Our Process
All projects at ATL, including internal R&D and external customer projects, must pass through our Product Development Process before moving to production.
Here we break down the ATL PDP to help you understand what to expect when partnering with us on your medical device project.
ATL's Product Development Process (PDP)
Phase One: Engineering Verification (EV)
This first phase lays the groundwork for the entire development project.
The EV phase begins with the ATL project team exploring the design space with the customer to understand which product features and processes will best meet the application requirements.
During the EV phase, engineering analysis and prototyping take place to help quantify, mitigate, and reduce risk to prepare the project for Design Verification.
Critically, the outcome of the Engineering Verification phase is the finalization of the product specifications.
Phase Two: Design Verification (DV)
This phase ensures that the design meets all customer and regulatory requirements.
During this phase, the ATL project team works with the customer to complete the product design and prepare it for Product Validation.
Any necessary product tooling is created during the DV phase.
DV testing is also performed at this stage.
This phase may also include the following outputs: CAD drawings, a validation master plan, a bill of materials, and other critical documents needed to ensure project success.
Phase Three: Process Validation (PV)
This is the last phase before the project is transferred to production.
During the PV phase, the processes for manufacturing the product are defined and validated to ensure that the end product meets the required specifications.
Throughout the PV phase, the PDP team works closely with manufacturing and operations to ensure that the processes, equipment, and technical knowledge necessary to produce acceptable products are in place.
Critical activities such as test method validation, process performance qualification, the expansion/ramp-up of tooling, and much more take place during the Process Validation phase to help ensure a seamless handoff to the production team.
ATL PDP Key Roles
The success of the ATL PDP depends on four key roles:
- The Customer,
- The Project Manager,
- The Product Development Engineer
- The Support Engineer
To ensure a seamless experience for our customers we leverage our global operations, assigning project managers, product development engineers, and support engineers from two ATL locations, providing nearly 24-hour support. Together, we bring your vision to life and deliver excellence at every stage of the process.
The Customer
At ATL, every PDP project has a crucial element: the customer.
Whether it's our management team exploring a new interconnect platform or an external R&D team seeking assistance to launch a new device, the customer plays a pivotal role.
Typically responsible for market research and defining the product's market space, the customer brings the initial idea and requirements to the ATL PDP team. Throughout all phases, the customer provides valuable direction, actively participates in design reviews, and offers essential feedback.
Indeed, the customer is an integral player in the ATL PDP. Without them, there would be no project, emphasizing their significance in our journey of innovation and success.
The Project Manager
Primarily, the project manager is to lead the project team and drive the project through each phase of the ATL PDP.
The project manager develops, maintains, and adjusts the project plan and schedule.
The project manager is responsible for communicating with the customer and the project team as updates and changes arise throughout the project.
We tap into our global operations and assign a project manager to provide our customers with "around-the-clock" access to their projects.
The Product Development Engineer
Within the ATL PDP, the product development engineer takes the lead in ensuring project success.
The product development engineer is responsible for understanding the customer requirements and determining how ATL will meet those requirements.
The product development engineer also owns the execution of designing and developing components; they are responsible for scheduling and leading the design reviews.
Though the project manager typically serves as the point of contact for the customer, as an engineer-to-engineer organization, the product development engineer often works directly with the customer’s technical team throughout all phases of the PDP.
The Support Engineer
The ATL PDP adheres to the rigorous demands of the medical device industry, entailing comprehensive documentation, testing, and engineering efforts for each project.
The support engineer plays a vital role in this process, diligently executing the day-to-day tasks that propel the project from one phase to the next.
With their profound involvement, the support engineer also serves as a reliable point of contact for the customer when needed, ensuring seamless communication and progress throughout the project.
Engineer-to-Engineer Approach
Learn MoreAn engineer partner that starts with the end in mind
To engineer the outcome of any product, you must begin with the end in mind. This is especially true with energy-driven devices, where the interconnect solution is a critical component of the device function.
Developing with a holistic approach
As the healthcare landscape continues to evolve, engineers are being forced to find better ways to bring devices to market.
Manufacturing for performance and quality
Getting your energy-driven device into the hands of the right people at the right time requires vertically integrated manufacturing capabilities and expertise.
Supporting you throughout the product lifecycle
The lifetime of medical device product lines is measured in years—not weeks or months.
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