Ensuring Patient Safety with Medical Device Testing

Medical devices play a significant role in the quality of health and well-being of patients globally. From adhesive bandages to heart valves, medical devices are used in the diagnosis, prevention, monitoring, and treatment of a broad range of medical conditions. Since these devices have many interactions with patients’ bodies and activities, medical device manufacturers must confirm that their respective products are built to operate with exceptional performance and reliability.

Improving the quality of life for those with chronic diseases like cancer and diabetes, as well as our aging population, has increased demand for high-performance medical devices while adhering to key regulations. As you work to develop novel medical devices, use TA Instruments to optimize and validate product performance and safety.

Analytical Testing for Medical Device Development Pathway

Before complete medical devices are implanted into patients, the development path from product idea to the final device is far from quick and easy.

The medical device development pathway – benchmarking native tissues, characterizing biomaterials and device materials, measuring the reliability of device subcomponents, and testing the efficacy and durability of complete devices – requires testing rigor enabled by precise and reliable instruments. Developing high-performing medical devices depends on the quality of your lab and measurements.

Explore each category in the medical device development pathway for more information.

 

Characterizing Native Tissue

Investigating the behaviors of native tissues offers insights into natural or diseased tissue performance, allowing device developers to explore how these qualities translate into medical device functions. Similarly, techniques for tissue characterization can be leveraged for engineered tissue.

Many tissue-engineered medical products (TEMPs) can be assessed for properties such as mechanical stiffness, compliance, strength, or stability using the same instruments used for native tissue.

Investigate tissue behaviors to develop high-performing medical devices with TA Instruments solutions.

ElectroForce 5500

  • Cartilage, Tendons (of animal models), Ligaments (of animal models)
    • Strength
    • Stiffness
    • Durability
    • In Vivo Loading

ElectroForce 3200

  • Cartilage, Bone, Dentin/Teeth
    • Strength
    • Stiffness
    • Durability
  • Spinal Cord and Nerves
    • Strength
    • Stiffness
    • Response to injury

ElectroForce 3300

  • Muscle
    • Strength
    • Stiffness
    • Response to Stimulus
  • Bone, Dentin/Teeth
    • Strength
    • Stiffness
    • Durability

ElectroForce 3500

  • Bone, Tendon, Ligament
    • Strength
    • Stiffness
    • Durability

TestBench and Planar Biaxial

  • Heart valve leaflets, Pericardium
    • Strength
    • Stiffness
    • Durability
    • Anisotropy
  • Skin
    • Strength
    • Stiffness
    • Anisotropy

Commonly Used Testing Standards

  1. ASTM E794 Test Method for Melting and Crystallization Temperatures by Thermal Analysis
  2. ASTM E1356 Test Method for the Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry
  3. ASTM E1641 Test Method for Decomposition Kinetics by Thermogravimetry Using the Flynn/Wall/Ozawa Method
  4. ASTM E2550 Test Method for Thermal Stability by Thermogravimetry
  5. ASTM D5023 Standard Test Method for Plastics: Dynamic Mechanical Properties: In Flexure (Three-Point Bending)
  6. ASTM E831 Test Method for Linear Thermal Expansion of Solid Materials by Thermomechanical Analysis
  7. ASTM D5279 Standard Test Method for Plastics: Dynamic Mechanical Properties: In Torsion
  8. ISO 14801 Dentistry — Implants — Dynamic loading test for endosseous dental implants 
  9. ASTM F3211 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
  10. ASTM F2477 Pulsatile stent testing: Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

Don’t see what you’re looking for? Click here to explore a comprehensive list of ASTM/ISO standards for your material testing needs. 

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