Main image: Michael Earl, Director, Pharmaceutical Services, Owen Mumford Ltd.

Successful development of connected drug delivery devices is often a complicated challenge, with a range of considerations right from the start of the program. Owen Mumford’s Michael Earl goes back to basics, outlining core considerations for efficiently creating optimal products, while avoiding common pitfalls.

The first step before device development begins is to define the specific user and device requirements, bearing in mind the product's value proposition and market benefit. The context of use also needs to be considered – for example, who are the intended users and where will the therapy be administered? What data is critical and how frequently do those data need to be transmitted and to which stakeholders? Even at this stage, it’s important to go into the finer details. This makes it easier later to draft robust Requests for Quotes to source suppliers.

Device manufacturers have a useful role to play in the process of matching the appropriate technology and functionality with users’ needs and requirements. For instance, they can demonstrate the full range of indicators and sensors that can be incorporated into a device, and highlight the different options and combinations that are available to suit the specific drug and therapy area. 

One pitfall during development is that the relevant expertise is often split between different parts of an organisation. Although specific digital health teams are becoming more common within pharma companies, issues can still fall between the cracks if there is a fragmented approach. An integrated strategy involves the different functions and expertise needed right from the start – from design, engineering and software specialists to usability, data and marketing experts. A critical stage is the handover of information between teams conducting these different aspects; this is where problems can be most likely to originate. 

The addition of connectivity increases complexity and, with the electronics, the number of components in a device; these all need to be tested, validated and verified, so this has to be factored into development. Additional testing is also required for batteries and other electronic components – with consideration given to the different environmental conditions the device will be exposed to during its lifetime and potential impact on the shelf life of the batteries. For instance, biologics will use cold chain distribution, which could affect device components and electronics.

There also needs to be stringent quality control during manufacturing, transportation and storage to ensure the device is reliable throughout its lifetime. Battery life is becoming increasingly important; this means the algorithms that determine and optimise sensors, indicators and battery use need to be a particular focus.

The rigorous regulatory pathway for connected devices makes market access a challenge. The US Food and Drug Administration, for instance, now has twenty-four guidance documents related to digital health regulation. These help manufacturers to ensure they’ve covered the full range of concerns related to these products, including cybersecurity and interoperability.

To add to this complexity, requirements also differ between countries, particularly when it comes to the process of storing and managing data. There may be a requirement for data to be stored locally on servers within the country where it is collected, such as in China, where overseas data transfers come with specific conditions and processes, and which also does not yet have any international data protection framework or agreements.

Developing a connected add-on to an existing device may have an easier regulatory pathway; since the drug device combination product has already been validated and approved, a regulatory filing may be submitted solely for the accessory, which may not be defined as a medical device. But fully integrated connectivity requires specific additional human factors testing and user studies to evaluate the connectivity and functionality – and its impact on the performance of the combination product. 

Developing a connected drug delivery device can be a costly undertaking, increasing the cost of the finished product and also adding risk and time to the process of device development, testing and regulatory approval. You need to be clear about the return on investment when adding connectivity and give consideration to which markets are to be selected for product launch.

And it's not just financial costs that count – the cost to the environment is also a key consideration. Integrating electronics into single-use devices to enable connectivity generates electronic waste and disposal may also be controlled by regulations such as Wate and Electrical and Electronic Equipment (WEEE). Reusable connected devices have the benefit of not needing to dispose of electronic components after each use – the drug cartridge or pre-filled syringe is simply replaced.

However, it is important not to make assumptions about the difference in environmental impact between single-use and reusable systems; there must be a thorough analysis. A holistic approach is needed using tools such as Life Cycle Analysis (LCA), which includes an assessment of everything from the raw materials to the manufacturing processes and complete supply chain.

The connected drug delivery devices market is predicted to grow more than four-fold, from $0.87 billion this year to $3.92 billion by 2028 – driven by factors including the rising number of patients suffering from chronic diseases as well as the potential that connectivity offers for improved patient compliance.

Add in the growing trend for at-home treatment and it is no surprise that connected drug delivery devices are fast becoming an attractive option for pharma companies' product portfolios. For diabetes management especially, connected devices are leading the way, with devices (pen injectors or wearable insulin delivery systems) that are able to link to continuous glucose monitors and also connect to apps providing both patient and healthcare providers with critical information.

However, there is still vast scope for development in other disease areas. Digitalising products is a complex undertaking requiring an organised approach and multiple teams with different areas of expertise. Third-party experts can often help save time and resources by sharing their insights from extensive previous experience. It's all about having, or making, the right connections.

Learn more about the upcoming UniSafe^® 1mL connected auto-injector here.

Michael Earl joined Owen Mumford as Director of Pharmaceutical Services in November 2020. He was previously the Commercial VP at Bespak, leading the commercial team there to drive growth in their substantial medical devices business. Prior to that, he worked for a number of pharma, biotech and device companies. In a career spanning more than 35 years, he has been responsible for all aspects and stages of drug and device development and commercialisation. Michael has also completed a substantial number of commercial, licensing and M&A transactions.