Eric Sugalski, Founder and CEO, Smithwise, formerly Boston Device tells us what’s in store for the medical device sector in 2014?
In 2014, the medical device industry will see increasing interest in “agile development,” a process of iteration that has become a mainstay in software development. Rather than following the standard waterfall process, teams will rely on “sprints” (rapid iterations) to achieve functional embodiments of medical devices.
While these sprints may lack extensive up-front analysis, this way of working promises several advantages. Working in sprints enables the early discovery of flaws. Realizing these issues sooner allows teams to change directions without spending excessive time or money on a pre-selected pathway. Overall, agile methods will facilitate higher quality devices in shorter periods of time.
However successful, this shift will also create new obstacles. Medical device development requires a documentation trail that can be time intensive and prevent sprints from progressing at their optimal pace. Furthermore, verification requirements may slow down the sprint process. Quality system methods and documentation will need to adapt to be compatible.
Despite these challenges, we welcome the increasing implementation of agile processes that reduce costs for medical device manufacturers, increase product quality, and accelerate the path to market.