Design Input and Output Creation - A guide to efficient medical device development

The crux of medical device efficacy lies in precision-engineered design. The pathway from design input to design output is the baseline of engineering.

It's akin to constructing a bridge. Just as an architect meticulously considers every beam's specifications to ensure a bridge stands firm, in the realm of medical devices, developers need to start with a comprehensive groundwork of design inputs. These inputs form the foundation that supports the resulting structure—medical devices that are not only functional but safe for end-users, just like a bridge that can weather any storm.

The overall Design Control Model

The most common design control model for medical device development is the stage-gate model. This model divides the development process into distinct stages or phases, with each stage representing a specific milestone or deliverable. At each gate, a decision is made to either proceed to the next stage or make necessary adjustments before moving forward.

The stage-gate model typically consists of the following stages:

  1. Conceptualization: This stage involves identifying the need for a new medical device and defining its intended purpose and user requirements.

  2. Feasibility Assessment: In this stage, the feasibility of the device concept is evaluated, considering technical, regulatory, and market factors.

  3. Design and Development: This stage focuses on translating the device concept into detailed design specifications, including hardware, software, and user interfaces.

  4. Verification and Validation: The device design is tested and evaluated to ensure it meets the defined requirements and performs as intended. This includes verification testing to confirm that the design meets specifications and validation testing to demonstrate its efficacy and safety.

  5. Regulatory Submission: If required, this stage involves preparing and submitting the necessary documentation to obtain regulatory approval or clearance for the device.

  6. Manufacturing and Production: The device design is transferred to manufacturing, and processes are established to ensure consistent production of the device.

  7. Post-Market Surveillance: Once the device is on the market, ongoing monitoring and feedback collection are conducted to identify and address any potential issues or improvements.

The stage-gate model provides a structured approach to manage the design control process, ensuring that each stage is completed before progressing to the next. It allows for effective decision-making, risk management, and documentation throughout the development lifecycle.

According to this model, the gates are usually performed as reviews, and the expectation is that each phase is processed on the complete product design inputs and design outputs at certain points in time - often chosen as the milestones of the project development.

However in real life it turns out that for certain components or technologies within a product, specification of the one will be the requirements for the other. This requires the processing of design phases to be done component-based and even unit-based, before acquisition of design inputs for other components can be completed. We will discuss how to solve this contradiction later in this article. To solve this contradiction also will allow developers to make use of documentation that otherwise will just be created for regulatory stakeholders and authorities, while the main reason for thourough research and documentation of design inputs and outputs is to ensure the creation of a best-in-class product on the market.

What is Design Input?

Design inputs are essential for medical device development. They include:

  1. Stakeholder Requirements: Needs and expectations of business, clinical, and user stakeholders.

  2. Market Requirements: Regulatory, reimbursement, and distribution considerations.

  3. Technological and Clinical State of the Art Information: Up-to-date knowledge of technology and clinical practices.

  4. Requirements from Risk Mitigation Measures: Identifying and addressing potential risks.

  5. Legal (Patents): Considerations related to intellectual property.

  6. Technological Requirements: Specifications for functions and interfaces.

These inputs ensure that the device meets requirements, complies with regulations, and incorporates the latest advancements.

Aims of Design Inputs

Design inputs establish the foundational criteria for creating a medical device, articulating its purpose, functionality, and safety requirements.

By synthesizing technological needs and risk analysis, design inputs facilitate the development of devices that are reliable, safe, and meet both regulatory and user expectations, becoming the bedrock of innovation.

Clear and detailed design inputs guide the creation of robust design outputs, ultimately forging a pathway towards medical devices that excel in both efficacy and safety.

Aligning Stakeholder Expectations with Technical Necessities

Clear communication of design inputs ensures a balanced relationship between stakeholder needs and technical feasibility.

"In medical device development, efficacy and safety are not features but fundamental imperatives."

Achieving alignment calls for a nuanced understanding of requirements, coupled with transparency in translating these needs into viable technical specifications.

The convergence of stakeholder aspirations with technical realities fosters innovation within a framework of regulatory compliance, propelling the medical device industry forward. More practically, a thourough analysis of requirements and technological feasibility is the base for innovation also in the medical device industry.

Incorporating Market and Regulatory Prerequisites

Regulatory and market prerequisites critically shape the design input process, mandating compliance with stringent standards for safety and performance.

Understanding global regulatory landscapes is imperative for seamless market access.

The assimilation of regulatory requirements ensures the medical device's design is compliant from inception, reducing potential roadblocks during commercialization.

Integrating market and regulatory frameworks early in the design stage is not only vital for compliance, it also streamlines the development cycle, avoiding late-stage alterations that could impede time to market. This proactive approach ensures design output aligns with critical benchmarks for efficacy and safety, contextual to both legal and market contexts.

Harnessing Risk Management for Safer Design Choices

Identifying potential hazards early shapes safer, more effective medical device design outputs.

