In the medical technology industry, a rigorous process is necessary to ensure the safety and effectiveness of any medical device.
An essential part in order to assure the general performance and safety requirements (GSPRs) is to assess valid scientific evidence from published literature. That process is part of the Clinical Evaluation (EU) and Premarket Approval (FDA), and it is mandatory for any device manufacturer seeking entry into specific markets.
This evaluation is not just a formality. It involves careful documentation, rigorous compliance with government regulations, and input from various internal stakeholders. A successful clinical evaluation report requires integration of multiple documents from various departments and close collaboration with other regulatory processes, such as:
- Risk Management
- Post-Market Surveillance (PMS)
- Post-Market Clinical Follow-Up (PMCF)
Given the complexity of this process, thorough and well-documented evaluation is critical for device manufacturers. With the right approach, however, a successful clinical evaluation can be achieved, paving the way for safe and innovative new medical technology.
Clinical evaluation and systematic literature review is a vital process in knowledge management. It's not just a regulatory requirement, but a source of valuable information specific to your device. To ensure accuracy, cross-functional collaboration is necessary. Other outcomes of a structured literature review include:
- State-of-the-art Assessment
- Risk-Benefit Analysis
- Medical Communication Strategy
- Competitive Intelligence Review
- Patent Tracking
How to Structure the Literature Review -The PICO Concept
The PICO concept is a useful tool for structuring literature reviews and narrowing down research topics. It helps to identify the most relevant information quickly and efficiently when conducting a literature review. PICO stands for four components of a research question: Population/Patient, Intervention, Comparison, and Outcome:
- Population/Patient: This could be a group of people with a certain condition or characteristic, such as age, gender, or disease state.
- Intervention: This could be a medical product, procedure, event, factor, program or other type of intervention being studied in relation to the Population/Patient.
- Comparison: This allows you to compare the intervention and population/patient under study to other interventions or control groups not being studied, such as placebo treatments or standard care. This helps to draw conclusions about how effective an intervention may be for a particular population or patient.
- Outcome: This allows you to specify what outcome should be measured when conducting a literature review. This could be an event such as mortality rate or a change in patient’s health status, among other measures. It is important to define the desired outcomes for your research question prior to beginning a literature review.
The PICO concept is a framework to set up the search query and helps to identify the most relevant information quickly and efficiently when conducting a literature review. This allows researchers to focus on gathering evidence that is likely to have an impact on their study.
The amount of time it takes to conduct a systematic literature review depends on the scope of the study and the number of studies included. Generally, most academic and scientific systematic reviews require between six and twelve months for completion. However, some systematic reviews can take up to two years or longer depending on their complexity. Within the clinical evaluation, literature reviews take usually days to weeks and therefore require very efficient processes. Within the post-market surveillance phase, the scientific evidence in the ‘living systematic review’ will be continuously updated as part of the PMCF strategy.
Conducting a systematic literature review requires significant time and effort. Therefore, it is important to plan and give yourself enough time to complete the review properly. By following the PICO framework, researchers and medical writers can ensure they are conducting a comprehensive, effective, and time-efficient literature review.
How to Conduct an Efficient Review - Using AI to Save Time & Cost
Natural language processing (NLP), a branch of artificial intelligence (AI), is becoming commonplace in the medical and medical technology fields. Text mining and machine learning, examples of NLP techniques, are increasingly being used to improve reference prioritization.
NLP uses algorithms to uncover patterns in both structured and unstructured data. This technology can be used to identify PICO terms from published literature which can help researchers prioritize relevant studies for review. Recognizing PICO terms from published literature can facilitate knowledge discovery and critical analysis of relevant studies.
Text Mining
Text mining involves using software to extract pertinent information from a document or large group of documents. The extracted information is then used to generate a comprehensive list of PICO terms. This list can be used to identify relevant studies for review and further analysis.
Machine Learning
Another powerful technique, machine learning can be used to recognize patterns in text and make predictions about the relevance of a particular document or set of documents. Machine learning algorithms are trained using a large dataset of manually annotated PICO terms. The algorithm then uses this training data to predict the likelihood that a particular document or set of documents contains pertinent information.
Using machine learning and text mining can save researchers time and money while achieving the same quality as conventional methods. Saving time and money can allow for deeper analysis or more extensive improvements to the system. This helps to uncover meaningful insights which could lead to better decision making. Ultimately, this empowers researchers and medical writers to make better decisions and drive innovation.
Advantages of Using a Systematic Review Tool
Using a systematic review tool to manage your systematic literature review has several advantages over using manual excel-based processes:
1. Reduce Time-Consuming Tasks
Using a systematic review tool can eliminate or reduce tedious and time-consuming tasks such as manually entering data into spreadsheets and ensuring accuracy of the results. It can also automate tasks such as searching within documents for keywords or phrases, which would otherwise have to be done manually. This can significantly reduce the amount of time needed to manage a systematic literature review.
2. Collaborate On Projects with Multiple Authors More Easily
By providing a single, centralized platform for all authors to access and collaborate on the review process, it can make it easier for authors to communicate and stay up to date with progress. This is especially useful when working on a large and complex systematic literature review where multiple authors are involved.
3. Ensure Accurate Results
The tool's search capabilities are usually very precise, and it can be set up to search multiple databases at once. This helps ensure that all relevant information is included in the review process, which can help improve the accuracy of results.
4. Create An Extensive Database of Literature Sources
By creating and leveraging a comprehensive database of structured information, you can identify relevant studies quickly and efficiently and ensure that all relevant studies are included in the review process. This can help ensure that conclusions drawn from the systematic literature review are reliable and robust. Additionally, this feature can also be used to track studies over time, allowing you to easily identify any new research which may have emerged since your initial search.
Curedatis: Thoughtfully Designed for Speed & Efficiency
Curedatis is an innovative online platform that revolutionizes medical device companies' clinical evaluation process. It's fast, efficient, and smart - featuring intelligent documentation, streamlined regulatory compliance, and audit trails. With Curedatis, medical device companies can easily manage clinical evidence and achieve better compliance.
To ensure a successful clinical evaluation, project and knowledge management capabilities are critical. Curedatis and Article Galaxy make the literature review process streamlined and copyright compliant.
