Rising concerns about managing risk and proving compliance in the medical device industry

Perforce Software released the results of a global survey of medical device professionals. Key findings show increased concerns for mitigating risk and proving compliance during the development process.

“Balancing compliance and risk management with fast-paced innovation is a tough challenge for medical device developers,” said Tim Russell, Chief Product Officer, Perforce. “This year’s survey results illustrate how well respondents are addressing the challenge.”

Proving compliance and passing audits is critical in the medical device industry. Just 46 percent of the respondents were confident that they could pass an FDA audit.

Managing risk remains a concern as well, with 24 percent of respondents struggling with risk analysis. Many still use Microsoft Word and Excel to document development processes, which makes it difficult to manage risk.

More medical device teams (49 percent of respondents) are embracing Agile development to accelerate product delivery. Adopting the right tools will aid Agile development and provide traceability. This can help teams manage compliance and risk.

Innovating in the medical device industry can be difficult. Heavy industry regulations are a known challenge, and 57 percent believe that regulations get in the way of innovation. Using the right tools will help development teams free up time to innovate.

“Nearly 200 medical device professionals shared their opinions on development today,” said Janet Dryer, CEO, Perforce. “They want to keep up with technological trends, prove compliance, and innovate. By sharing these results, we aim to help others in the industry take positive next steps toward better medical device development.”