5 Phases of the Medical Device Development Process

Developing a medical device is a challenging but rewarding journey, essential for advancing healthcare and improving patient outcomes. Success depends not only on a clear development process but also on navigating a complex global regulatory landscape. From the FDA's structured pathways in the United States to the Medical Device Regulation (MDR) in Europe, understanding these diverse regulations is crucial for bringing a device to market.

Medical devices are not just everyday tools - they are life-saving innovations. When bringing medical devices from concept to market, they must be reliable, safe, and effective while meeting market demands and generating revenue for medical device manufacturers. While most companies invest in good development, many lack the resources, lack know-how about the quality requirements or do not develop documentation correctly for their target markets, underscoring the importance of thorough planning and precise execution.

This article explores the five essential phases of medical device development, focusing on a comparative overview of FDA CFR21 820 and EU MDR. Following these guidelines ensures innovations meet regulatory requirements while making a meaningful impact on patient care worldwide.

 

The 5 phases of medical device development

The FDA and EU MDR ensure devices are safe, effective, and meet market needs. Let’s explore the five essential phases of medical device development.

 

Phase 1: Idea, Risk and Opportunity Analysis

The initial stage of the medical device development procedure is primarily focused on planning, conducting research, and initial documentation. Ideas, risks and opportunity analysis is the first stage in the process of developing medical devices. It focuses on defining the medical problem your device aims to solve and assessing its feasibility. This is where the whole team lays the groundwork and foundation for the device itself, as well as creating a good basis to take the device from a vision to a profitable market-ready device.

This phase includes:

• Identify the need: Identify the medical problem / challenges that the device aims to solve.
  
  
• Idea phase: Generate possible solutions and formulate initial concepts for the device.
  
  
• Feasibility evaluation: Assess the technical and market viability of the gadget idea, including preliminary cost projections and resource needs.
  
  
• Early design stage: Creating early designs or models to visualize the concept.
  
  
• Regulatory compliance: To ensure regulatory compliance of the product a market analysis is done. It involves the definition of target markets, it’s regulations and laws (e.g, FDA, MDR or both) and the subsequent standards.
  
  
• Risk Analysis & IP Protection: Conduct preliminary risk assessments and assess patents to secure intellectual property (IP).
  
  
• Preliminary Planning: Establish a market-ready strategy, secure supply chains, explore potential regulatory requirements, and investigate what expertise is required in the project. Develop a funding strategy, define resources, and establish a Quality Management System (QMS) compliant with ISO 13485.
  
  

IMT AG rely on a certified QMS in order to be allowed to develop the entire range of medical products. By the end of this phase, you should have a clear understanding of your device's purpose, market potential, and regulatory requirements.

 

Phase 2: Prototype: Concept and Feasibility Analysis

It's time to bring the idea to life once the team has come up with the concept and set up the basics. Phase 2 ought to yield a concept and validate the functionality of your idea. This stage involves converting the conceptualized notion into a functional, testable prototype, which is thoroughly examined to guarantee its safety and efficacy. Thus, you must be ready to repeatedly revisit and revise the design, and keep in mind to record the alterations!

IMT Tip: Use rapid prototyping. Fail fast and early in the feasibility instead of later in the project where every change is expensive and time consuming.

 

During this stage, the prototype undergoes a series of rigorous tests, which are designed to simulate real-world conditions and identify any potential issues. It's a cycle of perpetual enhancement, where insights from trials are utilized to fine-tune and perfect the medical device. In this phase, the concept becomes a tangible, working prototype for testing.

This phase includes:

• Prototype Development: Create an initial model to demonstrate core functionality.
  
  
• Testing: Rigorous safety, performance and feasibility tests
  
  
• Iterative Refinement: Improve the prototype based on testing feedback.
  
  
• Regulatory Compliance: Refining which standards and local regulations apply and write quality relevant documents accordingly. Don’t forget to define the medical device class, which ranges from Class I to Class III.
  
  
• Design Transfer Preparation: Start the design transfer process during prototyping to make the transition from design to manufacturing less complicated, efficient and scalable.
  
