Since 2011, medical devices have become increasingly sophisticated, and as the level of sophistication has increased, so has the time needed by the FDA to assess complex 510(k) medical device submissions (the majority of which are class 2 devices). Most recently in 2015, the typical FDA approval process had grown to between 9-12 months. In the best case scenario it could be completed within 3 months, therefore poorly prepared FDA submission increases the cost of both bringing a device to market and any potential failure to do so. This increasing level of risk and complexity is of particular concern when you consider that the majority of delays could have been prevented despite the increased level of complexity.
The number of 501(k) medical devices approved in 2015 was the lowest in 5 yrs. Inadequate documentation is a leading cause of delay. Let us break down this statement a little further.
Why is Medical Device Development reliant on Embedded Electronics?
Medical devices are more complex because they are increasingly reliant on embedded electronics for sophisticated features that in turn are reliant on the software developed for the device hardware. Without the software, medical devices are useless. Ergo, inadequate documentation means inadequate software development documentation throughout the Application Lifecycle development process.
In application development speak the failure to adequately record medical device project requirements and any change in those requirements as well as any related testing data is a key problem. Of particular note here is that project requirement changes cannot change the initial intended therapeutic use of the medical device. Today most embedded development teams use Agile Development where the emphasis is on managing constantly changing requirements, – expected change, this is perhaps why manufacturers are often vague about defining the medical device use upfront, using the flawed logic that the more information they put down at the beginning the more likely they are to trip themselves up, during the FDA submission process.
The consequence is often a failure to adequately describe the product, which in itself is a major problem. Without a detailed description of product use, the FDA has little means by which to identify whether the documentation supports the intended use. What this means is that there is no way to test the final product effectively, – test it against what?
Another problem caused by an inadequate description and documentation of changes to product requirements is that it makes it difficult to identify whether the product fits into the specified category of products, i.e. can it be compared to other similar products within that category of products. For example, where a device deviates from the typical features set of like devices, there is difficulty in establishing whether the new features raise new questions relating to safety and effectiveness or not.
Premarket notification submissions with inadequate descriptions or missing testing data delays FDA review until such time that it can be supplied. The failure to supply performance data is also a common problem since without it the FDA cannot establish whether the device under review meets the required performance requirements for the type of device.
Perhaps the greatest of all failures is that of failing to abide by industry guidance or widely accepted standards, for which within the medical device development arena,- there are many. Indeed this failure often leads to many of the problems mentioned above (extensive list). Often the cause of delays is disorganization, ie the data exists but is miss filed, poorly recorded or updated (ie, changes to the initial plan).
The Solution: Medical ALM Software
A system must be put in place to trace and track document access, recording content changes (documents management), including all related materials – automatically. In software development terms, these document change dependencies are referred to as artifacts. Both documents management and requirements management are essential to the development process makes compliance to standards almost automatic, ensuring that when audits are done, that the required data is complete and easily accessible throughout the application development lifecycle.
Various software development tools can assist with these aforementioned problems; however, few of these have been designed with medical device development and the associated industry standards in mind. Most manufacturers use Product Lifecycle Management (PLM) software but this not sufficient to meet the needs demands and complexity of software development, where PLM is being used it must be integrated with the appropriate solution, which brings us to ALM Software.
Often referred to as ALM software in short, its long name clearly defines its purpose (Application Lifecycle Management Software). Medical ALM provides the features necessary for medical device development as well as support for industry standards. Where PLM is being used, it can be integrated with leading ALM software with the assistance of features such as Soap API, and Business Process Management.