Charco CUE1
Dates: July 2020 - March 2023
Role: Product Manager to Regional Manager
Range: Prototype to Production
Collaborators:
Lucy Jung (CEO), Archit Parhi (Product Designer),
Jake Kim (Front-end Engineer),
Dahee Han (Visual Designer),
Alex Dallman-Porter (Neuro Scientist),
Will Hardie-Brown (Data Scientist)
Web: https://charconeurotech.com
Outcomes:
BACKGROUND
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I joined Charco as the Product Manager for CUE1, leveraging my experience in ideating and mass-producing the Keeper project. At the time, CUE1 was undergoing clinical trials with Parkinson's patients and was in the prototype development stage. The CUE1 device, a wearable that utilizes vibration technology, attaches to the chest of Parkinson's patients. It operates on the principle of alleviating symptoms (like tremors and freezing of gait) through vibrations triggered at specific frequencies. CUE1's accompanying app offered symptom-tracking games and customizable vibration settings, beneficial for alleviating Parkinson's symptoms. My experience with the Keeper projects, with a similar mechanism except for the wearable aspect, contributed to Charco's R&D team.
DESIGN PROCESS - HARDWARE (IoT)
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Note: After resigning and signing a confidentiality agreement, I had to return all my work materials, which limits the data I can publicly share. The images available for sharing are from the User Manual of CUE1, a product already released and sold in Europe.
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CUE1 is a medical device and must comply with specific guidelines before design commencement. Every component must undergo rigorous safety and non-harmfulness assessments, applicable to both hardware and software. In general, most medical devices are developed more from a developer and regulatory perspective rather than user-centric and aesthetic considerations, often resulting in ungraceful designs. However, our goal was to ensure safety and seamless integration, also aiming for user-friendly and aesthetic refinement. Given that our target users, Parkinson's patients, are generally older, the design needed to be easy and straightforward. We focused on simplicity and intuitiveness in both the device and its mobile app, informed by interviews with Parkinson's patients in the UK.
DESIGN PROCESS - SOFTWARE (APP)
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From the outset, our guiding philosophy was to create an app that not only complemented the CUE1 device but also resonated with our users' needs. This meant diving deep into the user experience, understanding the challenges Parkinson's patients face daily, and how technology could alleviate some of these challenges. During the development process, a significant focus was placed on observing how users interacted with both the hardware and the app. This hands-on approach was crucial. I remember vividly how we would hand-deliver these devices to our users, keenly observing their interaction, noting the problems they encountered, and gauging their intuitive responses to the app's interface. This direct feedback was invaluable in shaping the app's development. One of the key challenges was striking a balance between data collection and user usability. The more data we could gather, the better the care suggestions the app could offer. However, this had to be weighed against the ease of use for our users, many of whom were not tech-savvy. My role involved making critical decisions on how to collect meaningful data while ensuring that the app remained accessible and user-friendly. This balancing act was not just about functionality but about respecting our users' capabilities and comfort. In our pursuit to refine the app, efforts were continually made to identify and eliminate key blockers and accessibility hazards. This aspect was particularly challenging given the diverse needs of our user base. The design had to be intuitive enough for someone not familiar with technology while being sophisticated enough to provide meaningful assistance.
PROCESS - DATA (USER TESTING)
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As part of the development, a significant phase was user testing, in which I actively participated. Prior to clinical trials, we conducted extensive testing with both hardware and software prototypes. The aim of these tests was not only to assess functionality but also to validate the principles of focused stimulation and cueing principle. My involvement was in two key tests: Beta CUE1 User Testing (Aug 2021) and MDS-UPDRS/Tapping & Usability Feedback (Dec 2020)."
Beta CUE1 User Testing: This involved 8 patients with Parkinson’s disease using the CUE1 device in their homes over 13.5 months, without any changes to their medication. The study aimed to assess the device’s effectiveness in daily routine settings. Participants provided feedback through questionnaires and diary entries, contributing valuable data on effectiveness and usability.
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MDS-UPDRS/Tapping & Usability Feedback: We recruited 14 participants, both males and females, with varying stages of Parkinson’s. The tests included MDS-UPDRS section III for motor performance, Timed Up and Go tests, and Timed Tapping tests, both with and without the CUE1 device. This comprehensive testing helped us gather data on motor performance improvements, usability, and the device’s risk profile.
This user testing phase was crucial for refining the CUE1 device, ensuring it met clinical guidelines and user needs. It provided a foundational understanding of how to conduct user testing and report findings in a medical device context, deepening my expertise in this field.
PROCESS - COLLABORATION
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Note: Most collaboration-related documents are confidential following my resignation and a non-disclosure agreement.
The cornerstone of this project was collaboration. From the Keeper project, I learned the vital need for extensive collaboration in developing IoT products. However, the Charco CUE1 project added another layer – it's a medical device. This meant not only internal tasks multiplied but also a significant increase in external collaborations. To develop a device compliant with medical device guidelines in various countries, partnering with a Contract Research Organization (CRO) was essential. Working alongside the CRO, we established guidelines for every stage, from prototype design to mass production. In collaboration with manufacturers, we carefully crafted the prototype, ensuring it met the stringent requirements of medical devices. In addition, we conducted clinical trials with partner hospitals, targeting patients to gather essential feedback and data. As the trials progressed, we collaborated with testing agencies to conduct various safety and efficacy tests, ensuring the product met all necessary standards. This phase of the project underscored the significance of multifaceted collaboration in the medical device industry and provided me with extensive experience in managing complex, interdisciplinary projects.
REFLECTION
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CUE1, being a medical device, presented complex challenges, including clini- cal trials, production, and safety certifications. My role at Charco enabled me to gain firsthand experience in navigating the intricate regulatory landscape for medical device import and export. Starting as a Product Manager in July 2020, I was chiefly responsible for the development and design of CUE1's prototype, focusing on the hardware and the UI/UX design of the app, as well as overseeing user testing and R&D tasks. My promotion to Regional Manager in 2022 marked a significant expansion of my duties, from R&D to include clinical trials, regulatory approvals, and securing investments, as I led the es- tablishment of the company's entity in Korea. Our collaborative efforts were instrumental in Charco securing over $10 million in seed funding, a milestone for the European health tech sector. Transitioning from a Product Manager to a broader management role, I learned extensively about the interplay between product design and regulatory requirements. This shift provided valuable insights into the complexities of medical device devel- opment and market strategies. During my tenure, I also had the opportunity to work in an English-speaking country for the first time, learning to communicate effectively in English, from everyday conversations to professional meetings. This experience was crucial in enhancing my communication skills and adapting to a global work environ- ment.