Medical Device Engineering Services

Engineering with clinical and regulatory insight.

Navigating the product development path from idea to approved medical device is an exciting journey. The medical device development community can all agree that the ultimate  goal is to put the best device in a physician's hands, so they can treat patients.  We all want to improve a patient's medical treatment; this is both satisfying to our engineers and engrained in our culture. The experience of the MED engineers can help you move your project from one phase to the next, bringing your idea closer to its realization. We’ve learned along the way, the better work you complete on the front end, the greater likelihood of success in later stages of development. We use  first principles of engineering to help move devices through the medical device development process, with the end goal of commercialization in view.

Every medical device needs to be tested to assess its safety. When your project comes into MED, we look at it as a whole. We listen to our clients needs while considering the clinical, scientific, regulatory and engineering perspectives before work begins. MED's experience helps you determine what tests are needed to properly evaluate your device. As we like to say, a good test is worth a thousand words and a bad test can cost many thousands more.

We collaborate with our clients wherever they are in the medical device development process.  Our engineering team has history and experience with upfront feasibility R&D including acceptance criteria development and material level testing, formal verification and validation testing that is needed for global regulatory submissions, and post-market competitor evaluations for claims. Our 13 year history of ISO 17025 accreditation has given us assurance that our efficient and well thought out reports will help you demonstrate how your medical device meets quality and safety standards. Our test reports are accepted by regulatory authorities globally.

We have medical device testing and engineering experience including design controls and validations, testing to support regulatory deficiency question responses, clinical case support and physician training on proper delivery of a wide range of devices. Some areas in which we have experience testing devices include:

• Orthopedics
• Biologics
• Women’s health
• Vascular stents, grafts, wires and other accessories
• IVC filters
• Heart valves
• Urology
• Endoscopy
• Vascular and endovascular grafts

Some of the services we provide

CLINICALLY RELEVANT ACCEPTANCE CRITERIA AND BOUNDARY CONDITION DEVELOPMENT

Defining robust clinically relevant acceptance criteria and boundary conditions can be a significant hurdle in the medical device development process. The clinical environment can be complex and highly variable. We have developed the acceptance criteria and clinical conditions for hundreds of devices in a wide range of clinical environments. Our efforts have helped produce medical devices that successfully stand up to their intended use and the requirements for regulatory approval.

TEST METHOD DEVELOPMENT

Many tests needed to develop a medical device are not currently prescribed in testing standards. In the absence of standardized test methods, it is up to the medical device developer to define and develop the testing methodology that will appropriately challenge the device. We have a robust history of test method development and validation. In fact, many of the tests that we have developed through the years eventually made their way into testing standards and guides. We are actively involved in ASTM and ISO standards and chair several of these efforts. We can help you identify an appropriate test standard or develop a new methodology. For a complete listing of our validated methods you can click here.

Accreditations

  • ISO 17025 Accredited Methods
PHYSIOLOGIC MODEL DEVELOPMENT

Anatomic modeling plays an important role in understanding human anatomy and disease and ultimately how your device performs in worst-case patient populations. Each person is unique, and so are the diseases and disease states that result in morphologic changes within the body. Developing a physiologic model for a diverse patient population to be used for design verification testing is a significant challenge. We can create physiological models that mimic the clinical environment by leveraging cadaveric models, experience of physicians, as well as other sources. These inputs combined with our experience have helped us create clinically relevant models and their associated justifications to evaluate device safety for many customers.

RISK ANALYSIS, RISK MANAGEMENT AND DESIGN CONTROL ENGINEERING

Device requirement generation is a useful and necessary step in the development process. We have experience with risk analysis, creation of user needs, design control file creation, process validation, clinical evaluations and many other activities as identified in ISO 14971 that are required to produce a safe medical device. We can help at any stage you are in with the development of your medical device.

