Leaning Into Change to Transform Medical, Legal, and Regulatory Review

Medical, legal, and regulatory (MLR) review has always been a pain point in life sciences. It’s a rigorous process that must be followed when submitting to regulatory authorities or answering their questions.

That’s the baseline. But it shouldn’t stop you from asking how to do MLR review more enjoyably and efficiently. The key question I asked of my colleagues as I began to transform the process at Exact Sciences was this: Have you considered doing this work in a different way? Any affirmative answer opens the door to change.

First, my goal was to put things in neutral. Not push forward or roll back. Just neutral so we could assess where we were and what we needed to move forward, from new technology to new review roles. Exact Sciences was using different technologies for MLR review in our two domestic business units, as well as in international. We had to get to neutral: one system with one policy and one way of working.

Build a foundation of support

Like any big change, our MLR review transformation wasn’t going to happen all at once and it wasn’t going to happen just because I said so. I needed to build relationships because when you’re putting a system together for a major change, it takes a village. Without it, I knew what the reaction would be: We’re in the middle of a pandemic and we don’t need any more change. Without relationships, it would just be too high a lift. You have to assess, ask a lot of questions, and ask why. And then ask why again.

We started to build a very small but mighty change network. These people were the boots on the ground who really helped us communicate why we were doing what we were doing. It changed our timing and our deployment schedule, but we now have 100% adoption of Vault PromoMats by internal stakeholders and a phased approach to additional change. Using one technology has helped streamline and optimize the workflow, in addition to providing a single source of truth. We can build from that and we will because we still have a ton of opportunities.

Teach more team members to be reviewers

One of the biggest changes we made was who could be a reviewer. When we began, we didn’t have dedicated operational people at the center of MLR review; we had senior vice presidents doing it. When I talked to these leaders, they said they had to do the work. So I asked them to imagine what the review process would be like if they could teach others to look for what they looked for, especially the showstoppers.

That’s a gift of teaching, coaching, and training. But it’s also broadening, expanding a task from one person to multiple people. It’s taken months to get there, but I’m happy to say that we have very few senior senior leaders who still do MLR review, because they’ve gotten to the point of trust. We’ve been able to build dedicated review teams, some are product specific, some are more portfolio. We still look at everything, but at least we’re away from the C-suite.

The runway ahead of us is long, and it isn’t all about technology changes. There are many opportunities that are both systematic and procedural to advance the way that we do MLR review. I look forward to doing that.

To learn more about how Chris Larsen changed processes for MLR review, read a Q&A with her.

The elements presented here are the views and opinions of Chris Larsen, and do not necessarily represent those of Exact Sciences.

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