New Approaches to Assessing Biocompatibility for Medical Devices

Audrey Turley

The regulatory environment for biological safety evaluation of medical devices is changing rapidly. Biological safety evaluations following ISO 10993 have typically been addressed with biocompatibility  testing on animals; however, alternate options are now available using literature research and chemical characterization tests when appropriate to reduce animal testing. Considerable progress is being made in the development and standardization of new in vitro test methods; particularly for cytotoxicity, sensitization and irritation, the basic tests performed for any medical device regardless of the device’s application. These alternative in vitro methods provide multiple benefits, including: less sample amount, less time required to perform the test, and reduced animal use.

Click here to view Research Scientist Audrey Turley’s presentation from MD&M West 2016.

What will be learned:
• Learn how to use a risk assessment approach for process and material changes
• Understand how to use material and chemical characterization to reduce animal testing
• Update on development of alternative in vitro testing methods for irritation and sensitization


MD&M West 2015: Celebrating 30 Years at the Forefront of Medtech Innovation

– Re-posted from PR Newswire –

SANTA MONICA, Calif., Jan. 12, 2015 /PRNewswire/ — In honor of the 30th anniversary edition of the Medical Design & Manufacturing (MD&M) West exhibition and conference, UBM Canon has announced a blockbuster line-up of content and special show features. As the nation’s largest medtech event, MD&M West 2015 will bring together thousands of global experts in the medical design field to celebrate the brand’s legacy of promoting innovation across the medical device manufacturing community. MD&M West will take place February 10-12, 2015 at the Anaheim Convention Center in Anaheim, CA. For more information and to register, please visit:

The highlight of the anniversary celebration is the 30-year roundtable at the Center Stage, where veteran industry insiders will debate trends that will rock the medical device industry in 2015 and beyond. Speakers scheduled to attend include:

  • Stuart Herskovitz, President, Qosina
  • Tom Black, Vice President, B. Braun Medical
  • Jeffery Nelson, President and Chief Executive Officer, Nelson Laboratories
  • Brian Nash, Vice President Sales and Marketing, Nusil

Attendees will find a plethora of in-depth and entertaining content for this year’s event such as: a 3D printed drone, former NBA player turned medical device inventor, live product teardowns, guided Innovation Tours of the expo hall, and dedicated Speed Networking sessions right on the show floor. This year will also see the debut of the “Do You Science?” trivia game, where 5 grand prize winners will receive a free Microsoft Surface Tablet, courtesy of Nordson EFD.

In addition to the vast MD&M West exhibition, attendees will also have full access to the entire co-located Anaheim exhibition and conference. Co-located with 7 other advanced manufacturing events in Anaheim, MD&M West brings together thousands of top suppliers from across the nation onto one show floor. Attendees will be able to source the latest design innovations, participate in free networking events, and take advantage of free educational opportunities over three days. Nowhere else will you find the same level of content and resources across industry lines.

Read the complete press release online at www.prnewswire.comFor information about Nelson Laboratories’ MD&M West schedule visit

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

Updates to the Bioburden Standard ISO 11737-1; Significant Additional Guidance. P.S. What Happened to the Microbiologists?

Did you miss MD&M Texas? Check out the Tech Theater presentation given by Nelson Laboratories scientist Martell Winters. As biological and tissue products and combination products become more prevalent, new questions are often asked related to microbiology that are different from those asked for traditional medical devices.  As these questions become more common, additional guidance is necessary for the industry.  Much of this additional guidance will be added to the new version of the ISO bioburden standard, 11737-1.  Some of this information must be added due to the lack of microbiological expertise in the industry.  However, when the information is added it will not be easily understood by non-microbiologists, meaning that some understanding must be present to fully appreciate it. Following are some main points to be added to the standard which will be discussed in the Tech Theater presentation.  Also some discussion will be provided regarding the microbiological expertise in the medical device industry.

  • Low bioburden products
    • How low is low?
    • Why are they different?
  • How should the bioburden test be performed?
    • Review of raw materials/manufacturing process
  • Optimization of bioburden testing
    • Increasing sensitivity (e.g. volume factors)
    • Pooling of bioburden samples
  • Reviewing bioburden data
    • Addressing TNTC values
    • Addressing spreaders/lawns

Process Validations for Newly Manufactured Devices – Is Your New Device Clean?

During the two-day BIOMEDevice Boston conference and showcase Alexa Tatarian, Material Characterization and Process Validation Scientist at Nelson Laboratories, presented at the Tech Theater on Wednesday March 26th at 1:40 pm. She presented Process Validations for Newly Manufactured Devices – Is Your New Device Clean? to help manufacturers understand how to properly monitor and assess the cleanliness of their finished product and key factors that affect cleanliness during the manufacturing process. Here is the video of that presentation.

MD&M Texas

MDM_Seminar_Event_imageNelson Laboratories will be exhibiting at the MD&M Texas show, May 7-8, 2014, at the Fort Worth Convention Center in booth #523.

Presentation: Medical Device Sterilization: Selection of SAL, Evaluation of Bioburden Data, Alert and Action Levels of Bioburden Excursions

During the two-day conference and showcase Martell Winters, Senior Scientist at Nelson Laboratories, will be presenting a Learning Lab on Thursday May 8th from 10:00- 11:45 am. He will be presenting Medical Device Sterilization: Selection of SAL, Evaluation of Bioburden Data, Alert and Action Levels and Bioburden Excursions to help manufacturers understand sterility assurance and bioburden data. Of interest to medical device manufacturers is the “absolute” necessity of a 10^-6 sterility assurance level (SAL), use of “less-than” values with bioburden data and properly establishing alert and action levels. These topics are applicable to all forms of sterilization (e.g. ethylene oxide, radiation, etc.) and all product types, but are of special interest to combination products, biologics and tissues.

Register now for this exclusive event.

If you can’t make the Learning Lab presentation, Mr. Winters will also present at the Tech Theater on Wednesday May 7th from 1:00-1:30 pm on “Updates to the Bioburden Standard ISO 11737-1; Significant Additional Guidance. P.S. What Happened to the Microbiologists?”. If you would like to meet one on one with Mr. Winters, he will be available in the Nelson booth for FREE consulting sessions, a $500 value. Availability will be determined on a first come, first served basis. If you would like to reserve a time for a consult in advance, please email

Below are topics that Mr. Winters will be available to discuss at MD&M Texas:

  • Radiation sterilization
  • Selection of SAL
  • Aseptic Processing
  • Evaluating of bioburden data
  • Bioburden alert and action levels
  • Environmental monitoring
  • Manufacturing microbiology

Don’t forget to stop by booth #523 to speak with Nelson representatives.

Fort Worth Convention Center
1201 Houston St.
Fort Worth, TX 76102
Booth #523