Could you explain how your POD system works at MedRes?
First of all, we create a dedicated POD for each client’s project. A POD is a product-oriented design team of engineers working together on a project. They collaborate to create, develop, and test medical devices from the beginning to the end of the product development project. The POD team is supported by subject matter experts (SMEs) on a given issue. This helps streamline the workflow, improve efficiency, customer service, and shorten the duration of the project.
How are PODs built?
A POD is typically made up of Mechanical Engineers, among whom there is at least one person with a product design attitude who approaches design from a different perspective. One team member from the project team is appointed as the Project Lead Engineer. POD-leader responsibility is to interpret and summarize the customer needs, to prepare a project plan for the project needs, to distribute tasks among team members and to adhere to the budget. POD-leader is also responsible to ensure compliance with medical technology regulations and standards.
How are SMEs connected to the system of PODs?
SMEs are essential for the POD system to be as effective as a team with each function available within the team. They are called upon to provide their specialist knowledge when needed without increasing the size of the team. They lend their expertise and guidance to help ensure the project is successful.
What types of SMEs do you have on your team?
We have an Electrical Engineering team that includes software expertise. Our Main Constructor is independent of the project topic and can think of solutions from a construction perspective. We have Technicians who can be called upon for assistance when necessary, as well as a Clinical Research Engineer available to provide expertise in areas such as study research, clinical process analysis and biological, anatomical background.
We have a Product Assurance Specialist and a Process Engineer as well. The Product Assurance Specialist is responsible for product specifications, risk hazard analysis, design FMEA and usability to ensure medical device certification. The Process Engineer is in charge of conforming with ISO 13485 and the design for manufacturing guidelines.
What are the benefits of this POD system for the customers?
We create separate PODs for each client’s project to ensure that only the necessary staff are actively involved in the project. This cost-effective system enables us to provide excellent services to customers of all sizes, no matter their stage of development and provides a team of consistently enthused and productive members.
It also helps to focus on several parallel running subject areas, which allows us to adapt quickly and effectively to changing customer requirements and project needs. Furthermore, it allows us to monitor the progress of each project closely and keep the customer up to date with the latest developments, thus helping to build trust and a strong relationship between the customer and the development team which is what we always strive for with our customers.