The medical development process can be tedious and require multiple layers of regulations. The medical development process is used to innovate medical devices or procedures that improve patient care. There are many reasons why clinicians might want to innovate a medical device. They might want to make their lives easier during a medical procedure or develop a new device that will change thousands of patient’s lives by improving their living standards.
Whatever the reason for the development of the medical device, it is always for the patient’s safety. The medical development process is strict and has several steps before approval. Here are the vital steps involved in the medical development process.
Phase 1- Ideation And Risk Analysis
This is the initial stage of the medical development process. It is essential to document this stage since it will be vital in the future. Here, you will need to consider the funding strategies and the market your intent the device for. Every market has different procedures and regulations and challenges that you will have to overcome. If you are considering developing a new product that has not been developed, ensure that you file for IP (intellectual property) and patent your idea.
Market research is also crucial at this stage. Research equivalent devices and evaluate whether or not you need clinical trials for your product. The need for a clinical trial or not will significantly affect the cost of your development process.
Phase 2: Formulation and Feasibility
This is the stage where you will have a working device to prove your idea. You will confirm that your device has a place in the market and is financially feasible, which will offset the development process. You will also need to start funding your medical device and trials.
It is essential to start thinking about your customer requirements at this stage. You can hear their voice through competitor analysis, surveys, and market research and adopt their suggestions for the design. Do not forget to document every stage of the process.
Phase 3: Design Verification and Validation
At this stage, your device is not taking shape. You have a working prototype and are done with the trials, but you have yet to put the design through its paces and haven’t proved that your medical device can withstand all the pressures in real life.
Here you will need to set up a design trace matrix to ensure you have not lost track of your customer requirements. You will need to translate the customer requirements to engineering requirements. You will also need to know which mode to verify and validate your medical devices.
Phase 4-Product Launch Preparation and Final Validation
Once your device has been verified and validated, you can start thinking about marketing and branding your final product. It is essential to put your marketing into the literature to ensure that it is backed by evidence. Your product can be rejected due to a lack of evidence.
Once that is done, you can gather your verification and validation data. Where applicable, you should have all your evidence for testing, such as electrical safety and biocompatibility. Make sure you perform all the stability tests and shipping trials. These tests will give you an insight into the regulatory requirements of a product.
Phase 5: Product Launch
Finally, you will need to check your technical documentation and see if you need to make any updates. Have a plan for post-market updates. You need to have a system that will capture complaints and feedback and address the information and how the information will be treated.
You can opt for a solid risk management system to deal with any issues that might arise once you release the product in the market. You might also need to have a post-launch assessment where you will need to design documentation; in some cases, you might be required to re-test and make changes.
The medical development process is complex and requires proper planning and documentation to guarantee its success. You might need to deploy a quality management system to track all the phases.
