Traditionally, the pharma industry has been focused on the development and manufacture of therapeutic solutions that are then prescribed by doctors without considering the subsequent patient experience.
The high costs associated with research and development have always put pressure on pharmaceutical companies to produce a successful formulation; but, in the modern day, which includes revisions to payment models, there is added pressure to attain positive patient outcomes.
This more patient-centric concept is becoming a major trend, leading the industry to look at more defined clinical and regulatory approaches, a rising proportion of biologic formulations, higher drug specificity and treatments that are linked to diagnostic data.
All this comes in addition to companies delving into a subsegmentation approach that focuses on the patient and wherein drugs may offer the highest benefit and efficacy.
However, efficacy and safety are still at the fore when it comes to developing a drug and are essential to gain regulatory approval. Yet, for many pharma companies, there is more of an understanding that the journey — from concept to end-user — provides a useful way to explore and ensure a product’s success.
An understanding of this journey not only delivers valuable insight into the requirements of stakeholders, but also gives the company the essentials to define the services needed for patients (and stakeholders) within specific subsegments. A good service model should be able to meet both individual and segment needs — which includes monitoring, adherence and compliance.
To gain value from differentiating between the drug and service when starting the development process, it is imperative that companies manage a smooth interaction with stakeholders. The shift in this balance means that bespoke connected health services will prove to be integral to getting it right.
A potential paradigm shift
It is possible for connected health services to instigate a paradigm shift in the pharma market by offering companies a direct relationship with the end user. This sort of applicability has been successful in other sectors, within which end-user ownership has led to a company becoming a market leader.
However, in the pharmaceutical space, there are regulatory and compliance issues, such as safety, efficacy and pharmacovigilance, which could prove to be problematic.
Despite these concerns, there are big companies such as Google and Apple that are collaborating within the health space to offer a solution that both serves the patient and influences market position.
These collaborative opportunities enable companies to share the risk with the payers and means that models driven by data and finance can be employed.
Additionally, through the use of smart devices, companies can introduce real-world data to support approvals. This is particularly useful in situations when evidence development and conditional approval conditions are concerned and allows companies to deliver post-market data that can prove secondary measures or outcomes.
So, even though doctors will still prescribe the drugs, the patient will be able to actively participate in their treatment, which can incorporate a combination of drugs, smart devices and services. In a service-driven environment, the end-user interaction will be controlled, to some extent, by the connected health service and data flow providers, leaving the pharma companies simply as the drug supplier. However, some pharma companies may decide to absorb this service responsibility also.
Managing risk
Working in an environment that is strictly controlled and regulated has left the pharmaceutical industry more concerned with challenges — rather than the opportunities that can arise out of new technological services, such as connected health. Those concerns that are considered to be the most important include security and data privacy — which although vital, are also controllable.
After the advent of smartphones, which enable people to stay connected easily, many companies across a breadth of industries have taken advantage of this connectivity to gain insight and knowledge into consumer behaviour. There is the potential for pharmaceutical companies to utilise this connectivity to fulfil patient-centricity claims, as long as the risks are managed appropriately.
Furthermore, smartphones and related devices can also offer patients independence in their own care journey, which is becoming more attractive and desirable for them in the modern day.
To be successful in the delivery of a system, companies must factor in some key strategic considerations and basic rules. At the base of it all is gaining an understanding of the needs and challenges of specific stakeholders in relation to disease management. By initially identifying these criteria, a company can then visualise the potential value drivers for the service.
This process should be done on an individual basis in a specific disease and care–journey context.
This individualised approach means that when designing and developing a smart device and connected health solution, flexibility and options that are unique to the user are imperative to keep patients engaged.
For example, the first fully connected solution that is available in the market from Bayer — the BETACONNECT electronic autoinjector and its associated myBETAapp regulated connected health platform — has undergone regulatory assessment for each aspect — device, service combination and product set-up — before being granted approval. This device and platform supports multiple sclerosis patients and their respective healthcare providers through the full care journey.
Time and cost implications
Meeting the specific needs of patients, which is the aim of smart devices and connected health solutions, does not necessarily mean that time to market will be dramatically increased compared with that of an off-the-shelf technology.
Using core technologies that have already been tried and tested in other devices is useful for companies as a starting point in the development of more specific and bespoke solutions. The development of these products should then be possible in a similar timeframe to off-the-shelf solutions ... but also enable companies to deliver solutions that are specific to stakeholders needs, such as connected health options.
It is also possible, by incorporating the underlying hardware, security, integration interfaces and analytics into the standardised platform, to rollout connected health solutions before launching a device. An added benefit of this can improve the value of the solution as it is possible to offer early interaction with stakeholders.
The software and app-interface development elements of a connected health solution usually deal with the drug and disease-specific features. These should only require a short lead time of around 12–18 months.
It is inevitable that there will be more costs associated with connected health services and smart devices, but these can be counterbalanced when considering the significant value gained from the stronger market position and longer-term relationships with stakeholders that is possible through these bespoke offerings. Therefore, companies should consider the move into this market as a transformative opportunity.
This means that companies should concentrate on how it can add value from different parameters in addition to the drug itself. By combining these different parameters with “the pure treatment” — a preventive care model — will mean that market opportunities are made broader for companies and connected health can prove to be a differentiator.
However, it is important for pharmaceutical companies to clearly see this future as an opportunity to not only be a provider of drugs ... but also a provider of total disease management solutions.
Industry influencer
As is the case in other industries, user focus is becoming of greater importance within the pharmaceutical sector. A greater requirement for solutions to be patient-centric and alternative payment schemes are trending and changing the way in which companies should address the development and design of disease solutions.
In this vein, it is obvious that connected health services and smart devices will play an integral role in influencing the industry.
There are already some technologies and solutions available that allow stakeholders to be more independent and have more interaction throughout their care journey. With more technologies and solutions being launched, it is important that companies realise the value of these services and start to implement them into their future development plans.
However, these changes do not necessarily mean that companies need to reinvent the wheel; instead, smart thinking can enable companies to adapt by using existing, proven technologies that reduce the risk associated with developing a connected service while still adding value and being competitive with off-the-shelf solutions.