Smoothing the regulatory journey for JRI Orthopaedics

"What we liked about the Medidata platform was the ability for us to better manage our clinical studies with improved oversight and reporting capabilities on one unified platform. The Medidata team has been great while setting up our clinical study. They are very professional and have been flexible and quick with all our changes. I’ve been very impressed."

-Emilie Stubbs, Clinical Project Scientist, JRI Orthopaedics Ltd.

The Introduction of the Medical Device Regulation

The EU Medical Device Regulation (MDR) was proposed in 2012 to replace the Medical Device Directive (MDD) and will go into full effect in May 2020. This regulation will ensure medical devices produced or supplied into the EU meet strict safety and quality standards. It significantly increases the amount of clinical data companies are required to collect to put and keep their products on the market. This means all existing registered medical devices will need to be recertified and companies will face a variety of requirements for compliance. If companies are not compliant, they can face risks such as loss of market access, loss of contract and reputational damage.

Before the implementation of the MDR, medical device companies had an easier roadmap to device approvals as they could claim “product equivalence”, claiming your device is similar to another device already on the market, and therefore could use the clinical data of the equivalent device.

Impact on Medical Device Companies

With the introduction of this new regulation, all medical devices currently on the market will have to undergo the same certification process as new devices. This includes extensive updates in the device’s documentation, labelling and requirements in clinical data. This means that medical device companies have to have their own clinical data and not rely on the data from an equivalent device.

JRI Orthopaedics’ Furlong® HAC femoral stem has been on the market for over three decades, with outstanding clinical results. Throughout the years, JRI Orthopaedics have introduced new hip and shoulder replacement devices, building on the legacy and success of the Furlong® HAC stem. With new products introduced to the market and in the development pipeline, JRI Orthopaedics started looking at different providers to help them manage their ever-growing portfolio of clinical trials and post-market clinical follow-up studies in a cost-effective way.

Accurate and Efficient Data Capture

 Under the MDR requirements, to obtain and maintain a CE mark, a manufacturer needs to prove clinical safety and performance of its devices, throughout their expected lifetime. For most joint replacements, this means that manufacturers must collect a least 10 years of clinical data. With the requirements for clinical data increasing, and hence more data to manage, JRI needed a comprehensive system to support the detailed and accurate collection of clinical data for both clinical trials and post-market clinical follow-up studies.

JRI Orthopaedics started a relationship with Medidata in 2019 to ensure efficiency, accuracy and control of the company’s clinical trials and post-market clinical follow-up studies to easily overcome the challenges presented by the changing regulatory environment.  They had worked with technology solutions in the past, but what they liked about the Medidata platform was the scalability allowing them to handle more complex requirements and a growing volume of data.

The Results

Enabled by Medidata’s technology, JRI Orthopaedics can now easily conduct long and complex multi-centre studies and manage the ever-increasing amount of clinical data generated by their new products. Medidata is supporting JRI Orthopaedics to conduct clinical trials on new products and offering an advanced clinical data system to collect required information on performance and success rates.

Using Medidata’s Rave Electronic Data Capture (EDC), JRI Orthopaedics is able to rapidly set up clinical studies, with maximum control to support a study of any size, length or complexity. With Rave’s flexible architecture, the clinical research teams can capture, cleanse and manage study data, ensuring efficient trial execution across every phase of the clinical trial life cycle. This allows for a consistent experience and real-time data visibility across sites, workflows and tasks, as well as the flexibility and ability to adapt processes and best practices for any study phase.

This new regulation means that the medical device world will see an uptick in clinical trials, and technology and platforms that can support this will be very useful. It will allow companies to quickly set up and manage their clinical trials seamlessly so they can keep their potentially life-altering products on the market and up to industry standards.