This presentation discusses challenges that QC laboratories encounter when testing a variety of medical devices, ranging from stents to catheters to spinal implants. Supporting the full product life cycle, these engineering solutions assist product development, prototype evaluation, manufacturing, and delivery.

1. Challenges in QC Medical Device Testing
Instron® Biomedical Applications & Solutions
September 2014

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Instron® Breadth of Knowledge to Evaluate Biomedical Product Lifecycles
Orthopaedics
•Research of materials for bone and joint replacement
•Implants of all types (fatigue, wear and simulation)
Biomaterials
•Soft and hard native tissues, artificial materials, tissue engineering
•Heavily university and research based
Dentistry
•Restorative and prosthodontic materials
•Implants (fatigue and wear)
Implants
•Stents, heart valves, delivery systems, catheters, guide wires, pacemakers, ocular and auditory implants
Consumables and Equipment
•Hospital and surgical supplies, needles, sutures, tubing, packaging
•Quality control and product development
Pharmaceutical
•Drug delivery systems, tablets, packaging
•Quality control and product development

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Example: Cardiovascular Stents
•Product Development
•Prototype Evaluation
•Manufacturing
•Delivery

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Component Selection & Testing
•Shape Memory Alloys (SMAs) are known for their large recoverable strains and are an ideal material for biomedical applications
•Nitinol (NiTi), the most popular SMA, employed primarily for vascular stents, are studied extensively in tension
•ASTM F2516 requires the materials to be loaded and unloaded in a cyclic test (as shown in the graph to the lower right)
•Solutions:
•Contacting or non-contacting extensometry to measure specimen strain (point to point)
•Digital Image Correlation (DIC) to develop a full field strain map
ASTM F2516 test method for NiTi in tension

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Component Selection & Testing
•Radial compression and relaxation (crimping and uncrimping) of stents using RX fixture as an optional accessories on standard Instron® frames to simulate forces on stents during use
RX fixture is an accessory on Instron frames

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Aortic Heart Valve
Prototype Physiologic Testing
A key factor for medical device success is biologic compatibility and physiologic function.
Instron® bioreactor systems allow R&D teams to evaluate this criteria for new devices and replacement tissues on the bench before initiating expensive animal testing.

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•Fatigue testing
(Simulate 10 years in vivo)
•Tension
•Compression
•Torsion
•Stent testing to match FEA Modeling
•Tension, Torsion, Bending
•Multiple Specimen Testing
•Instron® actively involved in
ASTM F04.30 committee
•Fatigue systems that utilize linear electric technology (versus hydraulic oil) are the preferred solution for medical device labs: no oil, low noise, small footprint
Final Product Durability Testing
E10000 with 12-head accessory for durability testing of stents over millions of cycles

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Final Product Delivery Testing
•Tortuous path represents vasculature
•Usually glass or plastic fixture
•Test stent deployment devices
•Test friction of catheters (coatings) in a physiological environment
•Machine can be used vertical or horizontal
Tortuosity tester with custom grip control accessory to customize pressure (friction) at device opening

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3 Challenges in Biomedical QC Testing
•Standards to follow and what others are doing in the market—what you test today may not be what you test tomorrow
1) Knowing How to Test
•Best practices to ensure a highest level of product quality
2) Ensuring Quality of Results
•Small investments to protect you for the future
3) Regulatory Compliance

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Knowing How to Test
Standards to follow and what others are doing in the market—what you test today may not be what you test tomorrow
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Biomedical Applications: Orthopaedics
Applications & Standards
•Spinal Implants: ASTM F1717
•Intervertebral Discs: ASTM F2346
•Intervertebral Fusion: ASTM F2077
•Hip Replacements: ISO 7208
•Knee Replacements: ISO 14879
•Hip Screws: ASTM F384
Recommended solution for spinal implants testing
Automated tuning wizard optimizes the system for a range of specimen stiffness. This allows for testing anything from hydrogels to bone on the same machine with optimal performance.
Testing Tip

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Biomedical Applications: Dental
•Dental implant fatigue to ISO 14801
•Fixture for testing endosseous dental implants
•2-15 Hz depending on materials
Testing Tip
A 30º angle of the dental implant during testing is considered to simulate the “worse case” scenario of loading conditions.
Testing to ISO 14801 in a BioBath
3- and 4-point bend testing on ceramic implants

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Biomedical Applications: Medical Consumables
•Syringes, needles: ISO 7886-1
•Sutures, staples, catheters: ISO 10334
•Gloves, masks, shields: ASTM D3578, ASTM D3577 ASTM D6319, & ISO 11193
•Bandages, tapes, pads
•Machines (EKG, Glucose, DO, etc.)
ISO 7886-1 specifies test conditions for aspiration and injection of fluids from hypodermic needles
BioBox allows for testing at and above body temperature
Testing Tip
Testing at body temperature vs. room temperature can drastically effect results. See results from our demo lab:

