Optimizing Access: Why Early, External Insight Is Critical to Commercial Success

Dominic Galante, MD and Ross Maclean, MD

In the biopharma and MedTech sectors, the development pathway for a new therapy is highly structured. Organizations invest in comprehensive project plans, establish formal go/no-go decision points, align cross-functional expertise, and leverage experienced leadership to manage complexity and mitigate risk. These well-established processes are designed to create predictability in a high-stakes environment. But even when a therapy achieves regulatory approval, optimal market access can be challenging.

This gap reveals a critical oversight — the failure to incorporate early, actionable insights from 3 key external stakeholders: clinicians, patients, and payers. These groups hold significant influence over whether a therapy is adopted, adhered to, and reimbursed. However, their perspectives are frequently underrepresented in early development, only to be urgently sought at launch. This article explores how and why integrating stakeholder insights earlier in the life cycle can transform outcomes, not only in access and adoption, but in delivering real-world value.

Treatment Adoption: Does the Therapy Fit the Realities of Clinical Practice?

While clinical efficacy and safety are essential, clinicians must be willing to prescribe and integrate the therapy into their workflows and that decision is often driven less by scientific novelty than by operational practicality. The central question is not always, “Does this work?” but rather, “Does this work in my practice?”

Healthcare delivery is under constant strain. Providers must manage time, staff, and financial resources while meeting escalating performance expectations. A therapy that streamlines care, reduces downstream burden, or improves throughput holds tangible value in this environment.

Strategic Approach

To support clinician adoption, innovators must understand the "business" of healthcare. This means designing development programs that consider real-world implementation — factoring in workflow compatibility, staffing requirements, procedural time, and downstream clinical impacts. These dimensions should be measured in parallel with the clinical endpoints of a drug, ideally as early as Phase II.

Proactively capturing data on the operational impact of a therapy, either through embedded trial endpoints or complementary real-world studies, can uncover value drivers that resonate more strongly with providers than traditional clinical outcomes alone.

Case Study: How Real-World Evidence Uncovered the Tangible Value of a Surgical Innovation

One surgical device developer anticipated that reduced operating room (OR) time would be the most compelling selling point for its product. However, field data revealed a more powerful differentiator. The team learned that decreased anesthesia exposure led to fewer catheterizations and urinary tract infections, and in select patient groups, enabled same-day discharge. These secondary benefits significantly enhanced provider support and payer receptivity, underscoring the importance of identifying and validating real-world advantages early.

Patient Relevance: Does the Therapy Improve Quality of Life in Meaningful Ways?

Even the most effective therapies can falter if they fail to resonate with patients. Regulatory approval is based on statistical significance, but patients make decisions based on tangible improvements in their daily lives. Does the therapy restore function? Reduce discomfort? Enable independence?

Patients do not interpret their health through abstract metrics. They assess progress through lived experience — walking without pain, returning to work, or enjoying time with family. If these dimensions are not addressed, adherence may be challenged, and outcomes can deteriorate.

Strategic Approach

To ensure relevance and engagement, clinical development must incorporate outcomes that align with patient priorities and reflect varying levels of health literacy. This involves: 

• Integrating meaningful patient-reported outcomes (PROs) into trials

• Designing endpoints around minimum clinically important differences (MCID)

• Translating efficacy data into patient-centered, emotionally resonant messaging

Communications, whether directed at patients, providers, or payers, must elevate what the data mean, not just what they show.

Case Study: Reframing Depression Data to Drive Engagement and Adherence

An antidepressant demonstrated statistically significant reductions in symptom severity. However, the data failed to resonate until reframed in a categorical manner. Instead, the data was presented as the percentage of patients who improved from severe to moderate depression, or from moderate to mild. This reframing provided a tangible narrative for patients, providers, and caregivers, improving both uptake and adherence.

Payer Alignment: Is There a Compelling Value Proposition for Coverage?

Payers face a difficult mandate to optimize population health while maintaining financial sustainability. To secure reimbursement, therapies must demonstrate that they can improve outcomes and reduce long-term costs. Too often, these evidence are generated post hoc, limiting payers’ ability to support the product at launch.

Preparing for the Realities of Access, Not Just Approval

Scientific rigor remains foundational, but it is no longer sufficient on its own. In an increasingly complex healthcare ecosystem traditional clinical development models, focused narrowly on regulatory approval, are being outpaced by access barriers, evolving stakeholder expectations, and real-world implementation challenges.

Commercial success now requires a broader, more integrated approach. Organizations that embed clinician, patient, and payer insights into early development will be better positioned to generate meaningful evidence, design relevant messaging, and accelerate adoption.

This is not about adding steps, it’s about redesigning the process to be fit for purpose in today’s landscape.

What the Most Successful Innovators Do Differently

• Start Early: Engage stakeholders as soon as proof-of-concept data are available

• Design Intentionally: Build trials and evidence packages that answer real-world questions

• Think Beyond the Molecule: Consider workflows, motivations, economics, and outcomes holistically

• Communicate Clearly: Translate evidence into value stories that resonate with real people

When biopharma companies take this broader view, they don’t just launch therapies; they improve access to life-changing therapies.