The expanding strategic role of legal leadership in global healthcare
Legal leadership no longer sits at the margins of the business. In global AI healthcare companies, it shapes enterprise success – driving growth, guiding risk, and accelerating innovation.
For years, in-house legal carried the reputation of a necessary brake pedal: cautious, reactive, focused on containment. In highly regulated industries like healthcare, that perception hardened. Legal was there to say “no,” to draft memos, to ensure the company stayed out of trouble. That model is no longer fit for purpose.
In global, AI-driven healthcare businesses, legal now sits at the center of strategy. The function does not simply mitigate exposure; it influences how quickly products reach market, how confidently executives make decisions, and how effectively companies scale across borders.
Few careers illustrate that shift more clearly than Fred Struve’s. A Danish-born legal leader operating across the US, Europe, and Asia, Struve leads legal for Lunit’s international cancer screening business – an AI medical device company working in more than 65 countries in one of the world’s most regulated sectors.
Lunit develops AI software for breast cancer screening, chest abnormalities, and precision oncology. It processes vast volumes of patient data. It navigates FDA oversight, European AI regulation, Korean governance frameworks, and emerging global standards simultaneously.
Compliance is non-negotiable. But compliance alone does not build a company. “Compliance is table stakes,” Struve states. “It doesn’t drive the business.”
So, what does? “How legal enables revenue growth,” he says.
That distinction – between protecting the business and propelling it – defines modern legal leadership.
Business leader first
Struve’s path did not follow the conventional trajectory into corporate legal. He began in business, worked inside an IP firm before law school, and built his early career advising health insurers and hospitals on complex commercial arrangements.
That grounding continues to shape how he leads today. “You are a business leader first, with legal expertise. Not the other way around.”
When he joined Volpara Health Technologies, later acquired by Lunit, the mandate was clear: enable revenue. The company had a growing US customer base and needed to scale its commercial operations.
“As you know, in the startup world, revenue is king,” he says. “That was the initial legal goal: how do we enable revenue growth?”
From the outset, legal success was tied to business outcomes, not legal outputs. “We focus on accomplishing the goals of the business. That’s what we measure ourselves on.”
For him, this philosophy requires abandoning a deeply ingrained professional instinct – the pursuit of the perfect answer. “The perfect legal answer often comes too late. What the business needs is the right answer at the right time.”
Modern legal leadership is not about eliminating risk. It is about identifying the risks that matter, clarifying trade-offs, and helping the business move forward consciously.
Scaling across borders without a single playbook
If leading legal in a regulated AI healthcare company were not complex enough, Struve does it across cultures and regulatory regimes. Korean parent company. New Zealand heritage. Major US commercial presence. European regulatory overlay. A Danish-based GC coordinating across time zones that stretch from Seattle to Seoul
“Risk tolerance and decision-making look very different in the US, Europe, and Asia,” he says. “You can’t apply a single legal playbook across regions and expect it to work.”
In the US, decision-making is typically faster and more iterative. Europe is moving aggressively on regulatory frameworks, particularly around AI. Korea brings its own stakeholder-driven governance dynamics.
“The US approach is faster paced, more direct, and more comfortable making decisions quickly and iterating,” Struve explains. “Europe is further ahead on regulation. That constrains how quickly we can move.”
For legal leaders, cultural fluency becomes a core competency. What is acceptable risk in one region may be untenable in another. Programs must flex without fracturing.
In the context of the EU AI Act and evolving global standards, building compliance infrastructure is not about control. It is about scalability. “Building scalable compliance programs is about enabling speed, not slowing it down.”
Legal as an operational multiplier
The strategic shift is most visible in operations , and as Struve points out, “If legal goes faster, the entire business goes faster.”
In a company where contracting intersects with regulatory review, data governance, security, and product validation, legal cannot be a downstream checkpoint. It must be embedded in the workflow.
Struve’s team works daily with sales, finance, product, engineering, regulatory, and quality functions. The goal is not merely contract approval, but friction reduction.
“If we can optimize contracting workflows – from initial lead to revenue recognition – we shorten the path to revenue.”
That may mean re-engineering templates. It may mean clarifying risk tolerance with the executive team. It may mean designing decision frameworks that allow frontline teams to move confidently without constant escalation. This is legal as infrastructure.
But infrastructure only works when it understands the business deeply. Struve sets a high internal bar: “Know the business as well as the CEO. That’s a goal.”
That level of understanding builds trust. Trust reduces friction. And reduced friction creates speed.
AI regulation and the pace of innovation
The paradox of leading legal in an AI medical device company is clear: innovation moves exponentially; regulation moves unevenly.
“AI regulation is moving faster in Europe than anywhere else, and that directly impacts how quickly companies can innovate,” says Struve.
For Lunit, obligations span medical device software regulation, patient data governance, cross-border transfers, and now AI-specific rules. The challenge is designing compliance systems robust enough to withstand scrutiny without freezing product development.
That balancing act is strategic. It is not about resisting regulation. It is about integrating it into the growth model.
Developing judgment in the age of AI
Even inside an AI-native company, Struve is deliberate about how automation shapes legal craft. “We’re definitely not shying away from using AI,” he says. The tools are powerful; they accelerate research, drafting, and contract review, but he is cautious about what he calls a “synthetic relationship” with legal work. “AI can accelerate legal work, but it can’t replace judgment.”
Junior lawyers still need to understand how contracts are constructed, how compliance frameworks interlock, and how risk materializes in practice. Without that foundation, they may not recognize when AI output is incomplete or wrong.
“There’s a real risk of creating a synthetic relationship with legal work if teams rely too heavily on automation too early,” Struve warns. Authoritative tone is not the same as accuracy. Judgment remains the differentiator.
For modern legal leaders, the task is not choosing between AI and craftsmanship. It is designing teams that use AI intentionally while preserving the development of deep expertise.
Legal leadership as enterprise influence
The stereotype of legal as a cost center is outdated, especially in highly regulated, AI-driven industries.
When legal understands the business, embeds into operations, navigates cultural complexity, and filters risk pragmatically, it does more than protect the organization. It strengthens competitive positioning. It accelerates growth. It builds resilience.
“In-house legal leaders today are business leaders first, with legal expertise,” Fred says.
In global healthcare – where AI, patient trust, and regulatory scrutiny intersect – that leadership shapes enterprise success in very real ways. When legal clarifies risk appetite, executives decide faster. When legal designs scalable compliance, innovation moves forward responsibly. When legal aligns with growth objectives, the organization advances with confidence.
That is not a peripheral influence. That is strategic leadership.
For senior legal leaders, the question is no longer whether legal belongs in growth conversations. It is whether your function shapes enterprise success or simply reacts to it.
To hear more of Struve’s perspective on modern legal leadership across borders and technologies, listen to the full Legal Leaders Podcast episode.