Accreditations

  • ISO 13485 Certification
COMPUTATIONAL MODELING AND SIMULATION

Our highly experienced computational modeling and simulation team can support product development activities as well as regulatory approvals. We can perform finite element analysis, computational fluid dynamics and RF heating simulation related to MRI on a wide range of devices. We are active in research and publication with the ultimate goal of reducing the burden of the medical device approval process.

Some of the tests we perform

MR MEDICAL DEVICE SAFETY TESTING

MED has a dedicated team built around performing MR safety testing for RF heating, displacement force, torque and image artifact as well as crafting the appropriate marking of implantable devices with metallic or radiopaque additives. We can also combine this MR safety testing with MR heating simulations to lower the total cost of testing.

Our scientists are part of the ASTM standard working groups for MR testing and have direct interaction with regulatory bodies on a regular basis to ensure that we’re always informed of new testing requirements. We are also active in publications and research posted here and in our newsroom.

.pdf

MR Comsol Poster view »

.pdf

MR ISMRM Salt Lake City Poster view »

Test Methods

  • ASTM F2052
  • ASTM F2119
  • ASTM F2182
  • ASTM F2213
  • Lab developed medical device testing method MRI-400
DURABILITY/FATIGUE MEDICAL DEVICE TESTING

Durability testing may include pulsatile, flat plate, low- and high-cycle longitudinal, bending, axial, torsional, and custom-designed loading modes. The actual tests that are performed will depend on clinical boundary conditions, such as what kind of movement, strain, and force will be present after the device has been implanted in the body. We also have a dedicated FE team that can help with worst case identification prior to durability testing.

We have substantial fatigue testing experience. For example, in 2014 we put approximately 38,000,000,000 cycles of fatigue on devices across the loading modes listed.

Test Methods

  • ASTM F2477
  • ASTM F2942
  • ASTM F3036
  • ASTM E739
  • ISO 25539 - 1, 2, 3
  • Lab developed medical device testing method FATG-320
  • Lab developed medical device testing method FATG-401
  • Lab developed medical device testing method FATG-500
  • Lab developed medical device testing method FATG-700
  • Lab developed medical device testing method FATG-800
  • Lab developed medical device testing method FATG-900
FAILURE ANALYSIS AND SURFACE CHARACTERIZATION USING SEM INVESTIGATION AND ENERGY DISPERSIVE X-RAY SPECTROMETRY (EDS)

Sometimes you need to know what is going on with your medical device on the microscopic level. We have the tools to analyze metallic and nonmetallic devices. Some examples of our past work include manufacturing-process-improvement analysis, surface analysis, contamination analysis, fracture analysis, contact angle measurement and more.

Test Methods

  • Lab developed medical device testing method MED-007
PHYSICAL BENCH MEASUREMENTS AND EXAMINATION

Many minimally invasive devices are deployed with fluoroscopic guidance. We use fluoroscopy to simulate clinical procedures in a wide range of representative anatomies. We have two fluoroscopic suites available for simulated-use testing, and the tests can be viewed remotely through live broadcast.

Test Methods

  • ISO 5084
  • ASTM D1777
  • ISO 7198
  • ISO 25539 - 1, 2, 3
  • Lab Developed Medical Device Testing Method MED-007
  • Lab Developed Medical Device Testing Method MEAS-825
  • Lab Developed Medical Device Testing Method MEAS-829
  • Lab Developed Medical Device Testing Method MEAS-830
  • Lab Developed Medical Device Testing Method MEAS-832
RADIAL FORCE TESTING

Understanding the chronic outward force is useful for many medical devices. We can run the sling method as well as 0.5-55 mm in our MSI iris radial force testers. These testing techniques have been used to characterize almost any medical device that you can think of (stainless and superelastic stents, absorbable stents and devices, consumer products, and women’s health, for example). The tests are performed under conditions that are similar to clinical conditions and can be very valuable for design and regulatory approval.

