From Concept to Market: Understanding the FDA Medical Device Product Development Process

 

Medical devices are integral to healthcare. They need to be reliable, safe and effective, but also drive revenue. Therefore, when creating a new device for use in the USA, the FDA-regulated, 5-step medical device product development process must be followed. Knowing how to navigate these steps during the product development project is key to ensuring a new device is a medical and financial success.

Each of the 5 steps in the FDA’s medical device development process is designed so new devices not only meet rigorous safety and efficacy standards but also address market needs, regulatory requirements, and other risks that can lead to project failure.

75% of medical device start-ups in the US don’t succeed. You can avoid being part of this statistic by following the right measures.

In this article, we’ll help you build an understanding of the FDA’s medical device new product development process, broken into 5 steps.

What is the New Product Development Process for Medical Devices?

The medical device product development process is a structured sequence of phases the FDA requires to bring a medical device from concept to market. This ensures devices are safe, effective, and compliant with regulatory standards. It applies to a wide range of medical devices, from simple tools like bandages to complex technologies like pacemakers.

Companies involved in developing medical devices, including manufacturers, start-ups, and researchers, must follow these processes. This isn’t just a set of best practices but a regulatory requirement enforced by the FDA.

Types of medical devices that need to gain FDA approval:

• Class I: Low risk, such as bandages and hand-held surgical instruments (However, most Class I devices and some Class II are exempt from FDA approval).
• Class II: Moderate risk, including powered wheelchairs and some diagnostic equipment.
• Class III: High risk, such as implantable pacemakers and heart valves.

Following this rigorous process is essential for ensuring a medical device meets the high standards required for patient safety and efficacy – elements crucial for a device to launch on the market. All entities involved in medical device creation must adhere to these FDA-mandated steps to legally market their products in the USA.

Now, let’s explore the FDA’s 5 steps to medical device product development.

Step 1: Device Discovery and Concept

Device Discovery and Concept is the initial phase in the medical device development process. During this stage, innovators and researchers identify a medical need and conceptualize a device to address it.

For example, In 1963, Dr. Arnold Kadish faced a problem: He couldn’t stabilize insulin levels for his diabetes patients. He took steps to solve this by developing the first “wearable” insulin pump. It was an oversized, heavy, backpack – not user-friendly – but it paved the way for many other researchers to create the life-saving, modern-day insulin pump.

Stage 1 is also when a new idea is evaluated for usefulness and feasibility. After all, having a good idea doesn’t mean it’s a viable one worth investing millions of dollars and years of labor. This is where developers lay the groundwork and foundation for the device itself, as well as for creating clear pathways to take the device from a good idea to a profitable investment.

The key activities of stage 1 in the medical device product development process include:

1. Identify the need: Understand and define the medical problem that the device aims to solve.
2. Conceptualization: Brainstorm potential solutions and develop preliminary ideas for the device.
3. Research: Conduct background research to understand existing technologies, market needs, and potential barriers.
4. Feasibility assessment: Evaluate the technical and market feasibility of the device concept, including initial cost estimates and resource requirements.
5. Preliminary design: Creatine early design sketches or models to visualize the concept.
6. Intellectual Property (IP) considerations: Explore patentability and protect intellectual property through patents or other means.
7. Planning the path to success: Create a go-to-market strategy, explore supply chain issues, explore potential regulatory requirements, and look into what professionals need to be brought onto the project.

 

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Step 2: Preclinical Research – Prototype

After the initial spark of an idea and the foundational groundwork laid in Step 1, it’s time to bring the concept to life in Step 2: Preclinical Research – Prototype. This phase is about transforming the conceptualized idea into a tangible, working prototype to be rigorously tested to ensure it’s both safe and effective.

It’s also where real-world considerations take place. What will the end-users want in this device? What market will it be sold in and what regulatory requirements will it need to meet? Will parts need to be customized or are there readily available components that can be incorporated into the design?

During this stage, the prototype undergoes a series of rigorous tests in the lab, and if necessary, on animal models. These tests are designed to simulate real-world conditions and identify any potential issues. It’s a process of continuous improvement, where feedback from testing is used to hone and refine the device.

Pro-Tip: To speed up the prototype and design process, consider leveraging a development platform. These platforms are tailored to different device specialties and allow new developers to use established solutions instead of building them from the ground-up.

Key activities in Step 2 of the medical device product development process include:

• Prototype development: Create a working model or prototype of the device based on the initial concept.
• Laboratory testing: Conduct extensive bench tests to evaluate the device’s performance, safety, and reliability under controlled conditions.
• Animal testing: If applicable, perform tests on animal models to assess the device’s biological effects and gather preliminary data on its efficacy and safety.
• Refinement: Make necessary modifications and improvements to the prototype based on test results and feedback.
• Regulatory compliance: Ensure that all preclinical testing complies with FDA regulations and guidelines, preparing for the next phase of development.
• Design transfer preparation: Start the design transfer process during prototyping to make the transition from design to manufacturing less complicated and more efficient.

