By Fran DeGrazio, executive editor
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Welcome to (or, back to) my two-part article series on Design Controls. In the previous installment, “Design Controls For Drug Delivery Devices, Part 1: A Process Primer,” I laid out foundational concepts, such as design inputs and outputs, as well as a simplified version of fundamental process steps, including design verification and validation, design review, and change controls. For the uninitiated or for those in need of a refresher, I certainly invite you to start with or return to that piece.
In this second and final installment, I offer, as promised, practical tips and solutions for the successful implementation of Design Controls in building a device or combination product that delivers a drug or biologic to a patient.
Getting Design Controls Underway
The first step is determining when to commence Design Controls in your product development process and timeline. Before initiating Design Controls, it is essential to assess the feasibility of integrating a device with a drug or biologic. In that early stage, identifying basic functionality and assessing the economic viability of a finished product are obvious, must-do activities. Only after this initial proof-of-concept stage, when a decision is made to proceed with actual execution on product development, should Design Controls be implemented.
Given that a drug-device combination product, both conceptually and practically, aligns the world of drug/biopharmaceutical formulation with the world of delivery systems, the process must start with a well-qualified and well-rounded project team. Who should be on it? Frankly, a strong team would include formulation development scientists, packaging engineers, device engineers, process engineers, medical experts, manufacturing personnel, and other stakeholders.
Documenting Design Controls
Within the cross-functional team, the design engineering organization typically owns the Design History File (DHF). The DHF is a complete record of the design and development process, proving that Design Controls were diligently embedded in the process and that all associated regulatory requirements have been addressed.
To enable this cross-functionality, I recommend leveraging software specifically designed for documenting R&D activities and related data collection for medical devices, drugs, and combination products. Using general software tools such as homegrown databases or Excel to capture data and hold reports will likely be cumbersome at best.
Frankly, managing knowledge is critical for execution due to the importance of capturing, integrating, and leveraging information not only within individual development programs but also across various programs, teams, and functions. The optimal system will bring together not only Design controls but Quality by Design (QbD), Human Factors Engineering (HFE), and Risk Management. Utilizing purpose-built software will ensure the use of structured data, which, based on my experience, is essential for facilitating the digital sharing of information.
Now that we know when to start, who to involve, and how to document the cross-functional work around Design Controls, I will add perspective on three critical, related elements of a well-thought-out and well-controlled design and development process. Those include risk management, compatibility, and compliance. It is my feeling that you cannot achieve a successful design control program without having these three factors interacting throughout the planning and framework.
Continue Reading…
Welcome to (or, back to) my two-part article series on Design Controls. In the previous installment, “