Executing Successful Large-Scale Change

Over the next few years, the global combination products market is set to grow at a compound annual growth rate of 7.9 percent, creating opportunities for new organizations to enter the market while putting pressure on you to reassess your organization’s operational model and consider the need for large-scale change. The ability of your organization to adapt to change could mean the difference between staying profitable and going broke in a competitive market. Follow these tips to make large-scale change work for you. Read more »

How Drug and Medical Device Manufacturers Can Accurately Communicate about Products Online

Using online platforms like Twitter, Facebook, Tumblr, LinkedIn, and others is a standard component of communicating with consumers in today’s business. And, it’s no different for drug and medical device manufacturers. In the life sciences industry, it’s even more critical to know how to communicate via social media, while still meeting regulatory standards. Here is some insight. Read more »

Obtaining a Combination Products Jurisdictional Designation

Combination products, by their very nature, are harder for the FDA to regulate than singular products. The former can be any type of manufactured goods that falls under the specific FDA guidelines and includes some combination of drugs, biologics, and medical devices. Since the FDA has created a more streamlined way to regulate these products, attempting to obtain a jurisdictional designation for combination products is the first step manufacturers should take toward meeting this regulation. Read more »

Understanding the Intent of FDA’s Design Control Regulation

Every manufacturer must meet a set of design control regulations given by the FDA for each medical device they produce. An important part of the product manufacturing process, each of these design control requirements must be relevant to all devices, no matter how complicated or simple they are. Nevertheless, many manufacturers put too much emphasis on simply following the FDA’s regulations and not enough on actually understanding them – resulting in much longer product approval timeframes. Read more »

Establishing Control Over the Quality of Your Biologic

When it comes to creating any form of medication, reputation is everything. Customers expect their medicine to have the correct ingredients, to be safe, and to work as described, with limited side effects. Should a medication fail to live up to those expectations, a company’s reputation could be at stake, and an entire product line might be scrapped due to concerns over efficacy or safety. Read more »

The Growth Outlook for the Global Combination Products Market

The global combination products market is growing and will continue to do so over the next five years. A study conducted earlier this year has forecasted that this market is likely to grow at a compound annual growth rate (CAGR) of 7.9% between 2013 and 2019. While this is fantastic news in many ways for your combination device manufacturing company, there are still important factors to consider such as the reasons behind the growth, the rise in competition it could cause, and the trends that are likely to follow. Read more »