Test Methods

  • ASTM 3067
  • ISO 25539 - 1, 2, 3
  • Lab developed medical device testing method RF-300
ELECTROCHEMICAL CORROSION TESTING

Corrosion resistance is an important attribute to evaluate for your medical device. Understanding the appropriate solution, method and acceptance criteria is also very important. Our team has run thousands of experiments and is prepared to run thousands more. We have gained an understanding of the accelerated comparison of the corrosion properties of metallic implants with that of the in vivo environment and have presented at SMST and are currently publishing some of our research on nitinol. A strong understanding of electrochemical corrosion is very important to demonstrate that medical devices correctly meet regulatory and safety standards.

MED Institute is actively involved in ASTM Standards committees and in reviewing publications that describe proper testing techniques and acceptance criteria. The research we have completed has been cited and discussed by governments around the world in their efforts to set standards for testing requirements.

Test Methods

  • ASTM F2129
  • ASTM F3044
  • ASTM G59
  • ASTM G71
  • Lab developed medical device testing method ECOR-001
IMMERSION CORROSION TESTING

Real-time or accelerated immersion tests are an alternative to electrochemical corrosion tests. We have experience in simulating most body fluids and testing durations. We have run several long term immersion corrosion cycling studies evaluating the digestion process. Additionally, we have built custom anatomical models to simulate various aspects of immersion corrosion.

Test Methods

  • ASTM F1980
  • ASTM F1089
  • ASTM G31
  • ISO 10555
  • ISO 11070
  • Lab developed medical device testing method ACOR-716
TENSILE AND COMPRESSION TESTING

Tensile testing is very important and setting relevant criteria around your medical device can be challenging. We frequently perform the full spectrum of tensile testing from raw materials for finite element (FE) inputs to final device subassembly testing. This has given us a complete understanding of the complexity that can occur during what is often seen as a simple bond strength test. Other tests that are commonly performed as part of a vascular device testing regimen: a determination of circumferential and longitudinal tensile strength of a textile, separation force for modular components, a measure of migration resistance, and a measure of the strength of a stent or an attachment system to a graft.

Test Methods

  • ISO 10555
  • Lab developed medical device testing method PULT-210
  • ISO 25539 - 1, 2, 3
  • BS EN 1615
  • BS EN 1617
  • BS EN 1618
  • ASTM E8/E8M
  • JIST 3213
  • JIST 3247
  • ASTM D412
  • ISO 7198
  • ISO 11070
  • Lab Developed Medical Device Testing Method PULT-204
CRUSH RESISTANCE AND LOCAL COMPRESSION

These tests use a wide range of testing techniques to characterize crush resistance and local compression for almost any device (stainless, superelastic, or absorbable) under multiple loading modes. The tests are performed in an environment that is representative of the clinical environment.

Test Methods

  • ASTM F2606
  • ISO 25539 - 1, 2, 3
  • Lab developed medical device testing method COMP-220
  • ASTM E9
  • ASTM D695
TORQUE

During clinical procedures, the delivery systems of most devices must withstand the torque from operational use. MED has worked with devices in a number of clinical specialties and clinical environments and understands the different torque requirements of various materials and uses.

Test Methods

  • ASTM A938
  • Lab developed medical device testing method TORQ-553
  • ISO 25539 - 1, 2, 3
PARTICULATE MATTER COUNTING, SIZING AND IDENTIFICATION

MED’s testing regimen for medical devices that require particulate testing has been designed to collect and measure particulates that are released from devices during simulated deployment and tracking under multiple fatigue models. Following particulate counting and sizing we have the capability to identify the particle composition using our FTIR and microscopes.

Test Methods

  • ASTM F2734
  • ASTM F2942
  • Lab Developed Medical Device Testing Method PART-02
  • Lab Developed Medical Device Testing Method PART-03
  • Lab Developed Medical Device Testing Method PART-04
  • Lab Developed Medical Device Testing Method PART-05
SIMULATIVE USE (FLOUOROSCOPY, ULTRASOUND, MR)

Many minimally invasive devices are deployed with fluoroscopic guidance, others are delivered under ultrasound and some are even delivered with MR guidance. We use these tools to simulate clinical procedures in a wide range of representative anatomies. We have two fluoroscopic suites, an ultrasound tower, and 1.5 T and 3.0 T magnets that are all available for simulated-use testing. If you cannot make it to West Lafayette Indiana to see your medical device tested, we have live broadcast capabilities that have been shown around the world, much like you would see at a live case at a major medical meeting.

