Date/TimeDate(s) - April 12, 2022 - April 14, 2022 All Day
LocationAnaheim Convention Center
800 W Katella Ave
Anaheim, CA 92802
Join NAMSA at the annual MD&M West in Anaheim, CA on April 12-14. Bringing together medtech professionals from all different scopes of the industry, this event provides an opportunity for thought leaders and innovators to explore the latest trends and challenges within the medtech landscape, and network with fellow peers.
NAMSA invites you to our one-day educational session on April 12 in Hall B, Room 204B to discuss some of the most pertinent topics in medical device preclinical testing. Attendees will hear direct from NAMSA experts about the biological safety and chemical characterization of materials, alternative in vitro testing for blood contacting devices and best practices for optimizing your surgical feasibility testing submission plan.
Attendees can expect to gain valuable knowledge in:
- Regional nuances of chemical characterization and its use
- Overcoming challenges with chemical characterization testing with complicating devices
- Planning for biological safety to mitigate unnecessary cost and lost time
- Alternative thrombogenicity test methods for blood contacting devices
- Optimizing your surgical feasibility testing submission plan
Visit us at Booth 2876 for complimentary 30-minute consultations with NAMSA’s experts throughout the event. We welcome the opportunity to discuss with you the most cost-effective pathways to market based on your unique product development requirements.
Please contact us to reserve your consultation time, or simply stop by the booth in the exhibitor area to meet with us. We hope to see you there!
Preclinical Testing for Efficacy and Biological Safety
8:30 - 8:45 AM
8:45 - 9:45 AM
Medical device organizations that manufacture products that involve patient contact are most often required to perform some level of chemical characterization evaluation, per ISO 10993-18, to ensure end-user safety. Depending on a device’s intended clinical use, chemical characterization—specifically, extractable/leachable testing—may be required by various regulatory agencies to address biological safety. However, utilizing this type of testing methodology to address various updates to medical devices can prove to be a cost-effective way to assess device changes and their potential impacts to biological safety.
With the anticipated issuance of ISO 10993-18, manufacturers are given further guidance and direction as to the use of material characterization and the implementation of testing for chemical entities. This session will highlight the main focus of the document and the top 10 items manufacturers need to address immediately in the biological evaluation programs.
9:45 - 10:00 AM
10:00 - 11:00 AM
Since 2009, the emphasis on a risk management process and characterization of materials continues to shift the biological safety paradigm. Put simply, the days of medical product manufacturers simply contracting with a testing laboratory, reviewing and accepting a recommended product evaluation plan is no longer a globally accepted practice.
Join this session to learn how a well-planned strategy utilizing chemical characterization can have favorable and even cost saving implications for the commercialization of your product. This session will be a start to finish, step by step instruction on when to start your planning, what steps to follow to execute chemical characterization testing and/or biological testing, and how to keep your timelines as short or shorter than when performing conventional biological testing.
11:00 - 11:45 AM
11:45 AM - 1:30 PM
1:30 - 2:30 PM
2:30 - 2:45 PM
2:45 - 3:45 PM
3:45 - 4:45 PM
Amarjit Luniwal, PhD, DABTSenior Toxicologist
Amarjit “Al” Luniwal holds a PhD in Medicinal Chemistry, a Master of Science (Pharmaceutical Chemistry emphasis), and a BS in Pharmaceutical Sciences. Dr. Luniwal has several years’ of laboratory experience with primary expertise in the areas of synthetic organic chemistry, analytical chemistry, mass spectrometry data interpretation, and toxicology/biocompatibility testing. He did postdoctoral research in molecular biology, and drug design and development at the Center for Drug Design and Development, University of Toledo prior to joining NAMSA’s analytical services department as a senior chemist. He has published his research in several peer reviewed scientific journals and has co-authored a book chapter in ‘Analogue Base Drug Design III’ on SERMs and is a co-inventor for a granted patent from the US PTO. Dr. Luniwal has been with NAMSA for over eight years, where he currently serves as a board certified toxicologist (DABT) and focuses on materials characterization and toxicological evaluation of extractables and leachables from biomaterials used to make medical devices, and risk assessment for biocompatibility and biological safety of the medical devices. Dr. Luniwal serves as a review editor for Frontiers in Pharmacology and Frontiers in Oncology and is an associate member of ACT and a full member of SOT.
Andy J. Wyen, MS, DABTSenior Toxicologist
Andy Wyen is a Board Certified Senior Toxicologist at NAMSA. With over 16 years’ medical device industry experience, his previous positions include R&D Technician, Chemist and Biocompatibility Study Director. Andy’s expertise includes In Vitro methods, analytical chemistry, chemical characterization, study direction, biocompatibility and toxicology. He obtained his Bachelor and Master Degrees in Pharmacology/Toxicology from the University of Toledo (Ohio, U.S.).
Mark E. Smith, BA, PhDStrategic Advisor - Laboratory & Consulting
Mark has been involved in preclinical safety and performance evaluations of class II and III medical devices for the past 15 years. He has been associated with medical device design and testing, operating over a wide range of therapeutic areas, including cardiovascular, structural heart, electrophysiology, neurostimulation, pulmonary therapies, GI systems and oncology. He has been primarily involved in successful study design and negotiations with the U.S. Food and Drug Administration (FDA) and other regulatory groups when questions or issues arise surrounding medical device submissions.
Mark’s time in the Pharmaceutical and MedTech industries also includes 20+ years in Pharmaceutical Discovery, which has provided him a thorough understanding of complex devices and combination products in the preclinical arena, including managing large animal interventional and surgical research. Dr. Smith is also responsible for oversight of assay development and strategies in hemocompatibility assessment of medical devices, specifically in thrombogenicity, with the continuing development of an In Vitro ovine blood loop assay.
Dr. Smith was one of the co-founders and served as Chief Scientific Officer at American Preclinical Services (APS), established in 2005. With the acquisition of APS by NAMSA in 2021, Mark transitioned to a role with the Commercial Team and now works directly with the Technical Advisors and Business Development Executives engaging in initial Client interactions and early program strategies, study design and planning.