Back by popular demand: Philip Desjardins and this RAPS Convergence session

RAPS Convergence is where the world’s regulatory affairs community gathers to share expert insights and create meaningful connections. We’re talking to the speakers behind this year’s event to get the inside scoop on the topics everyone will be talking about and their tips for making the most of your week. First up: Philip Desjardins, a partner 
at Arnold & Porter.

You spent a decade at FDA, first as regulatory counsel and later as associate director for policy at the Center for Devices and Radiological Health (CDRH). What do you remember most fondly from your experience at FDA? 

That's easy. It's the people that I got to work with at the agency. I've enjoyed all my professional paths, from CDRH to other parts of the agency, in industry at Johnson * Johnson, and in private practice as a lawyer. But there's something unique about starting your career working with really smart and dedicated people. With this core peer group that I came up with at FDA, we were all learning together: how does this industry operate? How are products developed? How are they regulated? And maybe most importantly, how should they be regulated in the future? And that final piece is what I ended up focusing on my career, in the policy space. 

You went from FDA to law practice, to over a decade in industry with DePuy Synthes and Johnson & Johnson, and back to a law firm as a partner. How does that combination inform the way you approach your current role? 

I like the way that you broke out those three careers. I bucket them into:

1. Government service
2. Industry roles, working, and representing a single client or a single organization
3. A multi-client practice, which is where I am right now

Each one of those roles has required me to lean on a different skill set, a different way of communicating, and a different way of thinking. I would argue the way that I'm the most effective is blending all those perspectives, understanding what is it that the R&D team, the client, the CEO, the regulator, and the courts all might need to understand about this product, about its safety, its efficacy, and how it's regulated. That trifecta of experiences informs almost everything that I do right now.

Can you briefly describe what your current role as a partner at Arnold and Porter entails? 

I'm a regulatory attorney. Within that broad category, the way that I think about myself is as a regulatory medical device attorney. The line between a regulatory attorney, a regulatory consultant, a regulatory affairs professional that works within a specific company, or even an FDA reviewer, is often relatively fine, because we're all evaluating the same types of issues. What is the regulatory framework that we're operating in? How is the product classified within that framework? And how do we bring forward, if appropriate, the right package to help regulators understand the safety and efficacy of our products in the pre- or postmarket context? 

My goal is to help my clients understand that framework, understand where their products fit in, and at the end of the day, understand what their legal and regulatory obligations are so that they can fulfill those obligations and meet all the requirements that the regulators apply to them. 

As you hint in your session title, “Back by Popular Demand: The Evolution of US and EU Regulatory Policies and Excellence,” this is a sequel to a session held in 2025. What can people expect from your presentation and how did your experience last year shape what’s to come in this year’s session? 

Rather than framing our discussion about a specific policy or issue, we want to talk about the evolution of regulatory policies for medical devices at the global level. This framing will let us have a timely discussion about the most relevant policies for the regulatory community as it exists today, and maybe more importantly, as it will exist in September.

We want to react and provide some context to the most relevant conversations that are taking place in medical device regulation. We're also trying to provide a little bit of perspective as to where the regulatory landscape is moving.  

One of the reasons the beginning of this session is titled, “Back by Popular Demand,” is that we received so many questions last year. We'd tee up a topic, you'd hear from the panel, and that discussion would result in even more questions. How does this policy apply to X situation? What are the downstream ramifications of FDA, a notified body, any other regulator taking a particular action? What are the impacts to industry? What are the impacts to public or patient health? 

For the remainder of the conference, we had people coming up to saying, “I wish you would have talked about this additional subject a bit longer.”  That told us that we should be ready for 

The session description says you “plan to evaluate the key policy shifts and organizational changes implemented by the new CDRH leadership as of 2026 and determine how these matured strategies influence current industry-agency interactions.” What is one topic you expect to come up? 

We discussed the Medical Device User Fee Amendments last year, but the user fee negotiation process between industry and FDA was really just kicking off in the fall of 2025. Industry, FDA, and the collective regulatory community have made significant progress on those user fees since then. 

I’ve been a negotiator for four cycles. I've not been at the negotiation table this time around, but I've been supporting companies throughout the process, which gives me a unique perspective on what's happening. 

(Philip recently shared his perspective with Regulatory Focus, RAPS’ independent news team, here.) 

And of course, I think it's impossible to have a conversation about US regulatory policies over the course of the last year without at least reflecting on some of the changes in organizational structure at FDA. Whether that be new leadership at the commissioner level and within most of the centers, or the impact to staff, we'll be talking about what the reduction in force means in practice. What do regulatory affairs professionals need to take into consideration as they're building the regulatory submissions and interacting at least with the US regulators? 

You’ve been a regular RAPS Convergence attendee. Why? 

I think I think of Convergence in two ways. 

First, it continues to substantively feed my need for education, my understanding of what the regulatory landscape looks like, and my understanding of where the profession is going.  

But also fulfills a personal and quasi-professional need. To me, it feels like a high school or a college reunion in the best possible way. You're coming back to see people you've worked with over the entirety of your career. There are people I'm going to see at Convergence that I worked with my very first year at FDA. There are people I worked with that I met much more recently. The best thing about Convergence, for me, is the opportunity to reconnect to those people. 

What’s your advice for someone attending RAPS Convergence for the first time? 

If I had any advice to anybody — early, middle, or later in their career — thinking about how they can grow as a regulatory professional at Convergence, it’s this: 

Substantively, absolutely pay attention from nine to five. Learn as much as you can in these sessions. But the day does not end there. 

Find out what people are doing for dinner, where they're going at 6 pm, and connect with those people. Or set something up yourself. Make a reservation for six people instead of two. And then as you're walking around the room, invite four more people to join you at dinner. Solidifying and building those relationships is one of the most important things I do every year at Convergence.