The market of orthopedic and spine medical devices is increasing through innovation and is estimated to be $30 billion in the USA and $25 billion in the EU. The FDA and medical device regulations remain an important barrier for innovation to get through, and clinical trials are a pivotal step in bringing these devices from concept to market. Contract Research Organizations (CROs) play a significant role in the early feasibility study (EFS) for these devices as well as Postmarket Clinical Follow-up (PMCF) by managing and executing these trials. However, not all CROs are equipped to handle the complexities of orthopedic and spine device trials. This article outlines the top 10 essential criteria that CROs must meet to successfully conduct clinical trials in the orthopedics and spine field.
- Regulatory Compliance and Expertise
Understanding of Regulatory Frameworks
Clinical trial CROs must possess comprehensive knowledge of the regulatory requirements specific to medical devices in orthopedics and spine. This includes familiarity with Regulation (EU) 2017/745 on medical devices (MDR). Expertise in navigating device equivalence rules as well as Pre-Market Approvals processes such as early feasibility studies (EFS) and country-specific standards is essential.
Experience with Regulatory Submissions
The medical device clinical trial CRO should have a proven track record of successful regulatory submissions and interactions. This experience ensures that the trial design meets notified body expectations as well as the competent authority’s, and that all necessary documentation is prepared accurately and efficiently. Manufacturers should check if the CRO has an internal full-time study start-up team.
- Specialized Expertise in Orthopedics and Spine
Clinical Knowledge
A deep understanding of orthopedic and spine conditions is crucial. The CRO’s team should have in-house clinicians specialized in spine and orthopedics, as well as clinical trials professionals with clinical backgrounds in orthopedics, such as orthopedic surgeons, spine specialists, and musculoskeletal researchers.
Check out our expert in Orthopedic and spine clinical trial
Dr. Nikhil Khadabadi
Guillaume CHARLES
Dr. Axel Schulz,
Experience with Similar Devices
Experience in managing trials for similar medical devices enhances the CRO’s ability to anticipate challenges and implement best practices. Familiarity with surgical procedures, rehabilitation protocols, and device mechanics contributes to more effective trial management.
Check-out what customers says about us :
https://www.eclevarmedtech.com/en/customer-feedback/
- Quality Management Systems
Compliance with Good Clinical Practice (GCP)
Adherence to GCP standards ensures the ethical and scientific quality of the trial. The CRO should have robust Standard Operating Procedures (SOPs) and a quality management system that aligns with international standards like ISO 14155 for medical device clinical investigations.
ISO Certifications
Medical device CROs are critical vendors for manufacturers. Possession of relevant ISO certifications, such as ISO 13485 for medical devices, is important. The CRO should demonstrate a commitment to maintaining high-quality processes throughout the trial. In addition, medical device CROs process very sensitive health data through their systems; the CRO should also have ISO 27001 for cybersecurity and data protection required by the GDPR.
- Patient Recruitment and Site Management
Efficient Patient Recruitment
Orthopedic and spine trials often require specific patient populations with particular criteria of inclusion and exclusion or anatomical considerations. The medical device CRO must have different strategies for efficient patient recruitment and site identification, including access to databases, interoperability of EHR and relationships with patient advocacy groups, and outreach programs.
Example:
MILO Site Select and Contracting: New innovative solutions that score sites based on patient population, experience of the site, and performance.
Established Clinical Site Networks
Strong relationships with reputable clinical sites and investigators expedite the trial process. The CRO should have a network of sites experienced in orthopedic and spine studies, ensuring high-quality data collection and patient care.
Example of sites partnered with Eclevar medtech:
- Data Management and Statistical Analysis
Advanced Data Collection Systems
The CRO must utilize robust electronic data capture (EDC) systems that ensure data integrity, confidentiality, and compliance with regulatory standards like 21 CFR Part 11. ECLEVAR MEDTECH uses MILO EDC as an electronic data capturing (EDC) system on electronic Case Report Form (eCRF), a secure, internet-based case report form. This system will be used to record all subject information collected in the investigation for secure data tracking. The EDC system used is MILO EDC, version 2023.3.0, delivered by ECLEVAR MEDTECH Inc. The system is designed to be compliant with the FDA requirements of 21 CFR Part 11. It is a validated data management system allowing only qualified and trained personnel to enter the system. The system has a full audit trail and electronic signature.