  

This stage confirms the feasibility of your device, addressing performance and regulatory needs. Furthermore, ensure you're familiar with the regulatory prerequisites for your device, as well as the safety and regulatory standards of the country/region you intend to market in (which should have been identified during your market analysis).

The stipulations in the US vary from those in Europe, and despite a significant overlap, the product approval procedures are notably distinct. See section on Comparative Overviews - FDA vs. EU MDR Classification and Approval Pathways.

IMT Tip: To streamline the prototype and design process, consider using a development platform. These platforms are designed for specific device types and enable developers to utilize existing solutions rather than starting from scratch. If you are looking for a real example, read more about our modular pneumatic development toolbox for the development of pneumatic devices such as patient ventilators.

 

Phase 3: Product Development: Design, Verification and Validation

The product development phase transforms your prototype into a fully functional product that meets design specifications and regulatory requirements. This entails documenting according to your quality and regulatory plan, categorizing, verifying and validating your device and preparing the documentation for submission to regulatory bodies. This phase ensures the device meets all regulatory, safety, and performance requirements.

 

This phase includes:

• Detailed Design: Develop engineering models and specifications.
  
  
• Verification and Validation:
  - Verification: Ensure the device meets design specifications.
  - Validation: Test in real-world scenarios to confirm effectiveness.
  
  
• Risk Management Plan: Document risks and mitigations using a design traceability matrix.
  
  
• Regulatory Submission Preparation: Create your technical documentation for submission to authorities such as FDA or notified bodies to get your product in the EU market.

 

The result of this phase is a complete, verified, and validated design ready for submission. The validation and verification of your medical device proves that it will withstand all the pressures of the real world.

 

IMT Tip: Define clear acceptance criteria for each test. A helpful approach is creating a design traceability matrix to track all your requirements. These requirements should be translated into engineering specifications, addressing questions like:   How will you fulfill the requirement? What mode of testing will you use to verify and validate? What processes do you need? What test equipment will you need? Have you established a manufacturing and quality plan, or will you outsource this?

 

This phase also calls for a robust risk management strategy. Document potential failures stemming from design flaws, manufacturing issues, or user errors, including foreseeable misuse. Be thorough—overlooking risks could jeopardize patient safety and prevent the device from reaching the market.

Regulatory consideration: Additionally, review and update your regulatory strategy. If clinical trials are required, begin testing the product under real clinical conditions, starting from the design freeze. Ensure you meet external approval requirements, such as obtaining clearance from an ethics committee.

 

Phase 4: Submission: Regulatory Validation and Pre-Market Approval

At this point, you should also have finalized your technical documentation. Compile a comprehensive tech file containing all the necessary evidence to present to a competent authority who will assess your file's completeness against anticipated standards.

This phase is the culmination of all the rigorous work, where the FDA or notified body under EU MDR assesses if the device is eligible for market approval. Upon approval, a manufacturer can begin crafting marketing materials, strategizing their product launch campaigns, and confirming production procedures are established. This phase is vital as it dictates if the device can be legally promoted and utilized in clinical settings, laying the groundwork for its debut in the healthcare industry. This phase involves submitting the device for regulatory approval and preparing for launch.

 

This phase includes:

• Technical Documentation: Compile all evidence, including testing results and design details.
  
  
• Safety Testing: Perform final safety tests such as biocompatibility, usability and electrical safety tests.
  
  
• Marketing Compliance: Align marketing claims with regulatory requirements of your target markets (FDA 21 CFR Part 820 / EU MDR requirements).
  
  
• Regulatory Submission:
  - FDA: Submit for 510(k) clearance or Premarket Approval (PMA).
  - EU MDR: Submit technical documentation to a Notified Body for CE marking.

 

Once approved, your device is cleared for commercial launch. It is important to note that regulatory bodies, including the FDA and EU MDR, consider marketing materials an extension of the product labeling. This means that all claims, advertisements, and promotional materials must align with the approved indications for use and the validated product specifications. Misleading or exaggerated claims can lead to regulatory action, including fines, product recalls, or additional scrutiny from authorities.

