Grounding Your Investment in a Foundational Needs Assessment

We sat down with leaders from top life sciences companies to discuss foundational needs assessments – how to do them, what can go wrong when you don’t, and why every investment decision should start with the question, ‘what is the need’?

Those we spoke with agree that Human-Centered Design (HCD) has radically changed how life sciences companies approach product development, particularly over the past 5-10 years. Today, there are in-house innovation groups, creatives in the C-suite, and sufficient track records for organizations to trace their HCD initiatives to bottom-line commercial success. The conversation is no longer about whether human-centered design can drive value, but the nuances of how to tether your product development pathway to a human-centered framework. Never is this more critical than right at the very start.  

“Because we’ve had success with how much more impact we can have applying human-centered design tools to our R&D efforts, I think personally I’ve seen a real shift throughout the business.” 

– Head of Engineering Sciences, Johnson & Johnson

Successful growth starts with user needs

Whether referred to as needs assessments, Jobs to Be Done, ethnography, or voice of customer, the core principle remains the same – grounding in a deep and holistic understanding of end users. As simple as that sounds, it can be particularly difficult for organizations whose legacies are built on applying science and technology to improve clinical outcomes and whose org charts are often arranged around solutions. But for innovation that moves the needle, life sciences companies are increasingly challenged to deliver value beyond the drug or device – by making meaningful, positive impact on the patient journey, disease pathway, or clinical workflow.

“If we don’t deliver value to the patients and caregivers, there’s nothing there. So, it’s not just about standard disease measures. It’s about delivering value to the patients.” 

– Sr. Marketing Manager, Medtronic

This is virtually impossible to do without a robust and empathetic understanding of end users. It requires digging deeper than the brief moments of direct user interaction with a solution – looking instead at the big picture surrounding the entire supporting cast, the landscape around them, the journeys that bring them there. What else is happening? What’s home life like? What’s going on environmentally, socially, financially? It can feel unfocused and overwhelming, but these are precisely the types of questions that begin to lay groundwork for successful investments.

“Too often in healthcare, it’s about an individual asset – whereas the foundational research means going beyond that. It’s not about your individual product – it’s about understanding your customer. I want to get to know that person day in and day out, what is working well for them, what are the challenges they’re facing.”

– Executive Director, Sage Therapeutics

To build a strong house, start with a solid foundation

When teams forego or skimp on this foundational understanding of users, assumptions and niche insights will fill the gaps. Blinders due to internal expertise or enthusiasm for an owned asset are perfectly natural, but can cause errors of omission or solve for ancillary rather than root problems. Even when end users are well-understood, success can hinge on how effectively teams translate those insights into prioritized, traceable needs and assets to inform downstream stakeholders along a PD path that can be several years-long. Simply put, without a strong foundational needs assessment, programs face missed opportunities, fraught decision-making, lackluster commercial uptake, and even failure.

“We’ve cancelled programs where we’ve been millions of dollars in, and it became clear that the perceived need was not nearly what we understood it to be, and we’d made a misguided judgment based on foundational assumptions.” 

– VP Procedure Innovations, Medtronic

When a program is built on a foundational needs assessment, PD teams at every milestone can benefit from greater clarity and confidence to support investment decisions. What’s more, foundational user research has a durability that extends beyond a singular product pathway. It can serve as a knowledge resource for the entire organization to be referenced in future and adjacent work. Pete Madson, VP of Research and Strategy at Worrell suggests: “You always have to come back to that need. Over and over, it’s going to help you make decisions in the product development process. Otherwise it’s tempting to say ‘I like this idea’, or ‘this would be easier to do from an engineering standpoint.’ By looking back at the need, you can answer if it addresses it or not."

Steps in a Foundational Needs Assessment

Needs Finding

When it comes to understanding users, ethnography is the best-in-class method. Based in anthropology, ethnography relies heavily on observation and in-depth interviews to cultivate empathy and uncover the “why” behind behaviors. Because its focus is deep, only a small sample is needed to reveal patterns of insight; 6-8 respondents per user group. Ethnography is ideally done in-person, but well-designed digital and remote tools can be effective proxies when appropriate.