Test Methods

  • ASTM F640
  • ASTM F2079
  • ASTM 2081
  • ISO 25539 - 1, 2, 3
  • Lab Developed Medical Device Testing Method RAD-01
  • Lab Developed Medical Device Testing Method SIM-01
ELECTROSURGICAL ACCESSORY TESTING

We offer a full complement of electrosurgical accessory testing options that include a high- and low-frequency breakdown of handles and active electrodes. Testing also includes leakage, simulative use, and fatigue testing.

Test Methods

  • IEC 60601-2-2
  • IEC 60601-2-18
  • Lab Developed Medical Device Testing Method ECT-491
CLINICALLY RELEVANT PRESSURE AND FLOW TESTING

This test category is diverse and interesting. We use clinically relevant means of generating pressures and flow rates to characterize a medical device for labeling purposes or to compare to a specified acceptance criterion. Other tests in this category include integral water permeability, water entry pressure, flow rate characterization, leakage testing, and deployment under physiologically relevant pulsation.

Test Methods

  • ISO 10555
  • ISO 7198
  • ISO 25539-3
  • ASTM F1828
  • ANSI/AAMI VP20
  • Lab Developed Medical Device Testing Method PRES-01
  • Lab Developed Medical Device Testing Method FLOW-302
  • Lab Developed Medical Device Testing Method FLOW-100
  • Lab Developed Medical Device Testing Method PRES-307
SECUREMENT TESTING

Devices that are mounted on balloons need to remain secure until the devices reach the intended target location. Determining the appropriate securement forces and then testing your medical devices in a repeatable manner is a very challenging endeavor. MED has done this before and has the methods and models for the majority of the vascular system (both arterial and venous) and has created a nearly complete model of the legs and aorta. We also have the ability to create unique models for different anatomical areas.

Test Methods

  • ASTM F2394
  • Lab developed medical device testing method MEAS-100
PHYSIOLOGICAL MODELS AND BOUNDARY CONDITIONS TESTING

Anatomic modeling can play an important role in defining the stages of human anatomy and disease. Each of us is unique, and so are the diseases and disease states that inflict morphologic changes upon us. We have created physiological models that mimic the clinical experience of physicians using medical devices on patients. Our clinical research, cadaveric testing experience, and input from physicians help us create clinically relevant models and boundary conditions to evaluate device safety. These models can be used to facilitate physician feedback on product usability, to collect imaging, and to verify product design.

RADIOPACITY TESTING

Radiopacity testing is often a design input for device design control documentation. MED uses various x-ray modalities to characterize the possible range of a device’s radiopacity.

MED’s teams are actively helping to set international standards for testing radiopacity.

Test Methods

  • ASTM F640
  • Lab developed medical device testing method RAD-01
ABRASION TESTING

Physiologically, abrasion of a medical device is a potential failure mode for some long term implants. Understanding the clinically relevant motions and how to successfully test for abrasion on the bench is one of our capabilities.

Test Methods

  • ASTM D4966
  • ISO 12947-1
  • ISO 12947-3
  • Lab Developed Medical Device Testing Method MART-100
YARN TESTING

Characterizing raw materials and building master files are of interest for many medical device OEM's. Yarn testing is one example of where we have devoted specific capabilities.

Testing Methods

  • ASTM D2259
  • ASTM D1907
  • ASTM D2256
  • ASTM D2259
  • ASTM D1779
  • ASTM D1423
  • Lab Developed Medical Device Testing Method Yarn-100

For more detailed information, please contact:

Justin Metcalf
Director of Engineering Services
Justin Renfrow
Director of Business Operations