AT: You have spent your entire professional career at Stryker. Can you give us an overview of the company for readers who may not be familiar with it?
TU: Indeed, I have. Believing in and feeling connected to Stryker’s mission “to make healthcare better” has been one of the main reasons, particularly coming from a scientific background. I’ve also had opportunities to contribute and grow in various capacities as well as the privilege to work alongside many gifted and talented colleagues around the world.
Stryker was founded by Dr. Homer Stryker, an orthopaedic surgeon from Kalamazoo, Michigan, USA. He found that certain products needed in his practice were not meeting his patients’ needs, so he designed new ones and started the company in 1941 as others became interested in using his products. That initial spirit of innovation and the practical approach to problem-solving are still very much alive today in the organization, as its growth is based on a diverse array of pioneering products and services in orthopaedics, medical and surgical, and neurotechnology and spine that help improve hospital outcomes and patient lives.
AT: You came to compliance after spending seven years in clinical research, initially managing clinical trials, and then spent some time overseeing (research) operations. I imagine by then you had a fairly strong opinion of what compliance is and isn’t. What were some of the surprises you found when you stepped into a compliance role?
TU: Knowing just how highly regulated our industry is, I was intrigued to discover the impact the compliance program had or could have on parts of the business I was less familiar with. I often say that I learned more about the organization after a year in compliance than I did in my first seven years on the research team because compliance impacted every function. I’d get calls or meeting requests from all areas of the business asking for advice or guidance. In the early days, the pace at which the questions were being directed to me was a great motivator to quickly familiarize myself with each function, identify the compliance risks, and determine what would be the most appropriate advice, guidance, or response to mitigate.
AT: The medical device industry is exceptionally regulated compared to many others. Can you give us an overview of the key risk areas?
TU: Examples of the key compliance risks in the medtech industry relate to patient safety, the privacy of patient information, and billing practices. One of the ways I like to reiterate the significance of the compliance programs in this sector is that unethical conduct quite literally puts people’s lives at risk. Imagine a healthcare professional taking care of your loved one. What if there were shortcuts made on the conformity assessment of the product they bought? Or if their decision about which product to use on your loved one was influenced by a personal benefit received from the manufacturer and not what is best for the patient? This often gets the audience’s attention!
The increasing focus of data privacy and protection in medtech is not only because of the use of patient data in research and development and postmarket surveillance, but also due to major advances in technology that have led to an increasing number of connected devices that can generate, collect, store, analyze, and transmit data. If patient data gets into the wrong hands, it can lead to insurance issues, fraud, scams, or even identity theft and can impact the quality of patient care. We’ve seen laws and regulations modernized to establish standards for information security, and govern the digitization, analytics, and use of the data. Compliance professionals in our sector are now either upskilling and dedicating a significant amount of time to developing programs to comply with the requirements or are partnering with in-house or external privacy specialists to oversee these programs.