Confidence, Not Comfort: The Under-Recognised Driver of Patient-Centric Drug Delivery

July 7, 2026

Stephen Roper

Edgar Pogna

Key takeaways

The most successful patient-centric delivery innovations of the past decade have focused on eliminating specific categories of patient uncertainty rather than solely improving comfort.

In complex self-administration settings, confidence that a dose has been prepared, administered and completed correctly is often a stronger driver of adherence than injection experience alone.

Many development programmes continue to allocate disproportionate investment to comfort-oriented formulation and device improvements relative to confidence-building design features.

Companies should incorporate measurable uncertainty-reduction objectives into patient-centric design briefs and development plans.

Patient-centric delivery has a confidence problem

For nearly a decade after biosimilar competition entered the pegfilgrastim market, Neulasta Onpro retained approximately half the U.S. market and protected a segment that Coherus estimated to be worth approximately $1.2 billion. The product’s differentiation was not based on the molecule, formulation or price. It was based on delivery.

The on-body injector automated administration within a narrow post-chemotherapy dosing window, removing the need for patients to self-manage a time-sensitive treatment decision while recovering from therapy. Its value came from eliminating complexity and uncertainty.

This example highlights a broader shift occurring across drug delivery. While patient-centricity is often associated with reducing pain, anxiety and injection burden, many of the most successful delivery innovations have instead focused on increasing patient confidence that treatment is being administered correctly.

As self-administration becomes more common across biologics and specialty therapies, understanding the sources of patient uncertainty is becoming increasingly important for development teams seeking to improve adherence, persistence and treatment outcomes.

Patient-centricity is about resolving uncertainty

The conventional view of patient-centric delivery focuses on comfort-related improvements such as smaller needles, lower injection force, reduced viscosity and less injection-site pain. These factors matter and can influence patient preference.

However, evidence from human factors research and real-world use suggests that correct administration is often determined by whether patients can confidently navigate the treatment process outside the clinical environment.

Three forms of uncertainty are particularly important:

Am I doing this correctly?
Did the full dose actually go in?
Did I administer the dose at the right time?

These uncertainties can emerge across the entire self-administration journey, from treatment preparation through to ongoing adherence (see Figure 1). Failure points are not confined to the moment of injection and often occur well before or after the dose is delivered.

The scale of this challenge is easy to underestimate. In one observational study of insulin injection technique among Canadian individuals with diabetes, every patient made at least one technique error, with the most common being incorrect applied injection force (76%), insufficient injection-site rotation (64%), insufficient needle dwell time (61%), incorrect reuse of needles (39%) and incorrect needle length (34%). These are not failures of willingness or comfort; they are failures of confident, correct execution that persist even in a mature, well-supported delivery category such as insulin.

Figure 1: Patient uncertainty extends across the self-administration journey, not just the injection event

The evidence is consistent across delivery modalities

Several commercially successful delivery systems illustrate how resolving uncertainty can create meaningful value for both patients and manufacturers.

For example, AUVI-Q addresses uncertainty around correct administration. During an anaphylactic emergency, treatment is often delivered under highly stressful conditions by individuals with limited training. The device’s audio and visual prompts guide users through each step of administration, helping ensure correct use when cognitive load is highest.

BETACONNECT addresses uncertainty around dose completion. Through visual and acoustic feedback, the device confirms successful administration and reduces ambiguity regarding whether treatment has been delivered correctly.

Neulasta Onpro and, more recently, Udenyca OBI address uncertainty around timing. Automated administration removes the burden of managing a narrow dosing window and reduces the risk of missed or delayed treatment.

The common characteristic across each example is that the design intervention removes a source of uncertainty rather than simply improving the injection experience. These confidence-oriented interventions eliminate specific categories of patient failure, whereas comfort-oriented interventions more often only deliver incremental improvements in the administration experience (see Figure 2).

Figure 2: Patient-centric design levers address different sources of patient uncertainty and adherence failure

Why development programmes may be missing the opportunity

Despite increasing recognition of patient-centricity, development investment often remains concentrated on formulation and engineering challenges such as viscosity reduction, container compatibility and injection force optimisation. These priorities are understandable. Technical feasibility is a critical development gate.

However, many programmes continue to prioritise comfort-oriented improvements after key feasibility questions have been resolved, while underinvesting in feedback systems, completion confirmation, sequencing controls and broader support mechanisms. The result can be a delivery system that performs well in preference testing but still creates avoidable administration errors in real-world use.

Industry analyses note that human factors validation failures remain one of the most common late-stage setbacks for drug-device combination products, and attempting to correct usability issues after formal validation often results in timeline resets. Food and Drug Administration guidance reinforces the point, cautioning that late design changes are expensive and delay market launch and that formative evaluation should run throughout development rather than shortly before approval.

Patient-centric design should incorporate measurable confidence objectives

Patient-centricity should be translated into measurable design objectives rather than treated as a broad aspiration.

Development teams should consider:

Defining uncertainty-reduction requirements within the quality target product profile
Measuring success against confidence-related endpoints during formative human factors studies
Evaluating feedback mechanisms, sequencing controls and timing support as core design features
Treating onboarding, troubleshooting and support services as part of the overall product experience

More broadly, organisations may need to reconsider how patient-centric investments are prioritised. Comfort and confidence often compete for the same resources, but they do not necessarily deliver the same outcomes.

This does not diminish the importance of comfort. In some therapeutic areas, reducing pain and injection burden can play an important role in supporting adherence. However, many of the most successful delivery innovations of the past decade have succeeded because they removed uncertainty. They helped patients understand what to do, confirmed that treatment had been delivered correctly and reduced the likelihood of errors occurring outside the clinical setting.

A useful test is whether patients could still complete treatment correctly if only the confidence-building features remained. If the answer is no, the design may be solving a secondary problem while leaving the primary challenge unresolved.

For development teams, the implication is straightforward. A truly patient-centric design brief should define not only how comfortable the experience will be but also how confidently patients can complete it correctly. Programmes that systematically identify and eliminate sources of patient uncertainty are likely to be better positioned to improve adherence, support persistence and maximise the value of self-administration.

How L.E.K. can help

L.E.K. Consulting helps pharmaceutical companies, drug delivery developers and investors evaluate the business use case for patient-centric delivery design and identify the most effective strategies to improve patient outcomes and commercial performance.

Our support extends from delivery strategy and product development through to go-to-market planning, partnerships and investment decisions.

To discuss how patient-centric delivery design could support your product and portfolio objectives, contact us.

[This article focuses on the role of patient confidence in supporting successful self-administration. For a complementary perspective on how delivery systems influence competitive differentiation and long-term franchise value, see The Device, Not the Molecule: The Under-Recognised Source of Franchise Durability.]