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Ask most companies when they engage regulatory expertise and the answer is some version of “when we were ready to file.” The 510(k) is coming, the IDE needs to go out, so it’s time to bring in the regulatory people.
By then, the testing strategy is set, the protocols are written, and a fair amount of what happens next is rework nobody budgeted for.
Nick Capman recently sat down with Leland Keyt, Vice President of Regulatory Affairs and Quality Assurance at Apreo Health, to talk about what early regulatory partnership actually looks like and where the preventable costs pile up.
Leland’s spent more than 20 years in medical devices across startups, mid-size companies, and global multinationals, working on drug-eluting and bioabsorbable stents, atherectomy, pulmonary valves and assessment systems, catheters, and glucose monitoring.
She’s currently building the regulatory and quality function at Apreo, a startup running a US pivotal study for an implantable airway scaffold in severe emphysema, which means she’s living the scaling questions she’s describing.
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Leland's key insights and practical takeaways
If you’re short on time, here are the most important lessons from the discussion.
Early means concept phase, not pre-submission! Leland puts the starting line further upstream than most companies do. For her (and we agree), regulatory belongs in early development discussions and first-in-human planning. One specific payoff she flagged is intellectual property. How you describe the product in your IP narrative during concept can matter years later in a regulatory submission. That’s not a connection most teams make while they’re still sketching the device.
Most companies engage at submission when the value is in the phase before it. The typical trigger is being ready to file, whether that’s clinical work, a 510(k), etc. But you actually want regulatory input while you’re building your testing and clinical strategies, so you write protocols with the right lens for the audience reading them. Nick added a cost most teams don’t anticipate: companies frequently run more testing than they need. Early regulatory involvement isn’t only about doing things correctly; it’s about not spending money on work that adds nothing. As Leland put it, efficiency in the early stages means answering the right questions with the least amount of data.
Risk tolerance is what gets companies in trouble as they scale. This was her most repeated point! How much risk you’re carrying, and whether it’s documented and mitigated, often doesn’t surface at IDE. It surfaces at PMA, or in audits, when someone starts digging. With the transition to the ISO 13485 world via QMSR bringing risk into more of the conversation, she stressed that teams should think about design FMEAs and let that risk analysis genuinely inform testing plans (rather than treating them as parallel exercises).
What’s acceptable in development is not acceptable in commercial. The same risk calculus changes as the company matures. In development, some risks are worth taking because you’re learning. Once you’re at PMA, with a PAI and a stream of audits behind it, they aren’t! The FDA isn’t in the room early on, but they will be, and the risks you accepted in the learning phase are the ones that get examined.
Postmarket obligations are often invisible until they’re a problem. Leland described the post-approval work as happening underneath the water: reports, adverse event reporting, maintenance activities that just quietly need to occur. Getting a clearance or approval is not the finish line; you have to keep it. The failure mode she named is a resourcing one. If your team is simultaneously maintaining an approval and developing Gen 2 and Gen 3, people end up juggling, and something gets dropped. What you needed in development is not what you need at commercialization, and if you keep developing, you need to add rather than reallocate.
Rework costs more than time, and time is already expensive. For an early-stage company on seed or Series A money, the run rate makes the timeline a genuine constraint, so slowing down is costly on its own. But Leland pushed past the obvious: rework is also product cost. You built it, you tested it, something failed, now you build it again. That’s fundamentally a supply chain question. Do you have enough product to rebuild everything? And while your team is redoing that work, they aren’t doing anything else.
Regulatory shapes product decisions, not just paperwork. The instinct is to file regulatory under compliance documentation. Leland’s counterexample is geography. Different markets interpret requirements differently, and biocompatibility is where this shows up clearly. Everyone points to ISO 10993-1, but how it’s interpreted in the EU or Japan can change what you develop, what testing you run, and when you run it. Knowing that early lets you make efficient testing decisions instead of discovering the gap after the fact.
Phase transitions are your signal to reassess. Moving from development into animal work, into first-in-human, into a pilot or pivotal study, each of those is an inflection point that typically ends in a submission and sets up the next one. That’s the moment to take stock: do we have the right resources, the right expertise, or do we need something in addition to what we have? Her framing is generous and worth noting, needing new expertise doesn’t mean the expertise you have is inadequate. Nick expanded on the options, full-time hires, a high-level strategist, temporary resources, FSP or outsourcing models, and both landed on the same point: what fits one phase may not fit the next, and the answer varies by company.
