Evaluation of Medical Device in Clinical Trials

“Anything that treats a patient without the use of medicine is considered a medical device by the FDA.”

Medical device makers in Europe must conduct clinical reviews to ensure the safety and effectiveness of their products. This process uses clinical data and the European Medical Device Regulation 2017/745, which has significantly changed the legal foundation for clinical assessments.

The medical device market is growing quickly, necessitating a number of standards and hurdles throughout the review process. The Clinical Trials Innovation Programme will offer a forum for talking about these issues, the risks associated with them, and potential solutions.

What is a Need for Clinical Evaluation?

• Medical device producers must ensure their products meet all essential performance and safety requirements before they go on the market.
• This includes demonstrating the device's performance under typical conditions, minimizing risks and adverse events, and backed up statements.

Medical Device Classification:

FDA has classified Medical Devices into following:

Class I:

• Class I include wheelchairs and crutches etc, that are non-invasive and pose minimal risk to patients and users.
• Most Class I devices are 510(k) Exempt, requiring no FDA approval.
• 47% of devices fall under this category, with 95% exempt from regulatory testing.

Class IIa:

• Hypodermic needles and dental fillings are examples of class IIa devices, which are low to medium risk and usually administered for at least an hour.

Class IIb:

• Lung ventilators and bone fixation plates are examples of class IIb devices, which are medium to high risk and need FDA approval.

Class III:

• Class III medical devices, including breast implants and pacemakers, pose a higher risk to patients, with only 10% of medical equipment classified as such.
• These devices require FDA pre-market approval based on robust clinical evidence.

How is Clinical Evaluation Conducted:

Clinical evaluation is crucial for a new project's success, starting from the beginning of the project.

Clinical Evaluation Report:

The results of the evaluation must be summarized in a Clinical Evaluation Report (CER), which is mandatory for the initial CE mark.

Guidelines:

The "MEDDEV 2.7/1 Revision 4" guideline, published by the EU Commission in 2016, provides a detailed process of clinical evaluation.

According to guidelines, clinical evaluation should have following steps.

Step 0: Planning:

• Outline the clinical assessment's purpose, format, product development category (new or existing technology, new application), and its intended usage.

Step 1: Identification:

• Identification of potential sources for clinical data collection, including scholarly literature, clinical experience, and clinical research.

Step 2: Assessment:

• Evaluating individual data and assessing its reliability and safety and benefits based on predetermined standards.

Step 3: Analysis:

• It involves evaluating all relevant data to assess the performance and safety of the medical device, considering factors such as safety, product benefits, data importance, and qualitative/quantitative evaluation.

Step 4: Report:

• A logically organized report on the assessment that includes step-by-step documentation and reasoning (clinical evaluation report).

Regulation and Standards for Risk Management:

Risk management is a crucial aspect of the medical device development lifecycle, ensuring product reliability, proper functioning, and safety.

ISO 14971:2007:

• It provides guidelines for manufacturers to navigate potential hazards, including risk analysis, evaluation and control.
• Provides guidelines for managing procedures during production and post-production.

Medical Device Usability Standards:

• Medical device usability standards are established by the FDA to ensure safe and effective products.
• These standards help manufacturers create products that are safe and effective for their intended users.

IEC 62366 is the most important international standard for human factors engineering and usability risk management.

ISO 14971 is a broader standard for risk management in medical devices.

These certifications are crucial for promoting device adoption in markets.

Post-Marketing Evaluation:

• It is a process that involves continuous monitoring of a device's performance after it's placed on the market.
• It involves collecting data from sources like complaints, adverse events, and literature reviews to identify issues that may not have been evident during pre-market clinical evaluation.
• Post-Market Clinical Follow-up (PMCF) activities are crucial for refining and updating Clinical Evaluation Reports (CER) and Summary of Safety and Clinical Performance (SSCP).
• These activities must be prepared to retrieve market feedback and respond to potential issues and health concerns.

Challenges:

Navigating Complex Regulatory Requirements:

• Medical device regulations are becoming more complex, particularly in the US and Europe, necessitating strict clinical proof from agencies like the FDA and EMA.
• Manufacturers face challenges in complying with these stricter criteria.

Solution:

• To overcome this, businesses should adopt a proactive approach, including careful recordkeeping, coordination with regulatory bodies, and early preparation for regulatory processes.
• This can minimize delays and cut costs by streamlining approvals and clarifying requirements through pre-submission consultations.

Solution:

• To maximize RWD benefits, manufacturers should invest in secure platforms, establish strong data governance policies, collaborate with data scientists, and communicate with regulatory bodies about surveillance results.

Cost Constraints and Resource Management:

• Medical device trials are costly due to the need for specialized equipment, long study durations, and expertise.
• Limited resources can hinder comprehensive clinical investigations.

Solution:

• To overcome this, companies can adopt a phased approach, focus on high-priority areas, collaborate with research institutions, and participate in public-private partnerships.
• Decentralized trials and remote monitoring can also reduce costs.

Technological Complexity:

• Advanced technologies in devices introduce risks and evaluation challenges, especially regarding reliability and cyber security.
• Rapid technological changes can make it challenging to keep evaluation criteria relevant.

Conclusion:

• Medical device evaluation is crucial for patient safety and efficacy.
• Manufacturers must adhere to rigorous testing protocols, regulatory engagement, and user feedback to navigate complexities and foster innovation.

Clinical Trials Innovation Programme:

Medical device clinical investigations pose a complex challenge, but with effective strategies, manufacturers can navigate regulations, ensure data integrity, and keep pace with technological advancements. Adopting patient-centered approaches, strong data governance, and emerging technologies can set new standards.

The Clinical Trials Innovation Programme, which will be organized by World BI, will offer a forum for discussing the difficulties in MDR and will also highlight solutions.

Participants will get the opportunity to learn more about this system, take part in conversations, share their thoughts and experiences, and look at ways to get over these obstacles.

For more details, visit our official website World BI.