 

Phase 5: Market Launch and Post-Market Surveillance

The launch of a medical device marks the culmination of years of hard work, but it is far from the end of the journey. Post-market surveillance (PMS) ensures that your device continues to perform safely and effectively in real-world conditions, meeting regulatory and patient safety expectations. This phase is critical for identifying unforeseen risks, capturing user feedback, and maintaining compliance with evolving regulations. Effective post-market monitoring not only protects patients but also strengthens trust in your product, giving you a competitive edge.

 

This phase includes:

• Manufacturing and Distribution: Scale production with adherence to Good Manufacturing Practices (GMP) if your submission is under FDA or follow ISO13485 and EU MDR requirements under notified bodies.
  
  
• Market Introduction: Launch with a compliance-ready marketing strategy.
  
  
• Post-Market Surveillance:
  - Utilize real-world evidence tools to gather data on your device’s performance across diverse patient populations - capture feedback, monitor events in the field, and implement improvements.
  - Implement robust systems to capture, analyze, and report adverse events to regulatory bodies - regularly check the device’s performance and safety.
  - Conduct regular internal audits to ensure adherence applicable standards and regulations such as FDA, ISO13485 and EU MDR.
  - Regularly provide reports to the legal authorities such as FDA covering safety issues, the device's functionality, any negative incidents, and any modifications to the device or its labeling.
  
  
• Continuous Improvement:
  - Use insights from PMS activities to refine designs, improve manufacturing processes, and update risk assessments.
  - Ensure your Quality Management System (QMS) integrates post-market data for iterative improvements

 

This phase ensures the device remains competitive, safe, and effective throughout its lifecycle. Makre sure you have a strong internal quality audit system to analyze your data and ensure that you are not taking shortcuts in the production of medical devices, complying with your QMS protocols, sticking to good manufacturing practices (GMP) under FDA, adhering to your feedback and complaint mechanisms and updating all essential technical documents as needed.

 

IMT Tip: For a comprehensive guide to implementing effective PMS, visit our dedicated article: Regulatory Market Surveillance for Medical Devices. It covers this topic and how IMT AG can help to maintain compliance and ensure your device’s long-term success in the market.

 

3. Comparative Overviews

FDA vs. EU MDR Classification and Approval Pathways

The FDA and EU MDR mandates a structured development process to ensure medical devices are safe, effective, and compliant with regulatory standards. This framework applies to a wide range of products, from simple tools like bandages to complex technologies like pacemakers and is essential for legally marketing devices in the U.S. healthcare system and European Medical Device market.

 

The FDA as well as the EU MDR classify medical devices based on their risk into three categories. Class I, Class II and Class III medical devices. The EU MDR further has distinct Class I and Class I*. Where Class I* includes devices with slightly higher risk: Ir (Reusable Class I medical devices, i.e. Surgical Instruments), Im (Class I Medical Devices for Measuring, i.e. Thermometers), Is (Sterile Class I medical devices, Sterile Gauzes). Generally speaking, with increasing risk, from Class I to Class III, the regulatory requirements and device development process increase proportionally.

Regarding the submission process, there is also a tendency that with increasing class and risk the complexity of submissions and the time required for approval increases.

Regarding the approval pathways there are different approaches by FDA vs EU MDR. Under FDA the class II medical devices are usually approved by 510(k) while class III devices require a PMA (premarket approval). Under EU MDR all medical devices with class II or III need a conformity assessment trough a notified body. However, both legislations handle class I devices in a similar manner. These usually only require a self-declaration due to their low risk. However, this does not mean that there is a huge gap in documentation and regulatory effort across medical device classes.

 

Of course there are costs involved in the registration of medical devices. FDA as well as the notified bodies under EU MDR have published their services and fees online. The costs corelate with the complexity and classification of the medical device.

 

Navigating the documentation requirements for medical device approvals across different regions is a critical step in ensuring regulatory compliance and market success. Each system has unique expectations regarding the type, depth, and scope of documentation required, reflecting the priorities and frameworks of their respective regulators:

• FDA (USA): The FDA focuses on concise documentation tailored to the device's risk classification. For Class II and III devices, manufacturers must provide detailed biocompatibility testing, risk assessments, and clinical data as part of the 510(k) or Premarket Approval (PMA) submissions.
  
