Stryker (Spine Division) [NYSE: SYK]

Georgia Mitchell

As the Director of Clinical and Medical Affairs at Stryker’s Spine division, Georgia Mitchell oversees the Spine division’s global clinical evidence, strategy, and execution. This includes company-sponsored and investigator-led research, including post-market clinical follow-up activities and evidence to support Stryker’s marketing claims reimbursement and market access needs. She is also associated with clinical value funds-related activities to support markets that utilize EU clinical evaluations.

How have you seen the med tech industry evolving in terms of technological advancements and processes?

Working in the clinical trials space for over 20 years, I have observed that the challenges and opportunities evolve dramatically as digital tech changes. For instance, the advent of electronic health records has transformed paper study files into structured electronic study documents, and the integration of software applications has enabled e-consent and remote data monitoring.

Using APIs, integrating software applications like e-consent and remote data monitoring, and linking electronic health records to these applications enable the concept of multiple data sources. These data sources can be anything from claims databases and clinical registries to company-sponsored projects. The information aggregated in a big data concept allows us to view not only clinical trial data but all aspects of data. Regulatory bodies can use this information to make informed decisions while evaluating the safety and performance of medical devices that impact patient care and safety.

“Accelerating medicine development, improving treatment outcomes, and facilitating earlier patient access to new treatments using novel technologies and the evidence generated from big data will benefit public health.”

The digital solutions are across the board, creating efficiencies in data collection. In trial study monitoring, the concept of remote data monitoring applications has really taken on as a result of the COVID pandemic. This has helped in saving travel costs and having real-time access to data. The electronic data capture systems have also enabled us to monitor and evaluate the data on a real-time basis.

What are the latest technologies that you are currently using for your projects?

We are utilizing platforms such as electronic data capture, clinical trial management systems, and electronic trial master files. We’re also working with third-party registry providers—that are sponsored by different healthcare organizations around the globe—to develop registries and collect real-world evidence. Combining the sponsor-initiated research along with registries and claims databases, we are rolling these data sets into the concept of real-world evidence.

Do you expect an acceleration in terms of fundamental technological or behavioral shifts that may reshape the industry to benefit patients, sponsors, or healthcare professionals?

I don’t see acceleration but certainly a continuation. A few aspects of clinical trials, like personal data protection, differences in access to healthcare and access to technologies, and lack of regulatory harmonization across the globe, will slow down acceleration efforts. However, trends like access to knowledge at our fingertips with just a click of a button on a mobile phone or computer will result in a fundamental technological or behavioral shift. Since people are habituated to receiving their products at their doorstep, they are expecting a similar experience in clinical trials as well. Clinical trials are inherently an iterative process, and trends like this will eventually apply to clinical trials though it is advancing slowly.

Where do you see the industry moving in the next few years, and what advice do you give to your peers to navigate this changing space?

The digital solutions that I see on the horizon are real-world evidence and big data solutions. Programs like the FDA’s National Evaluation System for Health Technology (NEST), a voluntary network of health organizations that aims to efficiently develop real-world evidence using real-world data to support medical device evaluation and regulatory decision-making throughout the total product life cycle, are at the forefront of future trends. Also, the joint Big Data Steering Group of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) are continually publishing their work plans to enhance the efficient integration of data analysis into the regulatory evaluation of medicinal products. The novel technologies and evidence generated from big data will benefit public health by accelerating medicine development, improving treatment outcomes, and facilitating earlier patient access to new treatments. These initiatives are the next big step in advancing clinical trials.

To navigate this changing space, I would advise my peers to stay informed as best they can and remain cautiously optimistic.