A comprehensive blueprint for patient-centred innovation
Have you ever used a health app or a medical device and felt like it was designed by someone who had never actually met a patient? In medical innovation, there is a recurring problem: technologies are frequently built in a lab and then "handed over" to users, only to find they don’t fit into the complex realities of daily life. To fix this, researchers use a collaborative process called co-creation.
Co-creation is a way of working where researchers, designers, patients, and healthcare professionals (HCPs) work together as equals from the early phases of innovation development. Rather than experts guessing what a patient needs, they define problems and design solutions with them. To guide this journey, within the Breath-Sense project we followed the Center of eHealth Research and Disease Management (CeHRes) Roadmap, a structured five-step path that emphasises human characteristics and the socioeconomic environment as essential factors for success.
In this blog, we take you through the first three essential phases of this roadmap and how to practically apply co-creation to develop a remote patient monitoring (RPM) product and process for Chronic Obstructive Pulmonary Disease (COPD).
COPD is a long-term lung disease that makes breathing difficult. People with COPD may experience breathlessness, coughing, and fatigue, which can affect their daily lives. They can also experience exacerbations: periods when their symptoms suddenly worsen, sometimes requiring hospital treatment. Preventing exacerbations and recognising them early are important to help avoid severe symptoms and hospital admissions. However, patients may struggle to recognise these exacerbations early because symptoms can resemble their daily fluctuations.
The Breath-Sense project is developing a novel breath analysis device to support the earlier recognition of these exacerbations, based on breath biomarkers. This device aims to support remote patient monitoring and transition COPD care from reactive to proactive by enhancing patients' ownership. By involving patients and HCPs in co-creation throughout the development process, we can develop care and support that better meet their needs and help them manage their condition.
Phase 1: Contextual Inquiry - A deep dive into the user's life and context
Before building, researchers must understand the "world" the innovation is aimed to be implemented in. This phase focuses on gathering information to understand not only what the medical problem is, but also how people living with COPD experience it, including what a typical day, week, month, and year looks like from the patient’s perspective.
How participants were involved
Stakeholder identification. Researchers worked with professionals and reviewed literature to identify seven key groups: patients, pulmonologists, GPs, nurse practitioners, nurse specialists, physiotherapists, and informal caregivers.
In-depth interviews. 34 semi-structured interviews were conducted with 18 patients and 14 HCPs to explore the traumatic nature of "lung attacks" (exacerbations) and the disorientation patients feel when they cannot breathe.
Collaborative co-analysis. In a unique step, six patients participated in a co-analysis focus group. They acted as "collaborative experts," reviewing interview quotes and grouping related terms into "brain maps" to ensure that the researchers' academic perspectives did not bias the findings.
What this contributes
This engagement highlighted that COPD care was often inconsistent and that patients frequently had difficulty recognising exacerbations at an early stage. Although existing interventions aimed at improving patients’ understanding of their disease provided valuable insights into their symptoms and well-being, patients still struggled to recognise when their condition was deteriorating and to take timely and appropriate action. These findings underscored the need for a more accurate and actionable tool that supported patients in monitoring their condition, recognising exacerbations, and managing their disease more effectively.
Phase 2: Value Specification – Turning Values into Blueprints
Once the context is understood, the team moves to Value Specification, in which the aim is to inform the development of the breath analysis device by identifying patients’ and HCPs’ values (i.e., what do people consider important), and translating those into product- and process-specific requirements (i.e., concrete elements or features of an innovation).
Where Phase 1 was about listening, Phase 2 is about making decisions. We take everything learned and distil it into a clear list of what prospective end-users find important in the innovation.
The translation process: Mind maps and personas
Based on Phase 1, the researchers defined 38 values, organised into nine core categories:
Patient-centred care and patient outcomes: Focuses on accessible communication and the personal bond between patient and provider.
User-friendliness and inclusivity: Prioritises accessibility for all, regardless of digital skill or literacy.
Agreements on RPM responsibilities: Defines clear roles for data monitoring and clinical decision-making.
Patient empowerment: Aims to increase the patient's sense of control and understanding of their disease.
Information provision and guidance: Ensures patients receive tailored feedback and clear action plans.
Enhanced care efficiency: Focuses on optimising resources and balancing provider workload.
Implementation process: Details the strategic integration of the tool into existing care pathways.
HCP care provision: Uses monitoring insights to improve clinical interventions.
Safety and reliability: Ensures technical accuracy and data security.
However, these values are too abstract to help developers make product- and process-related decisions. Therefore, we translated these values into product- and process-specific requirements. To translate abstract "values" (what people find important) into concrete "requirements" (specific product and process features), our research team held focus groups with 45 participants. They used interactive mind maps and Personas, imagined profiles of representative users with specific life stories, to prompt participants to think from different perspectives. During these sessions, the core guiding question was: “How can this value be translated into practice?”. This resulted in a final list of 142 requirements. The full overview of value categories, values, and corresponding requirements is available here: https://rpm-values.nell.eu/.
