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Mr. Siskey's specializes in applying experimental methods to assist in the product development process. While his focus has been on medical device development projects, he also consults on material selection, consumer products and consumer electronics. As the supervisor of the ISO 17025 accredited ISO (A2LA Certificate 2561.01) medical device testing laboratory in Exponent's Philadelphia office, he has a strong foundation in the quality system requirements for medical device development. Additionally, as a certified lead ISO 13485 auditor, he is able to bridge his experimental background and the regulatory and compliance issues that manufacturer's routinely face. Mr. Siskey's has extensive experience in performing wear and material testing in accordance with ASTM and ISO standards, conducting cadaveric testing, and developing customized protocols. This includes analyzing and testing devices from feasibility through post market surveillance and helping to obtain regulatory approval for their devices. His experience includes materials characterization, complete device evaluation, and a firm understanding of the device tissue interface including coatings characterization. Mr. Siskey also has experience in failure analysis of devices that has been used to help client's conduct root cause investigations of their devices and respond to FDA deficiency letters. While standardized testing plays a key role in characterizing most devices, new devices and new questions about existing products makes custom protocols a necessity in the lab. Mr. Siskey has experience with developing these protocols for devices and products, from Class I to Class III.