“I think understanding ‘today’ is the first step. You do that by going and observing it, talking to people – but people don’t always tell you their problems. You have to deeply immerse yourself, watch them and identify where they can’t do something or it’s not as efficient or effective – those points along the journey we would like to change.” 

– Head of Engineering Sciences, Johnson & Johnson

Needs Statements

We drive efficiency and reliability into a complex process by designing research materials with future synthesis in mind. Structuring ethnographic interviews and observation around journey maps, clinical workflows, or disease pathways helps reveal patterns, while tools like affinity mapping group related insights into manageable themes. From there, insights are translated into needs statements according to a structured framework to ensure each need is plainly stated, singular, and devoid of a solution. Worrell most often follows the framework outlined by the Stanford Byers Center for Biodesign as follows:

“We’ve used journey mapping almost like puzzle pieces, working in real time with Worrell and physician partners to map out a multitude of scenarios, understand the differences between and across settings, what other factors might affect the workflow, etc. I’ve got a patent on my desk that came from one of those sessions.”

– VP Procedure Innovations, Medtronic

Needs Validation

As a follow-on to an ethnographic study, surveys offer an efficient way to hear from a larger sample, increasing confidence that the identified needs are accurate and comprehensive. They also support tools like MaxDiff and the ISP Framework (Importance, Satisfaction, Prevalence), which provide quantified rationale for needs prioritization. This is critical for investment decision-making, because not every user need, however salient, will have the same resonance with the company’s mission, core competencies, technical constraints, and commercial opportunities. Selecting the right needs to solve for and setting the others aside is often half the battle.

“When clients see these unmet needs come out of an ethnographic study, they might say ‘Great, what was the sample?’ When we say 6 or 8, some people doubt that. But when you say, ‘We ran these needs by 200 users in an online survey and here’s how they’re prioritized’ – that carries way more weight.” 

– Pete Madson, VP of Research and Strategy, Worrell


A common challenge faced by life sciences companies is the long road to commercialization. Regardless of changes within the team or the business itself, the foundational needs assessment must remain accessible, legible, and meaningful to downstream stakeholders. Even years on, summary reports and explanatory visuals should inspire user empathy and understanding. Validated and prioritized needs statements should support informed tradeoff decisions. Raw data should provide traceability and confidence for all assertions made. Kai Worrell, Ceo at Worrell offers: “Memorializing what you’ve learned in a way that’s transferrable is a key value proposition from working with a team that knows how to design a study as well as how to document it in a way that’s useful. Video, simulations, recorded conversations, high-fidelity task flow visualizations – those are things that can be transmitted across large teams downstream to people that make PD decisions.”

Addressing barriers to success

Breaking down the steps in a foundational needs assessment can help demystify the process but also highlight opportunities where real world constraints around time, budget, or expertise can be directly addressed. Flexible tools that leverage the best of ethnography and the HCD toolkit, remote adaptations and powered-up surveys are just some of the ways you can drive efficiency into the process without sacrificing core objectives.

Partnering with an outside expert to shepherd the process can disperse the workload, reduce internal bias, and elicit more candid feedback from users. External perspectives will also bring new­­ ways of observing, asking questions, and cross-pollinating ideas to the internal team. When the partner is also a design firm, human-centered principles are reflected in every step – from the design of the tools to the richness of the output. Most importantly, they will anchor the work in its most steadfast objective: always come back to the question, “what is the need?”

“Partnering on the unmet needs with teams who understand design can be helpful because while we don’t want a tech push early on, it can help carry the needs forward. The design mindset is looking not just at a widget, but really looking at how a human interacts with their environment, and that’s really important.” 

– Head of Engineering Sciences, Johnson & Johnson