Frank Engel Rasmussen, director of business development, MGS highlights the importance of designing reliable drug delivery systems that scale.
MGS
The therapeutic value of a drug is realised when the delivery system is precise, reliable and usable for patients. As more therapies move toward self-administration, delivery systems have shifted from supporting roles to active drivers of adherence, clinical outcomes and patient safety. Systems that fail to support real-world environments risk undermining even the most promising therapies.
Nowhere is this more apparent than in biologics and GLP-1 therapies, which often require advanced self-injection systems patients can operate independently at home. These expectations raise the bar for manufacturers to scale solutions that meet regulatory requirements, cost and speed. Meeting these demands requires a fully integrated design and development approach that anticipates complexity early, embeds manufacturability and streamlines the path to commercialisation.
To ensure safe, intuitive use, teams apply human factors to align clinical intent with everyday operation. This structured process defines users and use environments, analyses risks and critical tasks, and validates usability through formative and summative evaluations. By aligning human factors with manufacturing from the outset, pharmaceutical companies mitigate risk, accelerate speed-to-market and deliver therapies that patients can use safely and confidently.
Designing with the patient in mind
Designing for patient usability is a regulatory, clinical and commercial imperative. As therapies shift toward self-administration, success depends on how well delivery systems fit into real patients' lives. For those managing chronic conditions, the delivery system is not just a device, it is part of daily life. Designs that simplify training, reduce injection anxiety or accommodate limited dexterity across user groups directly influence adherence and outcomes.
Addressing these needs early also strengthens development. Patient-centric insights guide human factors engineering and integration, which reduces design cycles, improves regulatory alignment and de-risks scale-up. This approach accelerates timelines while building confidence in both the product and process.
Formative usability testing and contextual research translate patient insights into design inputs well before summative validation is conducted. Whether it is a grip too difficult for patients with limited dexterity or user instructions that create confusion, resolving challenges early prevents costly rework and delays.
When the patient experience is embedded from the start, the result is a delivery system that performs consistently, earns patient trust and supports long-term therapeutic and commercial success.
Upfront design done right
Too often, drug delivery programs encounter late-stage issues that stronger early-stage design could have prevented. Short-term cost and time pressures tempt teams to skip usability testing, simulation or manufacturability reviews, only to face delays and rework later. Reframing early product development as a time saver, not a cost driver, changes the outcome.
A related pitfall is siloed development. When designers, development engineers, regulatory specialists, usability experts and manufacturing teams work in isolation with limited visibility into each other’s requirements, devices may appear viable on paper but fall short in regulatory submission or fail in the hands of users. Cross-functional integration closes these gaps by aligning expertise early to clarify user needs and manufacturability, which accelerates decision-making, reduces rework and keeps programs on track for scale-up and market performance.
That integration is reinforced by specialised disciplines whose expertise goes beyond traditional development. Usability engineers run formative studies that expose design flaws before validation. To predict product reliability, simulation experts use finite element analysis and mould flow modelling long before physical prototypes are built. Regulatory strategists guide structured risk management to keep documentation aligned with evolving requirements. Applied early, an integrated mix of design intent, engineering rigour, regulatory alignment, usability evidence and manufacturing readiness ensures devices are manufacturable, compliant and reliable, delivering systems patients can trust.
The challenge
Modern drug delivery systems must satisfy demanding user, technical and regulatory requirements, often under compressed development cycles. Devices are expected to deliver viscous biologics with precision, remain intuitive for diverse patient populations and comply with evolving global standards.
Meeting these expectations also depends on addressing the equally critical challenge of patient needs. Ease of use, adherence risk, training requirements, safety concerns and lifestyle fit all influence whether therapies succeed outside the clinic. Each of these factors adds complexity that, if overlooked, can undermine both outcomes and compliance.
Left unaddressed, these pressures often surface as late-stage risks. Usability issues, manufacturability gaps or documentation delays can jeopardise launch windows and drive up costs. The best defence is early planning. Embedding usability engineering, design for manufacturability and regulatory foresight during feasibility shifts teams from reacting to problems to proactively resolving them. This integrated approach ensures a smoother transition from design freeze through validated production and ultimately delivers systems patients can trust.
Human-centred design
Usability engineering provides a structured process from formative research through summative validation that ensures delivery systems meet both patient needs and regulatory requirements. In drug delivery, this discipline translates user needs into systems that are safe, intuitive and standards aligned. That includes defining activation forces patients can reliably achieve, integrating tactile or visual feedback that confirms dose delivery and shaping designs that support one-handed use or low vision.