  
• EU MDR (Europe): The EU MDR emphasizes in the technical files on robust post-market surveillance plans and clinical evaluations, especially for higher-risk devices.

Despite the different priorities of the two legislations, the basic content of the technical documentation for submission is quite similar and the alignment between them is increasing, making it less burdensome to strive for both submissions using the same documents. Sure, there are some differences, but if done correctly, a lot of extra work can be avoided, saving time and money.

 

For simplicity, here is a list with general technical file content which is needed for submission.

• Device description & specification
• Verification and Validation
• Accompanying material & Label
• Risk Management
• Device specific requirements, if applicable:
  - Electrical Safety
  - Biocompatibility
  - Clinical Evaluation
  - Usability
  - Software & Cybersecurity
  - etc.
• Post-Market surveillance
• Declaration of conformity

 

4. What is the ISO 13485 Standard?

ISO 13485 is an internationally recognized standard that outlines the requirements for a Quality Management System (QMS) specifically designed for the design, production, and distribution of medical devices. This standard ensures that medical devices meet consistent quality and regulatory requirements, promoting safety and effectiveness throughout their lifecycle.

IMT AG is proud to be ISO 13485 certified, demonstrating our commitment to maintaining the highest quality standards in medical device development. This certification validates that our processes comply with global regulatory frameworks, including FDA and EU MDR requirements.

By partnering with IMT AG, clients benefit from a structured and reliable development process that adheres to ISO 13485 requirements. This ensures:

• Regulatory Compliance: Our quality management system is aligned with FDA and EU MDR, regulations, helping clients navigate complex approval processes with confidence.
  
  
• Product Safety and Quality: We implement rigorous quality controls to enhance product reliability and patient safety.
  
  
• Efficient Development and Reduced Risk: Working according to ISO 13485 streamlines development processes, minimizes errors, and ensures robust risk management.
  
  
• Accelerated Market Access: Our adherence to this standard facilitates faster regulatory approvals and international market expansion.
  
  
• Long-Term Compliance and Improvement: We continuously monitor and refine our quality processes to meet evolving regulatory requirements and industry best practices.

 

ISO 13485 is more than just a compliance standard - it is a foundation for building trust, enhancing efficiency, and delivering innovative, life-saving medical devices to patients worldwide. At IMT AG, we integrate this standard into every stage of development, ensuring the highest level of quality and regulatory adherence for our clients' success.

 

5. Simplifying Medical Device Development with IMT AG

Developing a medical device is an exciting yet challenging journey. It’s not just about creating a great idea - it’s about ensuring your product meets complex regulatory requirements, passes clinical testing, and reaches the market safely and efficiently. At IMT AG, we understand how overwhelming this process can feel, especially when you're juggling innovation, compliance, and tight timelines. That’s where IMT AG’s experts are here to ensure a successful development path.

From the initial concept to market launch, our tailored solutions are designed to address the pain points that often hold medical device developers back:

• Regulatory Complexity: Navigating regulatory requirements can feel intimidating. Our experts guide you step-by-step through the approval process, ensuring compliance with global standards.
  
  
• Time and Resources: We help streamline your product development process with expertise, tools and strategies that save time and minimize wasted effort, helping you reduce the time-to-market of your product.
  
  
• Risk Management: Identifying and mitigating risks early is crucial. We implement robust quality management systems and work according to ISO 14791 (Risk Management) to keep your medtech project on track and compliant.
  
  
• Collaboration Gaps: Our solutions enhance communication and traceability, ensuring everyone on your team is aligned and informed.
  
  
• Medical device lifecycle stages: We’ve got you covered from concept through product development and device registration but are also here to support you with any lifecycle management related topics.

 

IMT AG has a background of developing, registering and marketing it’s own medical devices (imtmedical – bellavista patient ventilators and IMT Analytics – Gas Flow Analyzers, giving us hands-on experience and knowledge about challenges faced by our customers.

Ready to turn your vision into a market-ready product? Explore our medical device development services or regulatory affairs consulting. Together, we’ll ensure your success in this competitive landscape of medical technology.