Case-study-background

Blog

Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.

Today’s Medical Device Environment: Using Virtual and Outsourced Documentation Teams

Novatek’s technical writing team works with Janssen Diagnostics, part of the Johnson & Johnson family, to ensure regulatory compliance in their medical device labeling worldwide. In this interview, Julie Willmes, Manager of Global Labeling, Planning and Implementation at Janssen Diagnostics, LLC, shares her insights on industry trends and their impact on documentation needs for global products.

janssen_logo.jpgJulie, you’re responsible for both documentation and internal training of Janssen’s diagnostic product line worldwide. What challenges are you planning for in 2016?

The environment is changing, no doubt. Product line changes and regulatory changes will have the largest impact on our team’s work this year. We are balancing the need to keep documentation up to date to meet regulations, while carefully assessing whether some improvements are necessary in the long term, as products near the end of their lifecycle.

All new product launches have a common thread: they’re designed to be easy to use, and universal. Their documentation and training must be, too. The trend is toward pictograms, demonstrating how to perform a procedure with no text. This can eliminate translation, minimize future updates, and provide a more leverageable asset for product families.

You have worked in many aspects of the medical device industry over your career. What trends are you seeing in organizations today?

The shift toward virtual teams seems to be here to stay. Studies demonstrate that working from home makes for a more productive workforce, and it is certainly true here.

What’s the key to making a virtual team model successful?

Using the tools at hand. We use screen-sharing for nearly all our meetings, and web cams really help us to build relationships with face-to-face time. It’s important to look for what’s next.

This work practice also makes outsourcing much more successful.

Are outsourced technical writers a significant part of your team?

The outsourcing model helps us to drive out cost from documentation and training. Though offshoring is common in the industry, it can create a risk of quality issues. Long term relationships are very important to building expertise and managing risk.

You’ve worked closely with Novatek technical writers. What is that outsourced relationship like?

It’s quite different. We have a long term relationship with the employees of Novatek. They become the expert. Their technical writers are integrated into our documentation team, product lines, and culture. This has been very successful, and eliminates the misinterpretation and mistakes possible with other vendors.

For more insights from other market-leading companies...

Download our State of Knowledge report

Download Report

Topics: outsourcing, documentation

 EU MDR