From our digital archives: Device changes and design history files are integral aspects of design control that work hand-in-hand and should not be overlooked by manufacturers, industry experts said. Firms should keep copious records of design changes that can later be reviewed in a design history file (DHF); otherwise they could encounter what one expert dubbed “change creep.” This happens when a manufacturer makes numerous changes to a product, “and then all of a sudden we have a design that doesn’t even look like the original device,” John Gagliardi of MidWest Process Innovation said in December 2012. Further, firms should ensure that human factors are taken into consideration when design inputs are gathered.

Recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.

Recent executive-level company changes and promotions in the medical device and diagnostics industries.

Device financing dropped more than 40% to $714 million in Q1; Smith & Nephew’s $1.7 billion acquisition of ArthroCare overshadowed acquisitions. Diagnostics companies raised $568 million, a 34% increase over 2013’s final quarter; nonprofits provided assets to diagnostics firms in multiple licensing arrangements.