MDR-compliant mobile Health App for a medicinal cannabis inhaler
Position and responsibilities
As Usability Engineering Lead and Art Director, I was responsible for a 5-member interdisciplinary team, ensuring the product was consistently grounded in patient-centered principles. I led a contextual research program that — despite initial reluctance and lack of trust on the part of patients — enabled direct dialogue with individuals undergoing cannabis therapy in Germany.
The insights uncovered fundamental needs, corrected initial assumptions, and formed the foundation for the UX/UI and design strategy I was responsible for. The complete usability file (per ISO 62366-1) was delivered within 2.5 months — on budget and within the regulatory timeline. The app is currently in the MDR submission process.
The Process
The development process followed a five-stage approach that systematically aligned stakeholder perspectives with real patient needs.
Step 1: Stakeholder Workshops
In three successive workshops with executive leadership and subject matter experts, the foundations were established: Which user groups use the application? Which therapy and business goals should it address? This resulted in a stakeholder-centered requirements analysis as a starting point for user-centered validation.
Step 2: User-Centered Validation
The developed assumptions were verified in the field: AI-assisted desk research helped to explore patient problem spaces in advance. Contextual interviews with real patients then made it possible to uncover the actual needs and gaps in the stakeholder perspective.
The results of the analysis phase were 4 strategically critical user needs:
Reimbursement support: Assistance with the application process for cost coverage. The process is opaque and, especially under stress, barely comprehensible for those affected.
Need-based inhalation guidance: Visual and auditory support should only assist when needed and be user-controlled.
Medication independence: A variety of medications from different manufacturers is unfortunately the norm of patient daily life. Enable tracking of different medication types, not only Belfry.
Documentation without overload: Reducing complex inputs to the essentials.
The research results led to a strategic reprioritization of the product roadmap — the originally planned feature set was restructured and comprehensively developed in favor of the four identified patient needs (Steps 3 & 4). Validation through summative usability testing (Step 5) using moderated interviews and the System Usability Scale confirmed the resulting benefits for users (SUS score 82.5).
Onboarding process
Belfry Medical Companion Dashboard
Treatment overview
Inhalation assistant
Treatment Check-Up
Key Details & Numbers
Project duration
2,5 months
Creative Team led
5 designers / researchers
Contextual Interviews conducted
8x
Usability Tests conducted
10x
System Usability Scale Score
82.5 (Rating: "Excellent" per Bangor et al.; industry average: 68)
Methods
Stakeholder-Requirements Workshop
With company directors from varied business backgrounds, we clarified the clinical context and defined the core patient-centered problem, ensuring the team could think beyond purely commercial goals.
Stakeholder-Persona Workshop
We co-created realistic patient personas from different user groups to help a business-focused team design with genuine empathy.
Stakeholder-Product-Vision Workshop
Together, we envisioned the app as a trusted therapy companion, balancing business ambitions with empathy, clarity, and compliance.
Synthetic Interviews
AI-assisted interviews helped us validate early hypotheses and shape the discussion guides for contextual interviews, ensuring sensitive and relevant patient conversations.
Contextual Interviews
Revealed unmet needs, in particular the lack of support during the reimbursement process for patients with statutory health insurance, along with gaps in symptom tracking, progress visibility, and timely reminders. These patients are usually very emotionally affected due to the severity of their conditions, which required a sensitive and empathetic approach during interviews.
Usability testings
Usability sessions with real patients validated accessibility, tone, and workflows, adapting designs to their physical and emotional needs.
Regulatory Steps applied
Usability file documentation
(acc. to ISO 13485)
Analysis of hazardous situations
(acc. to ISO 14971)
Risk management documentation
(acc. to ISO 14971)
Establishing Usability Engineering process
(acc. to ISO 62366-1)
Research participants networks established
2x
Software Stack
Figma
Confluence
as Quality Management System
Adobe Creative Suit
After Effects, Photoshop, Illustrator
