Materials Characterization

Evaluating The Impact of Change with Chemical Characterization

Analyst performing FTIR Test to identify residuals

Analyst performing FTIR Test to identify residuals.

When dealing with orthopedic medical devices, even small changes in the manufacturing process or device materials can impact patient safety. With these changes comes the risk of introducing new compounds that may leave residue on the device or leach harmful compounds that put the patient at risk. Because of the high patient risk, the biocompatibility of the device must be re-evaluated after any change.

The most thorough method to determine the effect of a change is to repeat the biocompatibility tests that were performed in the original submission to bring the device to market. However, this can be costly and time-intensive. One alternative is chemical characterization testing. Chemical characterization test methods characterize the device materials and determine the compounds that may leach or extract from the device. Chemical characterization, combined with specific biocompatibility tests, is a more cost effective and efficient way to evaluate the impact of a change in the manufacture of a device.

Common changes orthopedic device manufacturers encounter are generally outside of their control. These changes include alterations to the device material or vendor supply. Internal changes are also implemented to improve the device or the manufacturing process which can impact the biocompatibility of the device.

When a change occurs, the manufacturer must evaluate the impact of the change on the device as a whole. A few key characteristics of evaluating change include:

  • Evaluate any new material or compounds that could be introduced to the patient as a result of that change.
  • Evaluate how much the change affects the patient contacting portion of the device.
  • If the affected portion of the device does not have direct patient contact there may be less testing required than a change that would affect the direct patient contacting surface areas of the device.
  • If a processing change has occurred, evaluate whether or not the new process removes residuals as effectively as the original process.

Because every orthopedic device is unique, there are many ways to assess the impact of a change. The potential impact to the patient must be evaluated with any change and chemical characterization is one way manufactures can evaluate that change.

Chemical characterization testing is most effective when the original device configuration is compared to the device after a change has occurred. If the characterization of the two devices is shown to be similar, fewer biocompatibility tests may need to be repeated. A test plan, along with a risk assessment, is the most successful approach to take when evaluating the impact of a change to the overall biocompatibility and patient safety of a device.

For more information on using chemical characterization to evaluate changes in medical device manufacturing we recommend Thor Rollins’ and Alexa Tatarian’s ODT Magazine article, “How to Approach Change in Orthopedic Device Manufacturing,” as well as their complimentary on-demand webinar, “The Power of Chemical Characterization to Assess Changes.” You may also visit Nelson Labs online at for more information about our biocompatibility testing laboratory services.

BIOMEDevice San Jose Focus On Biocompatibility

BIOMEDevice San Jose - Biocompatibility Training InvitationPlanning your BIOMEDevice conference schedule? Be sure to leave room for Nelson Laboratories, Inc. Nelson Labs will be offering a full schedule of biocompatibility focused lectures at BIOMEDevice San Jose, December 3 – 4, 2014, while also exhibiting in booth #321.

Bob Michaels’ recent Medical Product Manufacturing News (MPMN) Q&A interview with Nelson Laboratories’ biocompatibility expert, Thor Rollins, provides a sneak peek preview of the topics to be discussed in Rollins’ upcoming BIOMEDevice lectures. The following are excerpts from Mr. Michaels’ article, What Types of Biocompatibility Testing Do You Need To Perform? Visit to read the complete interview.

MPMN: Please go into ISO 10993-1 and why cytotoxicity testing is used for screening medical device materials.

Rollins: Cytotoxicity testing is used for screening materials because it is sensitive. In the body, body systems help protect against cytotoxins, protect the cells to wash away any pH imbalances, or even deal with some of the concentration issues or pressures that the cells cannot handle by themselves. Thus, to determine the potential impact of cytotoxicity testing, we take the device and put it right on the cells and then bombard the cells with pH, particulates, and osmotic issues. Thus, during testing, cells are subjected to substances that may not exhibit toxicity in the patient or that could only have a toxic effect if they are present in the body in large quantities. …

MPMN: How should a medical device manufacturer decide which tests are most appropriate for a given device?

