A familiar issue to most life science organizations is compliance—making sure your products and services meet the regulatory requirements necessary for clearance to market. Especially for growing businesses, ensuring compliance with things like design controls can prove to be a real challenge. To improve your teams’ efforts with design controls compliance, here are some quick tips to employ in your organization.

In March 2019, FDA’s Center for Devices and Radiological Health (CDRH) began their reorganization initiative first announced the year before. The Center has taken a major step forward in this process by launching the Office of Product Evaluation and Quality (OPEQ) in May 2019. With this new office, a number of important changes begin taking place at CDRH.

Implementing a robust risk management program into your life science organization requires a solid understanding of your needs, capacities, and goals. Whether to improve alignment with regulatory requirements and standards or adjust your overall risk procedures, identifying what you can do to bolster your current risk management programs is vital to promoting long-term growth. There are many ways out there to improve your risk management, but there are a few worth using as a baseline to build on.

Over the past few years, life science organizations have produced and marketed more products and services intended for mental health treatment. While certainly not a novel effort by the industry, the increased pace reflects cultural, economic, and scientific shifts that are changing the way we view and treat mental illness. For many organizations joining this new wave, the territory is unfamiliar and uncertain. However, there are a few baseline concerns that, once understood, can help development teams push for products meant to treat mental illness.

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.