Georgia Mitchell, Director of Clinical and Medical Affairs, Stryker (Spine Division)
Georgia Mitchell, Director of Clinical and Medical Affairs, Stryker (Spine Division)
As Director of Clinical and Medical Affairs for Stryker’s Spine Division, Georgia Mitchell oversees the Spine Division’s global clinical evidence, strategy and execution. This includes company-sponsored and investigator-led studies, post-market clinical follow-up activities and evidence supporting Stryker’s marketing claims reimbursement and market access requirements. She is also involved in activities related to the Clinical Value Fund to support markets leveraging EU clinical assessments.
How do you see the medtech industry evolving in terms of technological advancements and processes?
I have worked in the clinical trials field for more than 20 years and have observed that as digital technology changes, the challenges and opportunities are also changing dramatically. For example, the advent of electronic health records has transformed paper research documents into structured electronic research documents, while the integration of software applications has enabled electronic consent and remote data monitoring.
The concept of multiple data sources can be implemented using APIs, integrating software applications such as electronic consent and remote data monitoring, and linking electronic health records to these applications. These data sources can be anything from claims databases and clinical registries to company-sponsored projects. The information aggregated in the big data concept allows us to view not only clinical trial data, but also all aspects of the data. Regulators can use this information to make informed decisions while evaluating the safety and performance of medical devices that impact patient care and safety.
NumberHarnessing evidence generated by new technologies and big data to accelerate drug development, improve treatment outcomes and promote earlier patient access to new treatments will benefit public health 
Digital solutions are comprehensive and increase the efficiency of data collection. In experimental research monitoring, the concept of remote data monitoring applications has really taken off due to the COVID-19 pandemic. This helps save travel costs and provide instant access to data. Electronic data capture systems also enable us to monitor and evaluate data on an instant basis.
What are the latest technologies you are currently using on your projects?
We are leveraging platforms such as electronic data collection, clinical trial management systems and electronic trial master files. We also work with third-party registry providers sponsored by different healthcare organizations around the world to develop registries and collect real-world evidence. Combining sponsor-initiated studies with registry and claims repositories, we translate these datasets into concepts of real-world evidence.
Do you anticipate an acceleration in underlying technology or behavioral shifts that will reshape industries to the benefit of patients, sponsors, or healthcare professionals?
I don’t see an acceleration, but it will definitely continue. Aspects of clinical trials, such as personal data protection, disparities in access to healthcare and technology, and a lack of regulatory coordination globally, will slow efforts to accelerate efforts. However, trends such as easy access to knowledge at the click of a button on your phone or computer will lead to fundamental technological or behavioral shifts. Since people are used to receiving products at their doorsteps, they also expect a similar experience in clinical trials. Clinical trials are inherently an iterative process, and although progress is slow, such trends will eventually apply to clinical trials.
Where do you see the industry going in the next few years? What advice do you have for your peers to navigate this changing space?
The digital solutions I see are real world evidence and big data solutions. Programs such as the Food and Drug Association’s (FDA) National Evaluation System for Health Technology (NEST), a voluntary network of health organizations that use real-world data to effectively develop real-world evidence to support medical device evaluation and regulatory decisions throughout the product life cycle , are all at the forefront of future trends. In addition, the joint Big Data Steering Group of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) continues to publish its work plan to strengthen the effective integration of data analysis and regulatory assessment of medicines. New technologies and evidence generated by big data will benefit public health by accelerating drug development, improving treatment outcomes and facilitating earlier patient access to new treatments. These initiatives are the next major steps in advancing clinical trials.
To navigate this ever-changing space, I advise my peers to be as informed as possible and to remain cautiously optimistic.
