Upcoming Events
Design for Sterilization Enables Accelerated Time to Market
Tuesday, December 19, 2023 (1:00 PM - 2:00 PM) (EST)
Description
Sterilization validation -- an FDA required step -- happens late in the design process as physical devices are needed. Unfortunately, this is also true for optimization of the device/packaging design, packing configuration, and sterilization configuration. Addressing these design choices late in the process poses a significant risk to delay the time to market.
Dose Insight, a technology spinout of Triple Ring Technologies, changes this paradigm by offering modelling services to address radiation sterilization process optimization early in the design process - as soon as a digital model of the device exists. In this webinar, industry experts will discuss how this Design for Sterilization approach can help to improve the design workflow and get devices faster to market.
Speakers
 | Daniel Badali, PhD, Staff Scientist at Triple Ring Technologies Daniel Badali, Ph.D., is an expert in radiation sterilization and has over a decade of experience developing innovative radiation technology. As a Staff Scientist at Triple Ring Technologies, he has lent his technical leadership to a number of medical device development projects. Daniel holds a B.Sc. from the University of Toronto, and M.Sc. and Ph.D. degrees in Physics from the University of Hamburg, Germany. He is a certified Professional Physicist from the Canadian Association of Physicists. Daniel co-founded Dose Insight in 2022 as a spinout of Triple Ring Technologies. |
 | Emily Craven, Director, Sterility Assurance at Boston Scientific Emily Craven has been part of the medical device sterilization industry for more than 20 years and has spent most of her career in radiation process design, validation, and applications development. In 2020, Emily joined Boston Scientific as the Director of Global Sterility Assurance where she is responsible for end-to-end sustainable solutions across all sterilization modalities. A recognized industry leader in radiation sterilization and sterility assurance, Emily has co-chaired workshops and conferences, authored or co-authored presentations, papers, and book chapters on radiation applications, design, dosimetry, process control and mathematical modelling. Emily is active with AAMI Sterilization working groups, is the ISO Convenor for Radiation Sterilization, additionally represents Canada on ISO TC198 Sterilization working groups for EO Sterilization, Microbiological Methods, and Assurance of Sterility, and is the ASTM sub-committee chair for training for E61 Radiation Processing. |
 | Tobias Funk, PhD, VP of Technology Development, Triple Ring Technologies Tobias Funk, PhD, is an established business leader having co-founded Dose Insight in 2022, and is also currently serving as the VP of Technology Development at Triple Ring Technologies. He has a proven track record of developing radiation-based instrumentation and software products, several of which have successfully been brought to market. Tobias received his M.S. and Ph.D. from Freie Universität Berlin, Germany. Tobias is principal investigator on two ongoing FDA funded SBIR grants to develop virtual dose mapping. He has authored over 20 peer-reviewed publications and has over 20 granted and pending patents. He is the chairperson of the RTBN NIH study section, reviewer for various peer-reviewed journals, and member of the ASTM Radiation Processing committee. |
 | Larry Nichols, CEO at Steri-Tek Larry Nichols is the CEO of Steri-Tek, located in Fremont, CA. Larry began working in the E-beam industry for Nutek Corp in 1996 as the business manager. He soon assumed the position of Operations Manager, overseeing the shipping/receiving department as well as the machine operators. Shortly after that, he was promoted to VP of Operations, VP of Business Development and later VP of Quality. In 2009, he assumed the position of CEO. When Nutek closed in 2016, he co-founded Steri-Tek where he assumed the role of CEO. He is active on the committees ISO/AAMI 11137 and ASTM Dosimetry working group. He routinely gives talks at various industry events including: Rosatom Executive Roundtable Workshop on radiation in Moscow, Accelerating Towards the Future: Electron Beam and X-ray Technologies Workshop in Buenos Aires. Larry earned his BS degree in Business Management from Cal Poly in San Luis Obispo, CA. |
 | Sopheak Srun, MPH, SM(NRCM), CISS-EO, CISS-RAD, Principal Sterilization Scientist at Quality Tech Services(QTS), a Cretex Medical Company Sopheak Srun is a Principal Sterilization Scientist at QTS, which is a company located in Bloomington, Minnesota, that specializes in contract medical device assembly and packaging services. Throughout his seventeen-year career at QTS, Sopheak has been actively involved in a number of AAMI Sterilization Standards Committee working groups, including as a co-chair of the AAMI Microbiological Methods working group (AAMI ST/WG08), and a designated U.S. expert to ISO TC198/WG8 (Microbiological Methods). Sopheak has been involved in a variety of other industry collaborative efforts, which includes being one of the founding members of Kilmer Innovations in Packaging (KiiP). |
Sponsors
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