Phases of Manufacturing Medical Device Development
Medical Device Development idea seems to be revolutionary in theory but in practical a product without research cannot live upto the expectations of the market. It is necessary to analyze the user- requirements before proceeding to the next stage.
To develop a medical device, there are five phases to be implemented. Each phase requires detailed planning and documentation. So, do you have a medical device development plan in your mind? You can also understand the trends of medical devices that have taken a place after the emerging technologies in the healthcare industry.
A universe of medical device development is more than just assembling the device. Let me give you a detailed description on each of the phases that is involved in the medical device development.
Phase 1: Ideation and Risk Analysis
Document the planning done for the medical device. Analyze the risk involved in manufacturing and decide whether to move to the next phase or not. Define what is the USP of the product. Decide the target audience you have planned to target and determine the time and expenses that will be needed to get the product in the market.
Phase 2: Conceptualization and Planning
In this phase the process would involve testing, cost structuring, and scalability. One should also keep in mind the rules and regulations of producing a medical product. Now that you finalize the product concept, it is time to plan the strategy of the requirements of the raw materials and overall production cost. Pre-plan the logistics to avoid any delay in the development of the device.
Phase 3: Design & Development
After the initial discussion on the product development, proceed with the design of the product now. Shape a rough idea that covers mechanical design, industrial design, software and electrical & electrical design. Industrial designing involves testing of the design, mechanical design involves the aesthetics, software incorporates the UI/UX for easy operation.
Now that you have the POC, this phase is all about controlling the design process of the product to ensure:
- Capture the users needs effectively.
- Turning those needs and requirements into solutions
- Designing and building the medical product successfully
Throughout the stage of planning, reviewing design and approval, it needs to create an auditable trail of the steps to reduce the future risk.
Phase 4 : Prototype & Validate
The NPI validation involves checking the capabilities, machines, and efficiency of the production lines. This stage is the transfer of technology to the mass manufacturing stage. All the information should be gathered for approval with clinical trials. This piece of information should be technically sound in the eyes of FDA, and MHRA in different domains.
Phase 5: Product Launch and Post Assessment
Do final check of the document that you have prepared to develop the medical device. Once you have approval to launch the product, you need to transfer the plan to the manufacturer. The good set of eQMS tools throughout the process will determine the key to process seamlessly further. The manufacturing partner will need access to the documentation to produce the product.
Conclusion
The process of these five stages or phases right from the ideation to the launch of the product is complex. With moving parts, documentation requirements, abiding by the laws, all the hurdles can be resolved or overcome.
Post launch services involve providing a breakdown or fault by the user’s end. Any marketing done is recorded and reported back. Once the issue is identified the rectifications and implementations are planned to make the necessary changes.
Make medical devices effective to solve complex and daily health problems. There should not be any rush in manufacturing the device as you may miss out on any regulation that needs to be complied with.
