The launch of a new medical device is a time of great excitement. After all, you’re creating something that could potentially improve or even save lives. While the documentation of a new medical device isn’t quite so exhilarating, it’s crucial to your success. Read more »

In the realm of drug manufacturing, sterile products continue to pose challenges. With process failures identified nearly every year, improvement is a continual goal. This has led to exciting innovations such as barrier systems, innovative seals, ready to use components, stoppers, isolators, closed vial filling and cap overseals. Read more »

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 »

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 »

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 »

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 »

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 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 »

Medical device manufacturing is one of the most competitive markets there are and also one of the most highly regulated. In the past few years, the market has faced 510(k) reforms and a new meaning to substantial equivalence, steadily increasing operational costs, a new 2.3% sales tax on medical device supplies, and other significant changes. Read more »

Risk management is one of the most important parts of the manufacturing process when it comes to developing safe, effective, and beneficial medical devices. Your company needs to implement risk management at all levels in order to create the kind of products consumers and regulators want, which shows just how necessary the process is. Read more »