CryoCare: Reimagining Antibiotic Delivery in the Community

CryoCare sought to understand the experiences of patients receiving continuous infusion antibiotics through HITH services. Recognising the invasive nature of treatment via a peripherally inserted central catheter (PICC), field research was conducted, including patient interviews, detailed observations of HITH clinicians, dietitians, and pharmacists as they integrated the device into their workflows, and autoethnographic studies to deeply understand the challenges patients could potentially face while wearing CryoCare. Utilising a Research-through-Design (RtD) methodology, we synthesised these insights into two design directions: a hard vacuum-insulated flask and a soft insulated cooler bag. The flask prototype had greater thermal retention but presented issues in comfort and wearability due to its weight and rigidity. Conversely, the cooler bag offered enhanced range of motion, movement, and flexibility, but necessitated more frequent ice pack replacements. Through iterative testing and patient feedback, these prototypes were refined, leading to optimised carrying positions and improved user comfort. Comprehensive bench tests evaluated various phase change materials over 24-hour periods, resulting in refined computational models for optimal material composition. This rigorous testing process led to the development of segmented ice packs for improved storage and a thermoelectric dock for continuous cooling at home. The detailed design execution included the integration of OLED screens to display internal temperature and infusion status, reducing patient responsibility and increasing reliability. The final designs were professionally produced with industry partners ALPAKA, and Soft Serve Studios, using high-quality materials and details, ensuring durability and patient satisfaction. CryoCare resulted in two innovative, patient-centric solutions that maintain the necessary cold temperatures for temperature-sensitive antibiotics while significantly enhancing usability and comfort. Through a dual focus on clinical efficacy and user experience, these solutions meet desired clinical needs and enhance the overall quality of life for HITH patients and their carers, offering increased dignity and independence during treatment.

CryoCare evolved into a parallel research initiative that explored the benefits of both soft and hard solutions. By employing a novel approach to medical device design, the project prioritised patient needs through a human-centered design (HCD) process while successfully meeting essential clinical requirements for hospital use. The design research and prototyping phase revealed critical insights into the user experience of integrating cooling elements around the elastomeric infuser. These insights guided the development of ergonomic, easy-to-wear devices with optimised size-to-weight ratios. Through iterative prototyping and testing to meet clinical standards, a new phase change material (PCM) formulation was developed. Diverse patient feedback led to the creation of two efficient systems for daily ice-pack and infuser replacement, along with a range of carrying positions and movement methods. Outcome A features an OLED screen displaying internal temperature and infusion status, reducing patient responsibility as nurses handle daily replacements. In collaboration with Soft Serve Studio, a carrier bag was designed to fit various body types, ensuring comfort across different genders, ethnicities, and geographic locations. The carrier discreetly conceals the PICC line, allowing patients to maintain a sense of normalcy when leaving the house. The bag includes versatile attachments such as a one-handed magnetic clasp and silicone footing, enhancing usability in different living environments and for individuals with varying mobility levels. Supported by ALPAKA Gear, Outcome B incorporates aerogel particles into ultra-thin, flexible nonwovens, creating advanced soft insulation with a reflective liner. A custom bayonet lid simplifies infuser removal, easing the process of changing and showering for patients. Additionally, an active thermoelectric docking station was developed for overnight use. This research culminated in two prototypes designed to enhance patient comfort and ease of use. These devices maintain the stability of temperature-sensitive antibiotics while significantly improving patient mobility and overall comfort.

Despite the development of many medical devices for administering antibiotics at home, there remains a gap in products that regulate temperature and prioritise user-centric design. CryoCare addresses this gap with an innovative approach to the controlled administration of temperature-sensitive drugs through a 24-hour continuous infusion. As certain bacteria develop resistance to traditionally stable antibiotics, temperature-sensitive medications become crucial for specific treatments. Numerous new antimicrobials are being developed with enhanced stability. However, stabilising drugs such as meropenem involves extensive modifications, resulting in expensive new pharmaceuticals and patents. CryoCare challenges conventional HITH devices, which often prioritise clinical outcomes over patient experience. By adopting HCD principles, CryoCare developed a clinically effective flask (Outcome A) and cooler bag (Outcome B) that maintains temperature-sensitive antibiotics within therapeutic ranges without compromising patient mobility and comfort. Involving patients, clinicians, and end-users throughout the design process resulted in intuitive interfaces and features, specifically tailored to the preferences and requirements of healthcare providers, caregivers, and patients. By maintaining continuous feedback loops, we could leverage a deep understanding of the user experience in real-world settings. This iterative testing of actual vs intended use during development helped us refine the device’s functionality. Addressing a critical market gap, the CryoCare devices efficiently manage the delivery of temperature-sensitive drugs outside hospital settings, offering a faster and more cost-effective solution than pursuing drug stabilisation patents. Demonstrating how well-designed medical devices can relieve pressure from hospitals, and improve overall patient outcomes and treatment efficacy within HITH practices. The CryoCare exploration addresses the critical challenge of drug degradation caused by exposure to heat, ensuring the efficacy of temperature-sensitive antimicrobials, which are prone to breakdown at room temperature. By maintaining the correct temperature throughout the infusion cycle, CryoCare not only broadens the range of available therapies but also enhances treatment outcomes by addressing patient-centric needs.

The early design research revealed that delivering temperature sensitive antimicrobials via continuous infusion is not purely a clinical problem, but underscores a designerly commitment to improving patients’ lives during treatment. By incorporating regular feedback from patients and clinicians, CryoCare prototypes were developed that redefine clinical expectations, address specific user needs, and anticipate potential challenges within Hospital-in-the-Home services. Innovations included a new phase change material formulation, a streamlined workflow for daily cooling material replenishment, versatile wear options, and digital monitoring of cooling effectiveness. Additionally, the introduction of a removable core significantly simplified changing clothes, showering and cleaning for users. This iterative process resulted in minimum viable products (MVP) for both Outcome A and Outcome B, which are now being produced in small batches for comprehensive testing in patient trials and further refinement. Findings from this research are being published at the Design Research Society Conference (DRS2024) in Boston, USA, and the Design4Health Conference 2024 in the UK. Additionally, insights gained from patient interviews on the experience of treatment via elastomeric infusers is being compiled for submission to medical conferences. By enabling temperature-sensitive antibiotic delivery at home, CryoCare reduces the need for prolonged hospital stays, thus alleviating bed shortages and lowering the risk of hospital-acquired infections. This shift not only enhances patient comfort and recovery but also decreases healthcare costs, demonstrating substantial economic benefits. CryoCare demonstrates that by addressing real-world usability and ergonomic challenges, innovations can be achieved that not only fulfill unmet clinical needs but also enhance treatment outcomes and significantly improve the patient’s daily life. This challenges the status quo, and demonstrates the benefits of integrating a more empathetic and inclusive design approach within the medical device industry, presenting a path to combat antimicrobial resistance, advance Hospital-in-the-Home services, and improve patient care globally.