
The respiratory mask industry is at a crossroads. The COVID-19 pandemic underscored their importance, transforming masks from simple functional tools to sophisticated healthcare solutions. However, fuelled by this unprecedented acceleration in innovation, designs must excel not only in protection, but also in promoting user compliance and integrating seamlessly into a variety of environments.
Now, roughly five years after the surge of advancement spurred by the pandemic, the respiratory mask industry faces another critical juncture. To foster breakthrough innovation, traditional key performance metrics such as comfort, fit and sealing remain critical but are no longer enough in the current environment. Success now relies on improving other principles such as creating a new user experience, ensuring adaptability and prioritising ergonomic design. But successfully achieving these demands navigating the challenges of creating product value, addressing competing design priorities, and meeting diverse user needs.
Giving response to these challenges, Eric Siu, Industrial Design Technical Lead at IDE Group, examines in this article how mask design principles can inspire broader advances in respiratory care. By applying these principles, the industry can create solutions that not only meet changing healthcare demands but also improve respiratory health outcomes.
The need of redefining value in a crowded market
In a highly saturated market like respiratory masks, a well-defined value proposition is key for product success. This goes from identifying the specific problems to be solved to aligning the product vision with stakeholder needs.
Traditional user interviews and surveys alone often fall short in uncovering the full scope of these needs, as users won’t explicitly articulate them. To bridge this gap, a qualitative approach is needed in uncovering patterns, synthesizing findings, and generating meaningful inputs to inform the value proposition.
Effective methods for collecting deeper qualitative data include issue clustering (themes), frame innovation (reframing), product benchmarking, value proposition design, and co-creation and evaluation sessions with external stakeholders (users, purchasers) and internal teams (clinical, marketing, SMEs, among others). Following these approaches can help uncover recurring patterns, conflicting needs, and core underlying problems across stakeholders and research insights. These methods enable the identification, creation, and testing of needs and value: from easing the user’s burden, instilling confidence in clinical prescribers through effectiveness, and reducing return visits, to ensuring financial viability for clinic administrators.
Integrating real feedback and trade-offs across all development stages
Delivering both a high acceptance and high performing mask requires a heightened focus on the fundamental relationship between comfort, fit, and sealing. These factors are critical for user acceptance, population coverage (fit) and effective therapy, while also posing inherent challenges such as balancing soft interfaces for comfort with the need for stable high-pressure seals.
As such, rapid and constant user feedback is crucial for creating respiratory products that meet real-world needs. This is often obtained through testing mock-ups, prototypes, and stakeholder engagement. Frequent testing and well-designed tests significantly reduce risk and uncertainty in early design phases.
However, you can’t test all the people you need to ensure fit across a large global population. In such cases, a strategic approach using anthropometric data and mapping key anthropometric types to an internal team for testing can provide confidence and support development progress.
As an example, during the development of a paediatric CPAP mask for one of our clients, comprehensive facial shape data and physical user access were limited during the early stages of development. With only a handful of 3D facial anatomy scans available, we mapped these scans against anthropometric dimensions from published literature to assess their relevance to the global population. This let us anchor early design decisions, enabling us to move forward.
Balancing interdependent factors like comfort, fit, and seal performance requires trade-offs—usability versus technical complexity, robustness versus over-engineering, form versus function. Limited budgets or tight timelines require a conscious focus on what to prioritize and what to compromise. To address this, our approach is on emphasizing the unique value proposition over “nice-to-have” features. When balancing time and budget, if time-to-market is the priority, we focus on developing multiple concepts in parallel to quickly identify the best performer, rather than progressing sequentially.
Consistently getting feedback when you can and addressing trade-offs when they arise builds confidence in the development process. This enables us to keep going down a particular development path while focusing on the things that matter and avoiding risks that could jeopardize project success.
At the end, true validation occurs when users not only praise the product but actively prefer it to their current solutions. For example, in trials for a customizable nasal mask we developed, nearly all participants immediately wanted to replace their current masks, an encouraging indicator of success.
Understanding the fundamentals
Starting with a deep understanding of the fundamentals prevents scattergun approaches and ensures each design iteration builds on the previous one. Without this foundation, our experience highlights that teams risk making design decisions or focusing their efforts without fully grasping the underlying principles—an approach that falls short for three key reasons.
First, lacking a clear grasp of the fundamentals invariably leads to trial-and-error methods. While this may yield results, it lacks structure and offers no guarantee of finding the right solution.
Second, if you stumble upon a solution that seems to work, when it fails, you may not know how to optimize or fix it when it ‘breaks’, leading to more trial and error.
Finally, this approach can negatively impact both budget and time to market. Delays or wasted resources can result in missed opportunities or exhausted funds by the time the problem is solved. In respiratory mask design, these challenges are amplified.
Masks must physically interact with people, seal securely on faces while minimizing discomfort and other burdens for the user. Developing a high-performing mask that balances comfort, fit, and functionality is already a complex, iterative process. Without a clear understanding of key variables that affect it and what levers need to be adjusted, resolving issues become costly, time-consuming and inefficient. Understanding the fundamentals, the core engineering and design principles of the mask design or any other product you’re developing is essential.
This is one of the first aspects we analyse, decode, and document to minimize unnecessary effort and uncertainty. It’s a core principle we follow and one worth adopting, especially if you’re developing something completely new.