Imagine being handed a device that’s meant to help you — but instead feels intimidating, confusing, or painful to use. For millions of patients around the world, that’s the reality of managing treatment at home. Across ailments, the burden of self-administered care is growing, and with it, the importance of designing drug-delivery systems designed with the patient experience at their core.
Patient-centric design goes beyond usability metrics and checklists. It’s about building trust, reducing friction and enabling people to manage their health with confidence and dignity. The success of modern therapies increasingly depends not just on the drug, but on the delivery — and how it seamlessly fits into the patient’s life.
Yet, designing for real-world patients is easier said than done. From regulatory constraints to engineering and manufacturability limitations, developing truly patient-centric drug-delivery devices requires navigating a complex web of challenges.
Challenges in Drug-Delivery Device Development
Creating truly patient-centric drug-delivery devices is rarely straightforward. Behind every successful product lies a complex development journey shaped by competing priorities. Designing with the patient in mind means navigating each of these dimensions without losing sight of the human experience at the center. The path from concept to commercial device is full of nuance, and each step presents its own set of trade-offs that can impact both outcomes and adherence.
Regulatory Compliance. Product teams must constantly balance the needs of real-world users with stringent regulatory frameworks like the U.S. Food and Drug Administration (FDA) and Europe’s Medical Device Regulation (MDR). This challenge intensifies when working on combination products, where drug and device components must harmonize seamlessly while meeting the rigorous standards applicable to both.
To overcome complexity in regulatory compliance, teams should integrate regulatory strategy early — ideally from concept through design validation — rather than treating it as a late-stage hurdle. Close collaboration with regulatory experts, proactive alignment with FDA and MDR guidance, and thorough documentation of human factors and risk mitigation efforts can streamline approvals while preserving design intent. Early engagement with regulatory bodies and iterative usability testing can also help identify and resolve potential issues before they become barriers.
Human Factors Engineering. Drug-delivery devices must accommodate a wide range of users. A parent managing their child’s chronic condition and an older adult with reduced dexterity may have diverse needs — but both rely on the device to work simply, reliably and safely. Designing for this diversity calls for solutions that are intuitive, accessible and functionally sound, regardless of who is using them.
Overcoming human factors engineering challenges requires a development process grounded in deep, ongoing user insight. This begins early with qualitative interviews and direct observations to understand how patients interact with devices in real-life contexts. User research throughout the development process evolves to presenting users with prototypes, mock-ups, or sketches to gather real-time input that allows teams to make improvements based on user feedback.
Technological Advancements. Layered on top of usability is the influence of technology. Patients are increasingly familiar with smart devices in their everyday lives and expect similar features — like wireless connectivity, app integration and real-time feedback — from their medical devices. These expectations are raising the bar for design while introducing new human-centric challenges in data privacy, cybersecurity, and beyond.
A multidisciplinary approach can support an intuitive flow through digital screens and accelerate cognitive understanding by the user. Integrating design, engineering, and software expertise with usability, quality, and regulatory input enables the development of secure, transparent, patient-centric products that protect user trust and safety. Just as with physical usability, digital interactions must be intuitive, unobtrusive, and aligned with the realities of patient behavior. When done well, smart features not only enhance functionality but also strengthen engagement, adherence, and the overall therapeutic experience.
Manufacturability. Even the most thoughtful, compliant, and technologically advanced device can experience challenges with manufacturability. The biggest challenge? The most patient-friendly design isn’t always the easiest or most cost-effective to produce at scale. Turning a prototype into a commercially viable product requires close collaboration — and sometimes compromise — between design, engineering, and manufacturing teams to strike the right balance between usability, manufacturability, and assembly. Every decision — materials, mechanisms, assembly processes — must support not just innovation, but scalability, repeatability and affordability.
When design intent is at odds with manufacturability, the answer often lies in early-stage discussions. Rather than compromising usability after the fact, high-performing teams bring designers, development engineers and manufacturing experts together into the design phase to explore alternative solutions that preserve the core patient experience while ensuring manufacturability. This collaborative give-and-take, guided by clear priorities and shared goals, helps prevent costly late-stage redesigns and ensures the final product remains true to both its functional and human-centered event.
The Importance of Patient-Centric Design
For many patients, using a drug-delivery device isn’t just a treatment plan — it’s part of daily life. It may happen first thing in the morning, in a crowded room or during a moment of heightened stress or pain. In those moments, the device must work — reliably, intuitively, and without hesitation. There’s no room for second-guessing or confusion when someone’s health is on the line. When a device feels difficult, intimidating, or disruptive, the risk isn’t just inconvenience — it’s non-adherence. Over time, that can compromise outcomes, erode trust and ultimately reduce the effectiveness of even the most advanced therapies.
