Table of Contents
- [Video] As mapping and imaging devices continue to push the limits, how does that impact device design and development?
- How do you determine which people should be involved in the medical device product development process?
- During which phases of medical device development should the different team members get involved?
- How do you create alignment with cross-functional teams during medical device design and development?
- Additional resources
Bringing an energy-driven device to market is difficult.
To do so requires expertise in electromechanics, biomechanics, manufacturing processes, product commercialization, quality management, and a host of other fields.
Needless to say, it’s nearly impossible to develop an energy-driven device in a vacuum—it takes a team of knowledgeable people.
In this post, we’ll talk about how effective cross-team collaboration can be used throughout the medical device product development process to improve project outcomes.
[Video] As mapping and imaging devices continue to push the limits, how does that impact device design and development?
How do you determine which people should be involved in the medical device product development process?
The answer to this question depends on a variety of factors, including your organizational structure, quality management system (“QMS”), and your project management process.
Some organizations require consistent touch-points with people in regulatory affairs and marketing throughout the development process, while others do not.
At ATL, our product development process can involve cross-team collaboration from engineering, manufacturing, quality, sales, and marketing at any given point.
It’s important to note that not all of these teams are involved in every phase of the process.
In fact, for energy-driven device development to succeed, it’s vital that the right team members get involved at the right time.
During which phases of medical device development should the different team members get involved?
Unfortunately, there is no one-size-fits-all answer to this question.
Determining which teams should be involved at which time is dependent on the way your organization is structured, the way your projects are structured, and the type of product you are building.
The general teams and departments that should be involved during any given phase of the development process should be predefined by your organization according to ISO 13485.
Beyond the standard teams and players that must be included, it’s important to recognize that each project is unique and knowing how to identify the areas where teams can best contribute can help you streamline development and gather feedback and input in a strategic manner.
In a product development process similar to ATL’s, the product development engineering team is responsible for finalizing the specifications and defining process capabilities during the EV and DV phases.
However, in staying true to the idea of designing for manufacturability, it might be advantageous to include the manufacturing team so that they can help identify and solve potential problems before the design leaves those phases.
How do you create alignment with cross-functional teams during medical device design and development?
Having the right people involved in the medical device product development process is not enough to successfully bring a device to market—you must create alignment and point the different teams toward your desired project outcome.
To create alignment and achieve your desired project outcome, you must make clear what you expect from each team member during each phase of the process.
What’s more, assigning ownership of specific project deliverables is crucial to ensuring that the process continues to move along.
In a product development process like ATL’s, manufacturing engineering and quality assurance are responsible for supporting key activities during the EV, DV, and PV phases.
However, they are not responsible for moving the team and/or project through the different phrases.
That responsibility falls on the project manager—who manages “business-side” items like scope and budget—and the product development engineer, who manages the technical aspects of the project.
This creates a clear picture of expectations for each team members and guides collaboration towards the singular goal of finishing the project.
Developing an energy-driven device in an efficient, streamlined manner is challenging, which is why we recommend talking to an expert.
For additional information before venturing into your next energy-driven device development project, download our free eBook about energy-driven device development.