Kevin Murphy THUMB

Kevin Murphy

Talia Serrecchia THUMB

Talia Serrecchia

Engineering

Prototype Development

Human Factors Engineering

Bringing a groundbreaking medical device to life is an exciting yet complex process—especially when it comes to medical device prototype testing. Medtech entrepreneurs often envision transformative solutions to improve patient outcomes and are eager to deliver these innovations to market. However, navigating regulatory requirements—particularly when preparing a prototype for clinical evaluation—can be daunting. 
At Delve, medical device prototype testing&nbsp;is a topic that comes up frequently in conversations with our medtech startup clients. 
<h2>Medical Device Prototype Testing: How to Ensure Clinical Trial Success</h2>
Many innovators grapple with questions about when their medical device&nbsp;prototype is ready for real-world, in-human clinical testing. It’s understood that a ‘prototype’ level device can be used in clinical studies, but what is the fidelity of that prototype? What testing needs to be completed? Does the development of the investigational device fall under design controls?
This article is structured to guide you through the effort required to develop a medical device&nbsp;prototype suitable for clinical testing and to discuss the applicable regulatory pathways at this stage.

We've been developing medical devices to meet rigorous standards for 55 years.

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2025 01 31 Is Your Medical Device Prototype Ready for Clinical Testing INLINE1

<h2>Delve’s Product Development Process for Medical Devices: A Quick Overview </h2>
Before diving into the specifics of what it takes to prepare your medical device&nbsp;prototype for clinical testing, it’s important to understand the broader product development process for medical devices and the type of clinical testing that occurs at a given time. This process ensures that your device complies with relevant standards and requirements before review by a regulatory body to determine if it is safe and effective for the intended use. 
The effort at each step varies depending on the device’s classification and intended use, but here’s a high-level overview: 
<ol><li>Concept & Design Exploration. This is the initial phase where the device is conceptualized, designed, and prototyped. At this stage, you'll define the intended use, explore designs, and identify potential risks. *Early Feasibility or Pilot clinical studies are typically conducted at this stage of device development or prior.</li><li>Design Engineering & Prototyping. A single device design concept representing the production intent embodiment is designed and built. Iterative prototyping and pre-verification testing typically occurs. *Traditional Feasibility studies may occur at this stage.</li><li>Design Freeze & Verification/Validation. During this stage the client’s manufacturing team will produce the samples for verification and validation. Verification activities are performed to ensure that design outputs meet design inputs. Product Validation is then performed to ensure that all User Needs are met. * Pivotal studies are typically conducted at this stage.</li><li>FDA Review</li></ol>

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<h2>You Are Here: Preparing for Early Feasibility or Pilot Clinical Testing </h2>
If you're reading this, you have likely already assessed the technical feasibility of your concept and determined there’s a ‘there’ there with bench testing and animal labs. You understand the intended use of the product and the unmet clinical need this device will support.
The next crucial step in designing a prototype fit for clinical testing is to understand the following:
<ul><li>the clinical safety of the device and device-specific aspects of the procedure;</li></ul>
<ul><li>whether the device can be successfully delivered, implanted or used;</li></ul>
<ul><li>operator technique challenges with device use and human factors (e.g., difficulties in comprehending procedural steps);</li></ul>
<ul><li>patient characteristics that may impact device performance (e.g., anatomical limitations)</li></ul>

The focus of the prototype design for early clinical testing is to meet the requirements for safe in-human investigational use, not to create the vision of the final, finished device for commercialization. The goal is to provide proof of principle and initial clinical safety data and chances are the prototype device used in early feasibility study will look dramatically different from the final marketed device.
It’s important to understand the differences between different types of clinical evaluations as well as the differences in the [fidelity/design/quality of the] test articles evaluated in them. There are also differences in the regulatory pathway to clinical evaluations based on the risks associated with the use of the device. So, let’s go ahead and define some important terms. 
<h2>What Makes a Medical Device “Investigational”? And Other&nbsp;Key Terms You Should Know </h2>
An investigational medical device is one that is still undergoing testing to assess its safety and effectiveness before it can be marketed for public use. These devices have not yet been reviewed by regulatory agencies like the FDA for general use. 
Early feasibility study, including First in Human (FIH). A limited clinical investigation of a device early in development, typically before the device design has been finalized, for a specific indication (e.g., innovative device for a new or established intended use, marketed device for a novel clinical application). 
Traditional feasibility study.&nbsp;A clinical investigation that is commonly used to capture preliminary safety and effectiveness information on a near-final or final device design to adequately plan an appropriate pivotal study. 
Pivotal study: A clinical investigation designed to collect definitive evidence of the safety and effectiveness of a device for a specified intended use, typically in a statistically justified number of subjects. 
Before you can begin any type of clinical study of a medical device, it is crucial to understand how the FDA classifies investigational devices. The level of risk the device poses determines the classification and also dictates the regulatory requirements that must be met by your device prior to initiating clinical testing. (The full regulations for IDEs are captured in the Code of Federal Regulations Title 21 Part 812, commonly referred to as 21 CFR 812, and primarily apply to Class III PMA and De Novo submissions, as well as a small fraction of 510(k)s that require clinical data.)

