Mechanical Testing of Biomedical Products


BIOMEDICAL TESTING

Testing Solutions for Medical Devices, Pharmaceuticals, Packaging, Biomaterials, and More

Instron brings a wealth of knowledge to the biomedical industry, serving as a strategic partner to companies of all sizes. Our equipment and services are primed to help you investigate new technologies and ensure product quality, all while maintaining the highest levels of data integrity and security. Being embedded in the biomedical industry for over 75 years, the technological, regulatory, and manufacturing challenges facing our customers have driven us to develop products and services to address their needs. These developments include specialized fixturing, compliant software, and automation capabilities. Our most valuable asset is our extensive customer network, which represents a wide range of medical device and pharmaceutical manufacturers, CDMO’s, universities, test houses, and startups.

Supporting Innovation

Our customers are on the forefront of medical technological innovation, working to improve patient outcomes by developing new and better products. These companies are increasing the efficacy of minimally invasive treatments, developing the next generation of wearable sensors, and reimagining a future where surgical robots are commonplace in the operating room. In each case, Instron has helped build a robust mechanical testing program able to meet the requirements and overcome the hurdles of each step of the product development process.

Testing Systems







APPLICATION FOCUSED SOLUTIONS
Testing Systems and Extensive Fixturing Options

The range of biomedical applications spans a vast array of therapeutic areas, bringing with it an extremely broad range of testing requirements. Various fixturing arrangements must be added to a universal testing system to properly hold or manipulate the test specimens and attain the necessary results. In many cases, international standards such as ISO or ASTM drive the ultimate design of these fixtures. Alternatively, many are custom designed specifically to the customer's device specifications. Our experience within the industry has helped create a catalog of grips and fixtures to accommodate the most common devices and meet the most frequently used standards. Our Engineered Solution Group is available to work with you to develop fixtures specific to your needs.

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Syringe Fixture



FIND YOUR APPLICATION






Adhesive Peel Test
TRENDING APPLICATION
WEARABLE DEVICE TESTING

Trends in wearable technology follow those of the broader biomedical and electronics industries – devices are getting smaller, smarter, and easier to use. Wearables in healthcare have moved toward solutions that reduce the device profile, provide more integration with smartphone apps, and most importantly enable patients to receive their treatments at home instead of in a doctor's office. As this trend continues, manufacturers are working to develop robust test methods to mechanically evaluate all aspects of these devices and ensure they are performing as expected. In addition to testing the injection device components, manufacturers also face challenges in evaluating and selecting the adhesives for these products.









DRUG DELIVERY DEVICE AND CONTAINER TESTING


The pharmaceutical industry relies on mechanical testing to evaluate drug delivery systems and their associated packaging. Drug delivery systems can utilize dermal, subcutaneous, intramuscular, oral, or nasal routes and come in a variety of different packaging formats. Universal testing systems are used throughout the product development process to help identify suitable materials, evaluate delivery mechanisms, perform design validation, validate manufacturing processes, and enable proper QC measures. The most common applications are related to needle based injection systems and involve either functional testing based on industry standards such as ISO 11040 and ISO 11608 or usability testing of products to supplement human factor testing.

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MEDICAL CONSUMABLES AND PACKAGING TESTING


Medical consumables represent the largest subsection of biomedical testing and include a wide variety of single-use products such as surgical tools, PPE, wound closure products, specimen collection products, and more. These products are typically either FDA class I or II medical devices, which, despite having less stringent test requirements, are produced in such large quantities that care must be taken to accommodate high volume testing. To compensate for the larger volumes, throughput and repeatability become critical test requirements, addressed through specialized fixturing, efficient operator workflows, and intuitive software.











CARDIOVASCULAR AND INTERVENTIONAL DEVICE TESTING


For both diagnostic and therapeutic purposes, the market for interventional vascular devices has grown exponentially. Products such as guidewires and catheters are essential for the mapping of vasculature, removal of blockages, and placement of stents or implants. Assessing the material and coating properties of these products is essential for ensuring they will perform as expected in vivo. Testing in vitro can also be accomplished using turnkey systems built to mimic real world conditions with anatomical models, measuring the forces related to the deployment and removal of these devices. Implanted devices such as replacement valves and stents are also tested for long term durability using dynamic systems to validate the long terms responses of these products to body conditions.











BIOMATERIALS TESTING


Biomaterials include the materials found in nature, the human body, and other animal species. These materials can be hard tissues such as bone or dental enamel or soft, such as tendons and ligaments. Biological variation and environmental factors affect the mechanical properties of these materials. They are also anisotropic and nonhomogeneous, making them challenging materials to re-create or engineer outside of nature.











ORTHOPEDIC IMPLANT TESTING


Orthopedic implants are implants that support the skeletal system. These include bone screws, plates, rods and pins for fracture repair, as well as entire artificial hips, knees, and spinal components. Orthopedic implants can be temporarily inserted into the body to assists a patient’s healing, or can be inserted into the body with the intent that the implant will outlive the patient. Depending on their use, orthopedic implants are typically considered to be Class II or Class III medical devices by the FDA and require a range and combination of static and fatigue mechanical testing.











