Maria Fontanazza, Editor-in-Chief, MedTechIntelligence.com
From The Editor's Desk

What You Do Beyond Compliance Matters

By Maria Fontanazza
2 Comments
Maria Fontanazza, Editor-in-Chief, MedTechIntelligence.com

We all talk about cross-collaboration, but do we really practice it?

Compliance is not optional. It’s a phrase that folks in quality and regulatory departments say often, but it applies across the board, throughout every department in a medical device organization. Although this was a common theme at the MedTech Intelligence Integrated Complaint Management conference last week, the conversation surrounding going beyond compliance to understand what makes the other departments tick—R&D, sales and marketing—is a message that resonated.

We all talk about cross-collaboration, but do we really practice it? Do you try to find a common ground with the folks outside of your department to encourage those value-driven conversations? Full disclosure: I cannot take credit for these salient questions. These thought-provoking points were drawn out by Sasha R. Pailet Koff, senior director of quality management systems at Johnson & Johnson, and the audience was quite taken with her remarks. Heads were vehemently nodding, and it got us all to think twice. Koff spoke of driving communication across the business through speaking the same language. Easier said than done, right?

“When it comes to cross collaborating with our partners, the onus is on us to change our verbiage in a way that allows them to be able to listen,” said Koff, who spent the last three years helping Johnson & Johnson’s quality organizations across the globe (the folks who manage complaints) understand how to speak to the company’s commercial organization. “What’s the language that’s going to connect with your commercial partners? What’s the language that’s going to connect with your R&D community that allows them to understand why this information is valuable? Why should they care?”

Translating the value of information to other departments is best accomplished when you truly understand their challenges, and how they think and operate. “When was the last time you left the office and went with one of your sales reps on a ride? When was the last time you went to a sales meeting? When was the last time you sat with your marketing team as they were going through the creation of the next marketing material?” asked Koff. “It’s just as much our obligation to educate them about quality and compliance and quality systems as it is on us to really understand what they’re doing so that we can communicate with them more effectively.”

The message about going beyond compliance is clear. It’s about engagement, and even embedding yourself at points, with colleagues outside of your department to learn how to speak the same language. Through this approach, you can recognize what is possible and open the door to more meaningful conversations about moving your business forward.

How are you engaging and cross collaborating with folks both inside and outside of your organization? And, are there industry resources that you are using to your advantage?

About The Author

Maria Fontanazza, Editor-in-Chief, MedTechIntelligence.com

Comments

  1. Dr. D

    Maria, excellent article. Far too often we quality and regulatory types remain huddled in our own little word. As a consultant, I have learned to cherish the opportunities to actively interface with professionals outside of my own professional areas of interest. The cross-communication has been welcomed and the opportunity to spread the FDA’s gospel on compliance rewarding. Be Well, Dr. D

  2. George Gary Calafactor

    Ms Fontanazza, you are indeed correct. However, regulatory compliance actually starts with top management. Regardless of the company size, if top management (1) is not quality and regulatory -minded; (2) believe that internal business goals, objectives, and policies should trump external laws, regulations, directives, standards, and guidance; and/or (3) roll the regulatory dice and hope that they do not get caught by the FDA or an international governmental health body (maybe because they are hiding something?), cross-collaboration within lower departments will not work. Additionally, if leaders and managers have a ‘us vs. them’ mentality with their staff, cross-communication will also be stifled. These are just a few barriers to quality that will eventually get the downward quality and regulatory spiral racing out of control and the people will not even know what hit them until it is too late (i.e. deaths, injuries, lawsuits, governmental sanctions, etc.)

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