Following the launch of its Aria Smart Autoinjector, Med-Tech Innovation News spoke to Kevin Deane, executive vice president of front-end innovation, Phillips-Medisize to find out more about the device.
What's different about this smart autoinjector?
The Aria Smart Autoinjector platform has been developed as a simple, patient-friendly, connected device that provides all the benefits of a disposable mechanical injector in a more sustainable, eco-friendly format. The platform offers improved user guidance, feedback, and delivery and enhances the quality of home-based healthcare by enabling remote monitoring and support and empowering patients. Phillips-Medisize is working with its customers to utilise the platform to develop innovative solutions to meet the current and anticipated market needs. In a recent survey on Digital Health and the Future of Pharma, conducted on behalf of Molex by Dimensional Research, an overwhelming majority of pharmaceutical executive respondents reported usability and sustainability as obstacles to adopting digital drug delivery solutions. However, over half of them expected digital drug delivery to provide tangible improvements to patient outcomes.
The Smart Autoinjector provides patients with a design that offers the familiarity of current disposable autoinjectors, with a similar level of needle safety, but benefits around better feedback and support. The needle is hidden by a moveable needle shield that protects before and after injection. It is only released once the cassette is loaded into the device and is locked permanently in place after injection, protecting against needle-stick injuries.
What sets the Aria platform apart from disposable devices are the connectivity options. The autoinjector comes with built-in Bluetooth connectivity as standard. It can easily be connected to mobile phones and tablets to work in conjunction with the companion app or those developed by third parties. The app can be used to help patients monitor and manage their medication.
Working with a pharmaceutical customer, Phillips-Medisize previously designed and developed the first FDA-approved connected drug-device combination product with a regulated digital service. Since then, the company has worked on many other connected electronic devices. The Aria platform builds upon this experience and is being developed to integrate into the complete Connected Health Platform solution, allowing pharmaceutical companies to understand better how their medication is used in the real world. This system also includes HCP Portals providing healthcare professionals, in real-time with historical-comparative analysis and historical trending, comparative analysis, and real-time data to understand better how patients take their medication in real-world conditions.
How does the Aria platform reduce waste?
The Aria platform consists of two parts: the reusable drive unit, which contains the electronics and combines illuminated icons with rich, audible sounds to provide clear feedback to users about injection progression and completion, and the disposable cassette that houses the syringe provides needle safety. The cassette is considerably smaller and uses less material than current single-use autoinjectors, resulting in less waste and less space required for transportation and storage. Additionally, the platform accommodates both 1ml and 2.25ml prefilled cassettes,allowing more versatility in supporting the delivery of a wide range of drug products.
The Phillips-Medisize Smart Autoinjector aligns with pharmaceutical companies' goals to be carbon neutral with reduced plastic usage. By utilising Life Cycle Assessment (LCA) and evaluating climate change impact for treating 100,000 patients with weekly injection, the Aria platform offers approximately 60% less environmental impact vs. 1ml single-use, 75% less impact vs. 2.25ml, and 85% less impact vs. single-use devices with connectivity.
What steps did you take to ensure the unit was reusable?
The key to reusability is the electronic drive unit designed and tested for three years and up to 500 injections. This unit can engage with a loaded cassette, deliver the drug, and then reset so the cassette can be removed and disposed of, allowing the unit to be stored ready for its subsequent use. It can also warn the patient when it is coming to its end of life or if there is an error that might affect the reliability of an injection. Spring-driven systems are harder to reset, which is a key reason why they tend to be single-use.
Can you tell us about the technology that went into developing the connectivity aspect?
This platform has Bluetooth connectivity built-in and RFID as an option. The device maintains a complete time-stamped log of all dosing events. Data is synchronised when the device is connected to an app, meaning dosing data is not lost if the device is not connected or not online at the time of injection. Direct-to-cloud communications are currently being considered for future releases. This approach eliminates the need for a smartphone to relay the data to a cloud-based data system.
What were the challenges when putting this together?
Achieving the requirements for connectivity and reliability required careful selection of components that support the size, performance, and cost targets for the device. It is also essential to consider a design that can be flexible and future-proof, so once the technology matures and the market need develops, new solutions such as direct-to-cloud can be easily and cost-effectively implemented. To achieve this requires a contract development and manufacturing organisation with broad capabilities in design and manufacture and the experience from a solid track record of marketed products to inform the new design and address cost, size, and performance targets.
Finally, developing a connected health system that engages patients and clinicians and ensures reliable data flow requires a systems approach to the complete ecosystem that combines user experience with technical and regulatory capability.
Anything else you'd like to add?
In Europe alone, almost 40% of people aged 65 and over have stated that they live with at least two chronic diseases, as reported in the latest Survey on Health, Ageing and Retirement in Europe (SHARE). This figure rises as people get older. In addition, in 2019, approximately 32.3 million adults were diagnosed with diabetes in the European Union – almost doubling since 2000. The economic ramifications of this are substantial, with an estimated expenditure to treat diabetes and its complications of €150 billion in 2019. More than 80 autoimmune diseases result in chronic, often debilitating, and, in some cases, life-threatening illnesses.
According to the National Institutes of Health, as many as 23.5 million Americans suffer from an autoimmune disease. Many of these are managed using disease-modifying biological drugs, which have driven the self-administration market and, hence, autoinjectors' uptake. National Institutes of Allergy and Infectious Diseases reported in 2011 that the cost of treating autoimmune disease in the United States exceeds $100 billion annually, a number that may well be understated. The Aria platform is ideal for this market, offering a range of benefits to patients and pharmaceutical companies looking to improve patient support and address medication non-adherence. The significant share of expenses incurred by patients living with a chronic disorder is driven by the frequent need to medicate, which may require repeated visits to hospitals or out-patient clinics. Providing a solution that enables self-care in a smart connected way, is critical to the evolution of home healthcare and alleviating the financial burden of chronic illness. Tech-enabled care delivery was identified as a significant contributor to this revolution in the Prioritizing health: A prescription for prosperity report conducted by McKinsey Global Institute in 2020.
Phillips Medisize is at the forefront of this innovation because we believe innovation grows at the intersection of market needs and emerging technologies. We pride ourselves on putting patients at the centre of the design whilst ensuring we plan for the ultimate manufacturing and assembly. Phillips-Medisize drives innovation, helping our customers bring better products to market, with greater speed and with a higher degree of confidence.