Utilizing this role to its fullest could minimize project risk and speed your product to market.

Don't Miss: A Chronically Underutilized Role in New Medical Device Development

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<h2>SR vs. NSR Devices: What They Are </h2>
The FDA classifies investigational medical devices into two categories based on their potential impact on patient safety: Significant Risk (SR) and Non-Significant Risk (NSR) devices. This classifications determines the regulatory path you’ll need to follow before beginning clinical testing. 
Significant Risk (SR) Devices. High-risk devices, such as life-supporting, implantable, or primary treatment tools. Examples include: 
<ul><li>Implantable stimulators </li></ul>
<ul><li>Respiratory ventilators </li></ul>
<ul><li>Infusion pumps </li></ul>
Non-Significant Risk (NSR) Devices. Lower-risk devices that don’t meet the criteria for SR classification. Examples include: 
<ul><li>Digital mammography systems </li></ul>
<ul><li>Conventional gastroenterology and urology endoscopes </li></ul>
<ul><li>Infant jaundice monitors </li></ul>
For a comprehensive breakdown of SR and NSR classifications, refer to the FDA’s <a href="https://www.fda.gov/media/75459/download" target="_blank" rel="noreferrer noopener">guidance on investigational devices</a>.

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<h2>SR vs. NSR Devices: What They Require </h2>
Once you've classified your investigational medical device as either Significant Risk (SR) or Non-Significant Risk (NSR), you can determine the regulatory requirements that apply to ensure that your device is safe enough for clinical testing and that ethical standards are met. 
<h3>Requirements for SR Devices </h3>
<ul><li>Investigational Device Exemption (IDE) An IDE grants devices for investigational use an exemption from certain requirements so that their safety and effectiveness may be evaluated in humans. An IDE application containing the investigational plan and report of prior investigations must be submitted to FDA and approved prior to conducting any study related activities. </li><li>Full Compliance with 21 CFR 812 SR devices must adhere to the FDA's 21 CFR 812 regulations, which establish the requirements for clinical studies of investigational devices. These regulations cover aspects such as study design, risk management, labeling, and data collection. Compliance with these rules is essential to ensure that the device's clinical trials are both ethically sound and scientifically valid.&nbsp;</li></ul>
<h3>Requirements for NSR Devices </h3>
<ul><li>IDE Exemption NSR devices are IDE-exempt, meaning they do not require formal FDA approval before clinical trials. However, they do require review and oversight by an Institutional Review Board (IRB). The IRB application must be approved prior to conducting any study related activities. </li></ul>
<ul><li>Compliance with Abbreviated 21 CFR 812 Requirements Although NSR devices do not require a formal IDE, they must still comply with the abbreviated requirements under 21 CFR 812.2(b), which include ensuring ethical testing procedures and the collection of accurate data during trials. </li></ul>
<h3>Requirements for All Devices</h3>
<ul><li>Preclinical Safety Testing Requirements and Risk Management Before an investigational device can be used in clinical trials, potential risks must be identified and assessed, and preclinical safety testing may be conducted. These tests, guided by regulations like 21 CFR 820.30 and international standards such as ISO 14971 (Risk Management), ensure that the device does not pose undue risk to human subjects. Demonstrating compliance and establishing the known safety and risk profile is crucial in this phase because it creates a baseline for safety that allows human testing to proceed. Standards such as ISO 10993 (biocompatibility) and IEC 60601-1 (electromechanical safety standards) play a critical role here. They provide structured guidance to identify and mitigate risks, ensuring your device is ready for ethical, compliant clinical trials. These results are not only necessary for the IDE application but also ensure a solid foundation for meeting FDA safety expectations. </li></ul>
While meeting regulatory and safety requirements sets the stage, it’s equally important to ensure that your device performs as intended in real-world conditions. This shift from compliance to performance is where practical testing and iterative design become essential.

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<h2>From Compliance to Performance: Practical Considerations for Clinical Prototypes</h2>
Achieving regulatory compliance is a critical first step, but a successful clinical evaluation demands more. The medical device&nbsp;prototype must not only meet regulatory standards on paper but also perform under real-world conditions. At Delve, we go beyond compliance by designing devices that thrive in both regulatory environments and practical use, ensuring they’re primed for clinical success and long-term viability.
Here’s how we help optimize clinical prototypes for real-world success:
<h3>1. Reliability</h3>
Medical device prototypes should function consistently under a wide range of conditions, minimizing the risk of failure during evaluation. To ensure reliability:
<ul><li>Perform comprehensive testing by simulating extreme conditions and edge cases to define the design’s limits.</li></ul>
<ul><li>Carry out a thorough risk analysis, addressing potential failure modes identified through processes like Failure Mode and Effects Analysis (FMEA) and ensuring compliance with relevant safety standards (e.g., IEC 60601-1 for electromechanical devices). By thoroughly addressing potential failure modes, you demonstrate to regulatory agencies that your device is prepared for safe and effective real-world use.</li></ul>
<ul><li>Verify the device across all intended use scenarios, ensuring it operates effectively while accounting for variations in user behavior and environmental factors.</li></ul>

Too often, “simulated use” translates to a table with a few chairs and a sink, as opposed to a simulated use environment that truly represents a home or a medical environment.

