Beyond the pill: what PDURS means for pharma and digital health

A turning point for digital health

The challenge has rarely been a lack of ideas. It has been demonstrating value, creating sustained engagement and finding a credible route for integrating software into the patient experience in a way that regulators, healthcare providers and payers can recognise.

The FDA’s PDURS guidance provides a useful framework for addressing these challenges. It recognises that software can play an important role in supporting the safe and effective use of a prescription medicine. Rather than treating digital tools as merely standalone patient support programmes, the guidance creates a clearer framework for software that better contributes to the overall treatment experience by helping patients use, manage or derive greater benefit from a therapy.

From ‘drug products’ to ‘care ecosystems’

Historically, pharmaceutical innovation has focused on developing better drugs. That will, of course, remain central. But outcomes are influenced by more than pharmacology alone.

Patients may also need support to understand their condition, administer treatment correctly, adhere to complex regimens, monitor symptoms and side effects, manage anxiety or motivation, and navigate healthcare systems. These are areas where software can play a valuable role, but only if it is designed thoughtfully.

This is why PDURS matters. It encourages pharmaceutical companies to truly think beyond the drug product in isolation and consider the wider ecosystem that surrounds treatment. That ecosystem may include digital companions, connected devices, digital instructions for use, adherence support, remote monitoring, behavioural interventions and clinician-facing insights.

For therapies with similar efficacy profiles, these surrounding experiences may become an increasingly important source of differentiation. The organisations that succeed will not simply be those that add digital tools to existing products, but those that identify where software can address a genuine unmet need and contribute meaningfully to the overall treatment journey.

Digital health starts long before software development

The process of integrating a digital solution into a patient experience starts right at the beginning. Long before requirements are written or interfaces are designed, we find the most successful digital programmes start with understanding people. Organisations must consider the realities of living with, managing and treating a condition. This means exploring patient needs and frustrations, healthcare professional workflows, adherence barriers, behavioural drivers, clinical objectives and the commercial priorities that will ultimately shape whether a solution can succeed.

For that reason, our digital health engagements often begin with strategy, patient journey mapping, and value proposition development rather than technology delivery. We help organisations define where digital can create meaningful value within a therapy ecosystem, identify the moments that matter most across the patient journey, and understand where digital intervention could have the greatest impact.

From there, we translate those insights into prioritised requirements, product features and phased roadmaps that balance user needs, evidence generation, regulatory considerations and commercial objectives.

These activities may seem far removed from software development, but they often determine whether a digital solution becomes useful, adopted and scalable, or joins the long list of underutilised healthcare apps.

PDURS reinforces the importance of this approach. If software is to play a meaningful role in supporting prescription medicines, it must be designed with a clear purpose, grounded in real user needs and built around a credible route to demonstrating impact.

PDURS principles in practice

But what does this mean in reality? We have been exploring many of the principles now reflected in PDURS through our work helping pharmaceutical companies develop digital health solutions alongside novel therapies.

In one programme for a rare disease therapy, we worked with a global pharmaceutical company to explore how digital technologies could support patients throughout their treatment journey, improve understanding of patient outcomes and create a more effective therapeutic experience. To do this, we began with an assessment of the digital health landscape and emerging technologies, including opportunities for patient support, remote monitoring and digital measures.

We then facilitated a series of human-centred design workshops to truly understand patient and healthcare professional needs, identify the most important problems to solve, define the value proposition of a digital solution and prioritise features and requirements for future development.

Looking back, much of this work aligns closely with the principles underpinning PDURS. The objective was not to create an app simply because digital engagement was desirable. It was to identify where software could play a meaningful role in supporting the use of therapy, addressing real patient and clinician needs, and creating measurable value for different stakeholders.

This is precisely the shift that PDURS encourages.

The next challenge: proving value

The opportunity created by PDURS also comes with a higher expectation: software linked to prescription medicines will need to actually prove that it delivers meaningful value.

For pharmaceutical companies, this means moving beyond measures of engagement alone. The key question isn’t whether patients download or interact with a digital solution, but whether it improves outcomes. It means asking what the software is intended to achieve, who it benefits and how that benefit will be measured.

The measure of this would ultimately depend on the intended use. It could be anything from evidence related to adherence, correct administration, patient understanding or symptom tracking, all the way to treatment persistence, patient-reported outcomes, healthcare professional decision-making or health system efficiency.

This evidence question is likely to become one of the most important challenges for drug-digital solutions. A well-designed user experience is essential, but it is not enough on its own.

In this sense, PDURS should not be seen simply as a regulatory pathway. It should be seen as a prompt for more rigorous thinking in the implementation of digital health solutions.

Designing digital solutions patients actually use

Of course, evidence generation depends on engagement. A digital solution only creates value if people use it.

As pharmaceutical companies increasingly explore software-enabled therapy experiences, user experience will become a critical determinant of success. Human-centred design plays a central role in ensuring that digital solutions are not only clinically meaningful, but also intuitive, accessible, motivating and inclusive.

Whether developing digital companions, digital instructions for use, patient support platforms, smart packaging experiences or remote monitoring solutions, the objective remains the same: to create experiences that fit naturally into people’s lives.

This matters because healthcare behaviours are shaped by context, and the system asks a great deal from patients. They are managing symptoms, appointments, treatment schedules, side effects, work, family life and emotional burden. Software that adds friction is unlikely to be used consistently. Software that provides timely, relevant and practical support has a much greater chance of becoming part of the patient’s routine.

For digital health solutions associated with prescription medicines, this is not simply a design preference. It is central to whether the solution can deliver meaningful and measurable impact.

What comes next?

We do not see PDURS as the end point. It feels more like an early step in a broader shift in how therapies are conceived, developed and delivered.

For years, the industry has talked about connected care, personalised medicine and digital health. What we are now seeing is the gradual convergence of these ideas into more integrated treatment experiences, where medicines may be supported by a wider ecosystem of digital technologies.

The possibilities are vast. Connected devices, digital companions, wearables, digital biomarkers, AI-enabled support tools or personalised behavioural interventions are all potential parts of future digital ecosystems. Increasingly, the distinction between a pharmaceutical product, a device and a software solution is becoming less clear from the patient’s perspective. Patients do not experience these as separate categories. They experience them as part of a single treatment journey.

This convergence may give rise to new treatment models that combine therapeutics, software and connected services into a more integrated experience. Some may describe these as hybrid therapies, although the terminology is still emerging. What matters is the underlying shift: value may increasingly be delivered through the combined effect of a medicine and the surrounding digital ecosystem, rather than by the drug alone.

As this convergence continues, successful organisations will need more than technical capability. They will need to bring together patient insight, behavioural science, clinical understanding, regulatory strategy, evidence generation, UX design and technology development. The ability to integrate these disciplines will be essential to translating digital innovation into tangible healthcare impact.

Our perspective

For us, PDURS is not really about adding software to drugs. It is about recognising that healthcare outcomes are shaped by experiences as well as therapies.

The most successful healthcare organisations of the next decade are unlikely to be those that simply develop better standalone products. They will be the organisations that create better treatment experiences, combining therapeutics, technology and support services in ways that fit naturally into patients’ lives and address real unmet needs.

That starts with understanding patients. It means defining the right problems to solve, identifying where digital can genuinely add value, designing solutions people can and will use, and generating evidence that demonstrates meaningful impact.

PDURS provides an important framework for enabling this future. But perhaps its greatest significance is that it legitimises a shift already underway across the industry: treating software not as an optional digital add-on, but as an increasingly important part of the therapy experience.