Author: Novarum DX
As the FDA issues the 5th recall for a diabetes management app, diagnostic app manufacturers may be wondering what could they do to avoid finding themselves in a similar position?
The diabetes app includes a feature designed to calculate an insulin dose based on various input parameters including a blood glucose measurement. Risk driven design approaches would clearly indicate that any part of their solution involved in calculating a medicine dose is a high-risk element of the system. In this case, confusion over the units of measurement, caused by changing the phone’s regional settings introduce a potential error. It is important that engineers developing Mobile Medical Apps (MMAs) understand both the medical implications of errors and the way that the platforms they operate on work – otherwise their risk assessment and mitigation will be misplaced.
Creating medical device software doesn’t stop when the developer compiles the code. Verifying that the code operates correctly in all the possible circumstances is a key stage in both IEC62304 and the FDA’s 11 steps for medical device software validation (described in our regulatory white paper). Manually testing software with every possible range of inputs and system configurations is time-consuming, expensive and so tedious that the potential for errors is high. With usually many versions of software being produced before a release candidate is available, these issues can become further amplified. Robust testing of software can often be better achieved by automating testing processes enabling, for example, the same test suite to be run using every regional setting on the phone where this has been identified as a risk.
Of course, it’s almost impossible to pre-empt every possible bug that might be found in software and it is essential that you are able to react constructively to issues that arise. Whether it is adding new features, fixing bugs, or coping with operating system updates it is almost inevitable that MMAs will have new versions released over time. It is important that MMA developers consider how best to roll out new versions to affected users and ensure that any revoked or recalled versions are removed from circulation as quickly as possible. Experienced developers working across regulated environments are likely to have well established processes in place for managing all of these challenges.
We hope you enjoyed our blog. The views expressed in this blog are those of the author. If you would like to learn more about Novarum™ smartphone technology and our mobile medical app development, make an enquiry: email@example.com