Software as a Medical Device – the Black, White and Grey

Unlike other fields, the medical device industry is bound by the regulatory constraints of the region in which the device is marketed for use. Historically, these regulations have been applicable to medical device manufacturers, however, the regulatory bodies have recognised the shift in changing technologies and now healthcare providers are being bound by these regulations. As a result, the recent European Medical Device Directive amendment (2007/47/EC) and the Food and Drug Administration (FDA) Medical Device Data System Rule directly refer to the role in which healthcare delivery organisations play in the safe and reliable performance of medical devices.
Of particular concern to regulatory bodies is the rise of mobile platforms used in healthcare environments. In and of themselves, these devices can act as e-readers containing medical text books which  clinicians can refer to, however, a number of these devices connect to internal healthcare networks which could inadvertently cause conflicts on the network. The FDA has provided specific guidance which medical device mobile application developers can follow when producing regulatory compliant software. Despite this, confusion remains amongst application developers and healthcare providers as to where the liability resides.
Ireland is one of the largest medical device exporters in the world. The medical device markets are typically dominated by large medical device organisations such as GE and Siemens. These organisations suffer diseconomies of scale i.e. slow to react to change.