Navigating Medical Device Development as a Start-Up with Jennifer Palinchik, President, JALEX Medical
CNY Biotech Accelerator, Upstate Medical University presents Navigating Medical Device Development as a Start-Up
Presenter: Jennifer Palinchik, President, JALEX Medical
Register in advance for this VIRTUAL presentation:
Medical devices help surgeons and physicians diagnose and treat disease or injury. Since they are used directly for patient care, medical devices are subject to strict regulations by regulatory agencies like the FDA (US). Without extensive experience, navigating how to bring a medical device to market can be challenging. Many organizations engage a medical device consultant to develop and execute the process.
Medical device consultants are experts familiar with all requirements of medical device development, approval, and manufacturing, guiding clients from concept to market in the most efficient manner possible. An experienced medical device consultant assists with each stage of the process, beginning with development of the regulatory strategy, to concept and prototype work, to product development and manufacturing, then proceeding through verification and validation, and finally achieving regulatory clearance and performing post-market surveillance.
To give you the best chance of success, it is critical to engage experts with extensive and appropriate experience in the following areas:
- Effective and transparent communications
- Solid design and engineering capabilities
- The ability to efficiently meet your regulatory demands
- Commitment to developing and maintaining exceptional product quality
- Dedication to your project, every step of the way
This presentation will thoroughly explain 1) the importance of choosing the right stakeholders to support you in development of your product, and 2) the medical device development process.
About Jennifer Palinchik
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 19 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