Have ‘smart’ devices arrived in healthcare? The emergence of digitally connected combination products

With the ever-increasing advance of connected consumer devices, the promise of ‘smart’ drug delivery seems poised to solve some of the healthcare industry’s greatest challenges. However, connected medical device developers face significant barriers. Regulators demand extensive evidence of safety and effectiveness whilst it is vital to ensure the security and confidentiality of collected data.

Two such connected devices are reusable inhalers and autoinjectors, both of which have shown great potential to be digitally enhanced. These devices are typically used for self-administration and are sufficiently technically demanding to warrant the added expense of incorporating a connected component.

Advances on this front are gaining momentum and took a big step forward in July when Novartis received a milestone approval from the European Commission for its Enerzair Breezhaler, including the first digital companion that can be prescribed alongside a treatment for asthma. The digital companion includes a CE marked sensor that connects to Propeller’s app and provides users with inhalation confirmation, medication reminders, and collect data that can be shared with their physician. These features can help inform patient treatment plans and could set a new standard in treating uncontrolled asthma, if the digital add-on proves to provide a substantial benefit to physicians and patients in the real-world setting.

The approval has been a long time in the making and demonstrates the complexity of developing a smart device. Novartis initially struck a deal with Qualcomm Life to develop a new, connected version of the Breezhaler in 2016 however, this collaboration failed to yield a product. Novartis subsequently partnered with Propeller to develop a custom add-on sensor and app for the Breezhaler in 2017, hoping to take advantage of the company’s connected device capabilities and digital health platform.

Since the feasibility of adding a connected component to an inhaler has been established, respiratory drug makers have been eager to capitalize on this technology to gain an edge in a competitive market. In May, the FDA approved AstraZeneca’s Symbicort inhaler combined with a sensor and app from Propeller, and the smart inhaler developer has previously also made deals with GSK and Boehringer Ingelheim.

Meanwhile, pharma companies are looking to utilize advances in digital medical devices beyond the respiratory space, especially as healthcare is progressively moving from the hospital to the home. The shift towards home-based care frees up valuable time and resources for caregivers whilst improving patient quality of life. However, issues surrounding adherence can be detrimental to a patient’s health and constitute a sore point for payers who want to maximise cost-effectiveness. The development of smart devices to address these challenges represents an opportunity for pharma companies to gain a competitive advantage.

As collecting and processing data is broadly gaining in importance across the pharma value chain, connected devices are shaping up to be a key piece in the puzzle that is the pharma industry’s digitalization. Companies may strive towards a position where they can exploit synergies between different digital technologies, from data collection to processing through to generating valuable outputs.

Look out for increasing prevalence of device integrated apps, advances in wearable sensors allowing for validation of new digital biomarkers and ‘closed‐loop’ systems, especially in diabetes.
Fuelled by a continuously growing demand for home administration, the future of connected devices seems bright, especially as the development and regulatory path becomes increasingly well-trodden. No big pharma player wants to be left behind as the field gains in importance, and companies may increasingly look to build up know-how and innovate internally. Understanding these trends, identifying new disruptive partners, monitoring competitor activity, as well as proactively assessing patient, care giver, and prescriber preference are key for pharma to innovate and lead in the 2020s.