Expertise in Patient-Reported Outcomes
Seventy percent of spine and orthopedic clinical trials include at least one PRO measure. In addition, incorporating PROs is considered a standard practice in the design and conduct of clinical trials within these fields. Furthermore, conditions in spine and orthopedics often involve pain and functional limitations that are best reported by the patients themselves. A CRO that has its own platform for PRO certified ISO is essential to conduct clinical trials in spine and orthopedics
ePRO questionnaire
Native ePRO questionnaire created within Milo EDC
Send invitation
Send email (QR code to download app) or login to mobile site
Responsive Survey
Participants fill out the survey on a laptop or mobile device
Notifications
Receive app/email notifications reminding when to take the survey
ePRO Data Capture
ePRO data captured in Milo EDC
Proficiency in statistical analysis tailored to orthopedic and spine trials is essential. Notified bodies and competent authorities are generally looking for justification of sample size before accepting the protocol or the PMCF plan.
Check out how ECLEVAR MEDTECH conducts high-level surveys for medical devices.
For more information, check out the MILO eCOA and some case studies.
- Ethical Considerations and IRB/EC Interactions
Patient Safety Protocols
Ensuring patient safety is paramount. The CRO should have robust processes for monitoring adverse events, implementing safety measures, and obtaining informed consent.
Experience with Ethics Committees
Navigating Institutional Review Boards (IRBs) or Ethics Committees (ECs) efficiently ensures timely trial initiation. The CRO should have experience preparing ethical submissions and addressing committee feedback.
- Risk Management
Adverse Event Monitoring
The CRO must have systems for real-time monitoring of adverse events and reporting them according to regulatory requirements. This includes establishing Data Safety Monitoring Boards (DSMBs) when necessary.
Risk Mitigation Strategies
Proactive identification and management of potential risks minimize trial disruptions. The CRO should conduct regular risk assessments and have contingency plans in place.
- Communication and Reporting
Transparent Communication with Sponsors
Regular updates and open communication channels with the device sponsor are essential for collaboration and trust. The CRO should provide detailed progress reports, data analyses, and be responsive to sponsor inquiries.
Regulatory Reporting
Timely and accurate reporting to regulatory authorities ensures compliance and fosters a positive relationship with regulators. The CRO must stay abreast of reporting requirements and deadlines.
- Financial Stability and Resources
Adequate Funding
Financial stability ensures that the clinical trial CRO can sustain trial operations without compromising quality. Sponsors can check if the CRO is backed by venture capitalists, such as ECLEVAR MEDTECH being backed by BALLAINVEST:
https://www.ballasinvest.com/investments
- Global Reach and Localization
Multinational Trial Capabilities
For trials conducted across multiple countries, the CRO must have the infrastructure to manage global operations. This includes understanding local regulations, cultural nuances, and language differences. ECLEVAR MEDTECH is a European CRO for medical devices with capabilities to run clinical trials in France, Germany, Spain, and the UK. The CRO must demonstrate proficiency and knowledge of regional regulatory environments to ensure compliance and facilitate smoother trial conduct in different jurisdictions.
Conclusion
Manufacturers of medical devices need to outline a clear process with stringent criteria for selecting a CRO partner with the right expertise and capabilities, which is critical for the success of clinical trials in orthopedic and spine medical devices. The complexity of orthopedic trials requires a CRO that not only understands the regulatory landscape but also has internal clinicians and robust quality systems, as well as effective patient recruitment strategies. By adhering to the criteria outlined above, medical device sponsors can partner with CROs that will enhance the trial’s integrity, efficiency, and ultimately contribute to the advancement of orthopedic and spine healthcare solutions
