Medical Device Design & Development Process
For over 40 years, ProPlate® has partnered with medical device engineers to develop manufacturable metallization solutions for minimally invasive devices. Our proven development roadmap helps move projects from concept through validated manufacturing.
| Our Five-Step Development Process |
|---|
| 1. Discovery, Proof of Concept, and Feasibility |
| 2. Process Design and Development Planning Input |
| 3. Process Design and Development Output (Validation & Verification and Scale-up) |
| 4. Process Validation and Manufacturing Transfer |
| 5. Customer Feedback and Continuous Improvement |
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Discovery, Proof of Concept, and Feasibility
ProPlate’s Discovery, Proof of Concept, and Feasibility phase is an early stage in the product realization process designed to determine whether a core concept is technically possible and practically viable. During this phase, ProPlate evaluates whether the available technology supports the concept, identifies engineering limitations, and establishes initial prototype and Design of Experiment (DOE) strategies. Key deliverables at this stage include validating technical feasibility, testing core functionality, assessing practical viability, and conducting early risk identification to surface potential obstacles before significant resources are committed.
This phase may require multiple proof-of-concept iterations and involves active collaboration between the customer and ProPlate’s Business Development and Engineering teams. Engineering Management makes the final determination on whether a project is ready to advance to subsequent phases.
Process Design and Development Planning Input
Once a customer opportunity has been approved to move into New Product and Process Development (NPPD), ProPlate’s Project Manager establishes a formal Process Design and Development Plan. This plan defines the project scope, schedule, team membership, competency requirements, resource needs, risk management methods, and phase gate structure based on both customer and internal requirements. The project is actively managed and monitored to ensure it complies with the approved plan and is thoroughly documented throughout. ProPlate also recognizes that customers may enter the development cycle at different stages, and the earlier ProPlate is engaged, the greater the opportunity to influence component manufacturability, Design for Manufacturability (DFM) activities, and overall process outcomes.
Process design inputs are documented to capture the functional, performance, and customer-specific requirements that serve as the foundation for process design and development. These inputs are derived from customer requirements, outputs of risk assessments, applicable regulatory standards, and information from previous or similar designs and manufacturing processes. Process design inputs may also include requirements related to process development and scale-up to manufacturability.
All process design inputs are reviewed for completeness and approved during the phase gate review to ensure they are comprehensive, unambiguous, internally consistent, and fully aligned with customer and product requirements. Any changes to process design inputs are communicated to the customer for final approval and are subject to the internal phase gate approval process before moving forward.
Product Design and Development Output (V&V and Scale-up)
Process design outputs consist of defined specifications that satisfy the process design input requirements established in Phase Gate II. These outputs contain or reference product acceptance criteria and specify the characteristics of the product that are essential for its manufacturability. All outputs are documented in a traceability matrix so they can be verified against the corresponding process design inputs, and the matrix is reviewed and approved prior to release and phase gate approval.
Verification and validation are carried out to confirm that design outputs satisfy the design input requirements and are performed according to an approved plan that defines verification methods, acceptance criteria, and statistical techniques with rationale for sample size. Risk analysis tools such as process FMEAs are used to support acceptance criteria development and ensure that risk tolerances are appropriately addressed. A design verification and validation report is documented, approved, and includes a summary of results, an evaluation of any deviations encountered, and a formal conclusion statement.
The scale-up portion of this phase bridges the gap between prototype builds and full production volumes. It ensures that processes perform reliably under increased volume, that tooling and fixtures hold up under repeated production use, and that supply chain partners can meet demand at the intended production scale. This phase is critical in reducing the risk of defects, major process changes, and scrap during sustained production, and ProPlate follows a structured scale-up strategy that is calibrated to actual production volumes and adjusted to meet customer requirements and part supply needs.
Process Validation and Manufacturing Transfer
ProPlate’s Process Validation and Manufacturing Transfer phase is a formally documented process for transferring process design and development outputs into production specifications and procedures. A phase gate review is conducted to confirm that design outputs are verified as suitable for manufacturing prior to becoming finalized production specifications. The transfer plan covers verification of specifications and procedures, minimum and maximum part quantities per rack or barrel, material and supplier qualification, equipment and facility qualification, operator training, inspection method development, process validation, and Device Master Record (DMR) approval.
All transfer deliverables are documented and approved, including an evaluation of any deviations encountered, corrective actions taken, results of transfer activities, and a formal conclusion statement for design and development transfer to production. This phase represents the active handoff between ProPlate’s development and production teams, with the mission of adequately demonstrating that the manufacturing processes used are thoroughly developed, controlled, and qualified before sustained production begins.
Customer Feedback & Continuous Improvement
Following manufacturing transfer, ProPlate continues to support each program through ongoing process monitoring, performance evaluation, and close collaboration with customer teams. Feedback gathered from production performance, device performance in the field, and evolving application requirements flows directly into ProPlate’s Corrective and Preventive Action (CAPA) process, Continual Improvement program, and Complaint Handling procedure.
This continuous improvement approach helps maintain long-term process stability, supports future device enhancements, and ensures consistent product performance throughout the full lifecycle of the device.
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Frequently Asked Questions About Medical Device Design & Development
At what stage of development should I engage ProPlate?
The earlier ProPlate is engaged in the development process, the greater the opportunity to influence component manufacturability, Design for Manufacturability activities, and overall process outcomes. ProPlate can engage at any step, from initial feasibility evaluation through process validation and manufacturing transfer. Engaging at Step 1 allows ProPlate to evaluate technical feasibility, identify potential obstacles, and establish development strategies before significant resources are committed.
What is ProPlate's New Product Process Development process?
ProPlate’s New Product Process Development process is a five step development framework that takes medical device plating programs from initial feasibility through process validation and full production transfer. The five steps are Discovery, Proof of Concept, and Feasibility; Process Design and Development Planning; Process Design and Development Output including Verification, Validation, and Scale-Up; Process Validation and Manufacturing Transfer; and Customer Feedback and Continuous Improvement.
Does ProPlate support Design Verification and Validation?
Yes. Step 3 covers process design and development outputs including verification and validation. V&V activities are performed according to an approved plan defining verification methods, acceptance criteria, and statistical techniques. Risk analysis tools including process FMEAs are used to support acceptance criteria development. A design verification and validation report is documented and approved, including a summary of results, evaluation of deviations, and a formal conclusion statement.
What does ProPlate's Process Validation and Manufacturing Transfer include?
Step 4 covers the formal transfer of process design and development outputs into production specifications and procedures. The transfer plan includes verification of specifications and procedures, material and supplier qualification, equipment and facility qualification, operator training, inspection method development, process validation, and Device Master Record approval. All deliverables are documented and approved before sustained production begins.
Is ProPlate ISO 13485:2016 certified for medical device development?
Yes. ProPlate is ISO 13485:2016 certified across both facilities in Anoka, Minnesota. The entire five step development process is executed within ProPlate’s ISO 13485:2016 Quality Management System, with IQ, OQ, and PQ protocol execution, in-house chemistry lab capabilities, and full traceability and documentation throughout every step.
Can ProPlate support prototype development before committing to full production?
Yes. Steps 1 and 2 specifically address feasibility evaluation and prototype development before any production commitments are made. ProPlate develops custom fixtures, masking systems, and process chemistry in-house for each new application. Ready-to-order prototype products including gold and platinum plated marker bands, electrodes, pull ring assemblies, and sample kits are also available through the ProPlate shop for engineers in early-stage feasibility evaluation.