Healthcare innovation has traditionally been driven by clinicians, researchers, and industry stakeholders. Yet today, a new approach is reshaping the landscape: patients are increasingly recognized as critical partners in shaping solutions that directly impact their lives. From drug development to digital health tools, co-creation, a collaborative process where patients actively contribute to innovation, is redefining how healthcare advancements are designed and implemented.
But why is this shift happening now? In this article, Alcimed explores what developments are taking place in patient co-creation in healthcare innovation and analyzes its benefits and current challenges.
The concept of co-creation, also called co-design or co-production, has been already well studied. Co-creation is defined as “a joint effort of citizens and public sector professionals in the initiation, planning, design and implementation of public services”. Within the healthcare domain, patient co-creation refers to the structured involvement of patients in ideation, design, and testing phases of healthcare products, services, or policies.
The European Medicines Agency (EMA) advances patient co-creation via the Patients’ and Consumers’ Working Party (PCWP), fostering advisory partnerships to align therapies with patient priorities in EU regulatory processes, notably in post-market evaluation and risk-benefit assessments. U.S. Food and Drug Administration (FDA) places greater emphasis on early (e.g., preclinical) patient involvement through the Patient Engagement Collaborative (PEC). These measures upgrade the patient’s role from symbolic participation to substantive co-creation by establishing long-term cooperation mechanisms, which directly affect the development and regulatory standards of medical products.
Patient advocacy groups have evolved from community-based organizations focused on securing access to lifesaving treatments into institutional stakeholders that now play a critical role in guiding research agendas, shaping clinical trial design, and informing regulatory decision-making. The number of PAGs is rising with around 3300 operating in the US, approximately 18% focusing on rare diseases.1Supporting patients through research collaboration. (s. d.). IQVIA. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/supporting-patients-through-research-collaboration The value of PAGs is well recognized by the healthcare players. For example, at the 2023 WAPO Global Summit in Buenos Aires, a very popular workshop on PAGs’ Interaction with Pharmaceutical Companies was run to discuss how these two groups can work together.
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Now, patient co-creation is widely adopted in the healthcare industry. For instance, Sanofi launched its Patient Community Charter and annually reports the percent of pre-clinical priority research program and development stage indications where patient perspectives and health related goals are incorporated. Merck has established a global Patient Advocacy and Strategic Partnerships team that works closely with patient organizations to ensure patient voices are integrated into their healthcare solutions. Roche focuses on patient-centric approaches by involving patients in the development of their diagnostic and therapeutic solutions, ensuring that patient needs and preferences are prioritized. The increasing collaboration between PAGs and industrial players exemplify how patient co-creation can lead to more effective and patient-centered healthcare solutions.
Patient co-creation offers numerous promising opportunities for the development of quality improvement initiatives that cater to all stakeholders.
Great patient engagement can lead to higher success rates in clinical research. A study by the Economist Intelligence Unit analyzed 4,000 patient-centered clinical trials and found that 87% achieved positive results, compared to 68% of traditional trials.2Economist Impact, State of patient centricity 2020: Advancing from patient-first intentions to true co-creation, 2020, https://impact.economist.com/perspectives/health/state-patient-centricity-2020-advancing-patient-first-intentions-true-co-creation The patient co-creation improves trial success by enhancing recruitment and retention, improving protocol design based on patient insights, and increasing trial relevance and patient adherence. For example, Novartis engaged CML patient experts for a Phase III trial. Based on their input, they removed an unnecessary biopsy requirement. This patient-driven change made the trial less invasive, accelerating enrolment and completing accrual 10 months early, demonstrating improved performance and patient experience.
Patients can contribute not only to co-creating tangible solutions such as medicines or devices, but also to shaping intangible aspects like patient journey. The patient satisfaction can also be improved with more patient engagement. A cross-sectional survey involving 637 patients in Guangzhou, China, demonstrated that when patients actively engage in their treatment – such as discussing their needs, learning their health conditions through online resources, verifying information with doctors – they are more likely to feel there preferences and conditions are understood and addressed, leading to increase satisfaction, improved health outcomes and better adherence to treatment.3Singh, D. R., Sah, R. K., Simkhada, B., & Darwin, Z. (2023). Potentials and challenges of using co-design in health services research in low- and middle-income countries. Global Health Research And Policy, 8(1). https://doi.org/10.1186/s41256-023-00290-64Fukami, T. (2024). Enhancing Healthcare Accountability for Administrators : Fostering Transparency for Patient Safety and Quality Enhancement. Cureus. https://doi.org/10.7759/cureus.660075Mai, S., Chang, L., Xu, R. H., Su, S., & Wang, D. (2024). Doctor interaction behavior, patient participation in value co-creation and patient satisfaction : cross-sectional survey in a tertiary-level hospital from Guangzhou, China. Scientific Reports, 14(1). https://doi.org/10.1038/s41598-024-73660-w
Patient co-creation also helps drug developers meet new regulatory standards. Agencies worldwide increasingly require evidence of patient input in submissions. For instance, the FDA now expects patient experience data during drug reviews, while regulators in the UK and the Netherlands demand proof of patient co-design before approving treatments. By integrating patient perspectives early in development, companies can reduce regulatory hurdles, avoid last-minute issues, and streamline approval and labelling discussions.
Implementing patient co-creation in healthcare presents several significant challenges.
Many companies openly acknowledge they simply haven’t done much patient engagement before, or lack proven successes. Without established processes, every new project feels like starting from scratch, leading to significant delays. For instance, organizing a global workshop for rare-disease patients became a major logistical challenge—requiring multilingual outreach and accommodating seriously ill participants—because there was no existing guidebook.
It is also hard to demonstrate the concrete value of patient co-creation. Over half of firms point to internal uncertainty about the ROI as a major barrier. Because there are no standard KPIs or economic models for this work, investing in it feels speculative. A recent industry review confirmed companies “have neither defined nor collected metrics uniformly” for patient engagement. This makes it tough for project managers to justify spending extra time or resources on co-design activities when the potential benefits—like faster recruitment or better treatment adherence—aren’t immediately quantifiable.
Neither companies nor regulators have yet settled on clear, agreed-upon guidelines for patient co-creation. This absence of standard operating procedures often pushes legal and compliance teams towards caution, slowing down or blocking innovative approaches. This gap was echoed in a recent systematic review of digital health co-design, which found “no clear consensus” or practical, industry-ready framework for meaningful patient involvement. Essentially, every team is forced to figure it out alone, leading to inconsistent practices and a strong tendency to avoid risks.
Patient co-creation is not a trend—it’s a necessity for sustainable healthcare innovation. By addressing challenges, stakeholders can unlock opportunities for more impactful, and even personalized solutions. As pioneers in healthcare exploration, Alcimed empowers organizations to integrate patient voices at every stage, ensuring innovations truly meet the needs of those they serve. If you want to transform your approach, don’t hesitate to contact our team!
About the author:
Chaoyue ZHAO, Senior Consultant Lead in Alcimed ‘s Healthcare team in France
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