Approaches such as formative usability testing, contextual inquiry and iterative prototyping uncover potential challenges early and ground design decisions in real-world use. Mapping patient journeys in diverse environments and testing prototypes against those scenarios transforms abstract user needs into quantifiable engineering requirements. Metrics like cap removal torque or feedback clicks become both patient-centric features and measurable inputs for verification.
By converting user insights into structured design inputs, teams reduce variability, strengthen regulatory submissions and ensure devices are both usable for patients and scalable for production.
Cross-functional integration
Scalable and reliable drug delivery systems are developed faster and more efficiently when design, usability and regulatory considerations align from the start. Usability and human factors engineering establish the foundation by defining patient needs and risk profiles that guide design decisions. Mechanical engineers then translate these inputs into CAD models that can be assessed for manufacturability, assembly feasibility and automation readiness.
Once CAD models are established, simulation tests their performance virtually, highlighting structural limits and manufacturability challenges before physical prototypes are built. These insights guide refinements that reduce costly iterations downstream. In parallel, risk management frameworks capture potential failure modes, and regulatory specialists map design choices to pathway requirements so compliance evolves alongside development.
Too often these steps are skipped or introduced too late, leaving critical risks unaddressed until development is far advanced. The result is misaligned specifications, reactive decision-making and costly delays. Integrating these disciplines from the outset embeds feasibility, safety and scalability into the process. The result is greater efficiency, fewer redesigns and faster progression to validated production, supporting therapies that patients can use consistently and successfully.
Simulation to physical testing
Simulation and modelling begin long before tooling is cut, using methods such as finite element analysis (FEA), mould flow and material modelling to identify potential issues early. These models highlight structural vulnerabilities, cycle time constraints and dose accuracy sensitivities under worst case conditions, allowing design teams to refine components before costly prototypes are produced.
Material modelling further strengthens these insights by creating virtual twins of polymers and device components. These digital representations allow teams to predict how materials will behave under stress, processing or sterilisation and to refine designs accordingly before moving to physical builds. With these parameters defined, early physical testing validates assumptions and confirms that systems perform as intended under real-world handling.
This integrated approach builds confidence in device performance while reducing late-stage redesigns and accelerating readiness for scale-up and regulatory approval.
From design to approval
Regulatory success depends on structured end-to-end traceability. Connecting user needs, risk controls, design inputs and verification plans early in development positions teams to meet U.S. Food and Drug Administration (FDA) and EU Medical Device Regulation (EU MDR) expectations, reduce review cycles and move confidently toward approval.
For all drug delivery devices, regulators now require use-related risk analysis and human factors evaluation that demonstrate devices can be used safely and effectively by intended users. This makes usability engineering, risk analysis and design control essential inputs, not optional checks. Showing that risks are identified, addressed and documented gives reviewers confidence that devices are safe and effective in daily use.
For combination products in particular, framing design control and usability engineering within FDA’s human factors guidance is critical. Human factors engineering defines critical tasks, those that if performed incorrectly could harm the patient. Building use-related risk analysis and usability testing around those tasks strengthens regulatory submissions and makes them far more defensible.
Quality management systems that follow ISO 13485 and risk management processes aligned with ISO 14971 provide the structure to capture and mitigate these risks consistently. Incorporating design control methods from IEC 62366-1 ensures usability engineering is not an afterthought but a formalised part of development. This integration makes it clear to regulators how patient needs, risk mitigations and verification steps are linked within the design history file.
By embedding regulatory logic into both design and documentation, companies reduce the likelihood of rework, prevent gaps that prompt questions from the notified body and build reviewer trust. The outcome is de-risked submissions and more predictable progress through FDA and EU MDR pathways.
A new standard for drug delivery development
Biologics, GLP-1 therapies and self-administration are redefining expectations. Today’s delivery systems must be intuitive for patients, efficient to manufacture and credible to regulators.
Meeting those demands requires anticipating complexity, designing for scale and regulatory readiness from the start. The new standard is integrated collaboration that brings together designers, development engineers, usability experts, regulatory specialists and manufacturing teams. Aligning design decisions with manufacturability, usability and compliance requirements from day one builds delivery systems that are both patient-centred and production-ready.
For manufacturers, this cohesive strategy replaces fragmented, reactive processes with development that integrates design, automation, simulation, testing and regulatory foresight. This approach delivers systems that not only meet today’s standards but also position drug delivery programs to scale with confidence in an evolving regulatory landscape.