MedTech innovation leaders gathered at the University of Texas in San Antonio to share their expertise with up-and-coming biomed talent. The Health Cell, a life sciences professional development and advocacy organization, created a pilot workshop series Developing and Clinically Introducing Medical Technologies. The four-part workshop focused on enabling scientists to become entrepreneurs began in October of 2016.
President of Nelson Laboratories, Jeffery Nelson, participated on a panel during the third workshop held on Monday, January 16, 2017. The focus of this panel was research, product development, manufacturing, verification, and validation.
“The Health Cell concept is a great way to support the growing Med Tech industry sector in San Antonio,” said Jeffery Nelson. “I was impressed by the group and honored to be invited to participate in their learning process.”
The need to educate bioscience professionals spurred the creation of this workshop series,” reported The Rivard Report. “Participants will learn how to develop a medical technology or MedTech device from concept, where patient needs are identified and a market is selected, to product development, testing, and manufacturing, all the way to clinical trials and market introduction.”
The fourth and final workshop in the series will include the topic of financing the pathway followed by a presentation of awards on February, 13, 2017.
More information on upcoming The Health Cell events can be found HERE.
Last week, Alpa Patel, Senior Scientist at Nelson Laboratories, and Kaumudi Kulkarni, Manager of Research and Development at Healthmark Industries, hosted the live webinar Endoscope Microbial Surveillance Testing Made Easy. The webinar was attended live by infection prevention professionals, sterile processing professionals, nurse managers, laboratory professionals, and others who work in healthcare facilities and wanted to learn more about performing surveillance on endoscopes.
The webinar discusses the outbreaks that have been in the news over the past few years regarding contamination of flexible endoscopes, and the benefits of performing endoscope surveillance in a healthcare facility. An explanation of the organisms of concern is provided which allows Patel and Kulkarni to review the options for positive growth of the organisms. Basic tests methods for surveillance of flexible endoscopes are covered.
The 44 minute webinar is now available on-demand. If you would like to watch the webinar, follow this LINK.
For more information, contact Alpa Patel at firstname.lastname@example.org.
The 40th International Meeting on Radiation Processing (iia) was held two weeks ago in Vancouver, Canada. Nelson Laboratories’ Senior Scientists Martell Winters and Wendy Wangsgard, PhD attended. Winters was the Program Chair and also led a preconference day workshop on dose audit failures. Wangsgard chaired the Healthcare Strand session on radiation microbiology. The discussion covered microbiology vs. math, updates to AAMI TIR35 and TIR17, and wrapped up with Winters presenting more in-depth details on dose audit failures.
Wangsgard presented a poster on “Validation of a Sterilization Dose for Products Using a 3D Printer.” Her presentation was very well received and earned the Best Poster award.
“I have been wanting to attend this meeting for 12 years, and I was delighted to be able to present a poster and chair a session,” Wangsgard explained. This was a very special day for Wangsgard as she not only was awarded the Best Poster award, but it was also her birthday. “Little did I know that I would receive the greatest birthday present by winning this award and by celebrating with industry experts who I have been looking up to for decades!”
The conference was well attended and Nelson Labs will be attending the next one in two years.
By Alyessa D’Ewart, MPC
Nelson Labs’ Alpa Patel was recognized by American Society for Testing Materials (ASTM) for her dedicated work as part of the cleanliness task force in the creation of a new standard giving guidance for selecting test soils for medical device validations. The document is scheduled to be released in early 2017.
As a member of the F04.15 committee, Patel has been working on this standard, titled ‘WK50782, Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices,’ for the past five years. This collaborative effort between the committee, the reprocessing industry, and the FDA is ongoing, as they will continue to add parts to the document in the future.
Patel has been a part of the F04.15 committee since 2007. As a certified microbiologist, she also serves as a senior scientist and a cleaning, disinfection, and sterilization consultant for Nelson Labs. Read her blog post Human Factor Considerations for Medical Device Manufacturers here.
Thor Rollins, Michelle Lee, and Audrey Turley have been accepted as U.S. experts to four working groups in the Biological Evaluation ISO Technical Committee 194: WG5 (Cytotoxicity – Thor), WG8 (Sensitization and Irritation – Michelle), WG9 (Effects on blood – Michelle), and WG6 (Genotoxicity, Carcinogenicity, and Reproductive Toxicity – Audrey). This placement allows participation in the annual ISO meetings to discuss changes to the ISO 10993 and movements surrounding the approach to biocompatibility of medical devices. These meetings have recently been closed, and only those that are nominated and accepted by the co-chair of the respective working groups are allowed to attend and participate in the international annual meeting. Meet the experts:
Thor Rollins started his career at Nelson Laboratories as the study director over cytotoxicity testing. He is familiar with the test procedure and can speak to its application to medical devices providing a deep knowledge of all the complexities that can occur in cytotoxicity testing. Thor frequently works with clients who run into issues with cytotoxicity and need help mitigating patient risk.
Michelle Lee has been highly involved in several ISO round robins over the last few years including a Hemolysis, Complement, and currently an in vitro irritation round robin. Nelson Laboratories have been the top testing laboratory involved providing input on sample type, sample preparation, and protocol development for these projects. Michelle is also working to develop an in vitro sensitization assay using 3D human tissues.
Audrey Turley was one of the key personnel in bringing the in vitro chromosomal aberration assay in-house at Nelson Laboratories. Once the test was validated, she stepped in as the study director for the next six years. Currently, Audrey is working as a technical consultant to help clients perform risk assessments to address carcinogenicity risks.
FDA released the long-awaited guidance document for international standard ISO 10993-1 this week. The guidance document represents the current thinking of FDA on the topic of ISO 10993-1 “Biological evaluation of medical devices – Part I: Evaluation and testing within a risk management process.”
Our team is reviewing the document and will provide an assessment of the changes in the near future.
The document can be found on the FDA website via this LINK.