In this post, we dive into the importance of optimizing clinical evaluation of medical devices and the challenges faced by device manufacturers. Further, how the process can be optimized with the use of Electronic Data Capture (EDC) solutions. For a more detailed explanation download the white paper from the bottom of this post.
All device manufacturers aiming to comply with the MDR will have to be able to present clinical data to notified bodies as and when requested.
However, if the process behind generating clinical evidence is not optimized, manufacturers will also risk prolonged time-to-market, which impacts both budgets and overall revenue.
Let’s dive in…
What is clinical evidence?
The latest MEDDEV 2.7/1 revision 4, defines clinical evidence as:
“The clinical data and the clinical evaluation report pertaining to a medical device.”
A simple and valid definition used to define the context in a regulated guidance document.
Yet, in a broader perspective, one can also interpret clinical evidence as:
“The process to which you collect and document scientific arguments of clinical -safety, and -outcomes, when applying a method or a solution to a certain care pathway.”
The generation of clinical evidence for medical devices requires both collection of data, and scientific documentation. The process requires cooperation between various groups of people specializing in clinical, engineering, QA, and regulatory know-how. All of which are often packed into clinical studies that involve sponsors, healthcare professionals, and patients.
The challenge with generating clinical evidence for medical devices
Through the years we have gained experience working with medical device manufacturers and participated in the process both as actors and observes.
The process of generating clinical evidence is often modeled as a “waterfall” process and the typical activities are as follows.
- Define requirements for study outcomes
- Design protocols, statistical analysis plans, and cooperation agreements.
- Setup the study i.e. write documents, forms, questionnaires, SOP’s, etc.
- Choose system vendors (if relevant)
- Conduct data collection – Clinical Investigation
- Transcribe and “clean” data
- Analyze collected data
- Generate reports and outcome documentation.
We believe it’s safe to state that for most medical device manufacturers, this whole process is slow, troublesome, and inefficient.
Therefore, we recommend optimizing the process as a whole.
In the white paper, we have outlined three key actions on how the process can be optimized by providing the answer to the questions below.
- Why is it important to digitize the data collection for a clinical investigation?
- How to improve the protocol design?
- How can you achieve higher quality evidence?
Consequently, from asking the right questions the benefits become evident.
Benefits of optimizing the process as a whole
The underlying belief is that Medical Device Manufacturers can benefit from optimizing all the processes that surround clinical evaluation. The benefits of optimizing the process as a whole are
- Increased data security and faster access to data
- Improved protocol design which results in fewer amendments
and clearer goals
- Designing better forms will result in increased compliance and less missing data
- Collection of quantifiable data will result in less complex analysis and clear results
- Improved collaboration and cooperation which results in improved efficiency, less stress, and minimized work-load
We work with medical device manufacturers who have applied these principles to the standard workflow. As a result, they have cut down on the time spent on planning clinical studies from months to weeks. Employees have improved collaboration and communication which also results in less stress and fewer delays. See how Oticon is generating quality data
You can request your own copy of the White Paper by clicking the button below.
Have you thought about how you can optimize the clinical evaluation process for your team?