Medical Device Testing Services
Medical Device Testing Services
 

FAQ

Frequently Asked Questions 

What types of test services do you provide?

We specialize in durability and fatigue testing of medical devices and components. This includes:

  • Radial fatigue of stents and stent-like devices
  • Axial fatigue of device components such as stent struts, pacemaker leads and other structural devices
  • Axial fatigue of orthopaedic implants and components such as bone screws, dental implants, spinal disks, spinal fusion, finger joints, jaw joints, hips and knees
  • Multi-axis fatigue including axial-torsion and orthogonal two axes testing
  • Static mechanical tests including tension, compression, torsion, and bending
  • Corrosion testing
  • Particle analysis during acute deployment and fatigue
  • Leaching testing combined with fatigue
  • SEM inspections and more.

We are adding to our test services on a continuing basis.  If you don’t see your application listed in the test services section, please contact us. There is a good chance we have already done it.

Are you ISO accredited, A2LA accredited, and GLP Compliant?

Yes. Medical Device Testing Services is ISO/IEC 17025 accredited by A2LA, one of the most stringent independent audit committees offering this accreditation. Through our ISO 17025 accreditation, all of our testing is in compliance with GLP. In fact, ISO accreditation (not to be confused with ISO 17025 compliance which does not require regular audits) guarantees greater security in accuracy of data and results. Our reports are widely accepted for regulatory agency submission with the FDA, CE, ASTM, and ISO. We maintain a full-time quality manager on staff. Quality Audits are done every two years. Our last audit was done in April 2015. Please see our quality page for more information. An audit report summary is available upon request.

Is A2LA a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA)?

Yes. An accreditation body's acceptance into the ILAC MRA is dependent upon their being successfully evaluated by peers from other accreditation bodies in accordance with relevant rules and procedures contained in ILAC publications. Each accreditation body that is a signatory to the ILAC MRA commits to:

  • Maintaining conformity with the current version of ISO/IEC 17011 Conformity Assessment – General Requirements for bodies providing assessment and accreditation of conformity assessment bodies and supplementary documents
  • Ensuring that all organizations that are accredited comply with appropriate standards (e.g. ISO/IEC 17025 General Requirements for the competence of testing and calibration laboratories, ISO/IEC 17065 Requirements for bodies certifying products, process and services)
When can I start testing once I contact you? I need the data yesterday!

Once you have made the decision to test with us we can provide you with a start date. The pacing item is typically the test fixturing. If we have the test fixturing on the shelf, we can get started very quickly. If we need to fabricate fixturing, the lead time is longer, typically 3 to 4 weeks. For stent tests, the pacing item is fabrication of the mock arteries, which usually requires 2 to 4 weeks. Often customers will provide us with a separate purchase order to fabricate the mock arteries in advance of the testing purchase order. This way, we can move quickly once we have received the purchase order. If you have a short term (1 or 2 day) feasibility test, we can usually accommodate your schedule within 1 week once we have your test protocol. We have a variety of standard test protocols that can be used or modified to expedite this.

How long will the test take?

The run time is dependent on the cycle count and test frequency. For orthopedic and intravascular tests, the 10 year equivalent cycle counts are 10 million and 380 million respectively. For orthopedic tests, the frequency ranges from 2 to 15 Hz. For intravascular tests the frequency ranges from 25 to 60+ Hz and is dependent on the device diameter and length. The test duration is calculated by dividing the desired test cycles by the number of cycles the tester can perform in a day. For example, a spinal disk test performed at 2 Hz for 10 million cycles will take about 58 days. A stent test performed at 60 Hz for 380 million cycles can be completed in about 73 days.

I would like to visit your facilities to help set up the test. Can I do so?

Please do. We want to make sure you have as much visibility and control over the test as you desire. Your involvement can range from working side by side with us to communicating with us solely through email.

Can you offer protocols for testing?

Yes. In many cases, we have standard protocols that can be used or modified to meet your needs. We have standard protocols for both intravascular and orthopedic tests and can point you to FDA guidance documents explaining the protocol foundation.

How many different device sizes can you include in one radial force test?

Typically, we test only one size device per test instrument because the mock artery response changes with different diameter devices. In some instances we have been able to combine different designs that are the same diameter. Please contact us for more information.

Can you perform postdilation on overlapped bent stents?

Yes, we perform postdilation on overlapped bent stents frequently. Note: we deploy the device in a straight tube and then bend the tube into the testing configuration in order to more accurately deploy the devices and to make it easier to insert the second device and larger balloon.

What type of particle shedding analysis can you provide?

We place the device in a flow loop and capture particles from each mock artery on a filter dedicated to that mock artery. Each mock artery has its own flow loop which ensures that the particles captured from the filter originated only from that device. This approach compares quite favorably against other offerings which use a common flow loop and in-line counters on only a few of the mock arteries.

