By Fran DeGrazio, executive editor
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A concerning trend I have noticed over the last several years is the increasing number of experienced scientific and technical personnel transitioning from biopharma to retirement. Their departure makes clear that the knowledge drain is real. For that reason, frankly, there needs to be a focused effort on educating those still in the industry, especially those much earlier in their careers. As an industry veteran myself, it is my intent to periodically use forums like this one to give back to the industry by providing foundational information to those whose industry experience may have thus far left key knowledge gaps.
One of the most critical topics for knowledge-bolstering is design controls. In the development of combination products and other drug delivery devices, Design controls ensure that the results of product development processes meet user needs and specified requirements. This article will lay out some of the most basic and, therefore, fundamental concepts. In a follow-up article, I will return to the topic of design controls to offer recommendations and tips for implementation.
QbD Is Not Design Controls
Design controls are crucial for combination product and medical device development, as mandated by various FDA regulations, such as 21 CFR 820.30 and an associated FDA guidance entitled Design Control Guidance for Medical Device Manufacturers. Additionally, ISO 13485 outlines design controls as part of section 7.3. However, individuals whose industry experience has been primarily in pharmaceutical development may be acquainted with control-related concepts such as Quality by Design (QbD) but may not be familiar with design controls for devices. A recommended practice for developing drug products, QbD shares similarities with design controls in being risk-based and in focusing on quality from the beginning rather than solely relying on testing at the end. However, in addition to using differing terminology, QbD is not mandated by law. Because, in my view, the future of drug delivery is in drug-device combination products; understanding only the pharmaceutical side of things is not enough.
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A concerning trend I have noticed over the last several years is the increasing number of experienced scientific and technical personnel transitioning from biopharma to retirement. Their departure makes clear that the knowledge drain is real. For that reason, frankly, there needs to be a focused effort on educating those still in the industry, especially those much earlier in their careers. As an industry veteran myself, it is my intent to periodically use forums like this one to give back to the industry by providing foundational information to those whose industry experience may have thus far left key knowledge gaps.