Combination products are defined by the U.S. Food and Drug Administration as products that are some combination of drugs, biological products and/or devices. For instance, a medical device packaged with the drug it administers would [...]

The last three decades have seen vast growth in the development of therapeutic and diagnostic products that are a combination of two or more components. These products, termed combination products, are a distinct category of [...]

Change is an inherent part of the lifecycle of a medical device. It can affect all aspects of Current Good Manufacturing Practice (CGMP), from research and development to production and supply. Change management is a [...]

The life sciences industry is particularly vulnerable to cybercrime, given the pervasiveness of the electronic storage of high-value assets such as intellectual property and personal health information. Research by the Ponemon Institute reveals a 125 [...]

The Medical Device Tax has been a divisive issue since even before the Affordable Care Act (ACA) came into effect. Lobbyists for the medical device industry have repeatedly sought to have the tax repealed, arguing [...]

As a medical device manufacturer, you need growth and margins to be consistent. If either of these aspects are dwindling, then it may be time for you to reassess your business model. […]