- M.S., Biomedical Engineering, Drexel University, 2008
- B.S., Biomedical Engineering, Drexel University, 2005
- Certified ISO 13485 Lead Auditor
- Drexel University, Department of Mechanical Engineering and Mechanics, Theoretical and Applied Mechanics Group Advisory Board
- ASTM Robert E. Fairer Award, May 2010
- ASTM Manny Horowitz Award, May 2018
- ASTM Manny Horowitz Award, May 2019
- ASTM Patrick Laing Award, May 2023
- A.J. Drexel Scholarship, 2000-2005; Alpha Chi Rho Richard V. Olson Scholarship, 2004
- Senior Design Honorable Mention: "Developing a Cost-Effective Mechanical Spine Simulator" (Jared Grochowsky and Ryan Siskey; Advisor: Dr. Steven Kurtz)
- ISO TC 150:
- • Chair of ISO TC150 SC5 - Osteosynthesis and Spinal Devices
- • Convener of ISO TC150 SC1/WG5 - Medical Plastics
- American Society for Testing and Materials:
- • Member of the Committee on Standards
- • Member of ASTM Committee F04 on Medical and Surgical Materials and Devices
- • ASTM Committee F04 Membership Secretary
- • Member of ASTM Committee D13 on Textiles
- • Member of ASTM Committee F15 on Consumer Products
- • Member of ASTM Committee F42 on Additive Manufacturing Technologies
Mr. Siskey specializes in applying his quality systems expertise and experience with 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, Mr. Siskey 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 during the product development cycle.
Mr. Siskey 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 have 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.
In his role as Office Director and Principal, Mr. Siskey is responsible for maintaining the Philadelphia Laboratory's ISO 17025 accreditation with A2LA and conformance to 21 CFR Part 58 U.S. FDA Good Laboratory Practices (GLP). Specifically, he is responsible for maintenance of accredited procedures, overseeing the development of new accredited procedures, overseeing the maintenance of existing equipment, developing strategic equipment acquisition strategies, conducting internal conformance audits and ensuring the proficiency of the lab personnel. His internal auditing experience and understanding of quality management standards has enabled him to assist manufacturers by conducting third party quality and safety audits. Additional quality related capabilities include gap assessment, root cause analysis, supply chain management, decision rule use in conformity assessment, and corrective action review.
Mr. Siskey has assisted medical device manufacturers by reviewing their laboratory facility design for engineering controls, equipment needs, and procedural flow. Specifically, the laboratory requirements included ensuring these elements would accommodate procedures related to handling and inspecting contaminated field returns and accepting, handling and disposing of human cadaveric tissues. Working with the manufacturer's contractors and architects, Exponent's expertise was used to ensure proposed solutions met the manufacturer's needs and budget constraints. Exponent specifically was able to review proposed solutions and provide an assessment of the benefits and risks at decision points along the design and construction pathway. Exponent also assisted in developing the process flow and procedures related to the new facility to expedite the training of staff and commissioning of the laboratory through process validation.
Mr. Siskey received his MTS certification, which enables him to develop customized testing procedures on the laboratory servo-hydraulic load frames and wear simulators. He also maintains an understanding of mechanical testing using a wide variety of testing equipment. Additional methods include surface characterization using a Zygo white light interferometer, and chemical characterization using FTIR. Previous experience in tribology has included re-design of a Matco hip wear tester, re-design of a biaxial knee wear tester, and design of a spine disc wear tester. Mr. Siskey has also developed procedures for devices including syringes, luer fittings, needles, and catheters.
Additionally, Mr. Siskey has conducted environmental monitoring with Exponent's Environmental Sciences group. Specifically, he has set up, maintained, and calibrated air particulate monitoring equipment and weather monitoring equipment. He has also conducted analysis of the data collected with these systems.