There are multiple challenges that many startups and manufacturers encounter when developing a product for the medical industry. The presentation will focus on key differences between product development and medical device development including quality systems, design best practices and roadblocks, manufacturing best practices and roadblocks, device classification, ISO13485 certification and more.
Medical device development is no walk in the park and if each step in the development and manufacturing process is not taken with care, the product will fail, or worse, people can get sick and die. Miller will provide his expert analysis on high-level components to the development process. His presentation will identify traits that make manufacturers more attractive to companies who need a manufacturing partner, as well as FDA requirements necessary for manufacturers to comply with. Product engineers and designers will learn how to overcome the hurdles in the development process, including the importance of documentation and the establishment of procedures that create two-way communication with manufacturing.