Of all the dynamic aspects of life science product development, risk management is one of the most important. From an organizational standpoint, controlling risks associated with your products protects your business interests; likewise, it ensures higher levels of care and safety for patients and users. When done in an iterative fashion from the start of development, thorough risk control can have significant impacts on your products, services, and organization.

After February 21, 2019, new FDA requirements for clinical investigations went into effect. These requirements are intended to ensure clinical data quality and integrity, as well as to protect human subjects’ well-being and safety. As a way of keeping domestic and international premarket medical device submissions consistent for regulatory review, the new acceptance criteria take aim at very particular issues in the compliance process for clinical investigations.

Managing the risks of your life science product can be a complex task. Some risks must be assumed, while others need to be controlled, transferred, monitored, or designed out of the product entirely. Implementing risk controls to reduce and manage the impact of associated risks, as well as their probability of occurrence, is the most common approach manufacturers leverage in their design and development efforts.

For many life science organizations, long-term growth is a primary goal. Whether focused on greater stability, increased revenues, or more diverse product portfolios, the need for expansion can drive how a company thinks and operates. However, pushing to expand your business is not without its difficulties.

As your life science organization advances and begins to expand its teams and portfolios, opportunities for productive, long-term growth present themselves. However, these opportunities aren’t always realized to their fullest extent or are missed out on entirely. If you’re struggling to grow your life science company, what could be slowing you down? To answer this question, there are four key areas you should take care of: process maturity, people, planning, and product portfolio management.

The medical device industry is in a state of immense change. Powered by technology, there are now incredible opportunities to improve patient outcomes, offer new and dynamic treatments, and help your organization thrive as a result. However, this technological change brings with it a number of new and evolving risk factors specific to our modern landscape.

Life science product development can sometimes be a niche enterprise, and for good reason—certain populations and conditions require specific solutions and treatments. Providing these can be a boon to both patient outcomes and your organization’s bottom line, as well as progressing that particular field of treatment.

We have entered the age of big data—the volume of data gathered in healthcare alone is becoming larger and more complex as the days go by. This wealth of information has sparked the rise of open access databases for public and commercial use around the globe. All this freely available data can be a boon to innovation in life sciences. However, the risks these databases present, and the approaches regulatory agencies take toward those risks, are important considerations for your organization.

Labeling is an important part of FDA’s quality system regulation for medical devices. So important, in fact, that labeling regulations are captured in several distinct parts of 21 CFR Subchapter H – Medical Devices. These sections cover how devices are tracked, the unique device identifiers (UDIs) and universal product codes (UPCs) necessary for that tracking, and specific labeling requirements.