing.
- A device that performs beautifully under ideal conditions encourages teams to believe it will behave the same in reality.