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Biomedical Applications: Pharmaceuticals
•Packaging: ASTM F88, ASTM D882, & ASTM D1894
•Caps for bottles, syringes, vials
•Residual seal force
Mean Max Load
Testing Tip
Testing packaging often requires a fast test and detection of quick events (e.g. first and average peaks). Setting the system data rate and bandwidth appropriately are important.
Different Data Rate and Bandwidth Effect Results

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Biomedical Applications: Biomaterials
•Biological Materials
•Bone, tendons, ligaments, muscles, skin, etc.
•Synthetic Materials to Mimic Biomaterials
•Hydrogels, polymer scaffolds, etc.
Tensile testing tissue with pneumatic grips
Testing Tip
Biomaterials are inherently slippery and difficult to grip. To get a better grip, without damaging the material, add friction. This can be done with surfalloy jaw faces or by simply using sandpaper between the grip faces. Also, using grips that can allow you to modify grip pressure, consistently (like a pneumatic style) can help significantly improve repeatability of results.

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Common Medical Device QC Systems
3300 Series
An affordable line of electromechanical instruments designed to provide Instron quality, reliability, and repeatability at an affordable price.
The premier family of electromechanical instruments designed to deliver superior accuracy and reliability, ergonomics, and upholds the Instron name as the most trusted in mechanical testing.
5900 Series
2300 Series
A family of electromechanical systems designed specially for the quality control industry in China.

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Ensuring Quality of Your Results
Best practices to ensure a highest level of product quality
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Why is this Important?
•Most common issue in global medical device QC labs
•“Why aren’t my results the same?”
•Quality, repeatability & reliability of test results are a MUST
•Multiple test systems in labs
•Multiple labs on site
•Multiple geographical locations of labs
•Multiple products being manufactured
•Challenges?
•Every sample/specimen/application is different
•Every QC lab has unique testing processes & procedures
•Every QC lab has a different set of critical results

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Qualitatively … Sources of Error
Testing Tip
Perform an audit of your lab, equipment ,and operating procedures to see which of these variables could be causing variability in your results!

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Quantitatively … GR&R
•Once you have completed a lab audit you can measure the quality of the results using a GR&R study
•GR&R = Gage Repeatability & Reliability
•Non-destructive testing (typically)
•Can be performed destructively, but BE CAREFUL!
•Used to qualify and/or validate equipment
•“Quantifies” total system error based on three components
•Part variation (PV)
•Equipment variation (EV)
•Appraiser (operator) variation (AV)
•GR&R threshold values (by AIAG)
•R&R < 10% = good (can identify process changes)
•10% < R&R < 30% = okay (can identify part variability)
•R&R > 30% = bad (can’t identify part variability)

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Regulatory Compliance
Small investments to protect you for the future
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Traceability & Data Security
•Instron® has been partnered with Xybion Corporation, experts in FDA compliance, for more than 10 years
•Together, we created ComplianceBuilder™
•Instron Bluehill® 3, WaveMatrix™, and Partner™ Software with ComplianceBuilder allows for 21 CFR § 11 Compliance
All methods & data are secured, with user sign-in and traceability of user, changes & all revisions of data and method files can be restored through the ComplianceBuilder file management system

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How does ComplianceBuilder™ Help?
•Allows use of electronic records; without an electronic file management system – you need to store paper files in a secured location (paper cost, space cost)
•ComplianceBuilder monitors data / methods used for Instron® systems and can produce a simple report to prove traceability for audit (required by FDA)
•Relevant Files: Sample, Method, Raw Data & Report Files
•Relevant Actions: Additions, Modifications & Deletions
•If any change is made to a relevant Instron file, ComplianceBuilder will capture it in a secure database, ready to be retrieved for an FDA audit
•Can use e-signature feature to sign-off on changes and modifications
When a change is made to an Instron sample or method file, the user can log in with a unique ID and password, and also explain the reason for the change; all changes (who, when, what) are captured

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Equipment Validation and Documentation
•21 CFR 820.72: Inspection, measuring, and testing equipment
•This requires IQ/OQ
IQ – Installation Qualification
•Installation Conditions
•Operation & Safety features
•Provided system manuals and documentation
•Environmental conditions
•Appropriate services & utilities
OQ – Operational Qualification
•Validation of correct results
•Transducer validation
•Speed and displacement validation
•Software functionality check
As part of our standard service offerings, Instron® can provide all IQ/OQ documentation needed for IQ/OQ – saving you time and ensuring full compliance with standards.

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THANK YOU FOR YOUR TIME!
Please contact your local
Instron® Sales Representative
with any questions.