In surgical settings, visibility and control shape clinical decisions. Founded in 1945 in Tuttlingen, Germany, KARL STORZ has grown from a two-person business into an international endoscopy and minimally invasive surgery company, now employing over 9,000 people worldwide. Its portfolio spans several thousand products for human and veterinary medicine, supporting procedures that range from cancer detection to minimally invasive surgery across multiple specialties.
The company’s technologies sit inside procedures where clinicians rely on precision imaging and instrumentation to guide decisions in real time. From visualization systems that enhance clarity in confined spaces to integrated operating room platforms that connect workflow and data, each product plays a defined role in care delivery.
Those products, including instruments, imaging systems, and operating room technologies, move through development, regulation, and supply networks before they reach clinicians. Each step brings requirements across regions and systems, placing legal within the path from development to patient care.
That responsibility shapes Erica Yen’s role as General Counsel and Executive Director of Legal for North America at KARL STORZ. She leads a team supporting the US and Canada, working directly with business leaders to connect legal guidance with operational decisions and product movement.
The North American market represents a significant part of the company’s global business, requiring close coordination across regulatory, supply chain, and commercial teams. With products moving across jurisdictions and into different care environments, alignment across functions becomes critical.
“In my role, I lead our legal team that supports multiple entities in the US and Canada. We focus on providing strategic advice while partnering closely with the business to drive practical, solutions-oriented outcomes,” she says.
She stepped into the role following a global reorganization that introduced a matrix structure across regions and functions. The shift brought teams closer together but required clearer processes around how decisions are made and how accountability is shared across the organization.
“I started nearly seven years ago, and the organization has gone through a number of changes since then. Navigating evolving structures and ways of working has been both challenging and rewarding.”
Embedded in decisions
When Erica joined KARL STORZ, the regional legal function was still taking shape. Without an established in-house team, she helped build one while defining how it would operate within the business. “There had been no regional legal department previously, so it was important to establish a foundation and define what we should be effectively supporting internally instead of externally,” Erica recalls.
The work began with identifying areas of risk, then expanded into how legal supports day-to-day business activity. Hiring reflects both priorities, with an emphasis on subject matter expertise as well as how individuals collaborate across teams.
“When building the team, we focused first on the subject areas of greatest need. That meant doing a risk-based assessment and hiring accordingly. From there, we placed equal focus on character and fit because we wanted to create a legal team that people want to approach and work with.”
That accessibility shapes how legal operates in practice. While the team receives formal requests for support, there is also a strong emphasis on engaging early both formally and informally, often joining conversations as ideas are taking shape. “We value relationships because potential issues aren’t always obvious upfront. Sometimes important considerations surface during a simple chat, so we look for team members who are curious about the business and enjoy proactively building those connections.”
As a result, legal becomes part of how decisions develop rather than a step at the end of the process. The focus shifts from review to involvement. “Our leadership supports legal and recognizes we’re here to partner, not just review things at the end. That tone from the top encourages increased collaboration and more thoughtful decision-making overall.”
Across systems
Healthcare products move through systems that operate differently across regions, where regulation, logistics, and cost structures remain closely linked. At KARL STORZ, that complexity reflects a global footprint built over decades and shaped by family ownership, as well as the need to deliver consistent product performance across diverse healthcare systems.
Those pressures often become most visible where supply meets policy, particularly when external decisions affect how materials move across borders or how costs are distributed across markets.
Erica points to tariffs as one of the clearest examples: “Tariffs have changed the landscape for many companies. We keep them high on our radar,” she notes.
That shift requires ongoing coordination across many business teams, particularly when managing supply continuity across borders and maintaining access to components critical to product development and distribution. “We work closely with our operations and trade compliance partners to ensure resilience in the supply chain and navigate import and export requirements, because cross-border movement inherently introduces risk.”
In that environment, decisions are often made without complete clarity. Legal works across internal teams and external advisors to interpret developments and determine how to act. “We rely on our external counsel often as an extension of the team, particularly given the pace of change and the uncertainty that many companies are navigating.” External partners help monitor changes and assess how evolving directives apply in practice, particularly as requirements continue to shift. “In many cases, you have to make informed decisions without perfect certainty, balancing risk with the need to keep the business moving forward.”
Building governance
Trade and regulatory pressures sit alongside another force shaping healthcare delivery: technology. Across imaging systems, operating room integration, and digital tools, innovation continues to reshape how clinicians work and how procedures are managed.
KARL STORZ’s progression reflects that shift, expanding from core instrumentation into connected systems and software that support procedure planning, visualization, and workflow inside the operating room. As those capabilities evolve, new governance requirements emerge alongside them, including increasing focus on data protection and cybersecurity.
Artificial intelligence now spans both internal systems and product development, creating additional layers of oversight across the organization and raising questions around use, access, and compliance.
“I’m on the Global AI Committee, a cross-functional team working to build governance as these capabilities develop. That includes embedding consistent standards across functions and being thoughtful about what tools we enable and how we use them responsibly,” she explains. That work requires balancing structure with speed. “Governance has to evolve alongside adoption, creating consistency and guardrails without slowing innovation or limiting how teams operate.”
It is a challenge that reflects the broader theme in Erica’s role: building structure within a fast-moving organization while staying closely aligned with the business. In practice, that means legal is integrated into how decisions are made, playing its role in ensuring that products move forward within the systems that define healthcare delivery.