  1. Incorporate Hazard Identification: Begin with extensive identification of potential risks associated with the device's intended use and technology.

  2. Conduct Preliminary Risk Evaluation: Assess identified risks for their severity, occurrence probability, and possible impact on device functionality and user safety.

  3. Define Risk Control Measures: Establish mitigation strategies for high-priority risks to ensure they are reduced to acceptable levels.

  4. Verify Risk Control Effectiveness: Implement verification activities for each risk control measure adopted to confirm their effectiveness in securing device safety.

  5. Monitor Risk During Development: Continuously monitor risk throughout the development process, incorporating any new findings back into the design inputs.

Through risk analysis, design choices pivot towards optimal safety and performance.

Robust risk management infuses confidence in the medical device's safety, underpinning essential design outputs.

What is design output?

Design output is the tangible result of design inputs, encompassing technical deliverables essential for the purpose, safety, and efficacy of a medical device. The design outputs include:

  1. Technical specifications: Detailed information about the device's functionality, performance, and design specifications.

  2. Software code: Logic and functionality of the device's software.

  3. Test results for verification: Demonstrate that the device meets specified requirements.

  4. Results from validations: Including usability and clinical evaluation, providing evidence of safety and effectiveness.

  5. Tools , processes and equipment for manufacturing: Necessary for production and assembly.

  6. Supplier information: Details about component or material suppliers.

Thorough documentation of design outputs supports regulatory submissions and production, ensuring the development of efficient, safe, and effective medical devices.

Connect Design Output From Design Input by Verification and Validation

Verification and Validation serve as the bridge between design input and finalized design output. It is the robust process of ensuring specifications derived from initial inputs are achieved without deviations.

Detailed verification and validation activities confirm that each design output matches the corresponding design input. This encompasses an evaluation against all predefined criteria, including functionality, performance, and safety parameters, and ensuring the device meets its intended use.

As verification and validation unfolds, discrepancies are identified and resolved, reinforcing the device’s alignment with its original design intent.

Best practices for high-quality design output

Verification and validation as safeguards for developers work:

  1. Analysis of Design Requirements: Assess intended device function against clinical needs and user expectations.

  2. Prototype Evaluation: Test and refine prototypes to meet design inputs, using results to inform further development.

  3. Detailed Verification Procedures: Establish systematic testing protocols for functional, performance, and safety criteria aligned with design inputs.

  4. Rigorous Validation Practices: Validate the device through real-world scenarios to ensure it meets user needs and regulatory standards.

  5. Continuous Feedback Integration: Incorporate feedback from testing phases into the design to enhance device reliability and performance.

Verification establishes conformity with design specifications, while validation demonstrates suitability for the intended user environment.

Through an iterative process, design inputs inform outputs and testing results may loop back as inputs, ensuring continuous improvement through development iterations.

Utilize Prototypes to ensure valuable V&V results

Prototyping is an integral step in materializing theoretical designs. Other than speculating on abstract concepts, prototypes allow tangible testing and iterative refinement of detailled design decisions.

From early conceptual models to advanced pre-production units, each prototype incarnation serves a critical role—bridging the gap between design input and potential design output realities.

Throughout the iterative design cycles, prototypes undergo testing and validation. These cycles not only refine the device but also solidify its efficacy and safety, crucial for successful design output.

Use Agile Development Strategies

Implementing Agile development strategies within medical device software development necessitates a shift towards incremental and iterative approaches. This facilitates continuous integration of design inputs and rapid prototyping, allowing teams to adjust to evolving requirements and emergent risks with agility. As such, Agile emphasizes regular review cycles and adaptable planning, which is essential for managing the complexity inherent in crafting high-quality, safe medical devices.

Central role of Change Management

Change management is integral to adapting design outputs to evolving requirements and feedback from verification and validation.

Seamless integration of change management strategies within the design process ultimately enhances the efficacy, quality, and safety of medical devices.

Prioritize Essential Outputs for Device Safety

Prioritizing safety-centric design outputs not only ensures patient safety but also helps align resources for development.

By focusing on outputs with the highest safety impact and standard requirements, extensive verification and validation can be conducted.

Implementing risk-based approaches and aligning with industry standards and regulations strengthens the assurance of device safety, harmonizing with FDA, ISO 13485, MDR and other medical device guidance.

Leveraging Digital Platforms to serve developers need and compliance requirements

For medical device development, compliance is non-negotiable. A digital approach to documenting design inputs and outputs provides invaluable transparency and traceability throughout the product lifecycle.

With digital tools like MatrixRequirements, interdependencies of development phases are mapped and managed with precision, facilitating seamless transitions from concept to market-ready devices. This kind of integrated platform simplifies compliance, mitigates risks, and elevates product quality.

These digital platforms serve as a conduit for not only maintaining regulatory compliance but also expediting the process. By leveraging technologies that offer item-based documentation and agile workflows, we enhance the diligence and efficiency of our development teams.

