Combination Product Industry News & Guidance

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

Part 1: Mastering the Problem Space

To unlock stronger outcomes for your patients and better results for your business, you must focus on the needs of your users early and often. In pharmaceutical development, particularly when creating combination products like drug delivery systems, success depends on your ability to deliver meaningful value to real-world users across a complex healthcare ecosystem.

Yet all too often, companies jump into design and development with only partial alignment (or worse, unvalidated assumptions) about what those users actually need. The result? Inefficient systems, unmet user expectations, rework, delayed launches, and lost market share.

This article offers a practical approach for applying user needs throughout the development lifecycle. Whether you’re leading cross-functional strategy or managing on-the-ground execution, your ability to define, prioritize, and solve the right problems will be the difference between a market success and a missed opportunity.

Start by Defining the Right Problem

The “problem” in drug delivery system development is rarely singular or obvious. It’s shaped by multiple stakeholders, including patients, providers, payers, regulators, operations, nurses, technicians, and internal business leadership. Each group may define success differently, and each perspective must be considered, clarified, and appropriately weighted.

Start by defining the problem space with a structured, user-centered lens. That means identifying:

• What are the intended uses?
• Who are the core users?
• What are they trying to accomplish?
• What makes their experience painful, inefficient, or risky?
• What’s getting in their way?
• How do they define success?
• Are the challenges they face technical, emotional, procedural, or environmental?

Importantly, don’t confuse internal business goals with true user needs. Prioritize:

• Usability factors that reduce cognitive burden or improve adherence
• Constraints that real users face (e.g., mobility, dexterity, training, context of use)
• Outcomes that matter to patients and clinicians—not just KPIs for internal review

Avoid letting marketing timelines or executive incentives override core design decisions. Business considerations should be addressed but should not drive product requirements.

Example 1: The urgency of getting the product onto the market to meet patient needs should be prioritized, but the urgency of getting the product onto the market to meet financial goals set by the Executive Suite should not.

Example 2: Limited packaging real estate should be prioritized for content that enhances safety and effectiveness rather than content for marketing or branding.

Use Business Drivers Strategically, Not Prescriptively

Business goals matter, but they belong in your business strategy, not your product requirements. Define how business success will be measured (e.g., market share, revenue growth, time-to-launch), but keep that lens separate from the product’s design intent. When internal business needs are treated as design drivers, teams risk developing solutions that hit benchmarks but miss the mark for patients and, consequently, market share.

Instead, align business goals with downstream business strategies and post-launch planning. Let your problem space and solution space be guided by user needs. Then, measure how well your product strategy delivers against business expectations.

This distinction reduces design noise and increases clarity:

• The Problem Space = What users need
• The Solution Space = How the product meets user needs
• The Strategy Space = How you deliver and measure success

Keeping these lanes separate will help your teams prioritize effectively and stay aligned. A cultural shift at the C-Suite level may be needed to make this happen. While business goals are generally concerned with the triple bottom line of social responsibility, financial responsibility, and environmental responsibility, a lot of U.S. companies are focused merely on revenue. Did you increase profit? Is there incremental revenue over last year? Within this revenue-focused culture, it is very easy to confuse design priorities.

Align Stakeholders and Translate Goals into Shared Language

It’s common for different departments to express goals in different formats—sometimes even in competing ways. Marketing, quality, regulatory, engineering, and commercial all express priorities differently, using different language, timeframes, and levels of abstraction. To get true cross-functional alignment:

• Translate all inputs into a shared syntax and measurable terms
• Establish a common hierarchy (strategic goals > sub-goals > KPIs)
• Facilitate early workshops or working sessions to level expectations
• Identify and resolve conflicts across functions before entering the design stage

One useful format to use across stakeholders is to provide the following for each provided input:

[Direction] + [Unit of Measure] + from [today’s level] + to [goal level] + by [end/goal date]

Without a shared understanding of what each team means by “success” and how these successes should be prioritized as a unified team, product design can suffer from fragmentation or misaligned trade-offs. Establishing clarity up front and transparent communication systems in daily change management and decision-making helps avoid costly course corrections later.

You will need to make sure these curated goals are aligned with the overall product strategy, initiating cross-departmental discussion (and ultimate removal or reconfiguration) regarding any goals identified as outside of strategy.  Even after strategy alignment, you will potentially realize conflicts between valid goals that must again be addressed cross-divisionally to prioritize, remove or configure as necessary. Many business stakeholders look at their goals as marching orders for the organization, but with so many contributing stakeholders and so many moving parts, there are inevitably trade-offs that must be made.

Transparency and effective communication are your best friends in these situations. And, ultimately, with the right clarity of goals and proper prioritization based on patient value (always going back to the Problem Space), trade-offs will result in the best product.

Segment With Precision—Not Assumption

Too often, companies define their market as a broad disease state. But saying “people with diabetes” ignores wide variation in patient behavior, use environment, and ability.

Effective segmentation requires:

• Understanding who actually uses the product (not always the patient!)
• Breaking down use cases by circumstance, channel, access, and value to business
• Validating segment size and viability against your financial model

There are many consumer segmentation methods that can help you define your core market segment:

Once your target market is clear, it is time to focus on the individuals inside that segment whose needs must be satisfied. You will need to figure out exactly who you are asking to be happy with your products in order for them to sell.

