The Medical Device Lifecycle – Overview and Automation Potential
The Medical Device development lifecycle consists of five phases, which must be strictly followed in order to meet the EU MDR compliance and to ensure design control, safety, and effectiveness. This is a complex process, requiring manufacturing knowledge in wide-ranging areas, as well as expertise in design and all regulatory requirements set by the regulating authorities.
- Design and Development Plan
- Concept and Feasibility
- Design and Development – Verification and Validation
- Final Validation and Product Launch
- Launch and Post-Market Follow-Up
In this article we focus on the general overview of each phase and present potentials on how to automate several aspects within the lifecycle. Just follow the links to get to our detailed Use Case pages and get inspired by our Medical Device Lifecycle approaches and insights.
1. Design and Development Plan
This is where the initial evaluation of the development of a medical device takes place. Risk analysis is essential in order to move to the next phase. You should first define your needs and collect data to use in the Risk Analysis. The analysis is not completed until later in the development process, but it must be created in the first phase, and updated regularly through each following phase.
First and foremost, you must define a clear purpose of the medical device, which involves a thorough investigation of similar products that already exist on the market. This will determine what the consumer demands and needs are, giving you valuable insight on what you should use to make your device easy to differentiate and worth pursuing.
Market research is also needed to identify the classification of the device, determining how expensive and time-consuming it will be to launch the product to the market.
Documenting every step by building your case within an eQMS will make sharing ideas and feedback with your team easy to store and share.
A typical use case is the creation of Summary of Safety and Clinical Performance. Learn more.
2. Concept and Feasibility
The second phase consists of risk assessment, regulatory and customer requirements, with the initial prototype of the device working as a proof of concept. This is where you will document customer needs, surveys, and research with patients and clinical professionals in detail. This process must be repetitively reviewed and controlled by a QMS. At the end of this phase, you will know if your idea is feasible. This is done by conducting a feasibility study, helping you identify any unknown variables and letting you start the engineering design work. eQMS helps you gather all the required documentation for approval before the next step in the Medical Device Lifecycle begins.
One use case or technology that helps not only throughout the whole MedTech lifecycle but also for example in Chemistry is concerning the population of tables and creation of documents. Adaptable to any other type of table or document. Learn more.
3. Design and Development – Verification and Validation
At this stage, you build a prototype version of the product and validate it against user requirements. The design validation process is required to determine whether or not the product meets the requirements of stakeholders and end-users. You should prove with objective evidence that the product meets the user’s needs and predefined regulatory requirements. This is where you plan, design, and review your product through a series of validations with the prototype device to reduce the risk of failure.
The next step is to initiate the plan for the clinical trials of your product. This should be a well-controlled series of tests of the medical device in order to meet the standards of the industry and to ensure the safety and effectiveness of the investigational device before marketing. Your risk and benefit analysis should be updated once again after the completion of the initial clinical evaluation. You should be able to capture and then turn user requirements into Engineering Design Specifications (EDS) to build and design your product accordingly, using an URS (User Requirements Specifications) document.
At the end of each Clinical Evaluation is the Clinical Evaluation Report, which presents and summarizes the results. A very powerful use case that can be used very successfully. Learn more.
4. Final Validation and Product Launch
Once the clinical trials are completed, your documents and data need to be ready for submission to the authorities for product approval. They will audit and inspect in detail the analysis of your technical files. These files are required in order for your device to be launched on the market, and they should include:
- Device Master Record (DMR) – the instruction manual for manufacturing the device;
- The Design History File (DHF) – complete record of how the DMR was compiled;
- The Device History Record (DHR) – a proof of demonstration that you have used the instruction manual or the DMR to manufacture your device.
You should once again check all the gathered documentation, as well as a final update on the Risk and Benefit Analysis, which should now be followed by reviews, ready to collect new data from when the product will be released. This is another case where the right eQMS shines, helping you collect all the documentation for the technical files necessary for the audit.
5. Launch and Post-Market Follow-Up
Following the certification of the Medical Device by Notified Body (EU MDR) should be launched into the market. You must inspect and audit the production and QMS processes regularly to make sure you are staying within budget and the device itself is safe to use, maintaining the highest quality. The quality should be identical across all of the batches, to prevent any discrepancies from one product to another.
As soon as your products are on the market, you should start the Post-Market Clinical Follow-up (PMCF) and Post-Market Surveillance (PMS) processes, regulated by the EU MDR. They are both needed to verify consistent product safety and no performance issues across the lifecycle of the Medical Device. They include gathering data from all users of the device, as well as the distributors and everyone involved in the process of getting the product to the market and the customers themselves.
- PMCF evaluates and collects data on the safety and performance of the device and runs on a continuous basis throughout the entire lifetime of the device. The PMCF report is a document that summarizes the findings of the collected post-market data, based on clinical outcomes, emergency risks, real-world evidence, etc.
- A PMS report must contain a summary of the results and the conclusions of all the post-market surveillance data. It requires a summary status update for the period included in the report, and the received feedback. It should also include a description of all the preventive or corrective actions taken during the reporting period.
Within Post Market Surveillance several use cases are viable. The overall PMS process is presented here. If you are explicitly interested in generating PSUR or PMS reports, learn more here.