The documentation that includes design input, design output and the stages of the development process is the Technical File (TF), while the final product specifications are the base for the Device Master Record (DMR). A compilation of the complete design and development process is also called Design History File (DHF), while the Device History Record (DHR) will include also production information like batch documentation. For more information on documentation requirements, read our articles on product realization and FDA and MDR compliance.

Digital Documentation Efficiency

Implementing item-based digital documentation streamlines design input and output management, enhancing traceability and regulatory adherence.

  1. Utilize a digital platform that integrates with existing CAD and software development tools to automatically capture and organize design data.

  2. Employ automated version control and approval workflows to maintain information integrity and reduce administrative burdens on engineers.

  3. Facilitate real-time collaboration and review processes, enabling agile development and rapid iteration of design elements.

  4. Adopt a centralized system to document and link requirements, specifications, and validation efforts, ensuring a cohesive design history file.

  5. Leverage systems capable of producing detailed information item and traceability reports, aiding in development project management, internal audits and regulatory inspections.

By focusing on digital documentation, teams can avert the disjointed nature of file-based systems and concentrate on product design and innovation.

Centralized digital documentation also provides the foundation for demonstrating the linking and decision base between design inputs and design outputs.

Optimizing Workflow with CAD and SW Development Tools

CAD and SW tools are indispensable for intricate medical device design.

Sophisticated CAD software, paired with agile SW development tools, accelerate innovation while ensuring precision. Optimizing these tools optimizes the design process, condensing complex iterations into efficient workflows.

By seamlessly connecting CAD and SW development platforms, we align multidisciplinary input with technological execution. This fosters a cohesive environment for both hardware and software teams, ensuring unified progress and design coherence.

Real-time synchronization between CAD models and software prototypes is paramount. This dynamic interface propels continuous integration and testing, sharpening the accuracy of both the design and the functional output.

Harnessing these tools effectively is key to sustaining competitive edge in medical device development. This ensures efficiency without sacrificing compliance or innovation.

Enhancing Approval Processes for Agile Innovation

Within the agile medical device development sphere, streamlined approval processes are critical for maintaining momentum. They enable swift transitions between iterations, allowing for continuous integration and improvement without bureaucratic drag.

To support this agility, an emphasis on selective item-based approvals embedded within a continuous development cycle replaces the traditional, overarching document-centric paradigm. Such an approach minimizes bottlenecks, allowing for prompt, targeted reviews that encourage rather than hinder rapid progression and refinement of design inputs and outputs.

Consequently, employing digital tools designed for agile methodologies can transform the approval landscape. These platforms facilitate item-level validation and controlled, swift adaptability, ensuring essential design elements keep pace with iterative advancements while remaining compliant with regulatory standards.

Finally, the integration of such agile-focused approval mechanisms into the quality management system (QMS) is vital. This ensures efficacy and safety remain central to the development process, with a steadfast commitment to producing impeccable medical devices. By enabling responsive, item-based approvals, development teams can accelerate innovation cycles, thereby driving the advancement of medical technology while maintaining impeccable quality and compliance.

Integrating QMS and ALM for Traceability

Quality Management Systems meet Application Lifecycle Management.

An optimal integration seamlessly links two critical domains. By bridging the gap between Quality Management Systems (QMS) and Application Lifecycle Management (ALM), a cohesive framework emerges, ensuring that every piece of the developmental puzzle is accounted for. Consequently, teams have the ability to monitor and manage the alignment of quality with product evolution in real-time.

Traceability becomes a natural byproduct of this synergy.

With integrated tools, redundancies diminish — streamlining efficiency tremendously. Integrating QMS and ALM creates a unified environment, which not only simplifies compliance but also embeds traceability into the DNA of the entire development process, from design inputs to design outputs.

Digital traceability fortifies regulatory adherence and product integrity. When QMS and ALM are orchestrated together through platforms like MatrixRequirements, they provide a robust framework that supports the meticulous nature of medical device development, in accordance with the dynamic standards of 2023 and beyond. This aligns with regulatory bodies' expectations, ensuring every design adjustment can be traced back to its origin.

Creation and demonstration of evaluated design output from design input is inevitable for the development of safe and effective medical devices. Design input serves as the foundation, incorporating stakeholder requirements, market demands, clinical and technological state of the art, risk mitigation measures, legal considerations, and technological specifications.

On the other hand, design output materializes as comprehensive technical deliverables, including technical specifications, software code, verification test results, and validation outcomes, specification of manufacturing tools and processes and supplier information.

Thorough documentation of design output and its relation to the design input ensures regulatory compliance, supports production processes, and solidifies the foundation for the development of innovative and reliable medical devices. By understanding and implementing these principles, medical device developers can navigate the complex landscape of design controls and deliver products that meet the highest standards of efficacy and safety.

About the Author
Regina Preysing
Partnerships Manager