Coming up with the design inputs for your life science product is not an easy task; your teams need to make sure their scope and applicability are appropriate in relation to the needs of your users and patients. But before you get to that point, you have to first generate the ideas and insights that will become those design inputs. Where do you find this data?

The transition between innovation stages and design controls is not simple to manage. It takes a lot of planning, preparation, and diligence to do well. Many life science organizations struggle in moving between these stages, and pinpointing the causes for this can be difficult. When evaluating your organization’s struggle with moving between innovation and design controls, there are four key areas to look at.

What does it take to build a robust risk management program at your life science organization?

In February 2019, FDA published a final guidance document that expanded parts of its 510(k) premarket notification program. The guidance establishes a new pathway: The Safety and Performance Based 510(k). With this novel premarket pathway comes several new opportunities and benefits to device manufacturers, plus some challenges. Understanding these benefits and challenges together—as well as where the Safety and Performance 510(k) fits in the premarket environment—can help your organization better navigate your device’s path to regulatory submission.

In order to lay the foundations of a robust risk management program at your life science organization, many important activities must be undertaken. One particularly critical component worth considering is an iterative approach to risk management.

The design and development planning stage can be an exciting time for your life science organization. However, it can also be stressful. Between making sure your teams can handle bringing your product from concept to realization and ensuring both compliance and quality throughout the process, there’s a lot you’ll have to manage. This can be very overwhelming.

Premarket notification is an intricate process for medical device manufacturers to navigate. Levels of risk, assurances of safety and effectiveness, device type, intended use, and a whole manner of other factors can shift your submission from PMA to De Novo to 510(k) in the blink of an eye.

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.