Rollins: This is the $1 million question for most of the tests that we perform. …
The amount of data required about a material and the depth of the investigation depends on the intended use of the device and the processes used to manufacture it, in addition to its function and how long it will have contact with the patient. Thus, if you have knowledge of the materials that were used to make the device and data about the potential leachable compounds, this information can be used together with a biological safety evaluation to help pool which types of testing are necessary. In other words, you take the history of the history, the processing methods used to create it, and some chemistry analysis and then evaluate all of these endpoints to help decide which testing should be performed to show that the device is safe. Thus, instead of using ISO 10993-1 as a series of checkboxes, you approach the safety assessment of the device scientifically based on several factors.

Each of Thor Rollins’ BIOMEDevice lectures is slated to focus on a different aspect of the swiftly evolving biocompatibility testing landscape, providing MedTech professionals the knowledge they need to navigate the challenges inherent in contemporary biocompatibility testing. Mark your calendar for Thor Rollins’ three Tech Theater presentations Wednesday December 3rd, and register for his Conference Presentation Thursday December 4th. To learn more visit

Half-Day BIOMEDevice Biocompatibility Lecture Series:
Wednesday December 3, 2014

  • 12:30 pm – 1:15 pm: Rethinking The Big Three: Cytotoxicity, Sensitization, & Irritation
  • 1:30 pm – 2:15 pm: The Power of Chemical Characterization to Assess Changes in Your Medical Device
  • 2:30 pm – 3:15 pm: How the New FDA Guidance on ISO 10993 Could Affect You

Biocompatibility Conference Training (BIOMEDevice registration required):
Thursday December 4, 2014

  • 2:45 pm -4:00 pm: Material Selection and Sampling Techniques for Biocompatibility ISO 10993

Biocompatibility Advancements To Be Showcased At MD&M Minneapolis ǀ Nelson Laboratories

In the midst of an evolving biocompatibility testing and regulatory environment, MedTech professionals face the challenge of staying informed of biocompatibility testing and regulatory trends. Intended to provide MedTech professionals the knowledge and expertise to navigate the challenges inherent in contemporary biocompatibility testing, the upcoming MD&M Minneapolis tradeshow is slated to offer four lectures by Nelson Laboratories biocompatibility expert Thor Rollins.

“Right now we have a very exciting, dynamic, and sometimes challenging biocompatibility testing landscape. I have been on the ISO Committee for almost 12 years and we have never seen as much development in the 10993 standards as we have in the last several years.” Rollins said. “We are in what I would consider the new age of biocompatibility testing.”

Biocompatibility test methods and regulatory behavior have changed dramatically over the last four years. While the future of biocompatibility testing hints at faster, more accurate, cost effective test methods, the contemporary regulatory environment has become increasingly complex. Changes to the ISO standard and diverse regulatory interpretation and application means that merely establishing a testing scheme will be wrought with challenges. According to Rollins, it is not uncommon for regulators to request additional testing beyond the scope of the current ISO 10993 standard. It is these unforeseen complexities that make understanding current biocompatibility testing trends so important for MedTech professionals.

Courtesy of Nelson Laboratories, Thor will be presenting four consecutive biocompatibility testing and compliance focused lectures beginning Thursday October 30th at 10:30 am central time.

MD&M Minneapolis tradeshow participants will be given complimentary access to Mr. Rollins’ three Tech Theater presentations which will include discussion of the Big Three, the power of chemical characterization, and how the new FDA ISO 10993 guidance could affect you.

Thor’s final presentation will focus on the latest FDA trends in biocompatibility testing for cardiovascular devices. This is a conference presentation scheduled to begin Thursday October 30th at 2:45pm. Registration is required.

Half-Day MD&M Biocompatibility Lecture Series:

The Big Three: Cytotoxicity, Sensitization, & Irritation
10:30 am – 11:15 am, October 30th

The Power of Chemical Characterization to Assess Changes in Your Medical Device
11:30 am – 12:15 pm, October 30th

How the New FDA Guidance on ISO 10993 Could Affect You
12:30 pm – 1:15 pm, October 30th

Hemocompatibility and the FDA: The Latest Trends From The FDA
2:45 pm – 4:00 pm, October 30th
Requires MD&M Minneapolis registration. CLICK HERE to register.

