Wearables at the regulatory crossroads with Priya Setty

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. Next up: Geethapriya K. Setty, global regulatory affairs manager at Hologic. 

You started your career in occupational therapy. How did you end up as a regulatory affairs manager?

Honestly, the short answer is curiosity, and the long answer involves a fair number of detours. 

For almost two decades, I worked as a pediatric occupational therapist, treating kids with autism, sensory processing differences and other developmental conditions. Every session was its own small experiment: observe, intervene, adjust, repeat. You learn to read risk constantly and to keep the person in front of you at the center of every decision. I didn't know it at the time, but that was my first real training in safety and systems thinking. I just didn't have the vocabulary for it yet. 

Somewhere in that same stretch, I was also working mornings as a hospital administrator and running my own therapy practice in the evenings, so I was managing a small system by day and delivering hands-on care by night. That combination is probably the real origin story, more than any one job title. 

The actual pivot into regulatory affairs happened almost by accident. I was doing my MBA and needed an elective, so I picked regulatory affairs mostly to finally understand what my husband, an engineer, meant when he said “510(k)” at dinner. I figured it would at least make for a fun conversation between the two of us, if nothing else. Instead, it rewired how I saw the whole industry. I realized this is a field where you don't just build the car, you help design the traffic system it drives on: the rules, the guardrails, the conditions that keep everyone moving safely. 

That curiosity pulled me in for good. I started in postmarket surveillance for high-risk devices, then moved into regulatory operations and advertising and promotional review, then global submissions and field corrective actions. Somewhere along the way, FDA published its first proposed framework for AI and machine learning, back in 2019, right as I was finding my footing. That leveled the playing field for everyone because nobody had seniority in AI yet. I started dabbling, one thing led to another, and here I am, moderating a panel about wearables, AI and the regulatory gray zones I still can't stop chasing.

In our conversation before this interview, you said the boundary between wellness product and medical device is “becoming one of the most consequential decisions companies make, but that it is one of the least understood.” Can you explain?

I think of it less as a line and more as a continuum. On one end, you have general wellness products. In the middle, there's a wide stretch of enforcement discretion — the real gray zone. On the far end, you have fully regulated medical devices. 

Here's a version of something that actually happened to me. I was sitting in a meeting one afternoon and my watch buzzed. I looked down, and it just told me my heart rate was running high. No context, no explanation, just the number. My first reaction wasn't calm curiosity, it was a small jolt of “wait, is something wrong with me right now?” Nothing was wrong. I was just in a meeting. But the device had handed me a data point with zero framing, and my brain went looking for a reason to worry. 

That's the gray zone in miniature. A watch that vibrates and says, “this looks different from your usual pattern, were you exercising? Did you just have coffee?” is doing something very different, both regulatorily and emotionally, than one that assigns you a severity score or a diagnosis. Same sensor, same signal, completely different experience and a completely different regulatory conversation. 

That tension is exactly what I wanted this session to sit inside. Where that line actually gets drawn isn't nearly as settled, or as well understood, as most people assume and I don't think most companies realize how much of that decision gets made long before anyone writes a single word of marketing copy. 

This session brings many voices into one room: regulatory, quality, notified body, and FDA. How did that come together, and what perspectives do each of these participants bring?

Getting a notified body and a FDA voice on the same stage is already rare as those are two different regulators with two genuinely different philosophies. The EU's approach leans horizontal and risk-tiered, while FDA's is more product- and intended-use-driven. Anyone building a global strategy needs to feel that divergence, not just read about it. 

Then you add a quality voice, because quality is the thread running underneath everything. Whether a product sits in wellness or crosses into a Class II device, the obligations change the moment you cross that line, and someone has to be the one keeping score. And you add an industry voice from the consumer tech side, because the business reality on reimbursement, packaging, labeling, market positioning is just as real a constraint as any regulation. 

It's one ecosystem, but manufacturing, quality, regulatory, and the regulators themselves are all looking at a different lane of the same intersection. Getting all of them in a room, actually talking to each other instead of past each other, doesn't happen nearly as often as it should. That's really the whole premise of this panel. 

You're turning part of this presentation into a Jeopardy-style format instead of a traditional panel. What will that look like?

I'll be honest, I'm being deliberately cagey about this one. What I can tell you is that we're breaking away from the traditional moderated Q&A. The format where everyone already half-knows the questions, and the answers come out a little too polished. This year's version is going to be more spontaneous and more audience-driven than that. 

What I love about it is that it puts FDA, a notified body, quality and industry in a position where they genuinely don't know what's coming next, any more than the audience does. That unpredictability is the point. I think it'll make for a more honest, more fun conversation than the usual panel format and I'd rather let people experience it live than spoil it here. Come to our session to see for yourself!

Last year was your first RAPS Convergence. What made you want to come back? 

Attending last year was honestly a bit surreal. I kept running into people I'd looked up to for years and thinking, “wow, this feels like the Oscars.” I'm looking forward to that same feeling again this year, except bigger, since it's RAPS's 50th anniversary. The topics on this year's agenda are genuinely strong, and the speaker lineup is impressive enough that I'm almost a little jealous of the people who just get to attend and not moderate. 

What is one thing you are looking forward to at this year's event?  

If I'm being completely honest, a small break. Between the day job and a household that treats “quiet time” as a personal challenge, getting on a flight to Convergence feels almost like a vacation, even though I know full well I'll spend most of it in sessions and hallway conversations, not by a pool. 

Beyond the socially acceptable escape from laundry and unpaid Uber driver for my kids and Teams notifications, I'm genuinely looking forward to reconnecting with my network, and probably overcommitting myself to sessions I can't actually all attend. When I read through this year's agenda, my honest reaction was “this is a scheduling conflict in every single time slot.” Everything looks that well-curated. I like that it isn't all AI, all the time, either. There's reimbursement, women's health, even sessions on optimizing your LinkedIn profile and becoming financially literate. It's a genuinely well-rounded agenda, and I think that balance is worth calling out.