Case Study : Medical Product in Repeated Failure Mode

Medical Device Regulations

How to Get Through Clinical Trial

Challenge :  It's one of the worst situations. You've got beyond design, build and prototype. You've told The Board the product's ready. Now it's in clinical trial but everything is going wrong. It's a situation we're not unfamiliar with, one we've seen many times. In this case we were invited in to bring perspective and get things moving. It often happens that the developers, who know the code backwards, end up not seeing the wood for the trees. They've seen the code too many times, debugged it a thousand, and now, frankly, they have had it. Plus the pressure is building. In this particular case, the clinical trial was a key element of the Usability and Validation for the product's clinical diagnostic functionality. The company wanted to get the product to market but the trial was repeatedly uncovering instabilities in the software. The confidence of the clinicians was noticeably dropping. Not a nice place to be.

Approach : When we analysed the situation, it soon became apparent that each new bug fix was introducing new 'unwanted' features into the product. The root cause was ambiguity in the specifications so some members of the development team had different interpretations. At this level even small differences in understanding can create major problems. We worked with the team to address key points including a lack of unit testing in certain critical software functions, lack of regression testing, loose technical specifications, and test protocols. Oh, and not enough attention to the ISO 13485 and IEC 62304 regulatory standards.

The end result :  The company re-organised the development team based on UDAs contribution of a tightened up design, new specifications, and test protocols. A significant step improvement was immediately seen in software stability and reliability. A rapid increase in clinical confidence based on improved performance lead to the company being able to push ahead with the manufacturing plan.