December 5, 2014

Overcoming Barriers to Improvement: A Key Challenge for Medical Device Development

After analyzing the results of this year’s State of Medical Device Development Survey, we identified three key challenge areas within the industry: managing risk, working with documents, and overcoming barriers to improvement. In previous blog posts, we examined what the survey revealed about managing risk and working with documents, and how TestTrack can help with these critical areas. In this post, we’re going to look at overcoming barriers to improvement. When we asked respondents to identify the top three barriers to improving their development processes, they chose budget, validation, and bureaucracy. Top Issues Preventing Improvement


It should come as no surprise that budget topped the list again this year, given the economic issues that continue to challenge the industry. Teams struggle under increasing pressure to reduce costs and get products to market faster, yet they may get pushback from upper management when they request new tools that will help them meet these demands. Fewer companies embrace the “spend money to make money” philosophy, leaving their teams handicapped with outdated development tools. Budgetary belts may loosen in 2015, as the economy continues to recover and the impact of the medical device tax has proven to be relatively small. This may allow companies to invest in new technologies to improve their development processes.

Validation Overhead

The cost and time spent validating new and upgraded systems moved into second place. Only 27% reported it as a top barrier to preventing improvement in 2013. This year, nearly half say it is keeping them from improving their product development processes.


Managers were the only respondents for whom bureaucracy remained the second biggest barrier to improvement, but it was still high on the list for non-management respondents. It's clear that companies need to simplify the complicated rules and processes that stand in the way of improving their development processes.

Streamline with Seapine

When you're ready to improve your product development processes, consider Seapine Software's medical device development solutions. Seapine's integrated solutions help major life science companies manage regulatory compliance initiatives by tracking and linking product development artifacts, verification and validation artifacts, internal validated IT systems, and other mission-critical activities—all without interrupting daily activities. Learn more about Seapine’s solutions for the medical device industry.