Combination Product Industry News & Guidance

Elevating Combination Product Success: Applying User Needs with Precision and Purpose

Part 2: Creating a Solution Space that Delivers

Now that we have prioritized user needs and we know how our customers will measure our success, we can leave the problem space and start talking about the solution space. The objective here is to generate an optimized solution, one that delivers the most value through meeting the user needs given the constraints of the project. Below, we will outline important considerations as you go through the process of solution optimization.

Don’t Mistake Speed for Progress

Fast prototyping can be seductive. But rapid iteration only works when it’s grounded in a well-defined problem space. If you haven’t validated the problem, building early solutions is a waste of time. The goal isn’t to move quickly—it’s to move purposefully.

In combination product development, misaligned assumptions cost years, not just months. It leads to rework, missed requirements, and increased risk—especially in regulated environments. Regulatory constraints, patient safety concerns, and clinical outcomes are not flexible. Neither is the time you’ll lose rebuilding once a project fails.

Give Space for Creativity—Within a Structure

Once you’ve prioritized needs, your team should:

• Brainstorm multiple options per need
• Identify measurable success criteria for each concept
• Explore trade-offs across features, cost, complexity, and risk

Don’t limit the conversation to “What can we build?” Instead, ask “What should we build?” and “What will have the most impact?”

Good design is iterative. Encourage bouncing between needs and features, which means allowing yourself to take a step back to adjust existing user needs and product design based on downstream discoveries. A great feature might lead you to discover an overlooked need—or a constraint for which you hadn’t accounted. Combination product development benefits from agile thinking and space to pivot.

Use a Formulaic Process to Assess Feature Fit

Each potential feature should be assessed on two axes:

• Value Delivered: How well does it meet top-priority user needs?
• Cost/Complexity: What does it add in terms of development time, risk, and regulatory scrutiny?

This lets you rank features in a way that balances patient benefit with business feasibility. Then, the question becomes “Will the feature introduce regulatory, technical, usability, or business concerns?” Use risk assessments, usability evaluation, engineering review, and team consensus to determine which ideas make the cut.

Build Multiple Concepts, Then Select Judiciously

With a robust list of features, build several conceptual designs that explore trade-off combinations and iterate to identify your best Gen 1 product.

As you evaluate concepts, consider:

• Which unmet needs are solved in each concept?
• Which concept satisfies the highest priority needs of our customer?
• What is the total risk burden?
• Will this concept differentiate us from the competition?
• Which aligns best with business and launch goals?
• What features can we save for our long-term development roadmap?

With cross-stakeholder alignment on the answers to these questions, your Gen 1 product concept will rise to the surface.

Plan Now for Lifecycle Development

Most combination product programs fail to build a pipeline mindset. But device and system development—unlike traditional drug programs—benefit from iterative enhancement.

This approach helps ensure you don’t over-engineer a Gen 1 product but still plan for evolution. Remember, your product concept is not a one-and-done solution. Think of it as the first in a pipeline of user-driven innovations. We can’t meet every possible user need all every time we make a product. We likely will only meet a subset of them, which go into our Design History File (DHF). For the rest, we maintain a library of needs that we didn’t meet to potentially revisit in post-market lifecycle review or next Gen product.

Gen 1 may focus on must-have capabilities. But Gen 2, 3, and beyond can:

• Improve usability
• Add digital features
• Expand to new segments or regions
• Reduce cost or complexity

Capture and catalog unmet needs throughout development. What you can’t address now may become your competitive edge later.

Conclusion: Let Patient Needs Drive Product Decisions

At every stage from strategy to design to launch, your guiding principle should be: are we solving for what matters most to the patient or user?

Cultural change is hard. Especially when internal stakeholders expect their goals to take precedence. But when trade-offs arise, if your team is serious about delivering a winning product, the highest priority must be the end-user.

User needs should be the benchmark by which product design decisions are made, anchoring your design priorities, your team alignment, and your long-term success. That’s how you build a product that drives outcomes for patients and for your business.

AUTHOR

Andrew Ozga, Principal Consultant, Suttons Creek –Andrew has been a Systems Engineer in the pharmaceutical industry for over 5 years. Throughout his career, he has developed well-rounded experience with systems engineering (ISO 15288), design controls (ISO 13485, 21 CFR 820.30), and risk management (ISO 14971). Andrew has leveraged his experience to drive the design and development of numerous drug-device combination products, including auto-injectors, injector pens, and enhanced prefilled syringes. Andrew is passionate about developing products that satisfy the needs of all stakeholders, including the patient, healthcare providers, business, and regulators.

Konrad Walzer, Director Technical Services, Suttons Creek – Konrad is an Engineering, Operations, Platform Management and Business Development specialist with more than 30 years of experience in Medical Devices, Sterile Injectables, Combination Products and Consumer industries. He has led successful programs in a wide range of applications, including complex infusion pump electromechanical systems, sterile injectables, and combination products. Konrad draws on these experiences to provide the leadership needed to deliver technical and business solutions.