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Bally Design, 40 24th Street, Pittsburgh, PA 15222
WIB-Pittsburgh & PDMA: The Interdisciplinary Approach to Medical Device Development
Join WIB-Pittsburgh and the Pittsburgh chapter of the Product Development and Management Association (PDMA) for a dynamic panel discussion featuring experts who will share insights on the journey of medical devices from concept to launch. Learn about the various roles, essential skills, and career paths involved, with tips for effective cross-functional teamwork and how AI is revolutionizing the medical device lifecycle. Food and drinks will be provided, offering a great opportunity to network with industry professionals and peers. Many thanks to Bally Design for hosting and sponsoring this event.
Learning Objectives:
Program
5:30 p.m. – 6:00 p.m. Doors Open, Welcome, & Check-in
6:00 p.m. – 6:15 p.m. WIB & PDMA Intros
6:15 p.m. – 7:00 p.m. Panel Discussion
7:00 p.m. – 7:15 p.m. Q&A
7:15 p.m. – 8:00 p.m. Networking
Speaker Bios
Saisri Akondi, Co-Founder and CEO of D.Sole
Saisri spearheads the development of a smart insole that detects and monitors foot complications caused by peripheral neuropathy in diabetic patients. The primary goal is to decrease hospital readmissions, lower amputation rates, and reduce healthcare costs, contributing to better patient outcomes and a more efficient healthcare system. Saisri earned her Master of Science in Biomedical Engineering, Business, and Design from Carnegie Mellon University, where she learned how to integrate engineering, design, and business domains to create impactful and sustainable products and services. She was also a James R Swartz Entrepreneurial Fellow and is passionate about solving critical health problems and improving people's lives in underserved communities using technology, human factors, and social entrepreneurship.
Julie Gulick, President & CEO of Bally Design
Julie began her career as a manufacturing engineer and design engineer before moving into upstream marketing, where she led efforts to define products in the medical device and services industry. Julie’s most recent role was as program director at Philips HealthWorks in Cambridge, Massachusetts, a startup incubator. Julie is currently the President & CEO of Bally Design, an industrial design and graphical user interface design firm in Pittsburgh. Julie holds bachelor’s and master’s degrees in engineering from Penn State University and an MBA from the University of Pittsburgh with an emphasis in finance and marketing.
Stephanie Kladakis, Executive Vice President, Chief Technology and Regulatory Officer at AgNovos Bioscience
Stephanie Kladakis is a seasoned leader with over 20 years of experience in research and development, regulatory, and medical affairs within the cardiovascular, orthopedic, and soft tissue medical device and biologics industries. She has a proven track record in product design, development, and commercialization, managing resources and budgets across departments and providing direct supervisory oversight for multidisciplinary teams, including directors, managers, engineers, scientists, and technicians. Stephanie excels as a cross-functional team leader, adept at planning and executing projects through all phases of design control, from concept to clinical implementation. Her expertise includes biologics requiring IND studies for BLA approvals, medical devices necessitating IDE studies for PMA approvals, and European clinical trials for MDR CE Mark approvals.
Erin McPeak, New Product Planning Manager at ZOLL Medical Corporation
Erin oversees the strategic planning and development of innovative healthcare informatics products and digital services, including a clinician portal, patient mobile apps, interoperability solutions, and more. Beyond her professional endeavors, Erin serves as the Secretary and Director of Strategy on the Board of Directors for Evolve Coaching, a Pittsburgh-based nonprofit organization dedicated to providing support services to individuals with autism and other disabilities. When Erin isn't working or volunteering, she enjoys cooking, getting outdoors, playing, or reading with her husband, twin daughters, and their dog.
Kim Olechovski, Product Manager at Techcyte
Kim is a Product Manager specializing in AI-powered SaaS solutions for clinical and anatomic pathology. With a diverse background spanning clinical patient care, research, and project management, Kim focuses on developing and launching innovative tools for hematology, including digital blood differential and FISH assay analysis products. She brings expertise in cross-functional collaboration, regulatory alignment, and customer-centric product development. With a career rooted in healthcare and technology, Kim combines hands-on experience in radiologic imaging, clinical content analysis, and AI-driven software to create impactful solutions that improve diagnostics and laboratory efficiency. Passionate about interdisciplinary teamwork, she thrives on bridging the gap between technical innovation and practical application in medical device development.
Lindsey Pamer, Project Engineer at Bayer Healthcare
Lindsey serves as a Project Engineer at Bayer Healthcare in Pittsburgh, focusing specifically on sterile disposables used in radiology. With more than 10 years of experience in research and development of devices and medical device manufacturing, Lindsey brings a strong foundation in both device design and testing principles and designing for manufacturing. She holds dual bachelor's degrees in chemistry from Butler University and biomedical engineering from Purdue University. Committed to innovation and quality in healthcare, Lindsey is focused on developing medical device solutions that enhance patient outcomes.
Pricing Information
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WIB-Pittsburgh
Pittsburgh@WomenInBio.org
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