DENTAL DEVICE TESTING


Dental materials are typically composed of metal, elastomers, and polymers. Restorative and prosthodontic devices are often composed of multiple materials that require mechanical testing to determine how these materials interact to form the finished device. A dental implant is a metal post, typically titanium, that replaces the patient’s entire tooth. Fatigue testing represents the most common form of mechanical testing performed on dental implants, following international standards to evaluate the expected wear of repeated use.










DATA INTEGRITY AND VALIDATION

The concept of data integrity is foundational to the manufacturing of biomedical products and drives the quality programs that ensure product safety. Globally, there are numerous regulatory frameworks that aim to define what data integrity is and how it should be ensured, whether dictated by the FDA, GMP, or other national or international bodies.


Materials Testing Lab

Regulatory Compliance

Within the biomedical industry there are both national and international regulatory bodies defining the protocols necessary to ensure that patient safety is at the center of product development and manufacturing. Organizations like the FDA and EU MDR demand stringent quality control and data integrity processes. Our suite of software and service products enable customers to better maintain compliance for their mechanical test programs.

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IQOQ Validation Services

Our field service teams provide validation and documentation services to support IQOQ processes designed to ensure that your Instron testing equipment performs to its intended purposes and produces valid results per 21 CFR 820.72 and ISO 13845. At the conclusion of our services we provide a Completion Certificate for Installation and Operational Qualification that will be signed by the Instron Field Service Engineer who performed the validations.

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Bluehill Central

Bluehill Central

Bluehill Central software is a laboratory management tool that enables centralized, remote management of Bluehill Universal software applications associated with multiple Instron test frames. The software allows you to remotely manage all Bluehill Universal users, test templates, results, file revision approvals, and audit trail data from multiple Instron systems.

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Traceability

Bluehill Universal’s Traceability Module enables users to meet the audit requirements associated with FDA 21 CFR Part 11 as well as those of ISO 17025, Nadcap, and other regulatory bodies. Through seamless integration of electronic approvals, revision history, and an automated audit trail, this powerful add-on combines with Bluehill’s built-in security to provide unmatched data traceability.

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CT6 Cobot Testing System




ACCELERATING GROWTH THROUGH AUTOMATION

Automation represents an opportunity for growth across a range of applications and throughout the entire product development process. In small and mid volume QC labs, the pains of operator turnover and hiring difficulties are driving the adoption of automation technology such as cobots and XY stages to improve lab efficiency. Even within R&D or device verification labs, automation can ensure that test engineers and other skilled employees are able to focus their time on value added activities rather than manual testing. As companies move to device production, achieving full in-line mechanical testing is a critical lever for improving manufacturing process control and reducing material waste or faulty products. Each instance of adding automation has the potential to improve lab efficiency, reduce variability, and simplify test procedures.

Go To Automation





RECOMMENDED TESTING SYSTEMS


Universal Testing Systems

Commonly used to perform tensile, compression, peel, and bend tests on medical devices, packaging, pharmaceuticals, and biomaterials.

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ElectroPuls E3000 with Pneumatic Grips

Dynamic & Fatigue Testing Systems

ElectroPuls systems provide an exceptional range of all-electric testing capability, for both dynamic and static tests on materials and components.

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Biaxial Testing of Luer Lock with Torsion Add-On

Torsion Add-On (Biaxial)

Commonly used to reduce product development time and simulate real-world applications of products such as Luer Locks and bone screws.

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Residual Seal Force Testing with AT2 Automated XY Stage

AT2 Automated XY Stage for Universal Testing Systems

The automated XY system can perform compression, flex, or tension tests on multiple components or multiple locations on a single device within a single test setup for improved testing efficiency.

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Automated XY Stage for ElectroPuls Testing Systems

Automated XY Stage for ElectroPuls® Systems

Designed for device durability testing, the Automated XY Stage for ElectroPuls systems provides a simplified testing environment for repetitive or multi-specimen and multi-location methods.

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Auto-Injector Testing System

Auto-Injector
Testing System

The auto-injector test system allows you to perform a variety of tests on pen and auto-injectors to ISO 11608-5 and allows for all required testing to be carried out in a single test method.

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ElectroPuls 16 Station Stent Testing System

ElectroPuls 16-Station
Testing System

Commonly used for in vitro testing of vascular stent components, the ElectroPuls 16-Station testing system performs very high cycle fatigue testing on up to 16 specimens simultaneously, with a fatigue rated load cell and precision adjustment for each.

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Curved Needle Testing System

Curved Needle
Testing System

The curved needle puncture testing fixture is used to evaluate needle sharpness and insertion force; the needle bend testing fixture is used to evaluate flexural properties of the needle during use.
 

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Impact Drop Tower Testing System

Drop Weight Impact
Testing System

Designed for determining impact performance characteristics, our drop weight impact testing systems provide a simplified testing environment whether you are testing specimens or final products.
 

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