Closed Loop Medicine is a UK-based TechBio company transforming chronic disease care by combining personalized drug therapy with digital health tools. Their integrated approach enables tailored treatment plans that improve outcomes, reduce side effects, and make precision care more accessible.

For their pilot product CLM aimed to combine the most effective treatment for insomnia, cognitive behavioural therapy (CBTi) with a natural sleep-inducing hormone, melatonin to treat patients with chronic insomnia. I worked as Senior Product Design Director to lead product definition and design.

Case Study | CBTi Programme Design & Treatment Engagement Strategy

Aims:

The first challenge was to determine how to deliver melatonin instructions and cognitive behavioural therapy for insomnia (CBTi) through a digital app. The experience needed to provide on-demand access to a CBTi programme, support adherence to both medication and behavioural change, help patients develop new sleep and medication habits, collect self-reported sleep data to track progress, gather adherence data to enable algorithmic dose timing adjustments, and instruct patients on when and how to change their medication timing.

Process:

I partnered with two clinical therapists to develop the therapy programme and UX foundations for the app experience. This included:

• Conducting observational ethnography of group CBTi therapy sessions to understand the content, method and challenges associated with traditional in-person programme delivery.

• Interview-based research with patients and clinicians to understand lived experience and unmet needs in the therapy journey.

• Desk research & collaboration to understand CBTi content and map it into a consolidated digital friendly content structure.

• Evaluation of competitor solutions to identify gaps, positioning and areas for differentiation.

• Mapping product features and aligning them with established behaviour change frameworks to encourage adoption and sustained engagement.

• Working with another UI designer to conceptualise the main screens and interactions for the product.

Case Study | Single Prescription & Autonomous Patient Onboarding

Aim:

To make the product feasible, prescribers needed to issue a single prescription covering both medication and app access. This required a packaging solution compatible with the UK pharmaceutical supply chain, allowing the medication to be dispensed by any pharmacy, patients to onboard independently, app access to be limited to the prescription duration, and restricted to those receiving the prescribed medication.

Process:

No precedent existed to solve the problem. I led a small team including regulatory experts, an external packaging design agency Tone and a UI engineer to find a feasible solution. This involved:

• Researching regulatory constraints on medication packaging

• Exploring various methods for restricting app access

• Consulting pharmaceutical manufacturers to define technical feasibility of concepts

• Exploring concepts for integrating app download instructions into packaging

• Developing app and packaging prototypes
  Conducting A/B usability testing for packaging and app onboarding concepts

• Close collaboration with manufacturers to finalise design specifications for production

Outcomes:

After user testing and development, we delivered a final packaging system that used standard, cost-neutral manufacturing techniques, making app distribution cost negligible. It achieved a 100% app download rate in simulated testing, validating both the packaging and onboarding experience. The solution also introduced a novel approach to app download within a packaging system that met existing medication regulatory requirements, making it eligible for regulatory approval.

Case Study | App Experience & Medical Device Certification

Aim:

With the CBTi programme and engagement strategy in place, we began building and testing the app experience with sample patients. The experience needed to win patients over and support their engagement with the CBTi programme, help them learn and adopt new behaviours as habits and routines, ensure accessibility in line with WCAG guidance for market access, and meet the requirements to pass summative evaluation for certification as a Class IIa medical device.

Process:

When the digital product moved into a production phase I built out a product design and development team including a Product Manger, Clinical Insomnia Therapist, User Researcher, UI Engineer and a Front End Developer. Together we worked to:

• Incrementally develop UI concepts and prototypes for content and product features

• Develop a usability engineering file; writing use specification, compiling a uFMEA risk file, conducting task based risk analysis of all product features to assist medical device certification

• Conduct iterative usability & utility evaluations with representative sample patients to verify all risks and controls were effective in simulated test environments

• Complete design specifications, write usability engineering documentation and collaborate with development teams to implement final designs

Outcome:

Over the course of a year, the team designed, tested, and released three versions of the app. The combined packaging and app experience achieved an average UMUX score of 4.7 for utility and 4.6 for usability in simulated testing. The product was certified as a Class IIa medical device with CE and UKCA marks, and submitted for MHRA market authorisation. Pending approval, it would become the UK’s first combination medication and medical device product.

Case Study | Clinical Decision Making Portal and AI Development

Aim:

A longer-term goal of the Ejuna SleepSync product was to create a system capable of autonomously adjusting treatment for patients using melatonin and engaging with the CBTi programme. As a first step, we developed an interface to share app data with clinicians during a trial period, enabling comparison between automated and human decision-making. The interface needed to help clinicians assess data reliability, identify the type of insomnia, track patient progress, and review medication and sleep routine adherence to support informed treatment adjustments.

Process:

I worked with CLM’s chief clinical officer and two external sleep therapist to define the logic for the clinical decision making report. This included:

• Mapping the natural steps taken to assess adherence to the programme, data validity, diagnosis of sleep disturbance type and dose timing decisions

• Translating this logic to a series of data graphs which could answer these logical steps

• Working with multidisciplinary team of UI designers and developers to create feasible designs

• Testing and iterating designs with clinicians to ensure data visualisation was effective

• Developing clinical instructions for use to support training and deployment

Outcome:

The work resulted in a clinical interface that enabled rapid assessment of patient progress and provided insights into behaviour change and medication adherence. It also supported dose timing adjustments to address different insomnia presentations, including late sleep onset, disturbed sleep, and early waking.