Pump It Up: User-Centered Infusion Pumps on the Rise

Key Trends in Parenteral Delivery

Ensuring Safe and Accurate Dose Delivery

Linda: Safe and accurate dose delivery is the bedrock of any drug delivery device. Following that, patient comfort and convenience are paramount. Technologies such as prefilled syringes (PFS), have significantly contributed to these goals. Prefilled syringes ensure precise dosing, which is crucial for patient safety, and they also streamline the self-administration workflow process, reducing the risk of dosing errors.

Jon: Initially used for vaccines, PFS are now being used for a wide range of therapeutics and have been a key enabler of patient self-administration, enhancing dose accuracy and convenience The use of PFS for SC infusion-based therapies represents a significant evolution in convenience, as patients no longer need to fill their devices at home.

While this advancement does pose some challenges, such as increasing the overall form factor of some ambulatory pumps, the benefits outweigh that challenge, and space can be saved, and footprint reduced, via innovative design.

The Rise of Connectivity

Linda: Another major trend is connectivity. As healthcare shifts from hospital and infusion clinic settings to the home, real-time understanding of patient conditions becomes crucial. However, the value of adding digital solutions to drug delivery devices remains a key question in the industry.

Our technology strategy is encapsulated in three words: “comfort, convenience, connected.” While connectivity is part of our strategy, it is a longer-term goal for KORU. It is important to note that although there are hundreds of thousands of healthcare-related apps currently available, the number that are currently reimbursed is a much smaller subset. The cost-benefit ratio is a critical factor for healthcare providers, payers, and patients.

Jon: Understanding what the drivers are for connectivity is key when developing drug delivery devices. Absolute focus on the users (including the patient, healthcare professional, and wider healthcare system) is paramount. Just because a technology can be implemented doesn’t mean it should be.

Transitioning Healthcare Settings

Linda: As more aspects of healthcare transition to the home, we encounter quite a different user base. Understanding users, their conditions and needs is the first challenge we face. Then, we aim to design solutions within a timeframe that does not disrupt the drug timeline or add additional risk.

Jon: It is true that the transition from clinic to home can be a challenge, but the potential improvement in patients’ lives is massive. The interruption of having to travel to an infusion center or hospital regularly and arranging appointments adds to a feeling of being trapped by your condition, which can have a huge emotional toll.

“Safe and accurate dose delivery is the bedrock of any drug delivery device. Following that, patient comfort and convenience are paramount.”

Designing for Diverse Groups

Innovative Solutions for Rare Diseases

Linda: Our products are often used within the rare diseases space. This brings additional challenges, as our patient populations can be extremely low in number – ranging from 10,000 to 50,000 globally – and geographically dispersed. Knowledge about the specific condition and treatment options is sometimes sparse too. We design and validate our products with this in mind, considering the needs of caregivers, self-administering patients, and healthcare professionals.

For rare disease states, KORU aims to support even smaller patient populations by modifying our pump or consumable set. This approach is more achievable than creating bespoke devices from the ground up, allowing us to support vulnerable patient populations with platform-based products that are easier to develop and faster to scale.

Jon: As an engineer, designing a product that can be adopted by such a wide range of user groups is hugely satisfying. The elegance of modifying a platform system without interrupting the supply chain – or causing large changes to the design history file and supporting verification documentation – allows for the smooth and crucially fast uptake of new therapies. By minimizing the number of change parts, we can also reduce the environmental impact of the product, reducing the number of SKUs and the effect on the supply chain.

Enhancing Workflow and Efficiency

Innovative Mechanical Infusion

Linda: At the core of our technology is a fully mechanical infusion system. This system cuts the need for batteries, electricity, or programming. It uses a constant force spring system to ensure accurate dose delivery.

Our pumps also enable the use of PFS, which cuts – often challenging – workflow steps, removing the burden of filling the syringe prior to use. This streamlined process reduces the entire workflow to just a few steps: load the syringe, connect the infusion set, insert the syringe into the device, and close the door – all of which can be completed in five seconds or less.

User-Friendly Design

Linda: Furthermore, our new infusion sets are ergonomically designed with specific design language cues. For example, we use color-coding – blue to blue, white to white – when connecting different components. This approach leverages best-in-class anthropometric data, making attachments easier for elderly patients and children to comprehend and carry out safely.