There are various tools such as:

• Purchase Process Mapping – outline of behavioral trends a consumer segment displays when they’ve decided to purchase your product.
• Information Flow and Processing Mapping – visualization of how information about your product gets communicated to your consumer segment, as well as that consumer segment’s cognitive steps in processing information about your product.
• Cash Flow Mapping – picturing the flow of money related to the purchase of your product, from the consumer’s perspective, across different stages of their buyer journey.
• Distribution Mapping – mapping of how your product is distributed within a market to identify gaps, opportunities and areas for improvement; often pictured side by side with competitor distribution mapping for a fuller market picture.

These frameworks help pinpoint not only whom you’re designing for, but who holds influence or control over purchase, reimbursement, or ongoing use.

Example Mapping Task: Purchase Process

Identify Key Purchase Influencers – the individuals that help a patient (the end-user) select your product.

1. Physician: Assesses the patient and prescribes a drug product
2. Nurse: Teaches the patient (or caregiver) how to deliver the drug / use the device
3. Technicians: Services the device
4. Payor: Approves insurance coverage
5. Pharmacy: Accesses/prepares the drug product
6. Patient (or caregiver): pays copayment or full price
7. Patient (or caregiver): acquires drug product from pharmacy
8. Peers: Providing the consumer with their own personal experience/knowledge using the drug product

Example Mapping Task: Information Flow

Identify each participant in the process of communicating your product information and purchasing process to the consumer.

1. Marketing Avenues: Touchpoints with your corporate drug product messaging that are likely to reach the consumer segment (as well as your competitor’s messaging)
2. Physician: Assesses the patient and prescribes a drug product, describing it to the best of their ability
3. Nurse: Teaches the patient (or caregiver) how to deliver the drug / use the device
4. Receptionist: Collects insurance information
5. Technicians: Services the device
6. Payor: Provides consumer with amount of out-of-pocket payment
7. Pharmacy: Answers patient or caregiver questions about the drug product
8. Customer Support: Your support/information/training materials, online information, phone/email/text support
9. Peers: Providing the consumer with their own personal experience/knowledge using the drug product

With these two examples in mind, you see that there’s a physician, a nurse, a technician, a payor, the pharmacy, peers, receptionists, customer support, marketing touchpoints…and a patient. Can we be successful by only addressing the needs of our patients, the end-user? In the case of a multi-participant purchase process, to maximize sales efforts and opportunity you have to keep the entire chain in mind while prioritizing on the most valuable participants.

Uncover the Real Jobs to Be Done

The foundation of strong combination product design – in addition to the ethnographic research done in your customer segment research phase – is clarity on what your users are actually trying to accomplish with your product. Though, it’s rarely about the product itself.

When defining the Problem Space, instead of focusing on features, study the job that the user is trying to do. One helpful tool in discovering the real job to be done is task mapping, or customer journey mapping. In addition to mapping your customer’s actions at each stage of product use, look for:

• Pain points (physical, emotional, logistical)
• Moments of friction or delay
• The customer’s thoughts and emotions around the experience and at each step
• Unmet or unspoken needs that are opportunities for improvement
• Interactions the customer has with your company, beyond the drug delivery system (website, social media, IFUs, customer service, etc.)

Customers don’t always want new features, and many would not be able to describe what a better or new feature should look like. Focusing on potential improvement opportunities in their drug delivery experience and gauging customer reaction to the possibilities, rather than suggested new features, is a more productive route to your solution space.

Often, customers want existing tasks to be faster, easier, more intuitive, or less stressful. Take, for example, a prefilled syringe. A patient isn’t just trying to inject a drug; they may be trying to regain control of their schedule, manage anxiety around self-injection, or avoid interrupting a family meal. These functional and emotional drivers shape what makes a solution “good enough,” what could make it better, where you can differentiate, and when adding or improving features will not reap rewards.

Collect, Clarify, and Prioritize User Needs

Once needs are collected—through qualitative research, contextual inquiry, observational data, and more—they must be processed to:

• Remove duplication and resolve contradictions
• Translate into customer language, not internal jargon and expert vernacular
• Cluster using affinity and hierarchy diagramming
• Trace to product requirements

If we have a list of user needs that we’ve gathered and can’t use them all, we need to prioritize them. If we have to make choices or trade-offs, it matters to us which ones are more significant. You will want to prioritize them by the importance of the outcomes that the customer is trying to achieve. Some prioritization tools include:

• Hierarchy diagramming – a pyramid of needs with basic functional needs at the base, working its way up to higher-level needs like delight
• Affinity diagramming – the grouping of similar needs for the sake of understanding needs and identifying patterns and importance.
• MaxDiff (Maximum Difference Scaling) – determining relative importance of different user needs by presenting interview subjects with sets of user needs and asking them to identify the most and least important of the set. Repeated questioning of various pairs of user needs results in a prioritization of user preferences.
• Analytic Hierarchy Process (AHP) – taking an approach similar to MaxDiff and also quantifying user needs using mathematical calculations to determine the weights of each criterion/user needs.

What emerges is a focused, structured map of validated and prioritized user needs that can confidently drive your design process.

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.