The Design Process Of Medical Devices At Devicelab Project Management

The Design Process of Medical Devices at DeviceLab: Project Management

Part 6: The Project Management Process at DeviceLab

Because we’ve done so many projects in our 20 years, we have developed a process for managing projects that establish needed controls, allows our teams to work effectively, and provides visibility to the client. This process is in compliance with regulations for outsourced development work and embraces the values of the Agile manifesto.


Medical project development starts with a discussion. There are many things we need to learn before we can determine that we have access to the skills needed for the project and that our organization has the capacity to handle your project. We need to understand the technologies involved, where you are in your work so far, and what goals you have for the product. This discussion is usually between our client’s program manager and a few of DeviceLab’s senior staff, often in a teleconference.


Based on all the input we receive, and if the project looks like a good fit for DeviceLab, we then prepare a Project Proposal which includes a description of tasks to be performed, estimated timelines and costs, and the deliverables to be provided. We submit our proposal and follow-up with a call to answer any questions or make any requested tweaks. If the proposal meets with your expectations, a Development Contract is executed, and DeviceLab begins work. 


A Project Manager is assigned as the main point of contact for all business issues (budgets, billing, and reporting), but they also serve as a technical leader for the DeviceLab team. We appoint designers and engineers to the team so that it is properly resourced, and establish project directories and charge numbers. A Project Plan is prepared so that you can see all of the required tasks and can track progress against each one. The plan typically shows the first phase in detail and the big picture in subsequent phases.


We like to start projects with a Kick-Off Meeting with all stakeholders present to make sure we receive all inputs available. It’s a good way to make contacts within the team and achieve consensus on the path ahead.


Once a project is underway, the project manager is responsible for keeping the customer in the loop. Regular progress reports, detailed billing, and frequent meetings prevent runaway projects. The project manager is also responsible for resolving technical disputes, providing resources, and chairing meetings, including design reviews. As the project proceeds, the project manager updates the project plan and associated cost and time estimates going forward.

When a project reaches completion, the project manager oversees the transfer of all of the materials, product, and information accumulated back to the client. Records may be retained, depending on the contract and whether future work is anticipated.


So that’s how we do project management at DeviceLab. We have a well-honed process that keeps problems at bay and delivers quality designs by design. In the next post in this series, we’ll talk about why we like to build prototypes in device projects, generally several times.