Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

Moody’s: US Medical Device Firms Face Soft Organic Growth Prospects

US medical device manufacturers dealing with lower market demand and rising pricing pressure will rely more on acquisitions and stock maneuverings to offset challenging growth prospects.

Moody’s Investor Service (via MarketWatch) anticipates slow sales for medical device firms over the next 12 to 18 months—especially for devices such as orthopedics used in elective procedures and cardiac products drawing more regulatory scrutiny due to safety and effectiveness concerns.

A weak global economy will necessitate share buy-backs, acquisitions and dividends by many firms in order to minimize losses, according to Moody’s. The ratings agency expects manufacturers to primarily borrow capital in order to fund such activities, which could negatively impact their credit standing.