This article shares tips such as knowing when to apply for your 510(k) device clearance, mapping out an application strategy, using the presubmission process, responding to FDA rejection of your application, and more.
By Meghan Scanlon, SVP and president, urology and pelvic health, Boston Scientific
Boston Scientific's SVP and president of urology and pelvic health shares her three lessons learned after working in the industry for two decades. Her takeaways have served as her guiding principles over the years and have become the core pillars of her personal and professional philosophy.
The medical device market is a land of both opportunity and risk for enthusiastic, innovative developers. Understanding the most common challenges device developers face, and how to successfully navigate them, can provide the competitive edge an entrepreneur needs to succeed in this environment.
By Mike Driscoll,Carclo Technical Plastics
When developing a part or device for the medical or optic industries, the goal is always to get that part to market as quickly as possible. The key to doing just that: developing a strong relationship with a molder early in the part design process.
When designing or considering the manufacturing process for a medical device, there’s an element that often gets left until the last minute: packaging. The right packaging can reduce costs, potentially optimize the sterilization processes, and aid in the manufacturing process.
Nordson MEDICAL utilizes engineering expertise along with a software platform, SimShaft™, to balance key characteristics to optimize the performance of delivery systems. Five key features to consider will be discussed in greater detail.