Medical device startups: Here ’s how you handle regulatory and reimbursement

The two “Rs” — regulatory and reimbursement — are critical elements of the environment in which a medical device product is developed. Bill Betten, Betten Systems Solutions [Photo by Simon Launay on Unsplash]This is the fourth in a series of articles that discusses the design of innovative products in the highly regulated medical environment.  But the “environmental” factors of regulatory and reimbursement actually influence all stages of the development. They impact everything from the process to the plan and the requirements. You need to consider their influence at the earliest stages of the development effort. This series focuses on the definition and execution of product development activities post-funding and includes the following: Idea – Without it, nothing to be developed Process – The structure for development Plan – The blueprint Requirements – The details Regulatory/Reimbursement – Critical to the medical device space (The article you’re reading.) Verification/Validation – The right product doing the right thing For the purposes of this article, I’ve included regulatory and reimbursement together, but they impact the product in very different fashions, particularly when international markets are considered. How to handle regulatory Let’s first consider the regulatory impact on the product development process.  While I’ll use the U.S. and the FDA as the example, virtually every other market in the world has some form of regulat...
Source: Mass Device - Category: Medical Devices Authors: Tags: Regulatory/Compliance Research & Development bettensystemssolutions Reimbursement startups Source Type: news