Developing an internal business case for a Combination Product

When Pharma and Biotech leaders begin considering a delivery device for their therapeutic, one of the first challenges is not just deciding what device strategy makes sense—but justifying that decision to boards, investors, or other decision-makers who control funding. The natural question we hear from project leads considering a delivery device for the first time: is there a standard template or a set of best practices for building a convincing business case?

The short answer is that while no single template works for every company, there are best practices and common elements that strengthen a business case for combination product development. These can be tailored depending on whether your leadership team is already aligned on pursuing a delivery system, or if they still need to be convinced of its value.

Start with the strategic context

Before jumping to cost estimates, ground your business case in the clinical and commercial realities of your therapeutic area:

• Competitive landscape: What delivery formats (vials, prefilled syringes, auto-injectors, on-body systems, IV infusions) are already available in the market or in development at competitors?
• Standard of care: What are patients and healthcare providers accustomed to today? Will your therapy need to align with or stand out from existing norms?
• Patient experience: Are patients injection-naïve? Do they value convenience and independence, or do they prefer in-clinic care and support?

This strategic framing signals to decision-makers that the device strategy is not arbitrary but built on real-world market expectations.

Build clinical and commercial flexibility into the case

At Phase 2, some parameters, like dose regimen, volume, frequency, and formulation, may still be adaptable. Your business case should demonstrate how device strategy could evolve with these variables. For example, if higher concentration formulation allows a shift from IV infusion to subcutaneous injection, that has profound implications for patient adoption, market competitiveness, and revenue forecasts.

Incorporate Expert and External Perspectives

Not every startup has internal resources with combination product expertise, but external advisors, health economics teams, and key opinion leaders can provide valuable input:

• Real world market research to build your strategic context
• Technical feasibility and device development pathways
• Health economics modeling to estimate the market and reimbursement impact of a chosen delivery route
• Advisory boards and KOL input to validate assumptions about patient and HCP preferences

These perspectives add credibility and mitigate the risk of blind spots in your proposal.

Include links to BRLS partners that can help, and links to SC service page (Epid, Modality,…)

Present a Transparent Cost Model

Combination product programs cost more than drug-only programs, and underestimating these expenses is one of the most common mistakes. A compelling business case should include:

• Device development costs: Fees to suppliers, purchase of development units, and manufacturing setup.
• Testing and regulatory costs: Human factors testing (formative and summative), device-focused stability and performance studies, regulatory submission authoring, and global filings.
• Clinical costs: Bridging or home-use studies, even if smaller than pivotal Phase 3 trials, can significantly add to budgets.
• Contingency allowances: Iterations in device design are common; your model should show buffer for rework rather than assuming a straight-line path.

Decision-makers often gravitate to the most visible line items (development fees and unit costs from suppliers) but a robust case highlights the hidden costs that can easily double early assumptions if not accounted for.

Show Options and Trade-Offs

A strong business case does not assume a single path. Instead, it frames choices and their implications:

• Stay in vials or syringes vs. move to auto-injectors
• Pursue a single device vs. multiple presentations (e.g., both infusion and self-injection to serve diverse patient preferences)
• Custom vs. platform device
• Outsource vs. build internal device development teams

By presenting options, along with their financial and strategic trade-offs, you enable leadership to make informed decisions rather than simply approving a budget.

Tie to Long-Term Value Creation

Finally, the business case must connect device strategy to outcomes that matter most to stakeholders:

• Market differentiation and competitiveness
• Patient adherence and satisfaction
• Reimbursement opportunities through proven patient benefit
• Potential for partnerships, acquisition, or investment

A device program should not be positioned as a “cost of doing business,” but rather as an enabler of commercial success, competitive advantage, and long-term growth.

Key Takeaway:

There is no universal template for combination product business cases, but the strongest ones integrate clinical context, patient and provider needs, external expertise, and realistic financial planning. By doing so, startup leaders can move beyond “should we do this?” and instead answer “what is the most strategic and financially sound way to do this?”

For access to multiple Business Case Hypothetical Examples based on the above template and recommendations, complete the below form.

AUTHOR

Jonathan Amaya-Hodges, Director of Consulting, Suttons Creek – Jonathan has over 16 years of multidisciplinary experience in regulated medical products (drugs, biologics, medical devices, and combination products) at multiple global companies. He has practical experience in Development/Engineering, Quality Assurance, and Regulatory Affairs for various types of combination products with a focus on drug delivery. Additional background includes digital health (including smart packaging/connected devices and software as a medical device, or SaMD) and in vitro diagnostics, along with clinical development (bridging) and lifecycle management for combination products. Jonathan engages with the global combination product community by speaking at conferences, lecturing in courses, serving key roles within prominent industry organizations, and interfacing with regulators on a variety of topics.