Industry Analysis & Industry Trends
Equipped for growth
Robotic surgery equipment will continue to comprise a fast-growing segment of the medical device industry. Growing acceptance of minimally invasive surgery (MIS) will bolster industry demand, as surgeons require the equipment to perform complex procedures in tight spaces. While high regulations will likely inhibit profit margins and reduce innovation activity, the industry will experience substantial growth in the next five years.
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Industry Report - Starting a New Business Chapter
Several barriers to entry exist in this industry, including heavy regulation, moderate investment costs, high competition and a fast rate of technological change. In this industry, most goods are manufactured under patent. This factor acts as a barrier to entry into certain markets.
Government policy is the most significant barrier for new entrants. Essentially, medical devices are subject to the general controls of the Federal Food Drug & Cosmetic (FD&C) Act, which are contained in the final procedural regulations in Title 21 Code of Federal Regulations Part 800-1200 (21 CFR Parts 800-1299). These controls are the baseline requirements that apply to all medical devices, necessary for marketing, proper labeling and monitoring performance... purchase to read more