Survey of 270 professionals shows only 38% “Very confident” they could pass a surprise audit; productivity and visibility challenges from manual development processes also raised
MINNEAPOLIS, MN, April 23, 2019 — Perforce Software, a provider of solutions to enterprise teams requiring productivity, visibility, security, and scale along the development lifecycle, released the results of a global survey of medical device professionals today. Key findings suggest ongoing struggles with manual development, a trend-bucking shift toward hybrid development methodologies, and decreased confidence in audit compliance.
For teams that changed development methodologies in the past year, nearly 40% of them adopted a hybrid Agile methodology — moving away from Scrum (pure Agile method) and Stage-Gate, a proprietary Waterfall method.
“Agile development has grown in popularity in recent years,” says Nico Krüger, Chief Technology Officer of Perforce Helix ALM. “It appears, at least for medical device developers, that perhaps pure Agile is not a final destination. Rather, a temporary stop along the way.”
Of those who changed methods, 75% were satisfied with the results. This shift is logical, according to Krüger, who added, “Given industry demands for both control and speed-to-market, an Agile hybrid can offer a more natural fit.”
While the use of specialized ALM tools has increased, survey results also show a majority of respondents (59%) use a predominantly manual development process (documents and spreadsheets) for managing the lifecycle.
Manual processes may be contributing to a host of productivity, visibility, and compliance concerns noted by respondents. Concerns ranged from wishing they spent less time tracking down project status (41%) to desiring they had more visibility into design control phase activities (44%) to decreased confidence in audit compliance (only 38% “Very confident” they could pass a surprise FDA audit).
In all, the report — which includes further insights on emerging technology, coding standards, and upcoming regulations — sheds light on an industry striving for balance between regulatory challenges and the need for innovation in a fast-changing market landscape.
“Nearly 270 medical device professionals shared their opinions on development today,” said Krüger. “By sharing their results, we hope to help others navigate industry change, and take positive next steps toward better medical device development.”
The results of the survey are available in the 2019 State of Medical Device Development Report.