Why Drug–Device Strategy Is Now a Board-Level Priority

In today’s biotech environment, value creation is increasingly shaped by execution choices made early—often long before a program reaches late-stage clinical development.

One of the most consequential of those choices is how a company approaches drug–device strategy.

For injectable biologics, and many specialty medicines, the delivery system is not an accessory. It is part of the product. It shapes the patient experience, influences dosing accuracy and safety, affects commercial positioning, constrains or enables manufacturing, impacts regulatory risk, and ultimately, the credibility of the development plan. In practical terms, how a therapy is delivered is becoming as important as what the therapy does.

Yet in many organizations, drug and device decisions are still made sequentially rather than as an integrated system. That gap is showing up more often in diligence, in regulatory interactions, and in late-stage program resets. The patterns are familiar: reformulation driven by device constraints, device redesigns triggered by product properties, unanticipated human factors findings, and expanding regulatory scope. Each introduces cost, delay, and execution risk— often at the point when flexibility is lowest and stakes are highest.

This is why drug–device strategy is shifting from a technical consideration to a leadership and governance topic. Boards and executive teams are recognizing that combination product decisions materially affect enterprise value, not just development timelines.

The question for leadership is no longer whether drug–device integration matters. The real question is whether the organization has the operating model, decision frameworks, and technical depth to treat it as a first-order strategic capability.

Early Architecture Decisions Shape Enterprise Value

Most development teams understand the science of their molecule well. Far fewer fully appreciate how tightly formulation, process, primary container, and device choices lock in future options.

Once a program commits to a given concentration range, fill volume, or container format, entire classes of delivery systems may become infeasible. Likewise, once a device platform is selected, it can quietly impose constraints on formulation space, dose escalation, and lifecycle management.

These decisions influence whether a product can transition from syringe to autoinjector, whether high-dose indications remain feasible, how cost of goods and supply chain complexity evolve, and what usability profile the product ultimately carries.

From an enterprise perspective, they also shape partnering attractiveness and perceived execution risk.

Organizations with mature operating models treat these choices as architectural decisions, made deliberately, with cross-functional input, rather than as independent, sequential workstreams.

The Cost of Treating Device as “Later”

When device strategy is deferred, the pattern is predictable. A formulation that appears robust on paper struggles with injectability. A chosen device platform cannot handle future dose growth. Human factors risks surface late, after major commitments have been made. Regulatory bridging work expands in ways that were never anticipated in the original plan.

None of these problems are unsolvable. But solving them late is expensive, time-consuming and value-dilutive. They consume capital, erode timelines, and weaken the credibility of development and commercialization plans.

The better path is not to over-engineer prematurely. It is to deliberately co-design drug and device from the outset so the program preserves optionality.

Optionality is strategic capital.

Patient Experience Is a Commercial Variable

Investors increasingly evaluate products not only on clinical differentiation, but on real-world usability.

A therapy that is difficult to administer, uncomfortable, or prone to use error will struggle to achieve its potential—regardless of how compelling the efficacy data may be. Delivery experience has become a proxy for commercial readiness.

Early, deliberate attention to patient experience reduces commercial friction. It supports adherence and persistence, strengthens payer and provider confidence and lowers the risk that usability becomes a silent barrier to uptake.

This is not about adding bells and whistles. It is about ensuring the delivery experience aligns with the intended patient population and treatment setting.

Programs that get this right build trust with patients and with the market. Programs that do not often discover, late, that usability has become a commercial risk rather than a differentiator.

Integrated Strategy Lowers Regulatory and Execution Risk

Regulators view combination products as integrated systems. Programs that reflect this reality tend to move more smoothly through development.

From a leadership perspective, integrated drug–device strategy simplifies regulatory narratives, reduces late-stage comparability risk, produces cleaner design histories, and improves predictability of timelines.

Predictability matters to boards and investors as much as speed. It underpins confidence in guidance, credibility in capital planning, and trust in the organization’s ability to execute.

An integrated approach does not eliminate risk. It makes risk visible earlier, when it can still be managed deliberately rather than absorbed reactively.

What High-Performing Organizations Do Differently

Across successful programs, a consistent set of patterns emerges. Teams engage in early cross-functional architecture discussions rather than deferring integration decisions. Target product profile, product attributes, formulation design space, and delivery approach are explicitly linked, so trade-offs are visible and intentional. Injectability and delivery feasibility are assessed quantitatively, not assumed. And leadership defines a forward-looking view of how delivery may need to evolve over the product lifecycle as indications expand, doses change, or patient populations broaden.

These are not massive undertakings. They are disciplined, senior-level conversations conducted early to shape outcomes rather than react to them.

A Leadership Lens on Drug–Device Strategy

For CEOs and boards, the key question is not “Which device should we use?”

It is:

“Does our product architecture preserve value, optionality, and credibility as the program evolves?”

When that answer is clear, the organization is positioned to navigate technical uncertainty with confidence. When it is not, the organization is almost certainly carrying more risk than it recognizes.

Bottom Line

Drug–device strategy is no longer a technical footnote. It is a value driver.

Companies that treat the therapy and its delivery as a unified system build more resilient programs, withstand diligence scrutiny, and retain more strategic flexibility.

In an environment where capital is selective and timelines are unforgiving, that discipline increasingly separates programs that advance from those that stall.