Medical Device Development

Design and analysis of studies to demonstrate the utility of new medical devices

The approval of new medical devices for routine clinical use now requires robust evidence on the patient safety, efficacy and utility of the device. Typically, this involves the prospective design and analysis of clinical trials to collect relevant data in a realistic setting. In this emerging field, the conduct of clinical trials is new to many of our customers and the need to work to certain standards, such as Good Clinical Practice, as well as developing and implementing quality standards is a daunting task.

Exploristics has extensive experience in the conduct of medical device trials and has developed a robust set of operating procedures to ensure that we work to the highest quality standards, making Exploristics the partner of choice for demonstrating the utility of the device and ensuring a smooth path to approval.

Our Approaches

Study set up

Exploristics can provide data management and statistical analysis expertise for the planning and conduct of pre-clinical and clinical studies for medical devices. In the study set up phase, we work with the client to develop the protocol, performing sample size calculations and ensuring the proposed analysis is aligned with the objectives of the study and describing all processes to maintain data integrity. Our experience also allows us to provide a general review of the protocol with specific insights on how to evaluate and demonstrate clinical utility.

Study conduct

We work with the client to develop a data management plan covering the design of case report forms (CRFs), the development and validation of the study database, implementation of data validation procedures and other processes that will ensure the study is performed to a standard required for regulators. We are also able to perform double data entry and manage the data clarification process.

Analysis and reporting

We work with the client to develop a statistical analysis plan providing a detailed description of all the analyses to be performed, including the outputs that will be produced. Where possible, we are able to develop the analysis code during the study so that we can produce final analyses once the database has been locked. We aim to produce statistical outputs that present the data in proper context. These include tables, listings and figures, with more of an emphasis on using graphics to facilitate interpretation. Typically, all analyses are performed using SAS but other packages such as R and Matlab may be used.

Our Experience

Medical device studies

We have supported numerous clinical trials for medical devices for a range of clients. Typically, these companies are small group of people with an innovative idea they want to develop. Often, the success of the study is pivotal to the future of the company. We collaborate with companies to understand what they are aiming to do and we design studies and use analysis methods that give the best chance of success. Given the importance of the study and the constraints faced by small companies, we focus on implementing practical solutions.

Establishing clinical utility

In medical device studies, it is important to present data is proper context. We have worked on studies where the device produced a live stream of data from measurements of vital signs. In this case, the production of tables is not meaningful and the visualisation of longitudinal data in comparison with other data (eg. clinical events) was critical. In one case, a device received a CE mark based on one of the graphics we produced to show the clinical utility. Another common device study involves the comparison of the new device with a gold standard. We have extensive experience in the use of Bland Altman plots and root mean square deviations to assess the level of agreement between the devices.

Regulatory issues

We work with customers to ensure that the study is fit for purpose and the device meets the needs of patients. Beyond that we provide support for the preparation of documents submitted to Regulatory Authorities and for product certification. We understand the industry and have the experience to efficiently and reliably collect and report the data to demonstrate that the product meets regulatory and quality requirements. We have provided support for CE marking and 510 K submissions and have interacted with the FDA, EMA and MHRA.