Educational Events

Medical Device Preclinical Bootcamp

 

Toxikon’s educational events give you front-row access to the scientists who not only perform world-class medical device testing, but help develop the industry regulations that govern testing programs. Learn from our 40+ years of experience to help make your next test program a success. During this complimentary workshop, we will explore the preclinical testing pathway from concept to regulatory submission, including relevant regulations and standards; the role each type of test plays in the overall testing program; and practical information you can use to facilitate getting your proposed device submitted efficiently.

 

Date, Time, and Location

March 30, 2018
9:30am – 2:30pm ET
Massachusetts Biotechnology Council (MassBio)
300 Technology Square, 8th Floor
Cambridge, MA 02139

 

This event is sold out. Thanks for your interest. 

Bootcamp Agenda

10:00 am - 10:15 am: Welcome and Introduction: The Medical Device Approval Pathway
Speaker: Rosalyn Año, Business Development Manager


10:15 am - 11:45 am: The Basics of Biocompatibility Testing
Speaker: Laurence Lister, Director of Biocompatibility

Abstract:
Biocompatibility simply refers to the properties of materials being biologically compatible by not eliciting local or systemic responses from a living system or tissue. This presentation will discuss the basics of biocompatibility testing. This presentation will discuss the history and evaluation of biocompatibility.  It will explain how to properly classify your device.  Then when biological endpoints are applicable for the properly labeled device will be covered.  Finally, a high level discussion of each biological evaluation and the various choices will be explained.


11:45 am - 12:15 pm: Lunch and Networking


12:15 pm - 1:00 pm: Chemical Characterization of Medical Devices: Strategies, Pitfalls, and Points of Consideration
Speaker: Stephen Doherty, Director of Analytical Chemistry

Abstract:
Recent regulatory guidance documents have emphasized the need for chemical characterization of medical devices as part of an overall device assessment. We will examine the types of information available from a chemical characterization and how to get the information you are looking for from the testing. Strategies for study design and execution will be discussed. Common pitfalls and potential shortcomings and how to avoid them will also be presented.


1:00 pm - 2:00 pm: Toxicological Risk Assessment Based on Extractable/Leachable Data: Why, When, and How
Speaker: Kevin Connor, Director of Toxicological Risk Assessment

Abstract:
Toxicological Risk Assessment (TRA) has been an important tool in the safety assessment of biomedical devices, providing a chemical-based approach which complements a more traditional testing program largely based on whole animal studies. The need for TRA is growing and in some cases, will be considered as a means of circumventing animal testing in the safety evaluation of devices. TRA is founded on the notion that, if all constituents of a product, including additive, impurities and contaminants, are known, then the safety (or risk) of a product can be assessed based on the toxicology of those constituents, ascertained through extractable / leachable (E/L) studies. However, the E/L analysis can face several pitfalls towards achieving the objectives of risk assessment and current regulatory guidance leaves the analyst having to make many choices based on their own judgment. However, this shortcoming of the data can be avoided with proper study design.  Potential pitfalls in the E/L analysis will be discussed together some tested methods for their avoidance, which will be illustrated with case studies.


2:00 pm - 2:20 pm: Toxicological Risk Assessment for Breathing Gas Pathway Medical Devices: ISO 10993 and ISO 18562
Speaker: Russell Sloboda, Analytical Chemistry and Risk Assessment Specialist

Abstract:
Breathing gas pathway medical devices such as breathing systems, ventilators, anesthesia systems, nebulizers and oxygen lines come into contact with patients at a particularly vulnerable point and time. As a result, the exposure assessment for these devices is an important step in the evaluation of device safety and needs to be particularly concerned with airborne releases, especially volatile organic compound (VOCs). ISO 10993 and ISO 18562 may both apply; yet in some instances each standard recommends a very different technical approach to the measurement of releasable chemicals and different assumptions for the risk assessment. The key differences in these two methodologies will be illustrated, along with an analysis of how different risk estimates derived using these regulatory guidelines points out the need to justify the use of one over the other.


2:30 pm - 2:23 pm: Tips for a Successful Sponsor-Laboratory Partnership
Speaker: Rosalyn Año, Business Development Manager

Abstract:
With over 40 years of experience and having completed thousands of studies, Toxikon has seen the good, the bad, and the ugly of medical device safety and efficacy testing. With our customers, collectively we’ve learned how proper preparation, comprehensive communication, and clear expectations on both sides creates an environment where studies are initiated efficiently and completed effectively. We will facilitate an open discussion sharing what we’ve learned about creating a successful partnership between the sponsoring company and the contract laboratory, to help your next project have the best chance for success.

This event is sold out. Thank you for your interest. 

Date, Time, and Location
March 30, 2018
9:30 – 2:30pm ET
Massachusetts Biotechnology Council (MassBio)
300 Technology Square, 8th Floor
Cambridge, MA 02139
 
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Educational Events