Step 3: Pathway to Approval

Step 3 is where the device proves it meets all the necessary regulatory requirements to proceed to clinical trials and, ultimately, to market.

This involves developing a robust regulatory strategy, assigning a classification to your device, engaging in pre-submission meetings with the FDA, and preparing an Investigational Device Exemption (IDE) application. The goal is to demonstrate that the device is safe enough to be tested in humans.

During this stage, risk management matters. The clinical trial design must be meticulously planned to gather comprehensive data on the device’s safety and effectiveness in humans. All preclinical data and proposed study protocols are compiled and submitted to the FDA for review.

Key activities in Step 3 of the medical device product development process include:

• Regulatory strategy: Develop a plan for interacting with regulatory agencies and determining the appropriate regulatory pathway for the device.
• Pre-submission meetings: Engage in meetings with the FDA to discuss the regulatory requirements and clinical study plans.
• Investigational Device Exemption (IDE): Prepare and submit an IDE application to the FDA to obtain permission to conduct clinical trials.
• Clinical trial design: Design clinical trials to gather data on the device’s safety and effectiveness in humans.
• Regulatory submission: Compile and submit the necessary documentation, including preclinical data and proposed clinical study protocols, to the FDA for review.

What are the biggest mistakes a device developer can make in the regulatory process? Watch this video for what to watch out for and how to avoid common mistakes.

Step 4: FDA Device Review

This phase is where all the hard work culminates and the FDA evaluates whether the device can be approved for marketing. Once approved, a developer can start preparing marketing materials, hash out their product launch campaigns, and ensure production processes are in place.

This stage is crucial as it determines whether the device can be legally marketed and used in clinical practice, paving the way for its introduction to the healthcare market.

During Stage 4, the FDA examines the safety and effectiveness data, inspects manufacturing facilities, and may even convene an advisory committee of experts to provide additional insights. This thorough review process ensures that only devices meeting the highest standards are approved for market.

Key activities in Step 4 of the medical device product development process include:

• Submission of marketing application: Prepare and submit a comprehensive application to the FDA, including all preclinical and clinical data, manufacturing information, and proposed labeling.
• FDA review: The FDA conducts a thorough review of the submitted application, examining the safety and effectiveness data.
• Inspections: The FDA may inspect the manufacturing facilities to ensure they comply with regulatory standards.
• Advisory committee meeting: For some devices, the FDA may convene an advisory committee of experts to review the data and provide recommendations.
• Decision: The FDA makes a decision to approve, deny, or request additional information regarding the device.

Other medical device development insights: How to Prevent Component Obsolescence From Becoming Serious Medical Device Obsolescence Risks What Is Biocompatibility Testing for Medical Devices? Questions You Should Ask Before Hiring a Medical Device Outsourcing Company

Step 5: FDA Post-Market Device Safety Monitoring

After a device hits the market, ongoing work is still required. Step 5: FDA Post-Market Device Safety Monitoring ensures that the device continues to perform safely and effectively in the real world.

This stage is essential for maintaining the device’s safety and effectiveness throughout its lifecycle, ensuring it continues to benefit patients as intended.

During this stage, manufacturers are required to report any adverse events or malfunctions to the FDA. This helps in identifying potential risks early and mitigating them before they cause significant harm. Regular periodic reports summarizing the device’s performance, any adverse events, and any changes to the device or its labeling are also submitted to the FDA.

Key activities in Step 5 of the medical device product development process include:

• Post-market surveillance: Continuously monitor the device’s performance and safety in the real world through various post-market studies and data collection.
• Adverse event reporting: Participate in mandatory reporting of any adverse events or malfunctions to the FDA to identify potential risks early.
• Periodic reporting: Submit periodic reports to the FDA summarizing the device’s performance, any adverse events, and any changes to the device or its labeling.
• Recalls and corrections: Implement any necessary recalls, corrections, or updates based on the surveillance data and FDA feedback.
• Compliance with regulations: Ensure ongoing compliance with FDA regulations and guidelines, including quality system regulations.

Master the Medical Device Product Development Plan

Turning a good idea into a successful medical device is no small feat; it’s a process that requires painstaking care and consideration. Without the right measures and support in place, it’s easy for a good idea to never evolve into a useful product.

Partnering with a team that has the product development process for medical devices down to a tee can bolster your chances for success. At Vantage MedTech, our decades of expertise give you the advantage you need to turn your idea into a successful medical device. From concept to product launch – we help innovators get new medical devices across the finish line.

To learn more on how we can support your medical device initiatives, contact us today.