Your Ultimate Guide to Mechanical Testing of Medical Devices

Welcome to ADMET’s guide on Mechanical Testing of Medical Devices. In this comprehensive resource, we delve into the critical importance of rigorous mechanical tests for ensuring the safety and efficacy of a wide range of medical products, from orthopedic implants and tissue engineering to medical adhesives and catheters. Learn how our state-of-the-art testing systems, compliant with ASTM and ISO standards and FDA 21 CFR part 11, provide unmatched reliability in evaluating these life-essential devices.

What are Medical Devices?

The definition of a medical device as defined by the Global Harmonization Task Force is any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent, software, material or other similar or related article that does not achieve its primary intended action in or on the human body solely by pharmacological, immunological or metabolic means and that is intended for human beings for:

  • the diagnosis, prevention, monitoring, treatment or alleviation of disease;
  • the diagnosis, prevention, monitoring, treatment or alleviation of, or compensation for an injury;
  • the investigation, replacement, modification, or support of the anatomy or of a physiological process;
  • supporting or sustaining life;
  • controlling conception;
  • disinfecting medical devices; and
  • providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body.

What Medical Devices Require Mechanical Testing?

Implantable Medical Devices

An implantable device or a prosthesis is a medical device that is supposed to replace a missing anatomical structure, function as a human organ, support a biological structure, or enhance the functionality of an organ, and which does not solely attain its functions by means of pharmacological, immunological, or metabolic means.  Some implants are also used for diagnostic purposes.  These devices are called implantable due to the fact that they are introduced into the human body partially or fully, surgically or by other means for a short or long period or for a lifetime. 

Orthopedic Implants

Musculoskeletal diseases including trauma create a need for biomedical implants to reconstruct bone and its associated soft tissues. With the increased activity of an aging population, the number of orthopedic devices being implanted worldwide is continuing to climb. These orthopedic implants include devices for fracture fixation, joint replacement, tumor reconstruction, soft tissue repair; and fusion, reconstruction, or stabilization of the spine.

Mechanical testing of these orthopedic implants may involve measuring implant rigidity, testing how many cycles it takes until it breaks, or how the implant influences the rest of the body around it. Regardless of the circumstance, it is important to recognize that the way in which an implant is tested should always attempt to represent the way in which it is mechanically loaded in the body.

Orthopedic Implant Testing Guide

Read our comprehensive guide on the Mechanical Testing of Orthopedic Implants.

This guide covers many implants including; Bone Plates and Scews, Hip and Dental implants, Knee Prostheses, Shoulder Implants, and Spinal Implants as well as the related test types and testing standards.

Orthopedic Implant Testing Guide

Tissue Engineering

The loss or failure of an organ or tissue is one of the most frequent, devastating, and costly problems in human health care.  Tissue engineering applies the principles of biology and engineering to the development of functional substitutes for damaged tissue.  Scaffolds to support the constructive remodeling of injured or missing tissues or organs can be composed of synthetic or naturally occurring materials and can be degradable or nondegradable.  These scaffolds are also engineered to have specific mechanical or material properties that closely resemble those of the tissue replaced.  Ultimately, the scaffold should facilitate the attachment, migration, and proliferation of the cell population required for structural and functional replacement of the target organ or tissue.  When implanted into the body, the scaffold will be subjected to in vivo physiological stresses and strains.  Thus, it is necessary to develop scaffolds that have mechanical properties similar to those of the native tissues.

Tissue Engineering testing guide

Read our detailed guide on the Mechanical Testing of Tissues.

This guide discusses the importance of studying the mechanical properties of tissue and the necessary testing equipment for performing such tests.

Tissue Engineering testing guide

Mechanobiology

Biomechanics is the science of the movement of a living body, including how muscles, bones, tendons, and ligaments work together to move. The European Society of Biomechanics defines biomechanics as “the study of forces acting on and generated within a body and the effects of these forces on the tissues, fluid or materials used for the diagnosis, treatment or research purposes.”

Mechanobiology is the opposite and studies the mechanisms by which cells sense and respond to mechanical stimuli. It focuses on how physical forces and changes in the mechanical properties of cells and tissues contribute to development, cell differentiation, physiology, and disease. By understanding how mechanical forces induce changes at the molecular, cellular, and tissue levels, mechanobiology provides insights into tissue physiology, disease development, and relevant therapeutic strategies. This field is leading to advancements in constructing engineered tissues and organs, repairing and regenerating damaged tissue and providing therapy for diseases.

mechanobiology testing guide

Dive into our complete Mechanobiology Testing Guide

This page covers the importance of understanding how cells respond to mechanical stimuli and what testing equipment is needed to perform high-resolution investigations into mechanobiology.

mechanobiology testing guide