Mastering the Design and Development Phase in Medical Device Production

Employee Spotlight - Clayton Cole

Nathan White, Co-Founder and VP of Product Design and Development

Nate has over 20 years of medical device product development experience, with diverse roles in technology innovation, R&D engineering, manufacturing engineering, program management, technical leadership, and organizational leadership. He has an extensive background in complex technologies, including minimally invasive laparoscopy, endoscopy, interventional cardiology and radiology, surgical stapling, vessel sealing, and ablation therapies. He is a named inventor on more than 30 U.S. patents. He holds a B.A. in Engineering Sciences from Dartmouth College and an M.S. in Mechanical Engineering from Stanford University, Design Division, and Biomechanics Division. Throughout his career, Nate has helped dozens of companies conceptualize, develop, and commercialize novel medical products and technologies for improved patient outcomes.

 

Introduction to the Design and Development Phase

The Design and Development Phase may be considered the cornerstone of the medical device product development process. It builds on the groundwork laid during the Concept Development Phase and focuses on the detailed execution of the design. This phase involves rigorous planning, design controls, and engineering testing to ensure that the product will meet all applicable technical and regulatory requirements. At Meddux, we understand the importance of this phase in transforming a concept into a tangible, reliable, and market-ready product.

Detailed Execution in the Design and Development Phase

The Design and Development Phase begins with a thorough review of the concept to ensure that all user needs and technical requirements are well established and documented. This involves developing detailed design specifications and creating comprehensive project plans that outline each step of the design process.

Developing Component Manufacturing Processes

One key activity during this phase is developing the component manufacturing processes. This involves selecting appropriate materials, designing components, and establishing appropriate manufacturing methods. Each component is designed to meet specific performance criteria and regulatory standards. We collaborate closely with suppliers to ensure they can produce components that meet our specifications.

Tooling and Internal Procedures

Tooling is another critical aspect of this phase. We work with our suppliers to develop the tooling necessary for manufacturing the device components, and we design and develop the necessary tools, fixtures, and equipment required for finished device manufacturing. This includes specialized equipment for testing and quality control. Proper tooling ensures that components are manufactured consistently and meet all quality standards.

Internal procedures are established to guide the manufacturing process. These procedures detail every step of production, from assembling components to final testing and inspection. Clear and detailed procedures are essential for maintaining product quality and ensuring that each device is manufactured to the same high standards.

Design Controls and History File

The Design Controls process ensures that design and development changes are reviewed, evaluated, and approved with respect to the effect of the change on the fit, form, function, performance, usability, or safety of the device.  At Meddux, we implement rigorous design controls throughout the Design and Development Phase to ensure that the product is safe, effective, and reliable.

Importance of Design Controls

Design controls are essential for managing the complexity of medical device development. They provide a structured framework for documenting design decisions, tracking changes, and ensuring that all design aspects meet regulatory standards. Because of our robust design control process, we can identify and address potential issues early in development, reducing the risk of costly delays or product failures.

Compiling the Design History File

Compiling the Design History File (DHF) is a crucial output of design controls. The DHF is the comprehensive document set that includes all records related to the product’s design and development. It provides a detailed account of the design process, including design inputs and outputs, risk assessments, verification and validation results, and design reviews.

The DHF serves as the backbone of the product’s regulatory submission, demonstrating that the device has been developed in compliance with all relevant standards and regulations. It provides a clear and traceable record of the product development process, ensuring that the product meets all safety and performance requirements.

Pre-Verification and Validation Testing

Pre-Verification and Validation testing are critical activities in the Design and Development Phase. These tests give us a dry run of the formal V&V builds and testing that will occur in the following phase and give us confidence that the design meets all specified requirements and performs reliably under real-world conditions.

Building Test Units

We build dry-run controlled test units of the product to evaluate the manufacturing process and device performance and identify any potential issues. Prototypes are tested in simulated V&V test scenarios to confirm that the final product is manufacturable and that it meets all functional and performance criteria.

Engineering Confidence Testing

Engineering confidence testing validate the design assumptions and ensure that the product meets all specified requirements to confirm readiness to exit the Design and Development phase. It involves putting the device through a series of tests that evaluate the product’s performance, safety, and reliability. These tests are designed to simulate real-world conditions and ensure that the product can withstand the rigors of everyday use. Tests may include mechanical stress testing, environmental testing, and performance testing.

Conducting these tests allows us to identify potential issues and make necessary adjustments to the design. This helps ensure the final product will meet all safety and performance requirements and is ready for regulatory submission.

Conclusion

The Design and Development Phase is a critical stage in the medical device development process. It involves rigorous planning, design controls, and iterative builds and testing to ensure the product meets all technical and regulatory requirements. At Meddux, we understand the importance of this phase in transforming a concept into a tangible, reliable, and market-ready product. By focusing on detailed execution, developing robust manufacturing processes, and implementing rigorous design controls, we can ensure that our products meet the highest quality and performance standards.

Key Takeaways:

  • Detailed Planning: Comprehensive project plans and design specifications ensure a clear roadmap for development.
  • Component Manufacturing: Selecting materials and developing robust manufacturing processes are key to quality.
  • Design Controls: Rigorous design controls and a well-documented DHF are critical for regulatory compliance.
  • Pre-Verification/Validation Testing: Dry-run builds and tests help identify and address issues early.
  • Engineering Confidence Testing: Rigorous testing ensures the product meets all safety and performance requirements.

Contact Meddux to see how we can help you bring your product to market. 

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