INTRODUCTION

Medical device companies are expected to deliver innovative, life-changing medical device(s) at an exceptional pace of development, all while maintaining compliance and achieving true quality - no pressure. 

For the product development and quality teams at these companies, the balancing act of documenting the right things, staying up-to-date with the ever-changing regulations while also satisfying the need to work efficiently and assure scaleable processes is a challenge that can be headache-inducing. 

To help paint a picture of the strategies, tactics, and technologies today’s medical device professionals are using to accelerate product development, ensure compliance, and promote quality, we are releasing the results of our first annual Medical Device Product Development and Quality Management Benchmark Survey.

We asked what it is that helps their teams or holds them back from becoming more efficient and nimble, while ultimately delivering better patient outcomes and positively influencing their company’s competitiveness in increasingly crowded markets.

Survey respondents shared helpful insights and critical information about how their companies are currently managing both their product development and quality activities.

This research report shares the results of hundreds of survey responses from medical device professionals across the globe. 

While the responses in this survey represent companies that span a range of different sizes and stage of development -- from premarket startups with less than 20 employees to large enterprises, we uncovered key indicators of what makes a market leader and what it takes or doesn't take, to get there in 2020 - without all the headaches.