Learning from a global health leader
GE Healthcare bases much of its global imaging products business in Wisconsin, and Chief Quality Officer Thomas Westrick will bring the lessons he’s learned leading a multinational company to the next Icons in Business event.
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Just about everyone is familiar with General Electric, the global conglomerate that can trace its roots all the way back to Thomas Edison. Less familiar, perhaps, is GE Healthcare, the $19 billion health care division of General Electric, which houses much of its imaging products operations right here in Wisconsin.
As a leading provider of medical imaging equipment, with more than 100 years in the industry and more than 50,000 employees across 100 countries, GE is a major player in the global health care industry.
In his role, Westrick leads the business’ Global Quality and Regulatory Affairs organization to ensure its products get to global markets efficiently and effectively, as well as overseeing all aspects of patient safety. But while his outlook is global, Westrick is a Badger at heart.
Westrick began his career in finance after graduating from the University of Wisconsin–Madison. He spent the first 13 years of his career with Arthur Anderson in public accounting before moving on to GE.
“I joined GE Healthcare in 2003 because I wanted to work for a large-scale global company that would provide me growth opportunities,” says Westrick. “I also had some experience in the health care sector and the proximity of GE Healthcare to my home was an added bonus.”
During his time at GE, Westrick has held a variety of challenging leadership roles, which has given him insights into different aspects of the business. In 2016, he made a shift from managing the financial side of the business to leading Quality and Regulatory Affairs. “This new role has brought me deeper into our manufacturing processes, customer experience, and innovation, which is at the heart of everything we do at the company,” Westrick notes.
Rules and regulations
Clearing regulatory hurdles to bring new products to market is no easy feat, especially in the highly regulated health care field. Anyone with a chronic medical condition who has waited for that next big development that’s “right around the corner” to actually come to fruition can attest to that. Westrick is quick to point out though that the regulations aren’t a damper to GE Healthcare’s business, and they are actually less of a headache in the U.S. than elsewhere.
“Since Wisconsin is a global hub for many of our imaging products, I spend a lot of my time focused on the products, teams, and leaders located here,” says Westrick. “Our shared goal is to deliver safe and quality products within the United States and to health care facilities globally. Every country’s governing body has its own regulatory requirements for medical devices. Knowing the requirements, navigating the processes, and meeting expectations involves not only my team but also many other departments and global experts. Typically, however, most regulators want to know the same things: what is the product, what does it do, and how is it used safely?
“For GE Healthcare, I don’t believe regulations are hampering our research and development,” Westrick continues. “Just last year we delivered 25 new products to the market. We understand the need for regulations and the obligation to ensure safe and effective devices.”
In the case of GE Healthcare, Westrick explains safety is the company’s number one priority for every product or service it develops, making it paramount that GE puts quality before speed to market.
“Precision health care is the new frontier, which is driven by software/artificial intelligence and data,” states Westrick. “Software solutions and innovations will likely be available much faster than a traditional manufactured device. [However], the pure volume of digital developments could slow innovation coming to the market. The industry is working with regulators now to look at these processes to ensure we can meet our safety requirements while also being responsive to the needs of patients who benefit from a new development.”
According to Westrick, the U.S. FDA provides clear and consistent processes and expectations for the companies it regulates. Medical device manufacturers such as GE rely on these to guide what they need to do for their products to be authorized for use in the U.S., he explains. In contrast, many other countries do not have such a consistent and disciplined approach.
“These variances make those regulatory environments more challenging,” Westrick notes. “Some of the less mature markets/countries also have a much longer process. For example, what might take 30 to 90 days in the U.S. can take over a year in another country. An example of how this can impact our customers is, depending upon their location, is that not all products are available for every customer at the same time.”