Jon: Good design cues help users simplify their routines. A great device should not be a burden or worry in the users’ already busy life. In fact, many create an emotional connection with their device – it becomes part of their daily or weekly routines, almost like part of the family. In a recent user study, one elderly user shared they had given their pump a name. “Frank” had become part of the patient’s life, as well as providing their life-saving therapy.

“This process reduces the workflow to a few steps: load the syringe, connect the infusion set, insert the syringe into the device, and close the door.”

Empowering Healthcare Professionals

Simplifying the Workflow for Nurses

Linda: Our infusion pumps are not only applicable to patients in the home setting. In recent years, over ten drugs have been approved for administration in infusion clinics. Currently, manual push is the standard mode of administration for many of those therapies, and it seems pharmaceutical companies assume healthcare professionals will manage, despite the user burden and impact on workflow involved with managing multiple infusions daily. We believe this is a substantial unmet need in the market, and we are focused on developing a solution.

Jon: Infusion nurses are often extremely busy, managing multiple patients with different therapeutic needs for example, conducting manual dose calculations, scheduling and pump setup and checks. Set-and-forget devices can reduce that burden, streamline clinic workflows, and provide a high level of confidence that the correct dose will be delivered at the right rate.

Linda: With the Koru system, they simply take the syringe, connect the delivery device, place it into our pump, close it, and walk away. There is no need to learn a new system or programming. The advantages relevant for home use are equally beneficial in infusion centers.

“Set-and-forget devices provide a high level of confidence that the correct dose will be delivered at the right rate.”

Innovation Driven by Market Needs

Overcoming Auto Injector Limitations

Jon: Autoinjectors (AI) were first introduced in the 1980s for emergency use, and their widespread adoption for regular home administration of biologics and other medications began in the mid-2000s. For volumes above 2 ml, there are still significant challenges to overcome, and though there are innovations within the AI space, current options include using multiple devices to achieve a dose above 2.25 ml. The limits in terms of volumes and rates for a single bolus injection are still being studied, but indications are that injection duration of up to 30 seconds is achievable. For viscous drugs or larger volumes, this duration may need to extend significantly, resulting in the potential of usage errors and partial dosing – not to mention poor patient adherence.

Linda: We are addressing the significant market need when autoinjectors are not suitable due to development time and constraints such as volume and hold time. This unmet need drove our innovation into delivery options for doses under 10 ml.

Efficiency and Cost-Effectiveness

Linda: Our focus is on further developing both our pump platform and consumables. The flexibility and simplicity of our 510(k) approved system means we can offer pharmaceutical customers shorter development timelines, both for clinical trials and in bringing a product to market with lower cost and lower risk. We keep the pump platform consistent, making small changes as needed, such as reducing a 20 ml pump to 10 ml to suit a specific drug volume, directly addressing market demands for flexibility and speed.

Facilitating Clinical Trials

Linda: By using the same pump and consumable platform, we also enable clinical trials for different drugs. We can easily modify the system to accommodate various viscosity and flow rate demands without a multi-year development process. We use the same fundamental technology repeatedly, knowing how to modify it for different drugs with unique needs and flow rates, allowing a rapid path to clinical trial readiness.

Reusable Platform

Linda: Our core pump is reusable, and the consumables are disposable, and we are making those disposables as environmentally friendly as possible. Our reusable platform is simpler to process at end of device life compared to electronic pumps, which have batteries and electronics that are more complicated to handle, addressing market demands for sustainability.

Seizing Market Growth Opportunities

Growth in Immunoglobulin Market

Linda: Immunoglobulins (Ig) still make up 95% of our business, and we are witnessing incredible growth in this area post-COVID. As people become more active, those with compromised immune systems require more immunoglobulin to combat infections. Companies are now looking to innovate drug delivery devices in this space.

Jon: Ig therapies are manufactured from human plasma donations and the production process is complex and time-consuming, taking 7-12 months from collection to the final product. The continued growth of Ig demand, quoted as 6-8% annual growth in a 2020 journal article¹, is putting significant pressures on the supply chain, with every precious drop being used in life saving treatments, and we see this across a number of our clients. An added benefit of using PFS with infusion pumps is the optimized dosing of these therapies, ensuring that patients receive the precise amount needed, with no waste, which helps maximize the efficiency and effectiveness of the treatments.