The Approach

Abish envisioned a patient engagement and retention platform with a value proposition that being able to easily connect with trial patients and helping them complete the trial saves money and time for all stakeholders. The envisioned solution would enable improved patient engagement and implement strategies to retain trial customers. Specifically, it would

1. Improve patient experience → Increase retention rates → better trial results (reduced risk and shortened timelines)
2. Improve remote engagement between providers and patients
3. Improve operational efficiency

But is that what the industry really needs? If so, why haven’t they focused on patient engagement before? What types of data and workflows are most needed? And what would this solution look like in terms of specific features?  These were the questions that framed the research effort.

In our initial dialogues, we also framed Success Criteria for the MVP:

1. We are able to sign-up 10-20 CROs within the first year of launch.
2. Our app interface would produce WOW factor with patients and all stakeholders.
3. Make it easy to communicate easily in real-time with patients.
4. In a controlled group setting, we would be able to quickly prove the value of the platform to stakeholders, directly related to improved patient engagement and increased retention.
5. Define SOP for site/patient onboarding that is easy and hassle free.
6. Have a clear business model identified.

Phase 1: Research

To meet these needs, we recommended a human-centered design approach that began with discovery, focusing on empathizing with all clinical trial stakeholders involved in patient engagement. By understanding their needs and pain points, we could then design a solution with confidence that it would improve people’s lives. A thorough exploration of the problem space would also help my client become a subject matter expert, helping him approach and work with future clients.

Objectives

1. Map out the problem space, identifying pain points, trends, and areas of opportunity.
2. Map business process and workflow diagrams. This included:
   1. Existing processes and transition map to digital process.
   2. End-to-end trial process with various stakeholders (pharma, medical devices, CRO, sites, patients, caregivers, ClinOps, Customer Support)
3. Avoid scope creep by determining the optimum sets of high value added, big problem solving features.
4. Validate assumptions made to ensure that the envisioned product features meet critical needs of patients and providers.

Methods & Tools

To meet Phase 1 goals, we chose a qualitative research design to provide actionable insights  and help drive product development. This methodology included:

• Recruitment of stakeholders from each of the key roles in the clinical trial ecosystem.
• Exploratory open-ended Interviews (N=30) via zoom.
• Codebook creation and interview tagging in Dovetail, a QDA software platform
• Data visualization to identify key patterns and themes
• Workflow diagramming in LucidChart
• User Journey mapping in Miro
• Developing a knowledge management system in Notion
• Secondary research that explored industry and academic literature, research studies, related products, online communities, conferences, and advocacy groups.

Deliverables

• Insight cards that summarize and present research findings with embedded user quotes, video highlights, and links to source data.
• Data visualizations of problems and needs
• User journey maps
• Process flow charts
• Facilitation of knowledge sharing workshop for all internal stakeholders
• Research report
• Keynote presentation for potential partners
• Concept validation
• Confidence

Discoveries

Three focal areas informed and drove concept development:

1. Research into the broad patient engagement problem space illuminated industry trends, pain points, opportunities, constraints, and areas where innovations are succeeding or failing.
2. Research into stakeholders, workflows, and existing processes revealed where systemic needs are, cultural and other factors that will affect adoption.
3. Research into patient experience, by contract, was granular and focused on individual experiences and needs, revealing what mattered most and how to improve engagement.

The most significant discovery was that while creating a patient engagement platform is needed and can readily meet most needs, implementing that solution faces the steep challenge of site burden. The clinical trial industry remains largely paper sourced, and digital transformation is bringing its own suite of new problems. Site staff are overburdened by too many systems, a lack of training and support, and simply not enough time to give patients the level of engagement they seek. Poor patient engagement is compounded by the industries’ historical treatment of patients as ‘subjects’, where all that matters in trials is ‘good data.’

We came to two conclusions:

1. A patient engagement platform that facilitates meaningful, humanized interactions can solve the problem of poor retention.
2. Getting sites to adopt this platform requires reducing their burden. It must eliminate complexity rather than adding to it.

From these and other insights, we have moved into the next phase of human-centered design– defining the concept and validating it with target users.

Phase 2: Product Design

Phase II began after early concept development and is ongoing. In Phase 2 we generated concepts, solicited feedback on solutions, and chose the best product design path among several UX iterations. The MVP is currently in development, with Bryan supervising this effort as the Product Manager.

Objectives

1. Develop detailed UX artifacts
   1. User personas, stories, and flows

1. Concept validation (ensure product meets core needs)
2. Iterative UX feedback and optimization
3. Iterative feature development to MVP
4. Develop product strategy
   1. Improve sales and adoption
   2. Identify key stakeholders and competition
   3. Understand organizational constraints / enablers
5. Write stories and create product roadmap.

Methods

• Storyboards
• Concept Development
• Concept Validation surveys
• Preference/ Comparison Testing
• Initial Usability Tests (paper prototypes, wireframing)
• Story writing (Jira)
• Workflow diagramming (Miro)
• Project managent
• (PMF) Product Market Fit research