FDA’s Design Controls regulation can be an open book but sometimes hard to read. Interpretations of the various regulatory requirements contained within 21 CFR 820.30 can vary both between and within life science organizations. The challenge becomes interpreting the requirements and implementing them into your development processes in such a way that does not negatively impact product quality or your larger quality system.

FDA’s Design Controls regulation has no clear mandate as to the purpose of design reviews. Rather, they are concerned with seeing evidence these reviews are conducted at regular intervals by appropriate parties. Determining what data comes out of a design review is ultimately up to your organization’s needs and objectives.

Compliance from the start—why make it a priority in life science product development?

In life science industries, many believe that regulatory inspections are focused more on postmarket activities. This attitude isn’t surprising; however, its results can be detrimental. Many companies elect to focus on bolstering their postmarket compliance, allowing other regulatory activities such as design controls to lapse or deteriorate over time. Unfortunately for these companies, the truth about regulatory inspections is starkly different than their beliefs, and that can come back to haunt them.

There are many ways to make your life science product development more productive, but these can sometimes be short-term or surface fixes. There are far deeper and more ingrained organizational issues that must be tackled in order to push your company’s productivity further. Beyond compliance or development planning, there are important initiatives your business needs to address that can change how your organization behaves in favor of greater productivity.

Product development in life science industries is not always consistent; it naturally ebbs and flows depending on a variety of factors, such as: project reviews, technological breakthroughs, changes in personnel, and so on. However, if your organization is struggling with being productive, some larger issues need to be addressed. To improve productivity at your life science organization, there are six different approaches you can take.

Life science organizations are continuously attempting to handle the ever-changing needs of the marketplace—especially those of users and patients. With the rising number of retiring Baby Boomers set to double Medicare and Medicaid costs by 2020, it is advantageous for organizations to build products and services that meet the needs of this population. However, shifting demographics are causing growing pains that life science organizations need to factor in for long-term stability and growth.

FDA Form 483 inspectional observations can be disruptive to life science organizations, causing anything from delays in time to market to lost profit on currently marketed products. However, it’s vital to tackle the disruption to minimize these issues; procrastinating on or ignoring a 483 only makes the situation worse.

Risk analysis is a vital component of life science product development. However, because FDA and other regulatory bodies aren’t specific about how to conduct risk activities that they deem appropriate, some organizations struggle in implementation. For teams dealing with this, there are a handful of ways to bolster your risk analysis.