Don't Miss: Medical Device Testing: Go As Far as Possible with a Simulated Use Environment

<h3>2. Durability</h3>
Clinical trials subject medical device prototypes to prolonged and repetitive use, including shipping, handling, and frequent operation. Ensuring durability is crucial to prevent disruptions during testing. To enhance durability:
<ul><li>Design for long-term robustness. Develop prototypes that can withstand extensive use, simulating hundreds of operational cycles to ensure they perform reliably over time.</li></ul>
<ul><li>Conduct physical stress testing. Assess resilience against environmental stressors such as vibration, impact, and exposure to liquids or particulates. This includes testing for ingress protection (IP) ratings.</li></ul>
<ul><li>Consider wear and tear from storage and transportation. Ensure your prototype remains functional after extended storage periods and the rigors of transportation.</li></ul>

<h3>3. Compatibility</h3>
A device’s compatibility with its operational environment and user workflows is pivotal for seamless integration into clinical settings. Focus on: 
<ul><li>Environmental Compatibility. Conduct Electromagnetic Compatibility (EMC) testing for electronic devices to ensure they operate without interference from other electronic equipment. </li></ul>
<ul><li>Material Compatibility. Ensure all materials that contact patients meet biocompatibility standards (e.g., ISO 10993) and are resistant to cleaning agents and sterilization processes. Ensuring material compatibility not only prevents adverse reactions but also satisfies regulatory requirements for biocompatibility, such as ISO 10993. This prevents adverse reactions and maintains the device's integrity over time.</li></ul>
A successful clinical evaluation requires more than just ticking regulatory boxes. It’s about ensuring your device is ready for the demands of real-world use. By prioritizing reliability, durability, and compatibility, you set your medical device&nbsp;prototype up for smooth evaluations and successful market entry. This strategic approach fosters trust with clinicians and regulatory agencies, driving lasting success for your product. 
<h2>Streamlining Clinical Evaluation: Real-World Tips for Prototype Success </h2>
Streamlining the clinical evaluation process minimizes delays while ensuring that regulatory requirements are met efficiently, ultimately accelerating your time to market. 
A holistic approach to medtech innovation—similar to the one we take at Delve—ensures that every aspect of development aligns with your goals. By addressing more than just the basics, products become more reliable, functional, and suited for real-world conditions. This focus not only supports smoother clinical evaluations but also simplifies the regulatory process, reducing delays and optimizing development timelines. 
Below are proven strategies we’ve honed over decades to help you navigate the clinical evaluation process and position your prototype for success: 
<ul><li>Plan Early Integrate practical testing considerations from the initial design phases. Proactively addressing testing considerations ensures your prototype is aligned with both regulatory requirements and real-world performance needs, giving regulators confidence in your device’s readiness. This proactive approach helps mitigate late-stage issues that can delay or derail the evaluation process. </li></ul>
<ul><li>Engage Key Stakeholders Actively involve clinicians, users, and other stakeholders in medical device&nbsp;prototype testing. Their real-world insights help identify potential issues early, reducing the risk of delays or additional regulatory scrutiny during clinical evaluation. </li></ul>
<ul><li>Iterate Proactively Leverage feedback from initial testing rounds to make iterative refinements. Focus on optimizing your prototype based on real-world use and feedback, ensuring that it meets both regulatory and practical requirements.</li></ul>
By following these strategies, you can streamline the clinical evaluation process, optimize your prototype for real-world success, and ensure that it meets the rigorous standards for regulatory approval. Ultimately, taking a proactive, user-centered approach helps set your device up for smoother clinical outcomes and accelerates its path to market. 
<h2>Ensuring a Smooth Path to Market</h2>
Decades of medtech design and engineering experience have shown us that a strategic, thoughtful approach is key to navigating this critical phase in your prototype’s development. Successful teams focus on: 
<ul><li>Designing functional, compliant prototypes tailored to your device’s specific needs and regulatory requirements. </li></ul>
<ul><li>Addressing real-world challenges like reliability, durability, and compatibility to ensure your device performs in diverse conditions. </li></ul>
<ul><li>Streamlining the clinical evaluation process to minimize risks, prevent delays, and accelerate time to market. </li></ul>
By addressing both regulatory and practical requirements, you lay the groundwork for a successful FDA submission and set your device up for long-term market success. 
A strategic, comprehensive approach throughout the entire development process—starting with early-stage prototypes and refining through to the final design—ensures that your device is not only market-ready but also optimized for real-world impact. 
Whether you're building your first medical device prototype or enhancing an existing one, the goal remains the same: to transform your concept into a patient-centered solution that meets both regulatory standards and the needs of healthcare users.

Learn more about&nbsp;<a href="https://www.delve.com/medical-devices" target="_blank">Delve Product Development Services for Medical Devices.</a>

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Is Your Medical Device Prototype Ready for Testing? Key Considerations for Clinical Trials

Is Your Medical Device Prototype Ready for Testing? Key Considerations for Clinical Trials

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