Click here to learn more about Thor Rollins MD&M Lecture Series! 

Nelson Laboratories On Demand Webinar: The Power of Chemical Characterization to Assess Changes in Your Medical Device

Nelson Laboratories Cytotoxicity Testing, Biocompatibility Testing

Click Here To Watch Nelson Laboratories’ On Demand Webinar

“Every change will have a different biocompatibility impact depending on the type of variable being introduced or taken away from the medical device.”
– Alexa Tatarian, Nelson Laboratories, Inc. Study Director

Join Nelson Laboratories’ biocompatibility expert Thor Rollins and Study Director Alexa Tatarian for on demand webinar The Power of Chemical Characterization to Assess Changes in Your Medical Device. While initial instinct may compel device manufactures to perform a costly re-test when alterations are made, this webinar highlights chemical characterization, a cost effective limited scope alternative for evaluating the impact of change on the overall biocompatibility of a medical device.  If you are a medical device manufacturer, don’t miss the opportunity to learn more about chemical characterization.

Webinar highlights:

  • Typical changes manufacturers encounter
  • Evaluating the impact of the change in relation to patient safety
  • Testing options available to evaluate changes
  • Case studies

Medical device manufacturers will walk away from this webinar with a better understanding of the opportunity to use chemical characterization to evaluate changes that may occur in their medical device from time to time. Attendees will also be reminded that any change no matter how major or minor requires testing, but that testing can be customized to account for the type of change because not all changes require the same level of testing. WATCH NOW!

What is Material Characterization and How to Use it to Supplement Your Safety Evaluations

Leachable and extractable studies have an increasing emphasis with biocompatibility. Manufacturers are using the data to help supplement safety evaluations to the FDA. In the Innovation Brief we will go over what are leachable and extractables, how you set up a plan for your product, what information will be given in the results, and how you use the data to supplement your safety evaluations.

This presentation was given at the Tech Theater at BIOMEDevice San Jose 2013.

Presented by: Thor Rollins

Nelson Laboratories to Offer Free Biocompatibility Consultations During BIOMEDevice San Jose

SALT LAKE CITY – Nov. 15, 2013 – Nelson Laboratories ( will offer free biocompatibility BIOMEDevice-SanJoseconsultations in its booth (#321) during BIOMEDevice in San Jose, CA Dec. 4-5, 2013 with expert Thor Rollins, biocompatibility specialist. Those interested in a consultation should register at

Rollins will also present, “Selection, Testing and Validation of Medical Devices According to ISO 10993,” from 10:00 am to 12:00 pm Dec. 5. The presentation is free, but participants should register at

“During the presentation, we will discuss materials that can have an impact on test results, which specific tests to use, and how to confirm test results,” said Rollins. “For those who want to dig a little deeper, we will also be conducting free biocompatibility consultations.”

During the consultations, participants can go over any biocompatibility topic they wish with Rollins. Some suggested topics may include:

  • Setting up a biocompatibility test plan
  • What happens if you fail a biocompatibility test
  • Materials characterization testing
  • ISO updates/changes
  • Materials justifications

Rollins’ presentation will cover:

ISO 10933 Test Requirements and how Materials Could Impact Biocompatibility Testing:

  • An overview of the most common biocompatibility tests and what materials could impact the results
  • How FDA and other regulatory agencies will interpret your results or test selection
  • How the new FA Draft Guidance might impact your future testing
  • How to categorize you device according to ISO 10993

Materials Characterization for Medical Devices per ISO 10993-17,18:

  • The correct way to extract your device to look for extractables and leachables
  • What tests to run to identify and quantify the compounds
  • How to determine the potential toxicological impact of the compounds

What To Do If You Fail A Compatibility Test:

  • How to confirm the result
  • How to trouble shoot and ways to improve you device
  • How to justify a failure

About Nelson Laboratories: Nelson Laboratories is a leading provider of full, life-cycle microbiology testing services. We are known for exceptional quality, but we look beyond the testing process and partner with you to achieve your long-term business goals. It’s what we call The Science of Success™. Learn how we can help move your products to market quickly and safely. Visit

Author: Thor Rollins |