Learn about the most common materials testing applications for medical devices, such as mechanical, biocompatibility, sterilization, chemical, environmental, and electrical testing.

In our experience, the key challenges with materials biocompatibility are faced when the specific medical device application requires incorporating cells within the 3D materials. In addition to common and well explored aspects of biocompatibility in 2D materials, culture of cells in 3D space requires exploring and further tuning of the material properties, including the mass transport (e.g., diffusion), as well as remodeling and degradation capacity of the materials. Further, material properties such as mechanical and biochemical features, are a lot more pronounced in the 3D, and require more careful tuning and optimization. One key challenge in the field is to get full biological function from cells within 3D materials.

What are the most common materials testing applications in medical devices?

Medical devices are products that are designed to diagnose, treat, or prevent various health conditions. They can range from simple bandages and syringes to complex implants and prosthetics. To ensure their safety and performance, medical devices need to undergo rigorous materials testing before they are approved and marketed. In this article, you will learn about some of the most common materials testing applications in medical devices and how they help to evaluate their quality and functionality.

1 Mechanical testing

Mechanical testing is the process of measuring the strength, stiffness, elasticity, and durability of materials under different loads and conditions. Mechanical testing is essential for medical devices that are subjected to stress, strain, fatigue, impact, or wear in their intended use. For example, mechanical testing can help to determine the fracture resistance of orthopedic implants, the tensile strength of sutures, the flexural modulus of catheters, or the compression behavior of spinal discs.

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2 Biocompatibility testing

Biocompatibility testing is the process of assessing the compatibility of materials with living tissues and systems. Biocompatibility testing is crucial for medical devices that are in direct or indirect contact with the human body, such as implants, stents, pacemakers, or drug delivery devices. For example, biocompatibility testing can help to evaluate the cytotoxicity, inflammation, irritation, sensitization, or hemocompatibility of materials and their degradation products.

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Vahid Serpooshan

Assistant Professor at The Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University Scientific Director @ Innovations Hub, Emory School of Medicine
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In our experience, the key challenges with materials biocompatibility are faced when the specific medical device application requires incorporating cells within the 3D materials. In addition to common and well explored aspects of biocompatibility in 2D materials, culture of cells in 3D space requires exploring and further tuning of the material properties, including the mass transport (e.g., diffusion), as well as remodeling and degradation capacity of the materials. Further, material properties such as mechanical and biochemical features, are a lot more pronounced in the 3D, and require more careful tuning and optimization. One key challenge in the field is to get full biological function from cells within 3D materials.

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Dan Coole

29 years in Medical Devices. MD at Surgical Holdings. MedTech Social Media Enthusiast. ABHI Surgical Instrument Chair.
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Chemicals and compounds used in manufacture must also be added to the biocompatibility work. This may be things such as cleaning compounds.

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3 Sterilization testing

Sterilization testing is the process of verifying the effectiveness of sterilization methods and procedures for medical devices. Sterilization testing is necessary for medical devices that are intended to be sterile or free of microorganisms that could cause infections or diseases. For example, sterilization testing can help to validate the exposure time, temperature, pressure, or radiation dose of steam, ethylene oxide, hydrogen peroxide, or gamma ray sterilization.

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Dan Coole

29 years in Medical Devices. MD at Surgical Holdings. MedTech Social Media Enthusiast. ABHI Surgical Instrument Chair.
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Sterilisation validation can often be overlooked, when the end goal is the performance of the device. The clean-ability of the device should be considered from step one of design

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4 Chemical testing

Chemical testing is the process of analyzing the composition, purity, stability, and interactions of materials and substances. Chemical testing is important for medical devices that contain or release active ingredients, additives, solvents, or impurities that could affect their performance or safety. For example, chemical testing can help to identify the chemical identity, concentration, potency, or degradation of drugs, coatings, adhesives, or polymers.

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5 Environmental testing

Environmental testing is the process of exposing materials and devices to various environmental factors and conditions that could influence their behavior or reliability. Environmental testing is relevant for medical devices that are sensitive to temperature, humidity, pressure, vibration, shock, or corrosion. For example, environmental testing can help to simulate the storage, transportation, or operational conditions of medical devices and assess their resistance, stability, or functionality.

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6 Electrical testing

Electrical testing is the process of measuring the electrical properties and performance of materials and devices. Electrical testing is applicable for medical devices that involve electrical signals, currents, voltages, or circuits, such as electrocardiographs, defibrillators, electrodes, or sensors. For example, electrical testing can help to evaluate the electrical conductivity, resistance, impedance, capacitance, or power of materials and devices.

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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What are the most common materials testing applications in medical devices?

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1 Mechanical testing

2 Biocompatibility testing

3 Sterilization testing

4 Chemical testing

5 Environmental testing

6 Electrical testing

7 Here’s what else to consider

Materials Science

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