Effective Change Management in Medical Device Manufacturing

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 »

Cyber Risk in the Life Sciences Industry

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 »

Combination Products: Can Partnerships Between Drug and Device Companies Streamline Efficiencies?

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 »

The Anatomy of an Effective Project Charter

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 »