Product Development Process: ATL Technology
As a partner of top medical device companies, ATL utilizes an ISO 13485 and 21 CFR Part 820 compliant product development process (“PDP“) to develop and commercialize devices.
All projects that are initiated with or transferred to ATL—regardless of whether they are an internal R&D or external customer project—must pass through the PDP before being transitioned to production.
Below, we provide an overview of the key roles within the ATL PDP and break the PDP down into understandable phases so that you know what to expect when partnering with ATL on a product development project.
Key roles within the ATL PDP.
Though there are many people who play a part in developing devices at ATL—from the Sales and Quality teams to the Management and Production teams—the success of the ATL PDP hinges on four specific roles:
- The Customer
- The Project Manager
- The Product Development Engineer
- The Support Engineer
To provide our customers with a seamless experience, we tap into our global operations and assign a project manager, product development engineer, and support engineer from two of our locations (i.e., United States and China or Costa Rica and China)—giving our customers nearly a 24-hour touchpoint.
Whether it’s our very own management team investing in a new interconnect platform or an external R&D team looking for help bringing a new device to market, for every PDP project at ATL there must be a customer.
The customer is typically responsible for performing market research, defining the market space for the new product, and bringing the initial idea and requirements to the ATL PDP team.
Throughout all phases of the PDP, the customer plays a key role in providing direction, participating in design reviews, and offering feedback.
The customer is an integral player in the ATL PDP because without a customer, there would be no project.
The Project Manager
The primary responsibility of the project manager is to lead the project team and drive the project through each phase of the ATL PDP.
As the owner of the project, the project manager also develops, maintains, and adjusts the project plan and schedule.
An important aspect of the project manager role is communication—the project manager is responsible for communicating updates, changes, etc. with the customer and the project team.
To provide our customers with round-the-clock access to their projects, we tap into our global operations and assign a project manager.
The Product Development Engineer
Within the ATL PDP, the product development engineer plays a lead role 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 as well as 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
As the ATL PDP follows the rigorous demands of the medical device industry, every project requires extensive documentation, testing, and engineering work.
The support engineer is responsible for executing many of the day-to-day tasks that must be accomplished to move the project from one phase to the next.
Being deeply involved in the project, the support engineer can also act as a point of contact to the customer when necessary.
Breaking down the three phases of the ATL PDP.
The ATL PDP consist of three distinct phases through which every development project must pass before entering full-scale production:
- Engineering Verification
- Design Verification
- Process Validation
Phase 1: Engineering Verification
The first phase of the ATL PDP, Engineering Verification (“EV”), lays the groundwork for the entire development project.
The EV phase begins with the ATL project team—along with the customer—exploring the design space to understand which product features and processes will best meet the application requirements.
It is during the EV phase that engineering analysis and prototyping is performed to help quantify, mitigate, and reduce risk and prepare the project for Design Verification.
Among the many important documents, forms, and designs that come from the EV phase, one particularly critical outcome is the finalization of the product specifications.
Phase 2: Design Verification
The second phase of the ATL PDP, Design Verification (“DV”), is intended to ensure 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 also created during the DV phase and DV testing is also performed.
Outputs from the DV phase may include CAD drawings, a validation master plan, a bill of materials, and other critical documents needed for project success.
Phase 3: Process Validation
The third phase of the ATL PDP, Process Validation (“PV”), 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 make sure that the processes, equipment, and technical knowledge necessary to produce an acceptable product is 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 PV phase to help ensure a seamless handoff to the production team.
To learn more about the ATL PDP and how it can help you bring your device to market, please reach out to us.