From FDA reviewer to WHOOP's VP of Digital Health: meet Infera's Head of Regulatory Nikki Batista

Growing up, Infera's Head of Regulatory Nikki Batista always thought she'd become a doctor because she loves helping people and was an athlete her entire life. At age 15, recovering from a torn ACL had given her a fascination for what surgeons could do. In college, her biomedical engineering major and an internship at a medtech startup showed her she could work on repairing the human body without seeing patients. When a former research labmate came back to campus recruiting engineers to be FDA reviewers — a role that would let her stay with her now-husband who was moving to Maryland — the opportunity felt like serendipity.

What sealed it was the role’s sense of purpose. “The mission of being boots on the ground, speaking directly to the people serving the public and helping them get the right innovations in front of people, was inspiring,” says Nikki.

From biomedical researcher to regulatory reviewer

There were no masters in regulatory affairs back then the way there are now, but Nikki had gotten a glimpse of the work at the startup where she'd interned — a company actively going through FDA approval. As she learned the ropes at the agency, she found that her research background was perfect preparation: “When you're conducting research, you're generating data to figure out your next move. The FDA is the recipient of those datasets, which are often incomplete, and you have to draw conclusions with pieces of the puzzle missing,” Nikki explains. “That really is the essence of regulatory. You have a slew of data from different disciplines — medical, preclinical, electrical safety, mechanical testing, material characterization, toxicology — and it paints a varying picture. It's not usually perfect, and you have to synthesize all of those perspectives and decide if it's good enough.”

Seeing software outpace the FDA

While Nikki was at the FDA, Apple would get its first clearance, which kicked off mainstream demand for software as a medical device and forced a reckoning at the agency. “It was the first time the agency ever experienced a really powerful, well-known consumer tech company trying to get into medtech. It felt like there were only a few people who could see software as something that could be used intelligently within the medical device space. When you blend consumer tech with medical device applications and clinical quality features, there's something really powerful there.”

She dove headfirst into supporting pilots and working with policy groups, helping her organization confront the fact that software is different and that traditional systems weren't built for it. Traditional devices decay over time, their performance deteriorating. “Software, on the other hand, improves over time — you're removing bugs, increasing efficiency,” says Nikki. The FDA had been designed for devices that decay, not ones that get better. At the time, the agency was also shifting toward a total product lifecycle approach, with one group now responsible for both pre- and post-market oversight, and real-world evidence starting to inform regulatory decisions. Software, which continuously generates new performance data as it improves in the field, was the perfect test case for that emerging model. “That teed up the FDA to get creative about how it generated evidence and exercised oversight, leaning on what a product does in the real world, not just what it demonstrated before launch.”

She worked on the Case for Quality program to reflect this difference, which Nikki describes as “trying to figure out how to create a lighter-touch, trust-based system — you've demonstrated that your device is safe and you’ve built quality into your processes, so compliance won't be as heavy-handed as we go on.” This work laid the foundation for the Predetermined Change Control Program, or PCCP, where AI-enabled device makers can pre-authorize algorithm changes with the FDA rather than returning for a new submission each time.

AI connecting dots we didn't know existed

Now, as AI becomes the defining force in the next wave of digital health, the new questions the FDA is contending with have once again reached an inflection point. “As we usher in the age of AI, we're really talking about connecting dots that we didn't even know existed.” With that comes new complexity in data sets and new regulatory questions about sufficient evidence. One of the most pressing is algorithmic drift — whether a device performs just as well for patients who weren't part of the original data set as it encounters the real world. The questions may be different, but Nikki's answer for manufacturers is the same: risk-based, data-based decision making done early on.

Moving to the other side of the review

Eventually Nikki came to oversee all cardiovascular SaMD applications at the FDA. But even then she hit a ceiling — at a large organization moving too slowly, with far more wisdom than she could openly share as a reviewer. So after more than five years at the agency, she followed her mentor and former boss to an industry-leading regulatory consulting firm, where she founded their digital health unit from scratch — serving the wave of companies building software as a medical device that traditional regulatory and quality firms weren't thinking about. It was there she fell in love with early-stage startups like the one where she and I first crossed paths. “I just loved how tenacious startups were, how hungry, and how open-minded. And that they really could put good guidance to use.” A chance to work at the intersection of startups, regulated consumer health tech, and sports made WHOOP a natural next step. When her son was born in late 2024, she left WHOOP to go back to consulting as the founder of Batista MedTech Consulting.

The FDA, consulting, and WHOOP together gave Nikki three beliefs about where medtech teams go wrong — and what it takes to get it right.

Compliance strategy is business strategy

“This isn't a novel tagline anymore, but for early-stage startups — especially people who have never done regulated product development before — that's where there's a huge learning curve. Through no fault of their own, they don't yet understand or appreciate that engineers can't just go off and do whatever they want. There needs to be some governance, checks, and balances.”

The strategic stakes of early regulatory decisions are often much higher than founders realize. “Do you want your device to be prescription use only or over the counter? The two are completely different business models with totally different risk profiles,” Nikki explains. “The FDA is going to ask you different questions. It's a different data set, a different validation package. It's literally only a checkbox in a regulatory document — RX only or OTC — but it changes everything.” This question is especially relevant with folks in the wellness movement and SaMD trying to figure out if they want to have a physician in the loop or to go direct-to-consumer.

The cost of starting late

“A lot of my work as a consultant was backtracking — doing rework to help teams figure out and document what the hell they did years ago,” Nikki recalls. “I once worked with a company who was two years down in the research pipeline, starting to test, and they couldn't agree on what the product did” — something that embedding quality in your process from day one prevents. “You can spend a lot of money in this industry not being strategic and spinning your wheels. When you're forced to slow down just a little bit and document, it really helps teams make sure everything is getting covered the first time around.”

Lead with the why

Creating a culture of quality before bad habits calcify starts with explaining why the record exists before asking anyone to build it. “It’s common for me to face a lot of pushback from engineers on documentation requirements,” she says. “Teams can have a really hard time understanding why some documents need to exist. But when I take the time upfront to sit down and explain, 'This is what the document is, this is why it's important, this is what it should ultimately inform the reader of,' rather than just saying, 'Here's a guidance document, go do it,' the dynamic shifts. Documentation becomes something engineers make space for and integrate into their timelines.”

One time, an engineering manager I worked with didn't fully understand the architecture of his own feature until the documentation exercise forced it onto paper. “Otherwise, you're just designing without a map of where you're going.” Finding gaps, spotting where coverage is thin, and identifying what changed without a corresponding update is exactly what quality and regulatory is when done right. “The foundation to ground engineers in is: we are a regulated product. We have governance, and that governance serves a purpose. It's not just to make your lives harder. It's so that we build good products that do the right things for the people we're trying to serve.”

What Nikki's building now

Nikki's consulting philosophy has always been that she wants her clients to succeed well beyond her involvement. At Infera, she’s helping us turn that intention into infrastructure — with a platform that helps teams translate between what they build and what regulators need to see, continuously, from the very beginning.