Phase 3: Design – Building and Testing the Vision
In the Design Phase, requirements turn into tangible technology. This is where the first "dummy" versions of the product are created and subjected to rigorous usability testing.
How participants were involved: Think-aloud sessions
A total of 26 participants, including 15 patients and 11 HCPs, participated in interactive think-aloud sessions. During these two-hour sessions, users performed specific tasks while verbalising every thought, opinion, and frustration they experienced.
Participants interacted with three specific prototypes:
The breath analysis device: A 3D-printed version where patients practised breathing into a sampler and replacing mouthpieces.
The patient application: A standalone app where patients navigated screens to check results, complete well-being questionnaires, and view their "action plans".
The medical dashboard: A web-based interface for HCPs to monitor patient trends and handle "Lung Balance Alerts".
Researchers used the Optimised Honeycomb Model to structure these sessions, looking at seven facets of experience: whether the tool was findable, accessible, usable, desirable, credible, useful, and valuable. Finally, users completed the System Usability Scale (SUS), providing a quantitative "grade" for the system's ease of use.
What this contributes: Refining the blueprint
This phase allows for iterative redesign before the final product is manufactured. Key contributions from this testing included:
Physical adjustments: Many patients found exhaling for 8 seconds physically demanding. This led to exploring alternatives like shorter, stronger breaths to ensure the device is accessible for those with advanced lung disease.
Digital navigation: Testing revealed that terms like "Status" or "Help" weren't intuitive for patients. Participants suggested adding visual animations and reducing the steps required to run a test.
Workflow integration: HCPs emphasised that the dashboard must look less like a complex medical report and more like a real-time dynamic data overview for rapid triage, enabling them to see at a glance which patients need immediate attention.
Interdisciplinary connection: The design needs refinement to ensure the system doesn't just "collect data" but integrates with Electronic Patient Records to support efficient clinical decisions.
The team fed all information gathered during the design phase back to the device developers to ensure the next version better aligns with the needs and preferences of prospective end-users. In determining which improvements to prioritise for the minimum viable product, the development team has to take multiple factors into consideration, including user needs, clinical relevance, feasibility, and the potential value for end-users. This approach ensured development efforts focused on features and improvements that could deliver the greatest benefit within available resources and constraints.
A foundation for others: The RPM values website
Starting a co-creation process from a blank page can be overwhelming; there are many different theories and possibilities to adopt. To help other innovators, the National eHealth Living Lab (NeLL) developed a dedicated resource based on this extensive work: https://rpm-values.nell.eu/.
This website acts as a practical foundation and checklist for further development. It houses the 38 validated values and 142 requirements identified by the participants in this project. Innovators can use the nine pillars found on the site to ensure their own projects are grounded in scientifically validated user needs.
So why does co-creation matter?
Thoroughly involving participants across these three phases, Contextual Inquiry, Value Specification, and Design, contributes three major pillars to the development process:
Trust and acceptance: When patients see their values (like privacy and personal connection) reflected in the design, they develop deeper trust in the technology.
Greater inclusivity: By involving people with diverse backgrounds and education levels from the start, the team ensures the innovation works for everyone, not just the "tech-savvy".
Successful adoption: Identifying navigation hurdles and physical limitations early prevents implementation failure, ensuring the tool fits seamlessly into the busy lives of both patients and doctors.
By using the tools available at rpm-values.nell.eu, we aim to help ensure that no one is left behind as healthcare technologies continue to evolve at a rapid pace.
The added value of co-creation for patients
Beyond the valuable input that patients provided to the development of the innovations, we found that patients also greatly appreciated being involved in the process. The interviews gave them an opportunity to share their personal stories and experiences and, importantly, to feel heard and acknowledged. Many patients also expressed enthusiasm about the opportunity to contribute directly to developing an innovation that could potentially improve COPD care.
The focus groups added another layer of interaction by bringing patients with COPD together with peers. For some participants, this was the first time they had spoken with other people living with COPD and heard about their experiences with the disease and the healthcare system. Exchanging experiences gave participants new insights into how others managed their condition and, in some cases, inspired them to reflect on or make changes to aspects of their own care or daily lives. In this way, participants learned from one another while simultaneously contributing valuable perspectives to the development of a novel innovation. This created a sense of empowerment and ownership that extended beyond simply providing feedback.
One patient captured this particularly well: “I told my children that I had participated in a session where we provided input for the development of an innovation in COPD care. They were so proud of me, which made me feel good.”
Written by Atena Mahboubian
Reviewed by Laura Verga, Javier Viña, Chiara Toffanin
