Medical device development is a arduous process with rigid requirements that must be met by FDA's approval and other compliances. The lifecycle require a system of phases to ensure safe and effective design control.
There are five phases in developing a medical devices to be cleared for public marketing. The quality system regulation (QSR) governs methods used, facility controls, the design, manufacturing, packaging, labeling, storage, installation, and services of all finished devices. The FDA requires five steps in development: Device Discovery and Concept, Preclinical Research, Path to Approval, FDA Review and Post-Market Safety Monitoring.
While medical devices are governed to be developed to meet the requirements for its intended use, there are other general steps in medical device product development that must be followed across the board.
You are correct. There are important phases when creating a medical device. The five phases of medical device development include: initiating phase, planning phase, executing phase, closing phase, and the monitoring/controlling phase. Each phase serves a different purpose, and the monitoring phase occurs throughout the development process.
I think the way a company approaches these phases depends on the relationship of tasks on a gantt chart. If I were establishing a device, my approach would be finish to start. I am a big believer in finishing a task before starting a new one. A lot of tasks are dependent upon each other, so this approach is needed.
How would your gantt chart look if you were developing a device?
@magan-rhodes If I were developing a device, I would finish a task before starting a new task. I like the feeling of knowing I am working towards a goal and I have checked the box and I am on to the next level. Having to circle back to a previous step does not feel like progress. I enjoy building the momentum. However, if it is necessary to retract to a previous step, then I will do so. Going back to revise the first step could make steps two and three seamless. Do you think there are instances where you must finish a task before starting a new one?
The purpose of any medical device is to benefit others and improve the quality of life. However, in order to keep patient and user risk at a minimum, authorities have tightened up regulations over recent years with the hope that manufacturers will build quality in, while taking risk out of a device. The phases are as follows: initiation, opportunity and risk analysis. This is mainly about planning, researching, and a lot of documentation. The second phase is about formulation, concept and feasibility. This phase deals with developing the concept and making sure it works. The third phase is all about design and development, verification & validation. This step focuses on validation and verification of your device as a way to prove it will indeed withstand all the pressures of the real world. The fourth phase is for final validation and product lunch preparation. This is more about branding and marketing. The last phase is product lunch and post market surveillance. It mainly reassures you have a robust internal quality auditing system to review your records.
Medical device development involves a few phases. The first phase is the initiation phase because do some research on the topic and get a better idea of the field and then figure where they are going to conduct the research. The second phase is the planning phase. In this phase researchers decide on a protocol, budget for the project, and timeline for the project. The third phase is the executing phase. In the executing phase researchers develop and design the product. The fourth phase is the closing phase. During the closing phase researchers are adding final touches and fixing glitches within the product. the last phase is the monitoring and controlling phase. In the last phase which typically occurs throughout the development researchers are monitoring the product and process to ensure that quality products are produced and standard procedures and measures were properly followed.
The development of a medical device is a project, so it would benefit from project management-related tools such as Gantt charts and WBSs. Especially in an industrial setting, planning in advance with these tools are absolutely essential in making sure the project actually finishes. In a project lifecycle, planning, in my opinion, is one of the most important steps. When properly planned, a project's execution can be much smoother than if it wasn't. Using these tools to map out what tasks need to be done, what order they need to be done in, and what groups need to be involved, one can plan ahead on exactly what this project will look like. They can also do important things such as contribute slack to the project timeline. As @anywilliams@msm.edu has mentioned, tasks should be completed sequentially in order to make progress. But, citing Murphy's Law, if something can go wrong, it will go wrong. Some tasks will need to be delayed or redone at different points in the project. It's difficult to adjust to sudden changes when developing a medical device without a plan. So although medical device development isn't strictly tied to project management, I think it would benefit greatly from project management tools being used on it.
@anywilliamsmsm-edu Instances where you'd have to wait for a step/process to completely finish before starting a new one would consist of either quality managements to product end-of-line testing. In the sense of Pre-clinical devices, some that come to mind include sponsorship identification/agreement, Approval documents (Likewise to quality but more specific to progress on certain orders or requirements) and overall supply chain requestions.
Still regardless of steps being step-to-step, overall monitoring must be considered so nothing is truly waiting on another step, but in fact waiting for a specific task within a step to be done to progress.
