Key team members: 

Michael Groh, Director of Legal & Compliance, EMEA

Hugo Pinho, Deputy Director of Legal & Compliance, EMEA

Matea Pukec Štander, Head of Legal & Compliance Manager, CEE

Marie Laure Fathay, Head of Legal & Compliance, MEA

Team size:   +20

Major legal advisors:    Sidley Austin LLP, Hogan Lovells, PLMJ

Jurisdictions your role covers: EMEA

What are the most significant cases or transactions that your legal team has recently been involved in?

From the beginning of 2024, Arthrex reshaped its legal and compliance in-house strategy for EMEA. We went for joint legal and compliance roles, grew internal teams, both at EMEA and country level, invested in a clear business partner mindset, mimicked the business organisation and are investing in specialisation, where different team members, from different seniority levels, are able to lead and become the main point of contact for EMEA wide topics. Although the journey is still in its infancy, and there is still so much to do, we have already accomplished so much, and it is now clear where we want to go and how we want to reach it.

As a support function, we really strive to become effective business partners in the amazing mission of Helping Surgeons Treat Their Patients Better®. As a global medical device company and leader in new product development and medical education in orthopaedics, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year and continues to experience unprecedented growth and demand for our products throughout the world.

This amazing growth, year over year, is sustainable, also, in big part, because of the terrific job of the legal and compliance team. This reshaped team has its focus on protecting the Arthrex Brand, the Company and all their employees.

You cannot have an amazing growth without many big deals! And our team also said “present” in this front. While we were growing and reshaping the team and long-term strategy, we were able to support many major deals throughout the region, from big supply contracts in private and public sectors, to strategic acquisitions, taping new business areas, supporting landmark marketing initiatives and providing guidance and guardrails concerning HCP interaction. We are also deeply involved in the expansion of all our subsidiaries, following the amazing growth throughout all our EMEA subsidiaries.

How does your team contribute to the overall business strategy of the company? Can you share an example of a recent legal-led initiative that had a significant impact?

As said, part of the new vision for the EMEA Legal & Compliance team is a clear business partner attitude. We want to be regarded as true business partners, that understand the business, their main pain points, KPIs and targets.

We strive to become the truster business partner to whom all relevant stakeholders in the business go to, not only in case they need support with Legal & Compliance specific topics, but that involve us from the start, as part of the broader business team.

We follow the business organisation, and we are part of local and regional leadership across EMEA. This provides us a theoretical seat at the table, but to be able to really support and help shaping the business in the correct way it is paramount that we are able to forge trusting relationships with the business – we are there to provide solutions, to share broader inputs and to help them protect the company and themselves and, by doing so, giving them the safe environment they need to be able to help Surgeons Treat Their Patients Better.

One of the latest examples of meaningful impact that the legal and compliance teamwork had on the business is the contract management tool we are rolling out in EMEA. This initiative was driven by the legal and compliance team and as an overarching impact on almost all EMEA departments (especially to the sales teams), speeding many processes, ensuring the necessary approvals in a fast way and, also, triggering an automatic legal and compliance support whenever necessary. It is regarded by the business as a very positive initiative that will clearly improve business outcomes and the response we give to our clients and partners (special kudos here to the legal coordinators team that has been supporting this initiative).

What are some of the biggest legal or regulatory challenges currently facing your industry, and how is your team preparing to address them?

Just after 18 months since we began implementing the new Legal & Compliance vision, strategy and structure, to better support the business in their mission of Helping Surgeons Treat Their Patients Better®, the legal and regulatory framework could hardly be more challenging.

We witnessed the growing trade tensions between the EU and the U.S. bringing uncertainty to many sectors, and medical technology was no exception here. Arthrex is headquartered in Naples, Florida (U.S.), with subsidiaries around the world, acting as a true global company. Approximately 85% of Arthrex’s products are made in the United States and the top six countries from which goods, services or materials are sourced outside the U.S. are: Germany, Switzerland, Israel, Netherlands, Italy and Taiwan. Therefore, these tensions have brought many challenges to the company and, of course, for the legal and compliance department.

And the trade tensions just added up to some of the most critical topics that we were already facing: digital innovation, regulatory evolution, sustainability, and patient-centred care.

In the regulatory front, we have many challenges. From EU’s Medical Devices and In Vitro Medical Devices legislation, that is now subject to additional evaluation from the European Commission – and this represents a significant opportunity to evaluate the effectiveness of the existing regulations and to promote changes that will better support the sector’s mission of ensuring ongoing patient access to life-saving technologies. Alongside this evaluation, the Commission is also preparing several short-term measures to reduce regulatory burdens and enhance the predictability of conformity assessment procedures. These changes are essential for ensuring that innovations reach patients more swiftly and efficiently, which is a goal we all share and where Legal & Compliance departments have a critical role supporting companies to navigate this volatile evolution.

We also see major challenges with the new AI Act, the upcoming Biotech Act and the dissemination of copycats’ threats within the sector. All these challenges demand a strong in-house Legal & Compliance business partner.