At the completion of each test the filters are placed within our Aspex 3025 Scanning Electron Microscope. Using that instrument’s Automated Feature Analysis (AFA) Software and Energy Dispersive X-Ray Spectrometer (EDS) we are able to capture individual photos of each particle and tell you its morphology (size and length/width ratio) and material make-up. We also provide counts of the particles in the 10-25, 25-50 and 50+ micron bin range. The individual photo capture, particle morphology and EDS material make-up are not available from other service providers. Click here to learn more about our particle shedding analysis.

How do you handle customer data and product confidentiality?

Protecting our customer’s confidential information is of utmost importance to us. Our ISO Certified A2LA Accredited Quality Policy has strict procedures for ensuring the confidentiality of our customer’s products and tests. For example, all test samples received by MDT are assigned a Customer Supplied Product (CSP) number which becomes the only identifier for them while they are in the building. They are subsequently stored in locked cabinets that are only accessible by MDT employees. They are returned to the customer at the completion of a test. Similarly, before a test is started in the lab, a project number is assigned to it. Any documents associated with that job are referenced only by the project number. This means there is no means by which visitors could identify that a particular test is for a particular customer.

Further precautions are also taken to prevent nonessential personnel or visitors from seeing the specifics of any test. Visitors are not allowed to enter the lab unless they are escorted by an MDT employee. Additionally, test systems are draped or covered during the test run time. Photos or videos are strictly forbidden and cell phones must remain outside the test lab. If photos or videos are requested by a customer as part of a test system protocol they must be cleared by the Operations Manager and performed either by the MDT project engineer or under the direct supervision of the project engineer.

For those customers that desire their own test space, we offer a private locked room for the customer’s exclusive use. Arrangements for a private room should be made in advance of the test start so that the room can be equipped with the necessary test equipment.

What is your pricing structure?

Our services are priced based on a daily rental fee. Each instrument has a short term (generally 20 days or less) and long term rental rate. The rental rate covers daily monitoring and inspection (on a schedule defined by you). Test set-up and engineering labor rates are priced separately and variable based on the test protocol. Inspections requiring a digital endoscope or high speed video camera are optional and can be used to enhance the value of your test. The prices for additional inspection equipment is also based on the test protocol. An estimate can be provided after a free engineering consultation.

In our over 25 years of business offering device testing services to the biomedical community, we have strived to offer the best value to our customers by providing high quality data at affordable and competitive prices while pursuing strong relationships with our customers.  Our customers range from small start-ups to Fortune 100 companies. When we work with customers we strive to be cost conscious because we understand that they have the option of working with another test lab or in procuring the equipment and performing the testing themselves. At the end of the day our hope is that the customer recognizes MDT’s value proposition…  that in addition to latest generation test equipment and test fixtures, our in-depth experience enables us to provide valuable insights that will ensure reliable, accurate data for internal or regulatory submissions in the shortest turn-around time in the industry.

My testing requires custom fixturing and/or protocol development. How expensive is that going to be?

We make custom testing affordable because we can rely on pre-existing designs and expertise to create what you need for your particular testing application. In fact, over 50% of the projects we work on have some custom content. We have a large inventory of test fixtures but if you require something we don't have on hand we will do our best to work within your budget and meet your testing needs.

Why should I choose MDT over another testing house?

We pride ourselves in being considered the gold standard in fatigue testing and have spent over 25 years building a strong reputation in the industry. We utilize the Bose ElectroForce 9100s for radial fatigue which features a twin pump design to provide the highest testing frequencies possible. We also have a large inventory of Bose and Instron electrically powered axial and axial torsion test systems. For higher force work we use MTS Bionix servohydraulic systems. These instruments are ideally designed for the rigors of high cycle fatigue testing. Our in-house machining capability enables us to provide rapid turnaround on instrument modifications and test fixture fabrication. We would be happy to provide you customer references as well as a free consultation.

My device type and test type are not mentioned on your website.  Should I contact you?

Absolutely. Our website highlights only a subset of our testing capabilities. We have performed testing on hundreds of different device designs requiring specialized fixturing. It would be very unusual if we did not have prior experience for handling your device. Since we were incorporated in 1990 we have continued to expand our testing portfolio and are confident in performing even the most complex tests that most other labs cannot perform. Sometimes additional costs will apply in terms of test setup or customization, but we have yet to turn away a customer due to a lack of know-how. Our in-house machining capability allows us to build and/or modify one of our existing fixture designs. This provides for a quick turn-around time.

I would like you to use one or more of our own instruments for the testing. Is that possible?

Our experienced staff has the ability to use customer-provided instruments for testing as needed. Please contact us for more details.

I am looking for a partner beyond routine contract testing. Are you a good fit?

Our company's origins are in the research and development of novel test instruments and control systems. Our co-founder and CEO, Kent Vilendrer, is involved in R&D projects on an ongoing basis. We are open to partnership opportunities.