Combination products, made up of two or more components, have skyrocketed in the healthcare industry in recent years; however, complying with evolving legislation can be a nightmare for manufacturers. Read more »
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 be a combination product. Read more »
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 medical products regulated in light of their constituent parts. Read more »
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 concept that ensures change is implemented in compliance with quality and regulatory requirements. It is the most critical element in a quality management system — inadequate change management creates a risk of non-compliance. Read more »
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 percent increase in cyber-attacks over the last five years, and experts predict that it is only a matter of time before a large-scale attack occurs. Read more »
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 Lobbyists for the medical device industry have repeatedly sought to have the tax repealed, arguing that it: Read more »
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. Read more »
The drug-device combination market is booming. On track to generate more than $115 billion by 2019, the industry is expected to overtake the growth of both the medical device and pharmaceutical sectors. Strategic partnerships between drug and device companies are a by-product of this sudden growth, and this one-size-fits-all model can significantly reduce costs, improve productivity and streamline processes. Here are three reasons why. Read more »
Projects move innovations from concept to commercialization. They can be standalone or part of a series, yet their aim always remains the same: to achieve the goals and objectives that will give you a competitive advantage in your market. A project charter enables you to first define these goals and objectives, and then communicate them to your staff and stakeholders in order to ensure buy-in and support for your project initiation activities. Read more »
Six Sigma is a set of strategies that focuses on improving the quality of products and services. Integral to the initiative is the DMADV method — DMADV is an acronym for the five main steps that make up the strategy: Read more »