That’s why patient-centric design is more than a trend; it’s a fundamental shift in how devices are designed, manufactured and evaluated. It recognizes that therapeutic success depends not only on what’s being delivered, but on how easily and confidently patients can use it.
Devices must be designed to simplify complex treatment regimens and reduce the potential for user error. Intuitive interfaces, ergonomic features and even customizable elements can make the difference between a product that’s tolerated and one that’s embraced. When patients feel confident using a device, they’re more likely to use it correctly — and consistently.
When approaching designs with a user-centric mindset, individuals may evaluate:
Desirability to ensure the product resonates with the user.
Feasibility to guarantee it can be developed with current technologies and processes.
Viability to confirm it meets business and regulatory objectives.
Balancing all three dimensions is essential for delivering impactful, patient-centered solutions that succeed both clinically and commercially.
Innovations in Drug Delivery
As patient-centric design continues to shape healthcare, it’s also driving a wave of innovation in drug-delivery technologies aimed at improving experience and outcomes. At the forefront of this transformation are next-generation devices that are not only redefining how medications are administered but are also elevating the standard of care through their blend of technology, design and functionality.
These next-generation products include:
Autoinjectors: Provide convenient, often single-handed self-injection; reduce anxiety and improve ease of use for patients with chronic conditions.
Wearable Injectors: Enable delivery of larger drug volumes over extended periods; support at-home care for treatments traditionally limited to clinical settings.
Smart Drug-Delivery Devices: Integrate digital features such as connectivity, sensors and data tracking to enhance patient engagement and healthcare provider insight.
These next-generation devices are changing the way patients interact with their therapies. Features like real-time feedback, dose tracking and usage reminders do more than just add convenience. They improve adherence. With intuitive interfaces and digital support tools, patients are more likely to follow their prescribed regimens, leading to better therapeutic outcomes and reduced complications. In this evolving landscape, innovation isn’t just about what devices can do. It’s about how seamlessly they fit into real lives.
Best Practices for Collaboration
Bringing a drug-delivery device from concept to market is a complex endeavor that requires more than technical excellence. It demands seamless collaboration between device companies and their contract development and manufacturing organization (CDMO), with partnerships rooted in transparency, shared purpose and active engagement across disciplines.
One of the foundational elements of effective collaboration is aligning goals early in the process. Both teams must develop a mutual understanding of what success looks like — not just from a commercial standpoint but also in terms of patient impact and healthcare system efficiency. When objectives are clearly defined and jointly owned, teams can make faster, more confident decisions throughout development.
Another key best practice is cross-disciplinary collaboration. Successful device development depends on input from diverse experts, including:
Designers, who work alongside customers to create designs that blend aesthetics, patient comfort and performance along with packaging, intuitive instructions, and more.
Development engineers, who ensure technical feasibility and design for manufacturability (DFM) while building in reliable and efficient functionality at scale.
Specialists, who guide compliance and regulatory, quality and usability aspects of the device development from early concept through final submission.
Moldmakers, who partner with design and development to design and build reliable, consistent tooling.
Manufacturing experts, who ensure that devices are produced and assembled to exacting standards with consistency, quality, and efficiency for optimal performance.
Engaging these roles from the outset ensures that usability, performance and regulatory alignment are built into the device — not retrofitted late in the game with added costs and time.
Finally, incorporating feedback and iterative design in early-stage development is essential to delivering a refined, high-performing product faster. Patient insights, usability testing, and regulatory feedback should inform development checkpoints, allowing for adjustments based on real-world data. Just as critical is the early involvement of a CDMO who can provide expert insights into materials, processes and assembly methods that uncover production challenges before they become costly setbacks. When user feedback and supplier expertise are integrated from the outset, the result is a device that’s not only safe, intuitive and compliant — but also ready for scalable production.
When teams commit to shared goals, interdisciplinary teamwork and continuous feedback, they create a dynamic framework for delivering safe, effective, and patient-centric solutions to market — faster and with greater confidence.
Taking the Next Step
Patient-centric design, fueled by deep collaboration between pharmaceutical companies and their CDMO partners, will define the next generation of drug-delivery innovation. By uniting technical excellence with real-world empathy, the industry has the opportunity — and the responsibility — to deliver devices that are not only effective and compliant, but intuitive, empowering, and truly aligned with patients’ lives. The future of treatment outcomes depends on it.
This article was written by Frank Engel Rasmussen, Director of Business Development, MGS, Germantown, WI. For more information, visit here .
