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.

Drug stability reporting is an integral part of pharmaceutical product compliance. For both the development of new drug products and the required annual monitoring processes, ensuring stability reports are done thoroughly and in a timely fashion is key. Quality is also important; the fidelity and integrity of all the data generated from drug stability studies and aggregated into your reports can impact your organization’s ability to market your drug products.

Implementing a critical-to-quality (CTQ) program in your life science organization’s product development process can be a valuable effort. Identifying CTQ requirements and working through both CTQ Flowdown and Flowup activities can lead to more robust, well-made products that meet your user needs.

Many life science organizations treat design thinking and design controls as separate product development stages. In reality, they can overlap; while this feels counterintuitive to some, it’s actually an important point that teams need to manage. For a more robust product development process, your teams should be thinking about how to use these two aspects of product development together. How design thinking can impact design controls is valuable to understand and evaluate as part of your organization’s plans for long-term growth.

The pace at which news travels nowadays makes it difficult to keep up with the latest life science industry trends. However, here are some great resources that we think are worth your attention.

Life science product development is all about process: to ensure safety and effectiveness of your product, processes must be in place to maintain high quality in your design and development work. In smaller organizations, these processes and procedures can be fairly easy to control and manage. However, as your business grows, so do the scope and complexity of your development activities. To maintain and improve your life science product development processes, there are a handful of methods your organization can undertake.