MEDICAL DEVICE DESIGN & DEVELOPMENT
For over 35 years, ProPlate® has helped medical device engineering leaders solve demanding device development challenges through unique metal coating technologies that drive commercial success, resulting in improved patient outcomes. We collaborate with global medical technology customers who are value-driven partners that share our core values, developing new and next-generation devices from concept to commercialization.
ProPlate’s dedicated new product process development team supports customer-centric medical device projects, providing medical device manufacturing solutions through our proven process roadmap. Our experienced team of engineers, scientists, and subject matter experts collaborate with medical device engineering leaders to develop innovations, leveraging ProPlate’s minimally invasive surgical and catheter-based metallization technologies.
We desire to be involved in a project as early as possible, allowing our team of experts to provide insight from the metallization process capability and component feature design perspective. ProPlate® uses our proven process to meet our customer’s device performance needs. We offer a consultative and collaborative service with a risk-based approach to designing for manufacturability and the overall device performance.
ProPlate® Offers Medical Device Electroplating and Metallization Development Services Through a Six-Step Proven Process Consisting of the Following Development Phases:
- Concept Generation & Discovery
- Proof Of Concept & Feasibility
- Product Design & Process Development
- Design Verification & Validation
- Process Optimization & Installation
- Process Validation & Manufacturing Transfer
Concept Generation & Discovery
ProPlate’s Discovery phase helps to identify key design inputs and processing techniques based on initial customer requirements to narrow the potential processing and design paths to consider for further development. This step includes an early feasibility evaluation to determine potential obstacles in the initial development phase, eliminate unnecessary costs and delays, and gain insight into project scopes and future manufacturing requirements. This step is critical in determining the appropriate plating technology, design, process method, and manufacturability paths.
Proof of Concept & Feasibility
ProPlate’s early feasibility assessment from the Concept Generation & Discovery phase identifies initial design requirements and potential production pathways while managing associated risk. The project moves into the Proof of Concept phase to run experiments and pilot prototypes, demonstrating that a design concept, processing method, etc., is feasible beyond the current stage. This stage typically involves evaluating one or more designs and/or processing methods to select for further development while establishing overall timelines and budgetary estimates.
Product Design & Process Development
Once an initial design has been approved and a process is initially developed, ProPlate® will move into a Product Design & Process Development phase by providing full-scale prototyping services to test device and metallization functionality. At this development stage, the goal is to collaborate with the end customer to secure a mutually stable design, complete initial design control documentation (design freeze), and determine and optimize production-scale processing methods.
Design Verification & Validation
ProPlate® streamlines the Product Development Process during the Design Verification & Validation phase. This phase defines the critical process inputs which affect the product’s overall risk moving into production. When a product gets close to a design freeze, ProPlate’s manufacturing engineers conduct a full review of the designs, suggest modifications for improvements where possible, and finally execute the design validation and verification testing to demonstrate that the design outputs meet the design inputs. The goal at this development stage is to support your project’s testing and regulatory approval strategy by rapidly ramping early production, ensuring you hit your test timelines, and having the product available for clinical trials while running more samples through the developed process to further mature it.
Process Optimization & Installation
During ProPlate’s Process Optimization & Installation phase, our production team works in tandem with our development team to complete full internal validation of the process, implementing any potential final process improvements where necessary ahead of Process Validation & Manufacturing Transfer. This stage intends to internally validate the process prior to formal validations while scaling the process up for optimized manufacturing.
Process Validation & Manufacturing Transfer
The Process Validations & Manufacturing Transfer phase includes executing a formal OQ/PQ protocol in collaboration with the requirements and defined risk tolerances from the end customer and those set out by ProPlate’s ISO 13485:2016 Quality Management System. The OQ typically requires two batches that are processed at high and low operating conditions, and the PQ typically consists of 3 batches run at nominal parameters, using manufacturing level documentation and quality standards. The mission of the Process Validation & Manufacturing Transfer phase, through the active engagement between development, production, and quality teams, is to adequately demonstrate that the manufacturing processes used are thoroughly developed, controlled, and qualified to transfer the process for the specific product into manufacturing.