The Cook government affairs team in EMEA takes shape alongside new regulations

This story was brought to Life@Cook by Emmett Devereux, Cook Medical’s director of government and regulatory affairs in EMEA.

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On the 5th of April, 2017, the European Parliament approved the new Medical Device Regulations (MDR). This updated regulation is important to Cook’s patient-centered mission, as the regulations are designed to provide stronger safeguards for patients without stifling innovation. After nearly eight years of debate and consultation, the new regulation enters a three-year transition period and will impact the way we do business globally.

As a regulatory geek myself, I have been immersed in the creation of this regulation all along the way. Now that we finally have results, I thought you might be interested in how this regulation was developed and Cook’s input into the process.

Early beginnings

I joined Cook in 2001. Within a few days, it was clear that Cook was different. One of the first things that I learned was that no matter what you do, you do it for the right reasons and make sure that the patient is at the forefront of any decisions. At first, my focus was in the area of quality and regulatory affairs in Cook Ireland, so this was very welcome and supportive advice to receive. I had worked with a few other U.S.-based multinational companies since graduating as an engineer from the University of Limerick. They were not like Cook. Here, Cook’s culture gave employees the opportunity to use their initiative and get involved in many areas, without being asked first to do so.

As my career developed within Cook, so too did the regulations around medical technology that we had to comply with to market products in the European Union (EU). Around 2008, the EU Commission (our EU civil service) asked industry and stakeholders to suggest improvements to the existing legislation to better protect patients and our customers.

During this time, I became aware of the work that Tom Connaughton, Cook global vice president of government affairs, and his team in the U.S. were doing with regulators and legislators, not just in the U.S. but around the world. When I met Tom at a global regulatory affairs meeting in Bloomington, I was struck by the amount of meaningful interactions Cook has had with legislators and regulators since the company was founded. In the early days, this effort was led by Bill Cook and Steve Ferguson. And they encouraged the leaders at Cook locations around the world to get involved with the process of the regulation of medical devices in their countries. Over the years, the role of engagement with government has grown and so too has Cook’s government affairs team. In addition to Tom who leads the team, Cook now has two senior government affairs professionals in Bloomington, Dan Peterson and Gretchen Gutman, and an office in Washington, DC, staffed by Tom Connaughton, Allison Giles, and Julie Hasler. This team works closely with Steve and the Cook executive team.

Developing the government affairs function in Europe

About ten years ago, I was asked by Tom to join with several of my colleagues in Europe who were working to implement government requirements affecting how the device industry is regulated and how Cook could obtain insurance coverage and reimbursement for its products. We also focused on developing and delivering a patient-centered message on what we felt should be contained within the new EU Medical Device Regulations legislation.

This was the beginning of an exciting seven-year journey that has led not only to the publication of EU Medical Device Regulations, but also has established a Cook government and regulatory affairs team within EMEA. I am now devoted to this work full-time.

Our efforts started slowly but over time and after attending many meetings, in Brussels and the various EU countries, our message was heard. The regulators began to realize that as a privately held company with a very strong patient focus, Cook had a very worthwhile and balanced position on the new proposed regulation.

For those of you who will read in detail the newly approved EU Medical Device Regulations, you can be proud of the fact that Cook has been instrumental in building in patient safeguards while still fostering an environment of meaningful innovation.

Is Cook ready for this next phase?

Over the past year, there has been much discussion over the implementation of the new regulation. To manage that process, Cook has appointed Sinead Quaid  as the global project manager, to lead and globally implement this new regulation.

In advance of the approval, Sinead started to coordinate efforts on behalf of Cook. An EU MDR management group has been set up. Members for a global steering team are also being identified. There will be a lot of work for all of our global functions and entities over the coming months. A total of ten project teams will be formed to spearhead implementation efforts.

Initially, the focus will be in the area of clinical data and our Notified Body requirements. We will also need to address new requirements with regards to labelling, post market surveillance, materials, the unique device identification (UDI) system, transition to new certificates, secondary legislation, and changes to the Quality Management System.

In her new role, Sinead will work with all the Cook entities, divisions, and functions and our customers to ensure that the regulation is implemented globally in a timely and consistent manner.

As for the government and regulatory affairs function within EMEA, we will continue to be involved with the MDR implementation and will closely monitor the 80 pieces of secondary legislation that will be generated by the authorities in Brussels.

Open for business

The journey for Cook government and regulatory affairs function in EMEA is in its early stages. We have been fortunate to receive support from many at Cook, including Tom, Allison, Bill Doherty, Jens Johannesen, Claes Waller, Enrique Clua, and Renata Tagliabue. With their help we have been able to begin supporting many Cook locations and teams in the EU. The firm message we want to give is that our team is “open for business” in Europe.

Like Cook, governments around the world are in a period of transition. Over the coming years, it will be important that we watch these changes closely and adjust our business models to suit the changed environment.

Globally, the Cook government affairs team can provide outreach and guidance on key issues and policies, so please talk to Tom, Allison, or myself. We will do our best to support and advocate on your behalf.

If the last decade is an indicator of the next decade, then we are in for an exciting time.