Medical device development is far from easy – in addition to government rules and regulations, developers have to deal with testing, quality control, and more. Because it is so complex, the medical device development process is usually broken down into five distinct stages.
5 Phases of Medical Device Development
The following phases have to be followed carefully in order for successful medical device development. They have been determined by the Food and Drug Administration (FDA) and ensure strict quality control and safety guidelines.
1. Initiation and Risk Analysis
This involves initial ideation and a risk analysis that will determine whether one should move on to the next step. It includes defining the function of the product, how it will used, whether it is required, how the approval process will be navigated, and the target audience for the device. It is at this stage that all Intellectual Property (IP) claims and patents are acquired. This is also the time to decide on a Quality Management System (QMS), such as the ISO 13485 standard.
2. Formulation Conceptualization and Feasibility
This stage involves creating a prototype that accomplishes what the device sets out to do. After proof of concept, it is time to start considering customer requirements, listening to feedback, conducting market research, and looking into competitors. This needs to be documented and proved.
3. Design & Development and Verification & Validation
At this stage, the design should be finalized, and all regulations should be taken care of. This is a critical stage that involves constant feedback and incorporation, analyzing risks and taking precautions until the device has been finalized. If clinical trials are required, this is the stage these should be planned – this includes any necessary documentation, approvals, and ethical considerations.
4. Final Validation and Product Launch Preparation
Since it is time to launch the product, all documentation has to be in order. This is submitted to the relevant authorities (such as the FDA) for approval and includes clinical trial results. Marketing and branding should also be considered, and evidence-based data provided.
5. Product Launch and Post-Launch Assessment
This stage is the one where everything comes together – after approval, the product is manufactured and launched. Post-launch assessment should be considered carefully, and customers’ concerns should be addressed. These can then be dealt with in the future when preparing for an updated version of the medical device.
The Key to Efficient Medical Device Development
Because the medical device development process is so complicated, it is imperative to entrust it to a company that not only specializes in it but has years of experience and wisdom to fall back on. Outer Reef Technologies is one such medical device development company. Not only do we have more than 11 years of experience, but we also pride ourselves on our commitment to producing quality products without compromising deadlines. Additionally, all of our designs are ISO 13485 compliant, and are held to the highest of standards.
If you’re interested, please contact us for additional information or a consultation – we’re here to help!