December 7, 2021
Developing a medical device is an extensive undertaking that requires expertise in engineering, manufacturing, regulatory affairs, and quality assurance, to name a few. Having a thorough understanding of the medical device development process and its key elements at the outset is essential to planning the development of an approvable product and can help anticipate timing and costs. This session will take attendees along the journey of creating a medical device from concept to market and provide high-level strategies to consider along the way. A few case studies will be presented to demonstrate the importance of all aspects of the process and how they yield a successful product launch and beyond.
Jennifer Palinchik, BSBME, MBA, is President of JALEX Medical, LLC. The company is located just outside of Cleveland, OH and provides Medical Device Design and Regulatory Consultation services to companies, hospitals, and surgeon inventors seeking entrance into the Medical Device Market. She brings over 18 years of experience in the field, specializing in design and development and regulatory affairs activities. Under her leadership, the company has experienced year over year growth and has achieved a significant amount of device clearances thru the Food and Drug Administration (FDA). Earlier in her career, she performed artificial pancreas and kidney stem cell research for animal studies and clinical trials. She is an active member in regional organizations that promote biomedical and healthcare in Northeast Ohio, has been a guest speaker at conferences for the medical industry, sits on several advisory boards, and has been featured in several local and national publications. She holds a Bachelor of Science in Biomedical Engineering degree from the University of Toledo and a Master in Business Administration in Executive Management & Entrepreneurship degree from Ashland University.
Learn more about Jennifer and JALEX Medical at www.jalexmedical.com