Guest Column | May 9, 2024

4 Critical Focus Areas For Medtech Compliance Leaders

By Dana McMahon, global chief compliance officer, Stryker

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Compliance leaders play a critical role in helping companies avoid legal and regulatory trouble. That gives them a unique purpose and relevance — but it doesn’t automatically give them a seat at the table. And more importantly, it doesn’t ensure they’ll keep their seat if they’re fortunate enough to get one in the first place. To achieve that status, compliance leaders need to show they can be drivers of growth and innovation.

At its heart, compliance helps organizations implement a set of consistent and well-understood policies and practices to reduce risk in many areas, from strategy development to sales interactions with customers.

But that’s the bare minimum. Rather than view our roles through a narrow prism that’s reactive and rule-centric, compliance can serve as the foundation upon which broader value and influence are built. Below are four approaches that I’ve found are important for medtech compliance leaders to create impact within their organizations.

1. Relevance

Tailoring compliance efforts is crucial. Compliance professionals must move beyond generic, one-size-fits-all approaches and conduct a thorough compliance risk assessment to identify and address the most pressing issues facing each part of the business. This is especially true for companies like Stryker that have a vast menu of products and operate on a global scale. With so many different business units operating across regions with their own distinctive needs and risks, the compliance plans must be tailored. In my sector, which is medical technology, a simple example is customized training. For R&D employees working in robotics, privacy-by-design training is critical, but on-label promotion training is not.

2. Timeliness

It’s important to anticipate the future needs of the company and see what’s coming around the corner. Compliance professionals who can look ahead and align their efforts with the broader business strategy can provide timely advice and solutions that enable organizations to move forward confidently and effectively. This requires a deep understanding of the business's goals, objectives, and priorities, and the ability to communicate compliance-related insights and recommendations in a clear, concise, and actionable manner.

An example: Our company offers a range of products for orthopedic surgery. To continuously improve these products, we need to maintain access to patient data. In the midst of, say, closing a sales contract with a large health system, we need to enable access to data. We also need to ensure on an ongoing basis that our businesses are keeping and using data the right way. A seat at the table helps maintain that focus.

3. Practicality

I always say that every compliance risk is a business risk first. Compliance professionals must recognize that their work has the potential to impact everything from the organization's reputation and financial performance to its long-term sustainability.

Here’s an example: Sales representatives at most medtech organizations routinely provide company-owned demos and loaners to customers. This enables customers to familiarize themselves with products for potential purchase. Loaners are also useful when purchased items need replacement or repair due to a breakdown.

If we lend a product to a customer and it isn't returned within a specified time frame, it becomes an obvious compliance concern by potentially creating the perception that we’re giving away free items to gain a business advantage. But failing to retrieve the item is also an obvious business risk in the lost opportunity to make a sale or to use the demo with other potential customers.

4. Getting To The Why

To better communicate why compliance is so important to the company’s culture and business, we rewrote our Code of Conduct. We’ve moved to principles-based standards that always spell out the “why” behind the principles. We also wanted to give practical tips and tricks in a visually appealing package that includes photos of Stryker employees. It sounds like a small touch, but it goes a long way toward building a culture in which compliance is seen as a point of engagement and collaboration.

We also strive to build a “speak up” culture at our company where people feel comfortable making innovative suggestions and raising concerns. This emphasis on a robust ethical culture positions our compliance not as an “enforcement” tool but as an architect of a healthier, more resilient organization.

Every compliance hiccup can affect how the company is perceived, its financial stability, and its future. Therefore, it's essential to focus on making a tangible difference rather than merely ticking boxes. This involves working closely across organizational lines with teams like legal, finance, and operations to tackle risks head-on — and building strategies that not only keep the organization safe but create space for growth and innovation.

By focusing on adding as much value as possible — through relevance, timeliness, and practicality, and getting to the why — compliance leaders can ensure that they maximize their impact on the long-term success of their organizations.

About The Author:

Dana McMahon serves as chief compliance officer for Stryker and is responsible for overseeing the company's global compliance, privacy, and enterprise risk programs and functions.