Balancing speed and compliance comes down to educating the room. Decisions in this industry are rarely made by one function. Leland’s approach is to make sure everyone understands the risks being taken and the consequences across disciplines, because a decision that’s great for manufacturing might be bad for quality and worse for regulatory, and still be the right call. What you want to avoid is making the decision and discovering those consequences afterward. That only works if people were informed going in.
In board conversations, regulatory should be shaping the growth map. High growth usually means commercial expansion, and geographies vary enormously in regulatory difficulty. Leland’s role in those conversations is knowing what the board and the commercial team see as attractive markets, then providing insight on what it actually takes to get in and stay in. Her example is pointed: you may be able to enter Israel, but if it yields three cases a year, is that the best use of the effort? The requirements to maintain an approval are real, and time spent there is time not spent elsewhere.
Structure regulatory around the company’s actual goals. To be forward-looking rather than reactive, Leland argues you have to understand what matters to the company and why, then let that shape your regulatory thinking. If the goal is value add, figure out what that means from a regulatory angle. Maybe that’s a different approach to FDA, maybe it’s the Breakthrough Device pathway, maybe it’s pursuing information in another geography because it’s faster. And as company goals shift, be in those conversations, both to inform them and so regulatory leaders execute knowing why they’re doing what they’re doing.
What regulators are watching more closely now. AI topped her list, less as a technology question than a governance one: how it’s used, how it’s regulated, whether it sits inside the device or inside your development process. In Europe, she pointed to expectations around clinical evaluation reports, where it needs to be clear you’re not just using AI but interpreting the information yourself. You can use it. How you use it matters. She also flagged usability as an underrated risk on longer development timelines, where teams get deep into design verification and validation and lose the usability feedback loop, and the product needs to work well for people with genuinely different skill sets, patient or physician. On FDA’s move to ISO 13485 for QMSR, her read is that it isn’t a major shift in itself, but aspects of your audit that were previously out of bounds are now in bounds, management review among them. And she noted that FDA is using AI in its own work, which is worth understanding so you can ask the right questions and respond well.
Her one piece of advice for CEOs: build a scalable QMS. She called it the bedrock. If the foundation isn’t solid, other things fall apart easily. It runs behind the scenes, but it isn’t an afterthought. Use your quality management reviews as a genuine diagnostic on the strength of the system, and bring the right people to the table when issues come up so the decisions that follow are informed ones.
One thing to bring back to your team
Look at your next major phase transition, whatever is closest, first-in-human, a pivotal study, a submission, and ask what regulatory input you need before it rather than at it.
Then ask the harder resourcing question:
If you get the clearance or approval you’re working toward, who maintains it?
Because that work is real, it’s mostly invisible, and it doesn’t pause while your team builds the next generation. The companies that get caught are the ones that made a reasonable decision in development and never revisited it when the risk tolerance underneath them changed.
Leland Keyt is Vice President of Regulatory Affairs and Quality Assurance at Apreo Health, where she leads regulatory and quality for the company’s BREATHE Airway Scaffold, an implantable technology for severe emphysema currently in a US pivotal study. She has more than 20 years of experience in medical devices, spanning startups, mid-size organizations, and global multinationals, with work across drug-eluting stents, bare metal and bioabsorbable stents, directional atherectomy, pulmonary valves and assessment systems, catheters, and glucose monitoring systems. Before Apreo, she was Chief Product Officer at Biorithm and spent six years at Pulmonx, rising to Senior Director of Regulatory Affairs and Quality Assurance, where she navigated the FDA’s Breakthrough Device Program for the Zephyr Endobronchial Valve System and achieved PMA approval in 178 total days. She has also held regulatory and clinical leadership roles at Avinger and CardioKinetix, and supported due diligence for financing, asset acquisition, and IPO preparation. Her experience includes a successful FDA Advisory Panel for the XIENCE V Everolimus Eluting Coronary Stent System.
Connect with Leland on LinkedIn here.
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