Kevin Deane, vice-president, innovation, Phillips-Medisize explains why he believes connected health offers promising potential for pharmaceutical companies and drug delivery device developers and manufacturers.
Filling the data void
As healthcare systems worldwide start to implement outcome-based reimbursement, the ability to measure medication effectiveness, and patient adherence plays an even more important role in managing and improving patient health. Unfortunately, little actual data exists that pinpoints when, or even if, patients take their medication, despite new prescription drug development costs estimated to be as high as $2.6 billion1. A range of research has demonstrated, though, that adherence rates are typically lower for patients with chronic conditions, and even clinical trials report average adherence rates of only 43 to 78 percent.2 Poor medication adherence is also the cause of 33 to 69 percent of all medication-related hospital admissions in the United States alone.2
Integrating connectivity into innovatively designed, patient-centric drug delivery devices can help fill this data void and support increased adherence by making it easier and simpler for people to take their medication on-time and as prescribed. Connectivity provides an efficient way to monitor patients’ adherence and condition, as well as to share both real-time and historical data with patients, clinical researchers, healthcare providers, caregivers and payers.
The connected health ecosystem
The connected health ecosystem includes three primary components:
- Connected devices - such as inhalers and injectors
- Digital interfaces - including patient and caregiver apps, and dashboards for healthcare professionals
- A cloud platform - enabling data integration with multiple sources including diagnostic devices, internet of things sensors and electronic health records in order to generate insightful analytics
Four years ago, Phillips-Medisize developed the first connected health system registered with the FDA for a specific drug. Since then, the number and popularity of connected health pilots has grown, but pharmaceutical companies sometimes struggle with how to scale the model, and extract and quantify the value created, which can impede additional investment.
Recognising the increased interest and demonstrable benefits that connected systems provide, Phillips-Medisize decided to invest in developing a highly scalable platform to service the expanding market, rather than developing and maintaining one-off, application-specific solutions for each new project.
The benefits
The resulting cloud-based connected health platform provides a scalable medical device data system (MDDS) for pharmaceutical companies and drug delivery device developers. By reducing the risk, time and cost associated with developing connected health solutions, it helps accelerate time to market.
Additional benefits include:
- Comprehensive information-sharing and analytics capabilities: It connects pharma companies, clinical researchers, providers, patients and payers, sharing and displaying information from connected drug delivery devices, biosensors and regulated Mobile Medical Applications (SaMD/MMA). Dashboards can be customised quickly and easily at any point, which saves time and money, adds high-value flexibility and streamlines connection with other supported external analytic systems. It also integrates medication, diagnostic and therapeutic data from multiple sources as well as supports global comparisons by normalising data across geographies.
- Robust cybersecurity: A connected health platform can be deployed in a secure private cloud with a credible legacy of health data security, in a cloud hosting option selected by the pharmaceutical company, or in the company’s own data centre. In addition, cost-effective and secure collaborative environments are available for situations where cross-industry partners want the ability to share data.
- Streamlined regulatory documentation: Full regulatory documentation services included with the connected health platform support premarket submissions for 510(K), combination products and CE mark to help lower project costs and speed time to clinical trial, regulatory approval and market, ahead of the competition.
- Modular approach: Working with a manufacturing partner who can deliver connected health solutions that incorporate devices with embedded electronics and sensors also speeds the development process and keeps costs low, for both reusable and disposable drug delivery devices. Connected health platforms that come with a software development toolkit and defined, extensible application program interface, allow any device to be connected to the system. Pairing a configurable app with the connected health platform and deploying it across multiple products using a standard Bluetooth interface further supports a rapid, low-cost path to clinical trial and market.
- Massive scalability. Building on a flexible, scalable platform rather than starting from scratch for each new drug makes it highly cost efficient to add or refine infrastructure for future projects. Because the price per user declines as the patient population increases, the costs for integrating connectivity for medications used to treat common chronic conditions also decrease.
A case study
A leading pharmaceutical company recognised the need to update its current drug injection device in order to retain existing patients and attract new ones. The company's drug had established safety and efficacy, but its injection device lagged in user friendliness. The company sought to use electronics to improve the injection experience but also wanted to help patients better manage their disease by offering seamless integration between the device and a patient app that could track injections and remind patients when and where to take them.
Teaming with Phillips-Medisize, they developed and manufactured an innovative electromechanical autoinjector connected to the cloud, featuring:
- Ergonomic design operated with one hand
- Secondary control functions hidden on the inside
- A dashboard for healthcare professionals to easily monitor patients
- Bluetooth connectivity that ensures data on injection time, volume and body location are synced with the patient app and dashboard
- Personalised, localised messages and reminders for patients on their device and in the app
The integrated system was introduced in countries worldwide after its initial launch in Europe. It has made injections more intuitive for patients, made it easier for caregivers and healthcare providers to coordinate and follow up on treatment, and helped the company retain its market position.
Meeting market needs
Only a few connected health solutions tied directly to medication have made it to market so far, even as healthcare becomes increasingly digital. The pace of development continues to accelerate as pharmaceutical companies and drug device developers and manufacturers seek to meet market needs. The opportunity to develop innovative connected health solutions using a secure cloud-based platform that provides a safe and scalable MDDS helps reduce risk, cost and time to market. At the same time, by demonstrating a clear pathway to value creation, these cost models can bridge the gap between pilot and program and encourage additional investment in connected health.
Footnotes
1Sullivan, Thomas. A Tough Road: Cost to Develop One New Drug is $2.6 Billion; Approval Rate for Drugs Entering Clinical Development is Less Than 12%. Policy & Medicine. March 21, 2019.
2Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-497.