Is Software a Medical Device?

Posted on May 23, 2014 by rcain

Is software a medical device? This is a question that is asked more frequently today than most had expected when the FDA published the Glossary of Computer Systems Software Development Terminology in 1995. The innovation acceleration rate of software development within medical products and services has been beyond even the most optimistic viewpoint of any industry analyst.

To put it in perspective, 1995 was the debut season for the TV show ER, which over its fifteen Golden Globe and Emmy award winning seasons had to make adjustments to the plot and scripting narratives to account for the technological changes within emergency medical centers. If you are not a fan of network TV or pop culture, then you may remember this was the year that IBM officially demoted the suit and put the corporate stamp of approval on “Casual Friday.” Soon after you were replacing your $50 slacks with $100 designer jeans and wondering if America had just invented another holiday to increase retail sales.

The launch of the world wide web in the 1990’s was a significant event in the ever-accelerating rate of technology adoption, enabling the dawn of big data and subsequently radically altering the manner in which patients researched medical information and communicated with healthcare providers. So much so that Continue reading →

Are Your Medical Devices Ready for the RoHS Recast Directive?

Posted on July 25, 2013 by rcain

In just one year, on the 22nd of July 2014, the RoHS Recast Directive for manufacturers and importers of medical devices will become law and all devices must be compliant or lose their CE mark.

It is hard to believe that it has been eleven years since Europe exported the RoHS Directive and the TV show American Idol to the United States. I find it interesting that over a decade later both are being re-branded to reach new markets and objectives. American Idol recently leveraged its loyal base of followers to successfully spawn the new hit show the X Factor and the RoHS Directive, well let’s just say it has been on a different journey.

Way back in 2002 the Commission of the European Union (EU) passed legislation
restricting the use of hazardous substances in electrical and electronic equipment EU Commission (RoHS Directive 2002/95/EC) and promoting the collection and recycling of such equipment (WEEE Directive 2002/96/EC). The legislation provided for the creation of collection schemes where consumers can return their used e-waste free of charge with an objective of increasing Continue reading →

Is Agile Management a Medical Device Innovation Solution?

Posted on February 26, 2013 by rcain

During the 1990′s the global business community was investing enormous sums of money on the automation of resources leveraging advancements in modern technology and systems software (Boom and Bust in Information Technology Investment), as well as supporting the consolidation of organizations via mergers as a means of gaining competitive advantages. Failure was commonplace and despite the subsequent increase in investments, firing of personnel, and executive leadership support, the business community continued to fall short in their efforts to produce innovative advantages. Big stakes for the international economy were at hand, so something had to change.

In February 2001 software developers met at resort in Snowbird, Utah to discuss lightweight development methodologies as a potential alternative for traditional heavyweight waterfall methods, which several were beginning to suspect as a contributing factor for why so many project teams were failing to provide the continuous innovation objectives their business management teams were demanding. The group gathering in the Rocky Mountains of Utah understood that early lightweight development methods were born out of challenging requirement projects; from the Easel Corporation project that helped spawn the SCRUM methodology in 1993 to the Chrysler Comprehensive Compensation System (C3) project that was credited with creating the Extreme Programming methodology in 1996. As the group of software developers discussed these case studies and analyzed other similar lightweight methodologies such as the Rational United Process (RUP), Crystal Clear, Adaptive Software Development, Feature Driven Development, and Dynamic Systems Development (DSDM), a common theme was emerging. Continue reading →